A SEMINAR ON

BY CH SUJITHA PHARMACEUTICAL ANALYSIS AND QUALITY ASSURANCE

NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES

INTRODUCTION
Established in 1982 as

NCTCF as per ISO/IEC Guide 25. In 1992, reconstructed as NABL Autonomous body under the aegis of Department of Science And Technology, Govt of India and registered under Societies Act Accreditation complies with ISO 17011:2004 Signatory to APLAC, ILAC, MRA

WHY LABORATORY ACCREDITATION?

The concept of Laboratory Accreditation was developed

to provide a means for third-party certification of the competence of laboratories to perform specific type(s) of testing and calibration. Provides formal recognition of competent laboratories, thus providing a ready means for customers to find reliable testing and calibration services in order to meet their demands. Laboratory Accreditation enhances customer confidence in accepting testing / calibration reports issued by accredited laboratories. The globalization of Indian economy and the liberalization policies initiated by the Government in reducing trade barriers and providing greater thrust to exports makes it imperative for Accredited Laboratories to be at

ACCREDITATION
NABL accreditation

procedures comply with ISO 17011:2004 Accreditation procedures followed are: ISO 17025:2005 for test/calibration labiratories ISO 15189:2007 for medical laboratories

ORGANIZATION
GOVERNING BODY EX-OFFICIO MEMBERS
Controls operation & responsibility Providing policy guidelines & direction Chairman: secretary of DST

Financial advisor of DST Director of NABL

REMAINING MEMBERS

NMI, National standards bodies, major lab groups, important regulatory agencies, industry associations Private organizational groups etc

ORGANIZATION
NABL SECRETARIAT
Director, technical operation manager, quality officer, PT officer, Training officer Complaints & appeals officer, accreditation officer, support staff

DIRECTOR

Administering & managing NABL secretariat Reports to chairman, NABL governing body

GOVERNING BODY

Appointed by parent organization, DST In accordance with memorandum of association of NABL

FUNCTIONS
Accreditation is given to following laboratories:
TESTING LABORATORIES Biological Chemical Electronic Electrical Fluid Flow Mechanical Non destructive Photometry Radiological Thermal CALIBRATION LABORATORIES Electro-Technical Mechanical Fluid Flow Thermal & Optical Radiological MEDICAL LABORATORIES Clinical Biochemistry Clinical Pathology Haematology & Immunohaematology Microbiology & Serology Histopathology Cytopathology Genetics Nuclear Medicine

ACCEDITATION PROCEDURE

Laboratory application updating

Secretariat (Document examination)

Preassessment

On Site assessment

IMPROVEMENT

Secretariat

Evaluation panel

NABL

Registered as NABL accredited laboratory

Regular surveillance

LABORATORY

FUNCTIONS
To promote, coordinate, guide, implement and maintain a

accreditation system for laboratories suitable for the country in accordance with the relevant national and international standards and guides.
To ensure that all measurements either during calibration or

testing by accredited laboratories are traceable to appropriate national / international standards maintained at National Physical Laboratory (NPL) and at Bhabha Atomic Research Centre (BARC) through an unbroken chain of comparisons.
To encourage Proficiency Tests / Inter-laboratory comparisons in

order to ensure accuracy, reliability and reproducibility of test results.

To ensure that the accredited laboratories adhere to all the

conditions of accreditation, by periodic surveillance.

 To organize Awareness Programmes on all aspects of laboratory

accreditation for the laboratories by various means including seminars, workshops and laboratory-industry-accreditation body meets etc.
To acquire travelling standards and artifacts for conducting studies

on measurements by the accredited laboratories and thereby to help improve reliability and reproducibility of results.
To establish and maintain strong linkages with international and

regional for a such as International Laboratory Accreditation Conference (hitherto referred to as ILAC), European Accreditation Cooperation for Laboratories (hitherto referred to as EAL), Asia Pacific Laboratory Accreditation Cooperation (hitherto referred to as APLAC) etc. and to take active participation in Plenary Sessions, Committee Meetings etc. in order to keep pace with the latest developments and for promoting Bi-lateral .
To undertake all the activities which shall promote undertaking Bi-

lateral / Multilateral Recognition Agreements between NABL and laboratory accreditation bodies in other countries so that test results of NABL accredited laboratories become acceptable in all countries.

BENEFITS OF ACCREDITATION
Formal recognition of competence of a laboratory by an

Accreditation body in accordance with international criteria has many advantages:

Potential increase in business due to enhanced customer

confidence and satisfaction. Better control of laboratory operations and feedback to laboratories as to whether they have sound Quality Assurance System and are technically competent. Increase of confidence in Testing / Calibration data and personnel performing work.
Customers can search and identify the laboratories

accredited by NABL for their specific requirements from the Directory of Accredited Laboratories. Users of accredited laboratories will enjoy greater access for their products, in both domestic and international markets, when tested by accredited laboratories.

SOME ACCREDITED LABS

Bangalore test house Eskaps (India) pvt ltd,

Kolkata GEO-Chem , Mumbai Industrial research and consultancy, Howrah Metallurgical services, Mumbai NSIC, Rajpura SIIR, Delhi SGS India Ltd, Chennai Vimta Labs, Hyderabad etc

OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION

INTRODUCTION
Occupational Safety

and Health Act of 1970, created the Occupational Safety and Health Administration (OSHA) to assure safe and healthful working conditions for working men and women by setting and enforcing standards and by providing training, outreach, education and assistance. Officially came into

ORGANIZATION
OSHA is part of the

United States Department of Labor. The administrator for OSHA is the Assistant Secretary of Labor for Occupational Safety and Health. OSHA's administrator answers to the Secretary of Labor, who is a member of the cabinet of the President of the United States.

OSHAs Purpose
Encourage employers and

Employees to reduce workplace hazards and to implement new or improve existing safety and health programs Provide for research in occupational safety and health and to develop innovative ways of dealing with occupational safety and health problems Establish separate but dependent responsibilities and rights for employers and employees for achievement of better safety and health conditions

OSHAs Purpose
Maintain a reporting and record-keeping

system to monitor job-related injuries and illnesses Establish training programs to increase the number and competence of occupational safety and health personnel Develop mandatory job safety and health standards and enforce them effectively Provide for the development, analysis, evaluation and approval of state OSH programs

FUNCTIONS
Responsible for enforcing its

standards on regulated entities. The agency sends Compliance Safety and Health Officers to work sites, where they carry out inspections and assess fines for regulatory violations. Inspections are planned for work sites in particularly hazardous industries. Inspections can also result in response to workplace incidents, worker complaints or referrals by other individuals.

FUNCTIONS
Issue workplace

health and safety regulations. These regulations include:

limits on chemical

exposure employee access to information requirements for the use of personal protective equipment, and requirements for safety procedures

FUNCTIONS
Standards development Standards adoption General duty clause

making the workplace free from any hazards Work place inspection priorities
Imminent danger Catastrophes and fatal

accidents Employee complaints Inspection report

INSPECTION PROCESS
Presenting inspector credentials
Upon arriving on site Insist on seeing the credentials

Opening conference
Why the establishment selected Scope and purpose of visit and inspection Copy of complaint may be produced

Closing conference
Free discussion of problems and frank Q &A Citations and penalties if any are discussed

Inspection tour
Inspector and employee representative will take Trade secrets kept confidential Photos and videos may be taken; may talk with employees

CITATIONS AND PENALTIES

Citations inform the employer and employees of regulations and standards alleged to have been violated and of the proposed length of time set for their abatement De-minimus: no penalty Other than serious violation: 7000$ Willful violation: 70000$ + 5000$ for each penalty Willful violation leading to death: 250,000$ for individual to 500,000$ + imprisonment for 6 months for corporation Repeated violation: 70,000$ for each violation Failure to abate previous violation: 7000$ per day

CITATIONS AND PENALTIES

Additional violations: Falsifying records, reports, applications: 10,000$ or 6 months in jail Violating posting requirements: 7000$ CRIMINAL PENALTIES: o willful violation causing death o giving advance notice of inspection o Providing wrong information o Killing, assaulting or hampering the information of the inspector

EXEMPTIONS
Mine and quarry workers Independent contractors and other self-employed

individuals Public sector employees Domestic workers Flight crews Farms employing only family members and farms employing fewer than 10 employees with no migrant labor housing Additionally, workplaces participating in OSHA's Voluntary Protection Programs are exempted from programmatic inspections, though they can still be subject to accident-, complaint-, or referral-

BENEFITS
Ensuring safety by enforcing rules and

supervising implementations Providing training, educational programs and workshops to adopt culture of safety and health Financial benefits: accident prevention is better than accident itself
Lower worker injury and illness Lower compensation cost Lower lost working days Lower product losses and equipment damage

BENEFITS
Lower accidents:
Knowledge to identify

and eliminate hazards Protect employers and workers from injuries Prevent loss of life Instigate a culture geared towards safety Boost employee morale

Management benefits:
More understanding of

implications of workplace hazards Comply with local, federal and state safety and health requirements

BENEFITS
Motivational factors:
Recognized employers

provided an exemption of 1yr from inspection which can be renewed Acts as motivation to follow safety standards

Harmonization:
Cooperative projects

enable the different organizations to attain harmony

REFERENCES
http://www.dst.gov.in/about_us/ar99-2000-ai

nabl.htm http://www.nabl-india.org/ www.qcin.org/nabl/ http://www.ijcb.co.in/iaft05i2p186/ http://en.wikipedia.org/wiki/National_Accreditation _Board_for_Testing_and_Calibration_Laboratorie s

REFERENCES
http://www.osha.gov/Publications/osha3150.pdf

http://www.ehow.com
http://www.osha.gov www.scribd.com www.maxhealthcare.in http://en.wikipedia.org/wiki/Occupational_Safety_

and_Health_Administration