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NABL 113

NABL

NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES

SPECIFIC GUIDELINES
for

ACCREDITATION OF FORENSIC SCIENCE LABORATORIES


AND CHECKLIST FOR ASSESSORS

ISSUE NO : 02 ISSUE DATE: 28.03.2008

AMENDMENT NO : 00 AMENDMENT DATE: --

AMENDMENT SHEET
Sl no
1

Page No.

Clause No.

Date of Amendment

Amendment made

Reasons

Signature QM

Signature Director

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National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 113 Issue No: 02 Specific Guidelines for Accreditation of Forensic Science Laboratories and Checklist for Assessors Issue Date: 28.03.2008 Amend No: 00 Amend Date: -Page No: i

Contents
S.No. SECTION PAGE NO.

Section I 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21

Guidelines for Forensic Science Laboratory Assessment Introduction Scope of Accreditation Quality Policy Statement Organization and Management Quality Management System Records Personnel Training and Development Evidence Management Methods and Procedures Quality Assurance Proficiency Testing Case Record Review Court Testimony Monitoring Corrective and Preventive Actions Instruments and Equipment Calibration Reports Procurement of Services and Supplies Accommodation and Safety Subcontracting of Technical Work

1 39 1 2 3 4 8 10 12 17 19 20 24 25 27 28 29 31 32 33 35 36 41 42 56

Section II Checklist for Forensic Science Laboratory Assessment

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 113 Issue No: 02 Specific Guidelines for Accreditation of Forensic Science Laboratories and Checklist for Assessors Issue Date: 28.03.2008 Amend No: 00 Amend Date: -Page No: ii

Section I GUIDELINES FOR FORENSIC SCIENCE LABORATORY ASSESSMENT

Introduction

Laboratory Accreditation activities are administered under the direction of the Board for National Accreditation Board for Testing and Calibration Laboratories (NABL), by involving Technical Committees and Evaluation Panels as the recommending bodies. NABL system is based on the ISO/ IEC 17011 for Accreditation Bodies, ISO/ IEC 17025:2005 General Requirements for the Competence of Testing and Calibration Laboratories for laboratories. The work in Forensic Science Laboratories being interdisciplinary in nature, there is a need to develop and supplement the General Criteria for Laboratory Accreditation for the purpose of accrediting Forensic Science Laboratories. The document Specific Criteria for Accreditation

of Forensic Science Laboratories has been evolved by a Technical Committee specifically constituted for the purpose. It supplements the document ISO/ IEC 17025:2005 General Requirements for the Competence of Testing and Calibration Laboratories and provides specific guidance on the accreditation of Forensic Science Laboratories for assessors as well as the laboratories who are preparing for accreditation. This Specific Criteria is in compliance with ISO/ IEC 17025:2005. NABL has adopted the following four objectives which define the purpose and nature of the programme. To improve the quality of laboratory services provided to criminal justice system. To develop and maintain criteria which can be used by a laboratory to assess its level of performance and to strengthen its operations. To provide an independent, impartial and objective system by which laboratories can be benefited through a total operational review. To offer to the general public and users of the laboratory services a means of identifying those laboratories which have demonstrated that they meet established standards. The information contained in this document must be read alongwith the document ISO/ IEC 17025:2005.

National Accreditation Board for Testing and Calibration Laboratories


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Scope of Accreditation

Forensic Science refers to examination of crime scene, recovery of evidence, laboratory examination, interpretation of findings and presentation of the conclusions reached for investigation and intelligence purpose. This field involves examination of wide range of tems and substances.

The scope of accreditation of NABL is applicable to the following disciplines/areas of activity in the Forensic Science Laboratories. 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. Chemistry Toxicology Biology Serology Explosives Physics Ballistics Questioned Documents DNA Finger Printing Forensic Psychology Fingerprints Narcotics Forensic Electronic Investigation Crime Scene Investigation

Accreditation in additional disciplines may be offered in future as per requirement.

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Quality Policy Statement

The laboratory shall identify the policies and objectives to be achieved by implementing the management system as per the requirements of ISO / IEC 17025:2005. The objectives shall be set out in a quality policy statement, issued under the authority of the Director or Chief of the Laboratory.

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4
4.1

Organization and Management


General

The forensic science laboratories, or the organization, of which it is a part, shall be legally identifiable. Where the forensic science laboratory is part of a parent organization, the position of the forensic science laboratory in the overall organizational structure must be documented, for example, by use of organizational charts. The forensic science laboratories shall be organized and be operated in such a way that it meets the accreditation requirements, while performing work in its permanent, temporary or mobile facilities (including field operations and regional laboratories). The laboratory shall clearly define and document the type and extent of the forensic science services it provides. Management must ensure that: a. the laboratory will not engage in any activities that might diminish trust in its competence, impartiality, judgement or operational integrity, and b. the laboratory personnel are free from commercial, financial or any other pressure that might adversely affect the quality of their work.

4.2

Organizational Structure

Taking into account the interrelations of various forensic disciplines the organizational structure must group the work and personnel in a manner that ensures efficiency of operation. The laboratory Director must consider and take appropriate action to correct any discrepancies with regard to numbers of personnel when grouping work and resources. The laboratory shall normally use only those personnel who are solely employed or under contract in the laboratory. When other personnel are used, the laboratory shall ensure that all the applicable accreditation criteria are met with in respect to such personnel. The laboratory must define and document, in the form of job descriptions and organizational charts, the responsibility, authority and interrelation of all personnel who manage or perform work affecting the quality of the forensic science services. The laboratory must have technical management structure which has overall responsibility for the technical operations and the provision of the resources needed to ensure the required quality of laboratory operations. The technical management shall also be responsible for ensuring that the accreditation requirements are met.

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A member of the laboratory's managerial staff shall be appointed as the Quality Manager (howsoever named) who, irrespective of other responsibilities, shall have defined authority for ensuring that the quality system is established, implemented and maintained, and for reporting on the performance of the quality system to the management for review, and as a basis for improvement of the quality system. The Quality Manager should have training in quality assurance concepts and techniques and ideally should have organizational autonomy from the technical operations. Where the forensic science laboratory is part of a parent organization, it may not be necessary for the laboratory to appoint its own Quality Manager. In such cases, however, a member of the laboratory's staff must be designated as being responsible for coordinating the maintenance of the quality management system in the laboratory. The Quality Manager shall have a direct access to the highest level of the management at which the decisions are taken for the laboratory on policy and resources. The scope of the responsibilities and the authority must clearly be articulated and should include the following: maintenance of the laboratory's Quality Manual, monitoring of laboratory practices to verify continuing compliance with policies and procedures, evaluation of instrument calibration and maintenance of records, periodic assessment of the adequacy of report review activities, ensuring the validation of new technical procedures, investigation of technical problems, proposal of remedial actions and verification of their implementation, administration of proficiency testing and evaluation of results, selection, training and evaluation of internal auditors, scheduling and coordination of quality system audits, maintenance of training records of laboratory personnel, training recommendations to improve the quality of laboratory staff, proposal of corrections and improvements to the quality system.

Wherever possible, deputies must be appointed for key personnel. This must include the laboratory Director, Quality Manager and Reporting Officers.

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4.3

Delegation of Authority

The laboratory Director's authority must be well defined. The laboratory Director must have authority commensurate with his/her responsibilities. There must be sufficient delegation of authority to managerial/supervisory staff, commensurate with their responsibilities. Each

subordinate must be accountable to only one immediate supervisor per function. Performance expectations must be well established and fully understood by the laboratory personnel. In every organization, someone must be assigned the responsibility for the efficient and effective performance of specific functions. It is important that the persons assigned such responsibilities also be delegated with appropriate and well defined authority to act or direct the actions of others. Effective organization is precluded unless the Director has the authority to accomplish the mission of the laboratory. As managerial responsibilities increase in scope and complexity, delegation of authority down the organization becomes necessary. A laboratory must have a structure that ensures maximum use of the knowledge and capabilities of its staff. Authority delegated to the lowest possible level serves to achieve this goal. It is important, however, that all staff clearly understand what is expected of them.

4.4

Supervision

There must be constructive discussion between supervisors and subordinates. Supervisors must carefully and objectively review the laboratory activities, methods and personnel. Clearly documented and well understood procedures should exist for personnel evaluations. Supervisory techniques must encourage creative thinking and recognize meritorious performance.

4.5

Communication

Clear vertical, horizontal and diagonal channels of communications must exist within and outside the laboratory. Vertical channels of communication should normally be used for

administrative functions. Documented procedures should exist for the following: a. b. c. duty hours, leave time, employees' grievances

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Staff meetings must be conducted on a routine basis. Good communication is essential for effective operation. Channels of communication within the laboratory should exist for coordination of case work and to ensure wide dissemination of technical information. All lines of communication, vertical, horizontal and diagonal, should be present and open in the organization. The most important tool for maintaining open communication with laboratory personnel is routine staff meetings.

4.6

Administrative Practices

A formal written budget must exist for the laboratory. The budget must be adequate to meet the laboratory's objectives. For example, if the objectives (quality policy statement) describe a full service laboratory providing timely results, but there is insufficient funding for staff or essential equipment in one or more of the service areas or if inadequate staffing has resulted in large back logs and lengthy turn-around time, the budget cannot be considered as adequate to meet the objectives. The laboratory must have a management information system which provides information to assist it in accomplishing its objectives. Reporting officers must have access to all such

information upon which the decisions can be based. Some of the information is most easily developed by, and derived from, a management information system. A management

information system is a system for the collection, manipulation, storage and retrieval of information (e.g. productivity, budget tracking) to assist laboratory management to determine how effectively and efficiently the laboratory is operating and to develop resource requirements to meet the laboratory's short and long term goals and objectives. Prior to undertaking new contracts or commencing new forensic services, the laboratory must ensure that: a. the client's requirements, including the methods, are adequately defined, documented and understood; and b. it has the capability (i.e. physical, intellectual and technical ability and personnel with appropriate skills and expertise) and resources to meet the client's requirements. Records of such reviews must be maintained.

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5
5.1

Quality Management System


General

The forensic science laboratory shall establish, implement and maintain an effective quality management system appropriate to the type, range and volume of forensic science activities it undertakes. The quality system shall include policies and procedures addressing all the criteria detailed in these accreditation requirements.

5.2 5.2.1

Documentation Quality Manual

All elements of the laboratory's quality system shall be documented. This will include all policies, systems, programme, procedures, instructions etc. where the absence of documentation would adversely affect the test or examination results. Documentation of the quality system will be in a Quality Manual with cross-referencing to related operations documentation, where relevant. The Quality Manual and, where relevant, the associated

operational documentation, shall be kept up-to-date under the authority and responsibility of the Quality Manager. Documentation of the laboratory's quality system must include, where appropriate, the protocol(s) permitting departures from the documented policies and procedures. Quality system documentation shall be readily available to all the personnel. Forensic science in administration of Criminal justice requires that intensive measures be undertaken to ensure the overall quality of scientific findings. To accomplish this, a quality system is required to provide laboratory management with continuing confidence that results and conclusions are accurate, impartial and relevant. Forensic science laboratories must, therefore, establish and maintain a quality system that is appropriate for the range of forensic disciplines as well as the types and numbers of examinations that are conducted. The success of the quality system depends on the commitment of the management and active participation of each member of the laboratory staff. To ensure that everyone fully understands what are the expectations, all elements of the quality system must be clearly articulated in the Quality Manual.

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5.2.2

Document and Information Control

The forensic science laboratory shall establish and maintain documented procedures to control all documents and information that relate to its quality system. (Document is any medium used to record information or instructions. Documents include manuals, work books, work sheets, charts, posters, notices, memoranda, drawings, plans software, Standard Operating Procedures etc. Documents maintained in computerised systems must also be considered. It may also include documents of external origin such as standards, regulations, manufacturer's manuals etc). All documents which form part of the quality management system shall be reviewed and approved for use by the authorised personnel prior to issue. A master list or equivalent

document control procedure identifying the current revision status of documents in the quality system shall be established and be easily available to preclude the use of obsolete documents. The procedures shall also ensure that: The authorized issues of appropriate documents are available at all locations where operations essential to the effective functioning of the quality system are performed. Documents are periodically reviewed and, where necessary, revised to ensure continuing suitability and compliance with applicable requirements. Obsolete documents are deleted from the master list and promptly removed from all points of issue or use, or otherwise, assured against unintended use. Any obsolete document retained for legal and/or knowledge preservation purposes are suitably identified. All documents shall be uniquely identified, such identification to include the date of issue and/or the revision number, the total number of pages or a mark to signify the end of the document and the authority for issue. Changes to documents shall be reviewed and approved by the same personnel that performed the original review and approval, unless specifically decided otherwise. The designated

personnel shall have access to pertinent background information upon which they base their review and approval. Amendments included in documents shall be clearly marked. If the laboratory's documentation control system allows for the temporary amendment of documents by hand, pending their re-issue, the procedures and authorities for such amendments shall be defined and shall ensure that amendments are initialed and dated. Documents amended by hand shall be formally re-issued as soon as practicable.
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6
6.1

Records
General

The forensic science laboratory shall establish a system that will ensure that all records required by its quality system are maintained. Some examples of records required by the accreditation criteria include case records, management review records, complaints, staff training records, quality assurance records (including quality control, proficiency testing, court testimony monitoring, corrective action, equipment maintenance and calibration records). The laboratory must document its policies for the identification, collection, access, storage, maintenance and disposal of records, whatever be their type and format. All records shall be legible and shall be stored and retained in such a way that they are readily retrievable in facilities that provide a suitable environment to prevent damage, deterioration or loss. All records must be accompanied by the identity of the person making the record. All observations and calculations shall be made by an initialed single strike out. Nothing in the handwritten information is to be obliterated or erased. Corrections to results, data etc. stored on computer must also be recorded. Retention times must be established and documented for all records but will not be less than three years. Central and/ or state legislative/judicial requirements may necessitate the retention of records for longer periods.

6.2

Case Records

The laboratory must maintain a case record in a designated location under unique case designator, usually a laboratory case number. Administrative and analytical documentation generated by a laboratory on a particular case constitute a case record. The laboratory must have documented policies regarding: a. b. describing its case designator system and detailing the information that is to be included in a case record.

All data and observations and any other analytical or administrative records which support conclusions must be generated and kept by the laboratory. Examples of administrative records include records of case related conversations, evidence receipts, description of evidence, packaging and seals and other pertinent information. Examples of analytical records include reference to procedure(s) followed, test(s) conducted, standards and controls used, diagrams, print outs, autoradiographs, photographs, observations and results of examinations. In general, the records required to support conclusions must be such that in the absence of the
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analysts/ examiners any competent analyst/examiner or supervisor could evaluate what was done and interpret the data. Where instrumental analyses are done, operating parameters must be recorded. Instrument charts and graphs on analyses that are batched eg. Blood alcohol determination, drug screening) may be more appropriately kept in a central location as specified in the laboratory's procedure manuals. Where appropriate observations or test results must be preserved by photography (eg. electrophoretic runs, physical matches), photocopies may also be suitable (eg. T.L.C. results questioned documents). When a test result or observation is rejected, the reason(s) must be recorded. Calculations and manual data transfers must be checked, preferably by a second person. The case record must include an indication that such checks have been performed. Each page of every document in the case record must bear the laboratory's unique case identifier and the analyst/examiner's name or initials. Laboratory generated examination records must be paginated using a page numbering system indicating total number of pages. Since case notes and records of observations are subject to summons and/or scrutiny, they must be of a permanent nature. Handwritten notes and observations must be in ink not in pencil. Pencil (including colour) may, however, be appropriate for diagrams or making tracings. Abbreviations are acceptable only if they are readily comprehensible to a reviewer. It must be clear from case record when the work was performed (eg. Relevant date and where appropriate, time).

6.3

Computers

When computers are used for capturing, processing, manipulation, recording, reporting, storage or retrieval of test/examination data or other information pertaining to an investigation, the laboratory must ensure that: a. b. the requirements of the accreditation criteria are met, computer software is documented in sufficient detail and validated or otherwise checked as being adequate for use. c. d. the computer is appropriately maintained to ensure proper functioning, and appropriate procedures are documented and implemented to maintain the integrity and the security of the data including the prevention of unauthorized access to and amendments of computer records.
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Personnel

Technical Management of Forensic Science laboratories must have relevant scientific qualifications and appropriate forensic experience. 7.1 Laboratory Director

The Laboratory Director is defined as the person with direct operational control of the laboratory. He/she must have a minimum of M.Sc. degree. However, it is desirable to have PhD degree and additional qualifications in management and administration with sufficient experience. He/she must be knowledgeable of the scientific functions and forensic aspects of the laboratory's work, preferably through experience as a forensic scientist. Where the forensic science laboratory is a part of the parent organization, the Laboratory Director does not necessarily have to be the Director or the parent organization.

7.2

Reporting Officers

The reporting officer shall have the qualifications and experience as given below for each subdiscipline. a. Physics

The minimum qualification for the reporting officer shall be Graduate in Science with physics as one of the subjects or equivalent from a recognized university with atleast five years experience in relevant field or postgraduate in physics / specialization in relevant field or equivalent from a recognized university with atleast two years experience in relevant field.

b.

Chemistry and Explosives

The minimum qualification for the reporting officer shall be Graduate in Science with chemistry as one of the subjects or equivalent from a recognized university with atleast five years experience in relevant field or postgraduate in chemistry / specialization in relevant field or equivalent from a recognized university with atleast two years experience in relevant field.

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c.

Toxicology

The minimum qualification for the reporting officer shall be Graduate in Science with chemistry / biochemistry as one of the subjects or equivalent from a recognized university with atleast five years experience in relevant field or postgraduate in chemistry / biochemistry / specialization in relevant field or equivalent from a recognized university with atleast two years experience in relevant field. Toxicologists must be competent to perform qualitative analyses for drugs, metabolites and other toxic substances in biological materials. They must also be able to make a systematic search for such substances and apply appropriate extractive and separatory procedures.

d.

Biology and Serology

The minimum qualification for the reporting officer shall be Graduate in Science with biology as one of the subjects or equivalent from a recognized university with atleast five years experience in relevant field or postgraduate in any biological science / specialization in relevant field or equivalent from a recognized university with atleast two years experience in relevant field. Serologists must have a knowledge of basic biological sciences and sufficient knowledge of chemistry to understand the procedures used. They must also have adequate knowledge of the statistics used in forensic serology.

e.

Ballistics

The minimum qualification for the reporting officer shall be Graduate in Science with physics as one of the subjects or equivalent from a recognized university with atleast five years experience in relevant field or postgraduate in physics / specialization in relevant field or equivalent from a recognized university with atleast two years experience in relevant field. Ballistic Examiners must have adequate knowledge of microscopy, special lighting techniques, preparation of impressions or casts, techniques of comparative examination and the concept of individualization. They must also have adequate knowledge of the nomenclature, and

operation of firearms, bullet and cartridge case comparisons, powder and shot patterns, distance determinations and types of firearm determination from a discharged cartridge case or bullet.
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f.

Questioned Documents

The minimum qualification for the reporting officer shall be Graduate in Science with physics / chemistry as one of the subjects or equivalent from a recognized university with atleast five years experience in relevant field or postgraduate in physics / chemistry / specialization in relevant field or equivalent from a recognized university with atleast two years experience in relevant field. Questioned Document Examiners must have knowledge of the principles of photography, microscopy, comparative examination and individualization. They must also have adequate knowledge of writing or printing instruments, ink, paper and copying processes.

g.

DNA Finger Printing

The minimum qualification for the reporting officer shall be Graduate in biological science / forensic science with genetics as one of the subjects or equivalent from a recognized university with atleast five years experience in relevant field or postgraduate in biological science / forensic science / specialization in genetics or relevant field or equivalent from a recognized university with atleast two years experience in relevant field.

He/she must have knowledge of scientific literature, procedures and practices relevant to DNA testing. They must have necessary skills to evaluate and interpret results of those tests. They must also have an adequate knowledge of population genetics and the statistics used in forensic DNA examinations.

h.

Forensic Psychology

The minimum qualification for the reporting officer shall be postgraduate in psychology / specialization in relevant field or equivalent from a recognized university with atleast two years experience in relevant field.

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i.

Fingerprints

The minimum qualification for the reporting officer shall be Graduate in Science from a recognized university with atleast five years experience in relevant field or postgraduate in science with specialization in relevant field or equivalent from a recognized university with atleast two years experience in relevant field. They must have adequate knowledge of comparative examination techniques, methods of processing, recovering and presentation of latest prints.

j.

Forensic Electronics

The minimum qualification for the reporting officer shall be Graduate in Science with physics / mathematics / electronics / computer science as one of the subjects or equivalent from a recognized university with atleast five years experience in relevant field or postgraduate in physics / mathematics / electronics / computer science specialization in relevant field or degree in engineering / technology in electrical / electronics / computer science or equivalent from a recognized university with atleast two years experience in relevant field. They must have knowledge of the principles of digital processing, exihibit handling, software / hardware analysis, data retrieval etc.

k.

Crime Scene Investigation

The minimum qualification for the reporting officer shall be Graduate in Science from a recognized university with atleast five years experience in relevant field or postgraduate in science with specialization in relevant field or equivalent from a recognized university with atleast two years experience in relevant field. Crime Scene investigators should possess extensive experience and be trained in the discipline. They must be competent in the application of principles of crime scene

photographer, scene examination, exhibit handling, safety and must have adequate knowledge of other discipline. They should be competent to independently perform the assessment of crime scene. In addition, every reporting officer must have a good understanding of the principles, uses and limitations of the instruments and the methods and procedures applied to the tasks performed.

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7.3

Supporting Personnel (Non-Testifying Staff)

Support personnel must meet the requirements of their job descriptions. The job description and the duties performed must be in agreement.

New members of staff, independent of previous experience, qualifications, must have satisfactorily completed laboratorys training program before being authorized to work independently.

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Training and Development

A training programme must be established and documented for each functional area of the laboratory. The training programme must include: a. b. the performance of competency test(s) in all applicable areas and where, relevant, the presentation of evidence in the court

Competency testing must include: a. b. an evaluation of knowledge of existing literature and the examination and identification of known and unknown materials

New members of staff, whatever be their qualifications or previous experience, must have satisfactorily completed the laboratory's training programme before being authorised to work independently. Laboratory Director must formally authorise staff to perform work

independently. Training records must be maintained for all personnel. Such records must include details and dates of: a. b. c. d. relevant academic qualifications, participation in the laboratory's training programme in-house and external training courses undertaken conferences, seminars, workshops etc. attended

Records must be sufficiently detailed to show that staff members have been properly trained, that their subsequent ability to perform casework has been fully assessed and that they have been authorised to perform work independently. A laboratory training programme must emphasize and teach the skills and knowledge required to achieve the optimum standards of competence and good laboratory practice within a specific area of work. Training must also include a substantial knowledge of forensic science across its wide spectrum and of criminal and civil laws and procedures. A demonstration of competence to perform what is expected must be included in the programme. It is recommended that the laboratory establishes a formal means of recognition of successful completion of the training such as a certificate, letter or memorandum. The field of forensic science requires examiners to present and defend their findings in the open court of law. Because of this unusual requirement, practitioners must develop the technical and personal skills to perform competently.

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Some experience/ training must be received in a forensic science laboratory. Credit for other experience/ training must be evaluated as appropriate in a particular case. Work experience and training should be considered with respect to intensity and diversity. Experience/training outside the forensic science laboratory may be substituted for experience/training in the forensic science laboratory to the extent that it has been demonstrated to be relevant and adequate. If there is little diversity in the person's work, correspondingly shorter periods of training/ experience may be sufficient. Reporting officers/ analysts must be acquainted with the methods that are generally accepted in the discipline. All examiners must be able to articulate concepts and provide opinion/testimony relevant to assigned tasks. Pertinent training must be given to all trainees prior to appearance as an expert witness in the court. This may include conducting moot court, actual court observations and provision of appropriate reading material. The laboratory must have an employee development programme. The library of the laboratory must contain current books, journals and other literature dealing with each functional area. A system must exist to encourage each employee to review appropriate new literature. The laboratory must foster an atmosphere wherein employees are encouraged to improve their knowledge and skills to grow as individuals and to develop their full potential. The primary means for accomplishing this is a dynamic employee development programme. It should address the various opportunities available to employees such as: professional organisations and their meetings, staff development seminars provided by the government agencies, and technical training courses conducted by various scientific institutions in-house technical meetings, seminars and courses, university courses

The developmental programme should state how employees can participate in it and must detail the procedures to be followed when applying for such training. If the laboratory has any special criteria for selection of personnel for the programme, they should be stated. It is important that such a programme demonstrates planning for the development of individual employee, laboratory sections and the laboratory as a whole. In the absence of a written programme, a well documented record of provision of time and funding to employees for training will serve to verify that the laboratory has an employee development programme.

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9
9.1

Evidence Management
Evidence Control

The forensic science laboratory must have a documented evidence control system. The control system is effectively designed when it ensures and documents the integrity of physical evidence. A chain of custody record (eg. Signature, date, time, description of evidence) must be maintained which provides a comprehensive history of each evidence transfer, over which the laboratory has control. Each individual item of evidence must be marked with unique case designator for identification. Should the item not lend itself to marking, its proximal container must be marked. Labeling on caps/ lids alone is not acceptable because of the risk of wrongly replacing the lids during batch testing of similar samples. The identification should be retained throughout the life of the item in the laboratory. The system shall be designed and operated to ensure that items cannot be confused physically or when referred to in records or other documents. Upon receipt of evidence, any abnormalities or departures from normal or specified conditions shall be recorded. When there is any doubt as to the suitability of an item for test or examination or when an item does not conform to the description provided or the test/examination is not specified in sufficient detail, the client shall b consulted for further instructions before proceeding with the case. Evidence must be stored under proper seal, specially designed and used for protecting so that its contents cannot readily escape or become contaminated and only if entering the container results in obvious damage/ alteration to the container or its seal. Tape used to seal containers must be initialed (or otherwise identified) to record the person sealing the evidence. Evidence must be protected from loss, cross transfer, contamination and/or deleterious change. When destructive tests are necessary, procedures must ensure that as much material as possible is retained for re-analysis, if necessary. Procedures for sub-sampling must ensure that sample integrity is maintained. When items have to be stored under specified environmental conditions, these conditions shall be maintained, monitored and recorded. A secure area for overnight and/or long term storage of evidence must be available. Access to evidence storage areas must be restricted and its access should be limited to the personnel authorised by the Director. 9.2 Evidence Retention and Disposal

The laboratory must establish and document its policy and procedures for the retention and disposal of exhibits following the completion of examinations and/ or testing.
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10
10.1

Methods and Procedures


General

Test methods and procedures used must be accepted in the field or supported by data gathered and recorded in a scientific manner. Since a variety of scientific procedures may validly be applied to a given problem, standards and criteria for assessing procedures need to remain flexible. In forensic science, well established procedures are often scattered throughout peer-reviewed literature as well as in less formal documents obtained from conference proceedings and in house laboratory manuals. Furthermore, minor modifications to improve published methods can be implemented by a laboratory as appropriate to a particular need. The important point is that the procedures used be demonstrably capable of producing valid results. Even though a procedure may be widely used, there is often no single document articulating a professional consensus as to its acceptability. Under these circumstances, it relies on the technical knowledge of its members, the inspection team and/or a NABL Committee comprising recognized experts in the field. The methods must be subjected to a validation study. This may be done internally, externally and/ or collaboratively. Exchange of blind and reference samples with another competent laboratory is particularly useful for detecting any internal systematic error. It should be noted that written documentation for each validation study needs to be maintained for future reference. The written technical procedures should include descriptions of sample preparation methods, controls, standards, and calibration procedures. They should also include a discussion of precautions, possible sources of error and literature references. Although many acceptable procedures may exist to perform a particular examination, considerable variations; in case samples require that forensic scientists have the flexibility to exercise discretion in selecting the method most appropriate to the problem at hand. The laboratory Director needs to ensure that the procedures used must meet acceptable scientific standards (e.g. the use of positive and negative controls). Additionally, standards and reagents used should be of satisfactory quality, (e.g. labelled of certified purity).

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Examiners in serology must have: a. ccess to well established population data bases on the distribution of all genetic markers which are typed in the laboratory and should have: b. access to generate local population data bases on the distribution of all the genetic markers which are typed in the laboratory. Where sampling is carried out as a part of the test method, documented procedures which include a sampling plan using appropriate statistical techniques must be used. Accreditation cannot be granted for tests/examinations that a laboratory has never performed or for which records of performance are not available. It is accepted, however, that forensic science laboratories are called upon from time to time to undertake analyses/examinations not covered by the scope of their accreditation. In such cases a laboratory may choose from the following options: a. The laboratory can perform the test/examination and report the result ensuring that no inference can be drawn that accreditation is held for the service. b. The laboratory can seek accreditation prior to performing the test/examination and reporting the results. c. The laboratory can perform the test/examination and report the result indicating that accreditation is not held for the service and seek retrospective accreditation for the test/examination. Retrospective accreditation can only be granted when a laboratory can demonstrate that all accreditation requirements (including method validation/verification, equipment calibration, staff training etc.) were met at the time the test/examination in question was performed.

10.2

Documentation

Test methods and related procedures (e.g. sample procurement) must be documented and readily available to the analysts/examiners. In addition to a description of the steps involved in the analysis/ examination, documentation of methods and procedures must include, where appropriate: a. b. c. description of the sample/ item to be tested/ examined. parameters or quantities to be determined. equipment/ instrumentation required.

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d.

description of sample preparation methods, controls, standards and calibration procedures.

e. f. g. h.

a discussion of precautions, possible sources of error or limitations of the procedure. criteria for the rejection of suspect results. data/ observations to be recorded and method of analysis and presentation. literature references.

The availability of documented methods will give the examiner the necessary resource material to support written conclusions and expert testimony. Where a test can be performed by more than one method, there must be a documented criteria for method selection. Where appropriate, the degree of correlation between the methods must be established and documented.

10.3

Method Validation

All technical procedures used by a forensic science laboratory must be fully validated before using them for casework. (Validation is the developmental process used to acquire the necessary information to assess the ability of a procedure to obtain a result reliably, to determine the conditions under which such results can be obtained and to determine the limitations of the procedure. The validation process identifies critical aspects of a procedure, which must be carefully controlled and monitored. Validation studies can be conducted by the scientific community (as in the case of standard or published methods) or by the forensic science laboratory itself (as in the case of methods developed in-house or where significant modifications are made to previously validated methods). Methods may be validated by comparison with other established methods using certified reference materials (where available) or materials of known characteristics. In validating test methods, the following issues (among others) may need to be determined, as appropriate: Matrix defects Interferences Sample homogeneity Concentration ranges Specificity Stability of measured compounds
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Linearity range Population distribution Precision

Methods developed in-house for both qualitative work must be validated by the laboratory before use. Where a significant modification is made to a validated method, the modification must be appropriately validated by the laboratory before the method is used. Records of all inhouse validations must be maintained for future reference. Where a laboratory introduces a new (validated) method, it must first demonstrate the reliability of the procedure in-house against any documented performance characteristics of that procedure. As a minimum, the method must be tested using known samples (e.g.

proficiency test samples, samples form an external agency). It is recommended that the method also be tested using non-probative samples. Records of performance verification must be maintained for future reference. 10.4 Reference Materials

Reference materials must be traceable to national and international certified standard reference materials, where possible. Reference materials, certified reference materials and reference collections must be uniquely identified and full details recorded. Purchase, issue and use of these materials must be controlled and records must be maintained. 10.5 Standards and Reagents

The quality of the standard samples and reagents must be adequate for the procedure used. Lot/batch numbers of standards and critical reagents must be recorded. All critical reagents must be routinely tested for their reliability. Standards and reagents must be labelled with: a b c d name of the reagent and standard, concentration, where appropriate, preparation date, identity of the preparer.

Where necessary, the following must also be included on labels: a b c expiry date, storage conditions, hazard warning.

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11.1

Quality Assurance
Quality Control

Analytical performance must be monitored by using quality control procedures appropriate to the type and frequency of the testing undertaken. The range of quality control activities available to laboratories includes the use of: Reference collections Certified reference materials Internally generated reference materials Independent checks by other analysts/examiners Statistical tables Positive and negative controls Control charts Replicate testing Alternative methods Spiked samples, standard additions and internal standards

Depending on the particular test/examination, one or more of these examples may be appropriate. Quality control procedures must be documented. A record must be retained to show that appropriate quality control measures have been taken, that quality control results are acceptable or, if not, that remedial action has been taken. Where appropriate, quality control data must be recorded in such a way that trends in analysis can be readily evaluated.

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Proficiency Testing

The laboratory must have a documented programme of proficiency testing which measures the capability of its examiners and the reliability of its analytical results. The documentation of a laboratory's proficiency testing programme must include how the test samples are obtained/prepared, who has tested them and in what time frame, which laboratory staff member directs the programme, how and where the testing information is maintained, what corrective actions are taken, if required, and who oversees them. Each laboratory must participate in atleast one proficiency testing / interlaboratory comparison program per sub-discipline, covering all sub-disciplines over a period of four years. Also, the laboratory must participate in proficiency testing programmes, which are provided by external test providers approved by NABL. The laboratory must complete a formal agreement with the test provider permitting release of the laboratory's test results directly to NABL. Such testing must be conducted annually in every discipline in which a laboratory seeks or holds accreditation. In addition to participating in external proficiency testing, a laboratory should conduct inter-laboratory or intra-laboratory proficiency testing using blind tests prepared internally or externally and submitted as normal casework evidence or re-examination by another examiner of evidence on which casework was previously completed or known samples prepared internally and externally. When participating in proficiency testing programme, the laboratory's routine test procedures must be used. Performance in proficiency testing programme must be reviewed by the Quality Manager and relevant supervisory staff. Wherever, necessary, corrective action must be taken. Proficiency testing records must include: full details of the analyses/examinations undertaken and the results and conclusions obtained, an indication that performance has been reviewed, and details of corrective action undertaken, where ever necessary.

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Note: A proficiency testing programme is a reliable method of verifying that the laboratory's technical procedures are valid and that the quality of each examiner's work is being maintained. The primary focus must be to identify areas where additional training or more rigid quality control may be of use and to demonstrate the current competence of the laboratory. To derive the maximum benefit from proficiency testing, the laboratory must emphasis the educational aspects of the programme and avoid a punitive approach while taking any corrective action. Proficiency test samples must be representative of the items normally examined in the forensic laboratory. A proficiency test sample must be apportioned among examiners, provided this may not alter the character of the testing. It is essential that proficiency tests be properly designed, appropriately administered and fairly evaluated. The testing procedures must be well understood by all participants. The proficiency of examiners/reporting officers is tested only if they complete the testing unaware of the results expected. For details of approach to proficiency testing, NABL guidelines for proficiency testing based on ISO/ IEC Guide 43 needs to be referred to.

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Case Record Review

The laboratory must have documented its policies and procedures for the technical and administrative reviews of case records. This must include: the criteria to be used for each type of review; the number/percentage of case reports to be reviewed; and the course of action in case any discrepancy is found.

Case records that have been reviewed must bear evidence of the review, for example, by initials of the reviewer.

13.1

Technical Review

Conclusions reported must fall within the range of acceptable opinions of knowledgeable individuals in the field of forensic science or be supported by sufficient data. The laboratory must therefore, review a sample of case records to ensure that the conclusions of its examiners are reasonable and within the constraints of scientific knowledge. Technical

review, often performed by a peer, may be carried out on a sample of completed case records (for example, 20 per cent or six cases, whichever is fewer per examiner per month). The sampling rate could vary depending upon the situation (for example, a new examiner may have 100 per cent of cases reviewed while a very experienced examiner my have only a few cases reviewed each month). Technical review, while important to the laboratory's quality assurance programme, must not be carried out to the extent that it shifts the perceived responsibility for the scientific findings from the examiner to the reviewer keeping in mind that it is the examiner/reporting officer who presents a sworn testimony to the findings.

13.2

Administrative Review

Administrative reviews must be conducted on all or most of the case records to ensure the completeness and correctness of the reports issued.

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Court Testimony Monitoring

The laboratory must have and follow a documented procedure whereby the testimony of each examiner is monitored atleast once in a year. Areas that must be covered in the evaluation include appearance, poise, performance, effectiveness of presentation. The monitoring

procedure must also prescribe the remedial action that is to be taken should the evaluation be less than satisfactory. A record must be kept of each evaluation.

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15.1

Corrective and Preventive Actions


Corrective Action

Procedures must be documented for corrective actions to be taken whenever the validity of results is questioned or departures from quality management system policies and procedures occur. The procedures shall include an investigation process to determine the root cause of the problem. Corrective actions taken to eliminate the basic cause of non-conformances and discrepancies shall be of a degree appropriate to the magnitude of the problem and commensurate with the risks encountered. monitored to ensure their effectiveness. When the validity of the results are questioned, for example, through proficiency testing or quality control results, the procedures (s) involved must be reviewed and, if necessary, withdrawn from use. The procedures (s) may be reinstated only when exhaustive review and testing demonstrate that they are not, or no longer, the source of error. Where the identification of non-conformances or departures casts doubt on the laboratory's compliance with its own policies and procedures or with the accreditation criteria, it shall be ensured the relevant areas of activity are promptly audited. Records shall be maintained for the corrective actions, investigations and analysis. The laboratory must promptly notify the clients in writing when any event casts doubts on the validity of the results or conclusions given in forensic report. management review. The results of corrective actions shall be submitted to the The results of the corrective actions must be

Internal audits, NABL assessments, quality control data, proficiency

testing etc. generate recommendations for corrective actions which must be evaluated, prioritised, implemented and evaluated for effectiveness. Consequently, the system for

monitoring progress must be comprehensive and adequately cross referenced. The Quality Manager should coordinate this system.

15.2

Preventive Action

All operational procedures shall be systematically reviewed at regular intervals to identify any potential sources of non-conformances and any opportunities for improvement, either technical or with the quality management system. Action plans shall be developed, implemented and monitored to reduce the likelihood of the occurrence of non-conformances and to take advantage of improvement opportunities. After the implementation of preventive actions, the laboratory shall monitor the results to establish any reduction in deficiencies or improvements
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to operations, thereby establishing the effectiveness of the preventive action. The results of preventive actions shall be submitted for the management review. Preventive action is a proactive process to identify improvement opportunities, rather than a reaction to the identification of problems or complaints.

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Instruments and Equipment

Where the laboratory needs to use instruments and equipments outside its permanent control, it must ensure that all relevant accreditation criteria are met. Each instrument/ equipment shall, when appropriate, be uniquely labelled, marked or otherwise identified. Each major instrument/ equipment must be recorded in an inventory, which includes: name of the instrument/equipment, the manufacturer's name, type, identification and serial number or other unique identification, date received and date placed in service, where appropriate, current location, where appropriate, condition when received (for example, new, reconditioned), where appropriate.

Instruments/equipment must be maintained in proper working order. Maintenance procedures must be documented. Records must be kept of all maintenance, servicing and repairs. Equipment known or suspected to be defective shall be taken out of service and clearly labelled or marked until it has been repaired and shown by calibration, verification or test, to perform correctly. Whenever practicable, all equipment under the control of the laboratory and requiring calibration or verification, shall be labelled, coded or otherwise identified to indicate the status of the calibration or verification and the date when re-calibration or re-verification is due. Documented operating instructions (for example, the manufacturer's operating

instructions) must be available for each significant item of equipment. When, for whatever reason, equipment goes outside the direct control of the laboratory for a period of time, it shall be ensured that the function and, where necessary, the calibration status of the equipment are checked and shown to be satisfactory before the equipment is returned to service. The laboratory shall have procedures for safe handling, transportation, storage and use of equipment in order to prevent contamination and deterioration. Special procedures may be necessary for equipment used for testing and related activities performed outside the permanent laboratory facilities.

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17.1

Calibration
Calibration - Instruments/ Equipment Where equipment used for tests,

Instruments/ equipments must be properly calibrated.

including equipment used for subsidiary measurements, have a significant effect on the accuracy or validity of the test results, that equipment shall be calibrated or otherwise verified before being put into service and shall be subjected to a programme of re-calibration and/ or re-verification.
Note: Laboratories can also refer to other NABL specific criteria to follow the calibration interval (e.g. NABL 103). These intervals are considered as maxima and can vary depending upon equipment capability, usage, staff expertise. Thus, it is necessary to make intermediate check of equipments / instruments.

The programme for the calibration of equipment in forensic science laboratories must ensure that, where the concept is applicable, all significant measurements are traceable, through certificates of calibration held by the laboratory, to the national standards of measurements. Where a laboratory performs in-house calibrations, by means of comparisons between reference standards and working/measuring instruments, the calibration procedure must be documented. Calibration records (e.g. calibration certificates, calibration data) must be maintained. The laboratory must have a mechanism that alerts staff when calibrations and subsidiary checks fall due and indicates the nature of work required.

17.2

Calibration Chemical Analysis

Quality testing in a testing laboratory, particularly in the case of its assessment, highlights the need to consider closely the question of the accuracy of its measurements and analytical results and to ensure that the principles necessary to establish demonstrated accuracy have not been omitted. The calibration of the parameters associated with chemical analyses and material tests deserves particular attention, because major errors can occur by neglecting or ignoring the basic principles of metrology which also apply to these areas.

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Reports

The information that must be included in the reports of tests/examinations is detailed below: a b a title (for example, test certificate, test report), the name and address of the laboratory and, if different from the address, the location where tests were performed, c d e f g unique identification of the report (for example, by report number) on each page, the date of issue of the report, the page number and the total number of pages (that is, page x of y) on each page, the name and address of the client, description, unambiguous identification and date of receipt of the item(s) tested or examined, h i j k date(s) of performance of the test (s) and or examination (s), identification of the test/examination method (s) or procedure (s), test/examination result (s), reference to sampling procedure (s) used by the laboratory where these are relevant to the validity or application results, l reference to other information where this may be relevant to the validity or application of results, m the name, title and signature or equivalent identification of the person authorised to release the report. It is accepted that forensic science laboratories may not be able to comply with all these requirements. In such cases, the case record pertaining to a particular investigation must include this information: a Where the results of tests not performed by the laboratory are included in reports, the source of those results must be clearly and unambiguously identified on the report.

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Preliminary or interim reports must be clearly indicated as such. Where preliminary or interim reports are issued, the following must be recorded in the case record: the date and time of issue the test/ examination result (s) given, the name of the person to whom the result (s) were given

A copy of the report issued for a test/ examination must be retained in conjunction with the case record. If, after the issue of a report, test data are found to be invalid. The original report must be withdrawn and, if necessary, replaced by one, which is clearly indicated as being a replacement report. The laboratory policies and procedures for issuing reports must be

documented. These must include: a b c d e f prescribed formats for reports, certificates, witness statements, etc., issue of preliminary or interim reports, electronic transmission of reports, retention of the reports in the case record, report authorization, withdrawal of invalid reports.

In case of electronically generated reports, laboratory must have appropriate controls such as access, storage, and back-up results and appropriate password protection. In case the report has to be accessed from the website by the customer there must be appropriate control to ensure that the report is downloaded in protected format.

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Procurement of Services and Supplies

The laboratory shall use, for services and supplies that affect the quality of its tests and/ or related activities, only those that can be demonstrated to be of adequate quality. Where no formal assurance of the quality of external services and supplies is available, the laboratory must have procedures to ensure that the purchased materials and the services comply with the specified requirements. Records must be maintained of all suppliers, from whom support services, equipment or supplies are obtained. Documented procedures must exist for the purchase, receipt and storage of consumables whose properties could affect the quality of testing and related activities. Where possible, the laboratory must ensure that purchased equipments and consumables are not used until they have been inspected, calibrated or otherwise verified as complying with the laboratorys requirements.

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Accommodation and Safety

One key responsibility of the Director of the laboratory is to provide an adequate and safe working environment. Laboratory facilities should reflect due consideration of space, design, security, health and safety. If each of these factors is properly planned and set in place, the laboratorys mission is enhanced and the responsibility of the Director is met. It is recognised that laboratories will be required to comply with Government building and safety legislation. The accreditation criteria shall accommodate the provisions of such legislation. 20.1 Space

Each employee must have adequate work space to accomplish assigned tasks. Sufficient space must be provided for storage of supplies, equipment and tools. Analysts/ examiners must have space available for writing reports and other official communications. Where possible, there must be a clear delineation of areas used for the clerical aspects of laboratory work and the areas used for testing/ examinations. Adequate and appropriate space must be available for records, reference work and other necessary documents. Sufficient space must be available for each instrument to facilitate its operation. Accessories should be stored near each instrument to facilitate its use and operation. (Labs. in which usable space falls below adequate levels may experience health and safety problems, compromised efficiency, adversely affected morale and productivity and an increased risk of mishandling and contaminating the evidence. In designing and planning for additional space or a new facility, future space requirements should also be projected. 20.2 Design

The physical design should permit the efficient flow of case exhibits from the time of its acceptance until its proper disposal. The relative locations of functional areas should facilitate the use of equipment and instruments. Adequate and proper lighting must be available for personnel to carry out assigned tasks. Adequate and proper plumbing and wiring must be available and accessible. The laboratory must have proper ventilation, adequate heating, cooling and humidity control as per the requirements. Bench and floor surfaces must be appropriate for the work being performed. The design should maximise laboratory functions and activities, safeguard the physical evidence, protect the confidential nature of the laboratory operations and provide a safe and healthy environment. Lack of space and / or fiscal

resources are not acceptable reasons for unacceptable laboratory practices.


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20.3

Security

Access to the operational area of the laboratory must be controllable and limited. Visitors must not have unrestricted access to the operational areas of the laboratory. A record must be retained of all visitors to the operational areas of the laboratory. Where a laboratory exists within a host agency facility, documented procedures may be required to permit entry during off-hours for emergencies. Such arrangements are acceptable if they include, for example, the breaking of a storage seal to access a key, code etc. and notifying an authorised laboratory person. Each emergency access to the laboratory should be properly documented. All exterior entrance/ exit points to the laboratory facility must be controlled in order to prevent access by unauthorized personnel. All security doors must have keys or other access devices limited to authorised personnel. The entire exterior perimeter of a forensic science laboratory must inhibit unauthorized access to the laboratory e.g. suspended ceilings which permit undetected entry to the laboratory are unacceptable. Short term and long term evidence storage areas require limited/ controlled access. Internal areas requiring limited/controlled access must have a lock system. Each access device (keys etc.) must be accounted for in a register and their distribution limited. The laboratory must be monitored during vacant hours by an intrusion alarm or by security personnel. The laboratory must have a fire detection system wherever possible. In keeping with any relevant statutory requirements appropriate fire extinguishing devices must be available and policies and procedures of laboratory security must be clearly documented. Laboratory personnel should be trained in fire fighting.

20.4

Health and Safety

Health and safety are everyones responsibility and require the commitment of each employee to be effective. Managements commitment is essential for long term success of a health and safety programme. Such a cooperative relationship will safeguard the employees of a

Forensic Science Laboratory as well as address managements responsibility and liability. All elements of the laboratorys health and safety programme must be clearly documented in a manual, which is readily available to all staff.

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Examples of procedures, which must be included, where appropriate, are: procedure for handling chemical spills, cleaning and disinfecting procedures for biological spills, cleaning and decontamination procedures for radioactive spills, procedures including follow up procedures such as counselling for dealing with needlestick injuries, evaluation procedures including a plan of the facility showing the location of safety equipments and fire extinguishers, policy on the use of protective clothing eg. gowns, coats, gloves, goggles etc., policy on eating, drinking, applying cosmetics etc. in the laboratory, waste disposal procedures, routine cleaning and disinfection procedures for work benches, floors, centrifuges, refrigerators etc., immunization policy, accident reporting protocols, special procedures for handling hazardous substances.

Material safety data sheets must be available in conjunction with the safety manual. Work related Accident Insurance coverage for all employees shall be provided by the Management. An officer must be designated as the Health and Safety Manager. Ideally, the Health and Safety Manager should have received training in occupational health and safety concepts and in the relevant legislative requirements. The health and safety programme must be monitored regularly and audited at least annually to ensure that its requirements are being met. Records of safety audits must be maintained. The laboratory must encourage the use of available safety devices required by its health and safety manual. Signs must be present to identify safety equipment such as fire extinguishers, safety showers, eye wash facilities, spill kits etc.

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Proper equipment and material must be available to handle toxic and carcinogenic biological and/or other dangerous material spills. Spill kits must be available for acids and solvents. Appropriate disinfectants must be available (It is recommended that 0.05 per cent sodium hypochlorite be used for routine disinfection and 0.5 per cent sodium hypochlorite be used for spills of blood and body fluids). Where appropriate, the laboratory should have safety showers and eye wash equipment of suitable locations and in good working condition. The operation of safety showers must be checked regularly. If commercial eye wash preparations are used, it must be ensured that the solutions are within their expiry dates or if distilled water is used the water must be changed at least once a week. Sufficient exhaust hoods must be available to maintain a safe work environment. Biology safety cabinets must be available for handling exhibits, samples etc. where protection of analysts/examiners from biological hazards is necessary. Fume cabinets must comply with relevant National/International Standards. Sufficient first aid kits must be available and strategically located. An adequate number of personnel must be trained in first aid procedures. Appropriate storage must be trained in first aid procedures. Appropriate storage must be provided for volatile, flammable, explosive and other hazardous materials. A flammable liquids storage cabinet is required for all but small volumes. Acids and solvents should not be stored together. It may be necessary to store some material in locked cabinets/cupboards and magazines. Storage on high shelves is

discouraged. Suitable carriers must be available to carry large bottles. The emergency exits from the laboratory must provide safe passage in an emergency. Evacuation routes must always be kept clear. General cleanliness and good house keeping must be apparent.

Foodstuffs must not be kept in laboratory refrigerators/freezers/ovens. Centrifuges used for the biological material must have sealed buckets or a sealed rotor. There must be a documented waste management programme, which includes procedures for the disposal of: chemical wastes biological wastes sharp and broken glass uncontaminated waste, for example, paper waste radioactive waste
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Laboratories are also reminded of the requirements of the Indian Quarantine Laws in relation to imported biological materials. The following must be in place: a record or inventory of imported biological materials, their source and when they were received by the laboratory, a documented policy on the disposal of imported biologicals from the lab. staff training covering : disposal procedures Indian Quarantine Laws Requirements.

A register must be maintained of laboratory accidents, injuries and other incidents and the follow up action taken. Suitable protective clothing/equipments must be available at all the times. The nature of these items will be dependent on the work being undertaken and might include: laboratory coats/ gowns disposable gloves rubber gloves heat/ cold resistant gloves protective eye wear face masks plastic/ rubber aprons foot wear

When radioactive and X-ray work are performed, detectors must be used regularly to monitor radiation levels and the wearing of film badges by staff may be necessary. Staff must be advised of immunization and other appropriate precautionary measures. It is recommended that relevant records be kept. Appropriate hand washing and hand drying facilities must be available. Hand basins should not be fitted with domestic taps but with a suitable alternative, for example, elbow or foot activated devices. The use of communal towels is discouraged. Single use towels or automatic hand drying devices are preferred. A suitable cleaning agent must be available. Gas cylinders must be secured. Samples/ specimens/ exhibits referred to other laboratories must be transported in accordance with the Indian Post or other relevant requirements.

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Subcontracting of Technical Work

Any subcontracting/ utilizing the others facilities is purely/solely the responsibility of the Forensic Science Laboratories and they (FSLs) are legally responsible for the test reports. Subcontracting should be placed with a laboratory complying with ISO/IEC 17025:2005 requirements. A register should be maintained of all such subcontractors and sub-contracted services.

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Section II CHECKLIST FOR ASSESSMENT

22

Checklist for Assessment

1.
1.1 1.1.1

Laboratory Management and Operation


Planning Objectives Standards and Criteria
Requirements*

1.1.1.1

Does the laboratory have written down return objectives

Yes

No

NA

1.1.1.2

Does the laboratory staff understand and support the objectives?

Yes

No

NA

1.1.2

Administrative Practices Standards and Criteria

1.1.2.1

Does the laboratory have a formal written budget?

Yes

No

NA

1.1.2.2

Is the budget adequate to meet the written objectives?

Yes

No

NA

1.1.2.3

Handling and preserving the integrity of evidence

Yes

No

NA

1.1.2.4

Facilities for Laboratory Security a. b. c. Men Material Information related to case records and reports d. Establishment

Yes

No

NA

1.1.2.5

Whether a standard format is available for preparation and storage of case records and reports

Yes

No

NA

1.1.2.6

Inventory control of capital equipment and consumables

Yes

No

NA

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1.1.2.7

Maintenance and calibration of equipment and consumables

Yes

No

NA

1.1.2.8 1.1.2.9 1.1.2.10 1.1.2.11 1.1.2.12 1.1.2.13

Duty hours Leave policy Job requirements and descriptions Personnel performance appraisal Employee grievances Does the laboratory have a Management Information System?

Yes Yes Yes Yes Yes Yes

No No No No No No

NA NA NA NA NA NA

D D I E E E

1.2 1.2.1
1.2.1.1

Organizational Policy Organizational Structure


Does the organizational structure group the work and personnel in a manner that allows for efficiency of operation, taking into account the interrelation of various forensic disciplines? Yes No NA D

1.2.1.2

Has the laboratory Director considered and taken appropriate action to correct any discrepancies with regard to numbers of personnel resources? when grouping work and

Yes

No

NA

1.2.2

Delegation of Authority Standards and Criteria

1.2.2.1

Is the laboratory Directors authority well defined

Yes

No

NA

1.2.2.2

Whether the administrative / financial powers are commensurate with the defined responsibilities of the laboratory Director

Yes

No

NA

1.2.2.3

Whether there is sufficient delegation of authority by the Director within the

Yes

No

NA

Organization

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1.2.2.4

Is authority of the Supervising Officers commensurate with their responsibilities?

Yes

No

NA

1.2.2.5

Is each subordinate accountable to one and only one immediate Supervisor per function?

Yes

No

NA

1.2.2.6

Are performance criteria established and are they understood by laboratory

Yes

No

NA

personnel?

1.3 1.3.1

Directing Supervision Standards and Criteria

1.3.1.1

Is there constructive discussion between Supervisors and Subordinates?

Yes

No

NA

1.3.1.2

Do Supervisors carefully and objectively review laboratory activities, methods and personnel?

Yes

No

NA

1.3.1.3

Do the supervisory techniques encourage creative, objective thinking and recognize meritorious performance?

Yes

No

NA

1.3.2

Communication Standards and Criteria

1.3.2.1

Do clear vertical, horizontal and diagonal channels of communication exist within and without the laboratory?

Yes

No

NA

1.3.2.2

Are vertical, channels of communication used for administrative functions?

Yes

No

NA

1.3.2.3

Are staff meetings a routine function

Yes

No

NA

1.3.3

Training and Development Standards and Criteria

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1.3.3.1

Does the laboratory have and use a training programme in each functional area for employees who are new, untrained or in need of remedial training?

Yes

No

NA

1.3.3.2

Does the laboratory have an Human Resource Development Programme?

Yes

No

NA

1.3.3.3

Does the forensic library contain current books, journals and other literature dealing with each functional area?

Yes

No

NA

1.3.3.4

Does a system exist to encourage each scientist literature? to review appropriate new

Yes

No

NA

1.4 1.4.1

Controlling Evidence Control Standards and Criteria

1.4.1.1

Does the laboratory have a well defined chain of custody record with all necessary data which provides for complete tracking of all evidence?

Yes

No

NA

1.4.1.2 1.4.1.3

Is all evidence marked for identification? Is evidence stored under proper safe custody

Yes Yes

No No

NA NA

E E

1.4.1.4

Is evidence protected from loss, cross transfer, contamination and/or deleterious change?

Yes

No

NA

1.4.1.5

Is there a secure area for overnight and/or long term storage of evidence?

Yes

No

NA

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1.4.2

Quality System (Please refer ISO/IEC 17025: 2005)

Standards and Criteria


1.4.2.1 Does the laboratory have a quality Yes No NA E

manual? 1.4.2.2 Is an individual designated as the Quality Manager? 1.4.2.3 Are audits of the entire laboratory Yes No NA E Yes No NA E

operation completed annually? 1.4.2.4 Does the laboratory conduct an annual review of its quality system? 1.4.2.5 Are the procedures used generally Yes No NA E Yes No NA E

accepted in the field or supported by data gathered recorded in a scientific manner? 1.4.2.6 Are new technical procedures scientifically validated before being used in casework and is the validation documentation Yes No NA E

available for review? 1.4.2.7 Are the technical procedures used by the laboratory documents documented available and to are the Yes No NA E

laboratory

personnel for review? 1.4.2.8 Are appropriate controls and standards specified in the procedures and they used to ensure the validity of examination a results? 1.4.2.9 Is the quality of the standard samples and reagents appropriate for the procedure used? 1.4.2.10 Does the laboratory routinely check the reliability of its reagents? 1.4.2.11 Are the instruments/equipment adequate for the procedures used? Yes No NA E Yes No NA E Yes No NA E Yes No NA E

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1.4.2.12

Are the instruments/equipment in proper working orders?

Yes

No

NA

1.4.2.13

Are the instruments/equipment properly calibrated?

Yes

No

NA

1.4.2.14

Do the scientists generate and does the laboratory maintain, in a case record, all the notes, worksheets, photographs,

Yes

No

NA

spectra, printouts, charts and other data or records used by examiners to support their conclusions?

Methods and Procedures


1.4.2.15 Do the scientists in serology/DNA have access to and generate local population databases on the distribution of all genetic markers, laboratory? 1.4.2.16 Do the examiners in serology/DNA have access to and generate local population databases on the distribution of all genetic markers which are typed in the laboratory? 1.4.2.17 Does the laboratory, conduct and Yes No NA E Yes No NA E which are typed in the Yes No NA E

document administrative reviews of all reports issued? 1.4.2.18 Does the laboratory monitor the testimony of each Scientist at least annually and is the Scientist given feedback from the evaluation? Yes No NA E

Corrective Action
1.4.2.19 If the laboratory has an indication of a significant technical problem, is there a procedure in writing and in use whereby the laboratory initiates a review and takes any corrective action required? National Accreditation Board for Testing and Calibration Laboratories
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Yes

No

NA

1.4.3

Proficiency Testing Standards and Criteria

1.4.3.1

Does the laboratory have a documented program of proficiency testing?

Yes

No

NA

1.4.3.2

Does

the

laboratory

participate

in

Yes

No

NA

proficiency testing programmes conducted by approved test providers? 1.4.3.3 Does the laboratory conduct inter or intralaboratory proficiency testing using the blind, re-examination, or known standard techniques? Yes No NA E

2
2.1

Personnel Qualifications
Management Standards and Criteria

2.1.1

Does the laboratory Director possess a degree in Natural Sciences or in

Yes

No

NA

Criminalistics or is the laboratory Director supported by scientific personnel of

sufficient managerial rank and authority? 2.1.2 Does the laboratory Director have at least five years of forensic experience? 2.1.3 Does the laboratory Director have some formal training in Management? 2.1.4 Does the laboratory Director have at least two years of managerial experience? Yes No NA E Yes No NA E Yes No NA E

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2.2

Controlled Substances Standards and Criteria

2.2.1

Does each Reporting Officer have either MSc with required experience or a

Yes

No

NA

Bachelor Degree in Science or Forensic Science 2.2.1.1 Does each have experience/training Yes No NA E

commensurate with the examination and testimony provided? 2.2.1.2 Does the Reporting Officer for Questioned Documents have MSc in Physics or Chemistry or Forensic Science with Yes No NA E

specialization in document examination? 2.2.2 Does each Scientist and the understand methods the and Yes No NA E

instruments

procedures used? 2.2.3 Did each Scientist successfully complete a competency test prior to assuming case work responsibility? 2.2.4 Did each Scientist complete an annual proficiency test? Yes No NA E Yes No NA E

2.3

Toxicology Standards and Criteria

2.3.1

Does each Scientist have a Bachelors degree in Natural Science, Toxicology or Criminalistics and does each have

Yes

No

NA

experience/ training commensurate with the examinations and testimony provided? 2.3.2 Does each Scientist and the understand methods the and Yes No NA E

instruments,

procedures used?

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2.3.3

Does each Scientist successfully complete a competency test prior to assuming casework responsibility?

Yes

No

NA

2.3.4

Did each Scientist complete an annual proficiency test?

Yes

No

NA

2.4

Trace Evidence Standards and Criteria

2.4.1

Does each Scientist possess a Bachelors degree in Natural and Science does each or in

Yes

No

NA

Criminalistics

have

experience/ training commensurate with the examinations and testimony provided? 2.4.2 Does each Scientist and the understand methods the and Yes No NA E

instruments,

procedures used? 2.4.3 Does each Scientist successfully complete a competency test in each of the evidence types processed prior to assuming Yes No NA E

casework responsibility? 2.4.4 Did each Scientist complete an annual proficiency test? Yes No NA E

2.5

Serology Standards and Criteria

2.5.1

Does each Scientist possess a Bachelor Degree in Natural and Science does each or in

Yes

No

NA

Criminalistics

have

experience/training commensurate with the examinations and testimony provided? 2.5.2 Does each Scientist and the understand methods the and Yes No NA E

instruments,

procedures used?

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2.5.3

Does each Scientist successfully complete a competency test prior to assuming casework responsibility?

Yes

No

NA

2.5.4

Did each Scientist complete an annual proficiency test?

Yes

No

NA

2.6

DNA Standards and Criteria

2.6.1

Does

each

Scientist

have

education,

Yes

No

NA

training and experience consistent with those recommended by the technical working group on DNA analysis methods (TWGDAM) in Guidelines for a quality assurance programme for DNA analysis? 2.6.2 Does each Scientist and the understand methods the and Yes No NA E

instruments,

procedures used? 2.6.3 Does each Scientist successfully complete a competency test prior to assuming casework responsibility? 2.6.4 Did each Scientist complete two Yes No NA E Yes No NA E

proficiency tests annually?

2.7

Firearms/ Toolmarks Standards and Criteria

2.7.1

Does each Scientist possess a Bachelors Degree with science courses?

Yes

No

NA

2.7.2

Does

each

Scientist and the

understand methods

the and

Yes

No

NA

instruments,

procedures used?

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2.7.3

Did each examiner have extensive training from a qualified scientist and does each have experience commensurate with the examinations and testimony provided?

Yes

No

NA

2.7.4

Does each Scientist successfully complete a competency test prior to assuming casework responsibility?

Yes

No

NA

2.7.5

Did each Scientist complete an annual proficiency test?

Yes

No

NA

2.8

Questioned Documents Standards and Criteria

2.8.1

Does each Scientist possess a Bachelors degree with science courses?

Yes

No

NA

2.8.2

Does

each

Scientist and the

understand methods

the and

Yes

No

NA

instruments,

procedures used? 2.8.3 Did each examiner have extensive training from a qualified scientist and does each have experience commensurate with the examinations and testimony provided? 2.8.4 Does each Scientist successfully complete a competency test prior to assuming casework responsibility? 2.8.5 Did each Scientist complete an annual proficiency test? Yes No NA E Yes No NA E Yes No NA E

2.9

Latent Prints Standards and Criteria

2.9.1

Does each Scientist possess a Bachelors Degree with science courses?

Yes

No

NA

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2.9.2

Does

each

Scientist and the

understand methods

the and

Yes

No

NA

instruments,

procedures used? 2.9.3 Did each examiner have extensive training from a qualified scientist and does each have experience commensurate with the examinations and testimony provided? 2.9.4 Does each Scientist successfully complete a competency test prior to assuming casework responsibility? 2.9.5 Did each Scientist complete an annual proficiency test? Yes No NA E Yes No NA E Yes No NA E

2.10

Technical Support Standards and Criteria

2.10.1

Do

support

personnel

meet

the

Yes

No

NA

requirements of their job descriptions? 2.10.2 Are the job descriptions and the duties performed in agreement? 2.10.3 If appropriate, did each member of the support staff complete a competency test prior to assuming casework responsibility? 2.10.4 If appropriate, was proficiency testing completed? Yes No NA E Yes No NA E Yes No NA E

3
3.1

Physical Plant
Space Standards and Criteria

3.1.1

Does each employee have adequate work space to accomplish assigned tasks?

Yes

No

NA

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3.1.2

Is there sufficient space provided for storage of supplies, equipment and tools?

Yes

No

NA

3.1.3

Is there adequate space available for Scientists for writing reports and other official communication?

Yes

No

NA

3.1.4

Is there adequate and appropriate space available for records, reference works and other necessary documents?

Yes

No

NA

3.1.5

Is adequate space available for each instrument to facilitate its operation?

Yes

No

NA

3.1.6

Are

accessories to

stored its

near use

each and

Yes

No

NA

instrument operation?

facilitate

3.2

Design Standards and Criteria

3.2.1

Does the physical design permit the efficient flow of evidence from the time of its acceptance until its proper disposal?

Yes

No

NA

3.2.2

Do the relative locations of functional areas facilitate the use of equipment and

Yes

No

NA

instruments? 3.2.3 Is there adequate and proper lighting available for personnel to carry out Yes No NA D

assigned tasks? 3.2.4 Is there adequate and proper plumbing and wiring available and accessible to carry out assigned tasks? 3.2.5 Does the laboratory have proper general ventilation? 3.2.6 Is the heating, cooling and humidity control as the case may be, in the laboratory adequate? National Accreditation Board for Testing and Calibration Laboratories
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Yes

No

NA

Yes

No

NA

Yes

No

NA

3.3

Security Standards and Criteria

3.3.1

Does each employee have adequate work space to accomplish assigned tasks?

Yes

No

NA

3.3.2

Doe all exterior entrance / exit points have adequate security control?

Yes

No

NA

3.3.3

Do

all

internal

areas have

requiring a lock

Yes

No

NA

limited/controlled system? 3.3.4 Are all keys,

access

magnetic

cards,

etc.,

Yes

No

NA

accounted for and is their distribution limited? 3.3.5 Is the laboratory secured during vacant hours by means of an intrusion alarm or, by security personnel? 3.3.6 Does the laboratory have a fire detection system? Yes No NA D Yes No NA D

3.4

Health and Safety Standards and Criteria

3.4.1

Does the laboratory have an effective health and safety programme documented in a manual?

Yes

No

NA

3.4.2

Is an individual designated as the health and safety manager?

Yes

No

NA

3.4.3

Is the health and safety programme monitored regularly and reviewed annually to ensure that its requirements are being met?

Yes

No

NA

National Accreditation Board for Testing and Calibration Laboratories


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3.4.4

Does the laboratory have available and encourage the use of safety services, particularly those required by its health and safety manual?

Yes

No

NA

3.4.5

Does

the

laboratory

have

proper

Yes

No

NA

equipment and material available for the handling of carcinogenic, toxic and/or other dangerous material spills? 3.4.6 Does the laboratory have safety shower and eye wash equipment in appropriate locations and in good working condition? 3.4.7 Are sufficient exhaust hoods available to maintain a safe work environment? 3.4.8 Are sufficient first aid kits available and strategically located? 3.4.9 Does the laboratory have an adequate number of personnel trained in first aid procedures? 3.4.10 Is appropriate space provided for safe storage of volatile, flammable and Yes No NA D Yes No NA D Yes No NA D Yes No NA D Yes No NA D

explosive materials? 3.4.11 Are the emergency exits from the Yes No NA D

laboratory adequate for safe exit in an emergency? 3.4.12 Is there general cleanliness and apparent good housekeeping in the laboratory? Yes No NA D

National Accreditation Board for Testing and Calibration Laboratories


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National Accreditation Board for Testing and Calibration Laboratories 3rd Floor, NISCAIR 14, Satsang Vihar Marg New Mehrauli Road New Delhi 110 067 Tel.: 91-11 26529718 20, 26526864 Fax: 91-11 26529716 Website: www.nabl-india.org

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