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LTD
TESTING LABORATORY
The following are the authorized holders of the controlled copy of Quality Manual
Quality Executive
03
Date
Page Sec. Rev.
No. of Description of Revision Approved by
No. No. No.
Rev.
1. Scope
This section sets out the methodology for establishing and maintaining procedure to
control all documents and data including both internal and relevant documents of
external origin.
2. Responsibility
The overall responsibility of document and data control is vested with the Quality
Executive.
3.1.5 Such clauses may have sub clauses which are numbered as
10.1.1.1, 10.1.1.2, 10.1.1.3.
10
3.1.6 Sub clauses may further have paragraphs which are numbered as
either a, b, c, or roman i, ii, iii, so on.
3.2.2 All documents are approved by the person who is given the
authority to approve and who is overall responsible for the
implementation of contents of the document delegatory process.
3.2.4 Cover page of all documents carry the issue number and date.
4. Numbering of Pages
4.1 The page number and number of pages of each section are shown in every
page. Eg. 2nd page in the LQM - 00 which runs to 41 pages is numbered as
page 2 of 41.
5. Revision Status
5.1 Every time a revision is made the first page of the section, contents page
and revision record gets next higher serial number as the new revision
number.
6.1 The issuing authority of the document originate the revision and
obtain the approval from the approving authority and effect the revisions.
(DD-Form-01).
6.2 A vertical line against the clause/sub-clause /paragraph shall indicate the
revised area.
6.3 The revised pages of the documents are forwarded to QE who distributes
According to the distribution list together with a covering memo.
(DD-Form-02)
6.4 The copy holders insert the pages revised and remove the obsolete pages
and destroy as per DD-Form-02.
6.5 This covering memo is returned to QE with signature and date as
acknowledgement of receipt of revisions.
6.6 In case of a revision, one set of obsolete pages removed from a document
are kept for 3 years in a mast obsolete record file by the QE.
6.7 When a second issue is made, 1st issued document will be totally
withdrawn and all revision numbers will be 00.
QUALITY RECORDS
1. Scope
This procedure describes the archive period, identification codes, location and who is
responsible for monitoring of the quality records on the common elements.
2. Responsibility
Quality Executive is overall responsible for ensuring that all Quality Records are
maintained. Other individuals who are responsible for maintaining Quality Records
pertaining to their sections are identified in the respective procedures.
3. Characteristics
Details of various Quality Records, their storage limits and persons responsible
are given in 4 below.
All records are stored in such a way that no damage/deterioration takes place.
After the expiry of the specified storage period, these records are destroyed.
Section No. QPM – 2 - QR
QUALITY RECORDS
QUALITY RECORDS
CONTRACT REVIEW
1. Scope
This section of the manual sets out the Contract Review Procedure for marketing
services offered by the Centre.
2. Responsibility
3. Procedure
MANAGEMENT REVIEW
1. Scope
This procedure covers the Management Review of all quality activities of the laboratory
and the effectiveness of the quality system.
2. Responsibility
3. Procedure
FLOW ACTIVITY R’LTY REF.
TRAINING
1. Scope
Training procedure for training personnel of all categories is outlined in this section.
All aspects which require training in areas of testing are addressed.
2. Responsibility
3. Types of Training
5. Imparting Training
5.1 The training needs identified are discussed with the Factory Manager Operations.
MRM –TR-Form-01.
5.2 The decisions are recorded in the minutes of Management Review
meetings MRM-Rec-01.
5.3 Depending on the MRM decisions training is arranged.
5.4 Training will be carried out by a competent person who has over
three years experience, in case of testing.
Section No. QPM – 5 - TR
TRAINING
6. Training Records
6.1 QE maintains records of training needs identified and the type of training
imparted to each of the employees.
6.2 This is recorded in TR-REC-01 for each employee. This record is copied to
Technical Manager.
6.3 These records are reviewed by the above personnel (along with an appraisal
form TR-Form-03) once a year to determine the future training needs of
employees at various levels.
6.4 A record of the number of tests, each employee has reached competency is maintained and updated every year (TR-
Form-05) to determine the progress achieved by each employee in achieving competence in different tests.
7. Induction Training
The induction training imparted to the new recruits is also maintained by the QM.
This training will be designed depending on the designation and experience of the
new recruit, covering the following aspects.
(1) Introduction to the profile of the Centre
(2) Introduction to staff of the Centre
(3) Quality awareness training & their role in achieving same.
(4) Working of the laboratory & its importance to achieve the objective.
(5) Role of the testing staff
(6) On the job training on selected equipment and methods
Duration to be decided on the basis of progress
(7) Evaluation of trainee by MR/QM using TR-Form-04
8. Competence of Staff
Whether an employee needs further training is decided on the marks system given
under the assessment and recommendations in TR-Form-04.
Those who require re-training are allocated a specific period of time to achieve the
required competence and records of such occurrences are maintained and followed
up.
Section No. QPM – 5 - TR
TRAINING
The marks are assigned for 10 areas under 2 sections, namely sample preparation and
testing procedure. Depending on the aggregate, the employees training needs are
categorized.
Each employee is expected to achieve competence in two additional tests during each
year.
The Technical Manager is responsible for identifying and arranging training in two
elected tests and to ensure that competence is achieved.
9. Training Evaluation
9.1 For Managers, Executives, Junior Executive, Evaluation of training imparted during the year is done by the Deputy
Director.
9.2 After the external training programmes questionnaires are being given to the
participants to evaluate the training programme. TR-Form-02
Section No. QPM – 6 - PC
1. Scope
This procedure outlines the method of dealing with samples submitted to the
Laboratory, testing of such samples and reporting the outcome of tests.
2. Responsibility
Laboratory Assistant
(1) Laboratory Technicians and Laboratory Assistants carry out testing and record
test results. Also responsible for accuracy of readings, storing of remnant
samples.
(2) Laboratory Executives are responsible for carrying out validation testing at
specified intervals and specified conditions, preparation of draft reports,
checking of results, during Textile Technologist's absence to receive samples.
One Laboratory Executive is also in charge of stores.
Section No. QPM – 6 - PC
4. Testing
PURCHASING
1. Scope
The procedure outlined in this manual is applicable for the purchase of chemicals,
standard reference materials, glassware and equipment.
2. Responsibility
PURCHASING
PURCHASING
5.1.1 Quality
(i) Fully conform to specifications = 3
(ii) Marginally conform to specifications and
adequate for purpose = 2
(iii) Does not conform to specifications = 0
5.1.2 Delivery
(i) Full delivery on time = 3
(ii) Part delivery on time = 2
(iii) Late delivery = 0
5.1.3 Packing
(i) Packing and labelling ensures safety of
product = 3
(ii) Packing is good enough for safety
of product but labelling not adequate = 2
(iii) Packing and labelling poor = 0
Total =
=
Evaluation
Excellent equal to 9
Good equal or more than 7
Poor less than 7
Section No. QPM – 8 - IT
1. Scope
This procedure outlines the systems adopted in the inspection of test records,
materials and equipment.
2. Responsibility
The Technical Manager of the laboratory is overall responsible for directing activities
of Laboratory work while the Laboratory Executives are responsible for supervision
of all laboratory work. Functional responsibilities are as indicated below.
1. Scope
This procedure ascertains whether the test results obtained are accurate.
2. Responsibility
3. Procedure
4. Frequency
5. Recording
The verification records are maintained on a file opened for each machine.
(VTR-Form-02/VTR Form 03)
6. Corrective Action
If any results are found to be out of specified limits, raise a non-conformity to proceed
with corrective and preventive action.
Section No. QPM – 10 - VTR
1. Scope
2. Responsibility
The Technical Manager is overall responsible for scheduling, carrying out and
recording the results of tests.
Two sets of samples, specially prepared and graded are used for this test.
All, who have reached competence in tests involving colour and pilling assessment
are subjected to these two tests once in 3 months.
Section No. QPM – 11 - MH
1. Scope
(i) Consumable
(ii) Glass ware
(iii) Customer Samples
2. Responsibility
The Technical Manager is overall responsible for the safety, and care of all laboratory
equipment, chemicals, standard reference material and machine parts, functional
responsibilities are indicated below.
Disposal 1. All chemicals after expiry of shelf TM/Lab Exec. Chem. Reg.
life is destroyed
Section No. QPM – 11 - MH
1. Scope
This section of the manual describes the internal quality audit procedure. The
objectives of internal quality auditing are;
2. Responsibilities
2.1 The Quality Executive (QE) is responsible and authorised for planning the
Internal Quality Audits, periodicity, work area for the audits, selection of audit
team and also for maintaining and documenting records. He is also
responsible for reviewing whether timely corrective actions are taken in case
of non-conformities recorded during Internal Quality Audits.
3. Audit Planning
QE plans the frequency, dates and department of internal quality audits. These
audits are carried out at least twice a year covering all the requirements of ISO
17025 quality systems to each. Ref.IA-Form-01
4. Audit Scheduling
4.1 QE in consultation with Director selects the Audit team members, including
audit team leader.
4.2 All members of the audit team have undergone the internal quality
audit training programme.
4.3 No employee of the Department is allowed to audit his own
Department.
4.4 QE intimates to the respective (Auditees) about the proposed dates, areas of
audit and audit team in writing in audit schedule. Ref. IA-Form-02
4.5 The QE intimates to the auditees and auditors one week prior
to the audit.
Section No. QPM – 13 - IA
5. Audit Process
6. Auditee must carry-out the corrective action and complete the relevant cage
in IA-Form-03.
7. Follow-Up Review
A follow-up audit is carried out immediately after the corrective action and before the
next scheduled audit and the relevant columns of IA-Form-03 of
the previous audit must be completed.
8. QE’s Comments
1. Scope
To prevent the release of non-conforming data and to ensure that it is reported so that
corrective action can be taken.
2. Responsible
All staff members are responsible for identifying any suspected or real non-
conformities. The TM is responsible for ensuring the control of non-conforming work
and for giving instructions for resumption of work or release of data once the non-
conformity is cleared.
The TM is responsible for initiating a report on non-conforming work and for
ensuring that the root cause is investigated and corrective action taken as per
procedure
QPM-17-PCCA.
3. Identification
4. Response
4.2 Reporting
1. Scope
To ensure that appropriate corrective action is planned and taken in response to non-
conformities. This procedure also provides for follow up to establish the effectiveness
of corrective actions.
2. Responsibility
Where corrective actions are in response to internal audit findings the auditor and
auditee are responsible for agreeing on corrective actions, time scale and for
assigning responsibility for carrying out the action.
The auditor and auditee are also responsible for establishing a plan for follow-up to
confirm the effectiveness of the corrective action.
The QE is responsible for monitoring the corrective action and for confirming that it
has been implemented effectively. ( Ref QPM- 12 –IA )
The TM is responsible for planning corrective action and for establishing a plan for
follow up to confirm that the action has been effective. It is normally expected that
this will be in discussion with the QE. The responsibility for taking the action and the
required date of completion will be assigned by the TM.
The QE is responsible for confirming that the corrective action has been completed
and is effective.
Section No. QPM – 15 - PCCA
1. Scope
To ensure that appropriate corrective action is planned and taken in response to non-
conformities. This procedure also provides for follow up to establish the effectiveness
of corrective actions.
2. Responsibility
Where corrective actions are in response to internal audit findings the auditor and
auditee are responsible for agreeing on corrective actions, time scale and for
assigning responsibility for carrying out the action.
The auditor and auditee are also responsible for establishing a plan for follow-up to
confirm the effectiveness of the corrective action.
The Quality Executive (QE) is responsible for monitoring the corrective action and
for confirming that it has been implemented effectively. (Ref QPM- 15 –IA)
The TM is responsible for planning corrective action and for establishing a plan for
follow up to confirm that the action has been effective. It is normally expected that
this will be in discussion with the Quality Executive. The responsibility for taking the
action and the required date of completion will be assigned by the TM.
The QE is responsible for confirming that the corrective action has been completed
and is effective.
Section No. QPM – 15 - PCCA
Corrective action must be such as to address the root cause of the non-conformity.
The action proposed and the plan for follow up to confirm effectiveness of the action
must be entered on form NC-FORM-01 or form IA-FORM-01 as appropriate.
The form must then be reviewed by the QE who will, if necessary, ask for additional
or modified corrective action. In particular the QE must be satisfied that the root
cause of any non-conformity is being addressed by the corrective action.
The QE is responsible for following up to confirm that the corrective action has been
carried out and has been effective. The follow up must be recorded on the appropriate
form, i.e. NC-FORM-01 or form IA-FORM-01.
Section No. QPM – 16 - PCPA
1. Scope
To ensure that the quality system is scrutinised to identify any areas where the
potential for non-conformities can be reduced and to identify opportunities for
improvement.
2. Responsibility
All staff and auditors are responsible for bringing to the notice of the QE any
suggestions which might improve the quality system.
Internal and external auditors, in addition to their prime function, are expected to
advise the QE of any suggestions they have for improvements to the quality system.
Formal scrunity of relevant information on the performance of the quality system and
identification of preventive action will be carried out at the Management Review
meeting. See QPM-5-MR.
The Management review meeting must consider all feedback on the performance of
the quality system with a view to identifying preventive actions, which can
practicably be taken. The review may consider the practical and commercial
implications of any preventive action with respect to the scale of the perceived risk.
All suggestions for preventive actions must be communicated to the QE who will
initiate a Preventive Action Record Form PR-FORM-01 summarising the reasons
why the action should be considered..
The QE must discuss the suggested action with the TM and decide whether the
identified risk and the action proposed are adequate.
If the QE concludes that the action is not required then the reasons must be recorded
on the form and no further action need be taken.
If the QE is satisfied that the action is required the planned action must be detailed on
the form and a person identified to carry it out. A time scale for the action must also
be entered.
The QE is responsible for following up to confirm that the preventive action has been
completed.
The QE must review the effectiveness of all preventive actions and record comments
on the form. The QE must provide a summary of conclusions on the effectiveness of
preventive actions to the next Management Review.
PR-FORM-01
Suggested by…………………………………………………………….Date……………
Signed…………………………………………………………………Date……………...
QE
Signed……………………………………………………………….Date :………………
QE
Signed……………………………………………………………….Date :………………
QE
Signed………………………………………………………………Date………………..
QE
Document No. :
Issue No. :
Revision No. :
Reference/Section No. :
Page No. :
Reason for Change :
Change Required :
: …………………
Issuing Authority
Date:
……………………..
Approving Authority
DD-Form-02
DOCUMENT REVISION INTIMATION/ACKNOWLEDGEMENT FORM
DOCUMENT REVISION
DOCUMENT REFERENCE NO.
Please find enclosed the revised document for section ………………….Page No………
of ……………. along with copy of updated revision record page.
(1) Confirm that you have received and incorporated all earlier revisions
to the document.
(2) Take out the obsolete pages from your copy and destroy same by tearing.
(3) Insert the revised pages including the revised “Revision Record” in your copy.
Please return this covering memo to me as confirmation of having completed the above
actions.
………………………..
Signature of QE
To : Quality Executive
…………………………
Signature & Name of the Copy-
Holder with Date.
TR-Form-02
1. Name of Participants :
2. Designation :
3. Training Programme :
4. Duration :
5. Venue :
6. Training conducted by :
Remarks :
(To be filled by the Officer In-Charge of training
on interview with participant)
Date : ……………
Name :
Division :
Designation :
Nature of Work :
Supervisor’s Comments :
Training :
(indicate if training is
required and the area)
Technical Manager :
Comments
………………………. ………………………..
Signature of Supervisor Signature of Technical Manager
A. Sample Preparation
Marks
Correct Incorrect
Sample Selection Procedure If correct 1 mark.
If incorrect 0 mark.
Method of Marking
Method of Cutting
No. of Samples
Total Marks
B. Testing Procedure
Total ……………
A. Sample Preparation
B. Testing Procedure
C. Safety
Recommendation
• Check whether the results are initialled by the person carried out the test.
• Check the sample reference, description, No. of samples and the date
clearly entered.
a) Client name
b) Client reference no.
c) Test report no.
d) Whether the cover and the pages are correctly attached
• Issue the report to the client and if required obtain his/her signature for
acknowledgement.
Report by………………………………………………………….Date………………….
Signed……………………………………………………………….Date :………………
Technical Manager
Signed……………………………………………………………….Date :………………
Technical Manager
Signed……………………………………………………………….Date :………………
Technical Manager
1. Name : ………………………………………………………..
a) Company ………………………………………………………
Contact Person ……………………………………………………...
Address ………………………………………………………
Telephone …………………………….. Fax …………………
E-Mail …………………………….
Services Provided ………………………………………………………
………………………………………………………
………………………………………………………
b) Company ………………………………………………………
Contact Person ……………………………………………………...
Address ………………………………………………………
Telephone …………………………….. Fax …………………
E-Mail …………………………….
Services Provided ………………………………………………………
………………………………………………………
………………………………………………………
Services Required:
…………………………………………………………………………………………..
…………………………………………………………………………………………..
…………………………………………………………………………………………..
…………………………………………………………………………………………..
Selection Criteria :
…………………………………………………………………………………………..
…………………………………………………………………………………………..
…………………………………………………………………………………………..
SUPPLIER/SUB-CONTRACTOR PERFORMANCE
4. Evaluation of Service
Quality =
Price =
Packaging System =
On time Delivery =
Supply of required Quantity =
Average Mark =
5. Comments : ……………………………………………….
……………………………………………….
……………………………………………….
……………………………………………….
……………………………………………….
……………………………………………….
………………………
Technical Manager
Name of Equipment :
Date Received :
Yes No Remarks
……………………… …………………….
Technical Manager Inspector
Name of Item :
Date Received :
Inspected by :
Yes No Remarks
1.1 Strength
3. Other Comments
……………………………
Inspector
8. What are the factors, which prompted you to obtain our services?
(Mark first three in order of priority as 1, 2 and 3 in appropriate cages)
Price Turn around time Technical assistance