Procedure for Quality Assurance

1.0

PURPOSE

The purpose of this procedure is to ensure that all testing activities

carried out at ENTERPRISE Labs meet requirements to assure the quality
of test results and that the results are accurate and precise.
2.0

SCOPE

This procedure is applicable to ENTERPRISE Labs where testing is being

conducted.
3.0

RESPONSIBILITY

3.1Management Representative (MR) is responsible to:

3.1.1
3.1.2
3.1.3
3.1.4

Ensure coordination for Proficiency testing (PT).

Approve Quality Assurance Program for the lab.
Ensure that the developed program is followed.
Approve list of selected PT providers.

3.2Deputy Management Representative (DMR) is responsible to:

3.2.1
Register Lab with finalized PT Providers.
3.2.2
Develop Quality Assurance Plan for the lab.
3.2.3
Develop list of selected PT providers.
3.2.4
Ensure execution of the plan and maintain documentary evidence of
its implementation.
3.2.5
Compile and store all the results and records that are generated
from Quality assurance activities.
4.0

PROCEDURE

In order to assure the Quality of tests being performed, lab management

is to make dedicated efforts to ensure strict compliance through Quality
Assurance Program. Laboratory quality control is an essential aspect
of ensuring that data released is fit for the purpose determined by the
quality objectives (i.e. accuracy and precision). Lab Quality Assurance
Program includes:
a.
b.
c.
d.

Participation in PT
Replicate Testing
Retesting
Estimation of Uncertainty

4.1Proficiency Testing (PT)

4.1.1

Selection Process for PT providers

DMR is primarily responsible for searching of suitable PT providers

especially for the tests in the accreditation scope. DMR in consultation
with MR short lists the PT providers and form initial contact via email, fax
or telephone. In case of more than one PT providers then DMR in
consultation with MR selects the PT provider considering the following;
a. International / Domestic Recognition of the PT provider

Procedure for Quality Assurance

b. Appropriateness of the PT scheme to parameters in the scope of
accreditation
c. Financial considerations
d. Suitability of program (time, parameter)
NOTE: Quality Assurance Program will be developed in accordance with
schedule provided by the PT provider.
4.1.2
a.

b.

Registering in a PT Program
DMR is responsible to identify PT providers for tests in the scope of
accreditation. Upon finalization of PT provider, DMR enters its details
in the List of Selected PT Providers and make preparations s per
the instructions provided by the PT provider.
DMR is responsible to store all communication records.

4.1.3
Managing PT Process for Participation and Test Result
Submission
a. Upon receiving Blind Samples, DMR inspects the following before
accepting it:
i. Packaging of the sample for any physical damage or tampering
ii. Sample container, and sample itself for any physical / visible
damage, leak, tampering, etc.
b. In case of any nonconformity, PT provider is immediately notified and
test on the sample is not performed until and unless PT provider gives
a go-ahead or re-issues a new sample (this step is also performed in
case sample is damaged by the lab itself).
c. If the sample is found to be in acceptable state, its acceptance is
reported to PT by DMR, while ensuring that date is noted to estimate
the total time available for performance of test and delivery of test
result (timeline is provided by PT service provider).
d. DMR ensures the following before performance of the test on blind
sample is initiated:
i. Analyst to perform the test is identified on the basis of his/her
authorization and expertise (supervisor level recommended).
ii. Test Method is available.
iii. Equipment is ready.
e. Analyst ensures the following before starting the test performance:
i. Availability of lab note book for documentation of activity.
ii. Availability of appropriate test method.
iii. Equipment and required additional apparatus is ready for use, and
work instruction available.
iv. Environmental conditions (if any) are in compliance with test
requirement and not exceeding the defined limits.

Procedure for Quality Assurance

v. Any additional documents or forms required for test are available
(based on test requirement or requirements by PT service
providers).
f. When everything mentioned above is confirmed and ready, Analyst
starts the performance of test.
g. DMR ensure monitoring while the test is being performed and ensure
fulfillment of required documentation requirements for submission of
test results to PT provider.
h. DMR will ensure that results are documented as per PT provider
instructions.
i. The results are communicated to PT provider utilizing the medium of
service providers preference.
j. Remaining sample is stored in a controlled environment for future
references and activities (where possible).
4.1.4
a.

PT Result Analysis
After receiving the result from PT service provider, it is determined
whether QA/QC results have been considered Satisfactory or NonSatisfactory (Questionable).
No further actions required in case of satisfactory result, DMR can
now initiate new program for PT, or start communication for next due
round.
In case of Unsatisfactory results, lab will follow these steps:

b.
c.

i. DMR initiate CPA form and investigate for identification of root

cause behind the issue following Procedure for Corrective and
Preventive Action.
ii. DMR also involves PT provider to collect their expert opinion.
iii. Based on the result of investigation, DMR decides to rectify the
problem as well as re-initiates PT process
iv. In case of unsatisfactory result of investigation (unable to discover
the actual cause of unsatisfactory test result), DMR will register PT
program with a new service provider.
4.2Retesting & Replicate Testing of Samples
4.2.1

Retesting

Retesting is a planned activity and performed at periodic intervals to

verify previously performed tests. It must be understood here that
retesting a sample because of a nonconformity or because of an
ongoing investigation or complaint is not the same. ISO 17025 asks for
retesting of samples as a QA/QC measure. It is a procedure of repeating
test on already tested samples. All such samples are kept in storage
under acceptable conditions. The intention is to get the same result as of
the first performance. It can also be adopted in case; an analysis is not
giving the required result. In Short:
Retesting means same person performing the same test
repeatedly under same conditions

Procedure for Quality Assurance

4.2.2

Replicate testing

Replicate testing is also a planned activity and performed at periodic

intervals to verify previously performed tests. It is performing tests on a
volume of sample after replicating it and distributing it to different staff
members. The intention is to get the same results out of each of them,
but lab supervisors must ensure that all sample replicates carry the
same characteristics/ In short:
Replicate testing means different persons performing same
tests under same conditions
Replicate / Retesting will be performed as per the formulated Quality
Assurance Program / Plan. Retesting is performed by rechecking
results by the same method and analyst whereas Replicate Testing is
performed by rechecking results by the same method but by a second
analyst.

a.

Selection of Personnel
Before finalizing Lab staff members to contribute in this activity (at
least 2), DMR should ensure the following;
i. Performer is fully trained in the selected testing activity and has
training records available to justify this statement.
ii. Performer is available on the required date/time for performance
iii. He has good practice on the equipment / apparatus being used.
iv. He understands the requirements of the replicate / retesting
activities and its importance in Lab Management System
v. He is capable of providing data that is relevant to testing report
vi. He is capable of highlighting weak areas and also can address
corrective actions

b.

Sample Preparation and Distribution Control

DMR is responsible for finalizing sample preparation procedure and
shall appoint a person (or perform himself) the activities and give
each sample a unique ID, e.g. REP-TEST-01 / RETEST-01, REP-TEST-02 /
RETEST-02, etc. This data shall be recorded in Replicate Testing /
Retesting Report, so that related data is available at one place.

c.

Result Compilation and Analysis

After collecting all results from staff members involved, DMR should
develop Replicate / Retesting Report which should include the
following;
i.
ii.
iii.
iv.
v.

d.

Dates / Time
Name of Personnel Involved
Sample results with their Unique IDs
Calculation of Average (based on Results)
Standard Deviation (based on Results)

Corrective Action and Its Follow up (Wherever Applicable)

Procedure for Quality Assurance

In case results or any condition varies and difference at some level is
very high, activity should be rescheduled for the same type of
sample. If the difference persists then corrective action should be
initiated to address the problem.
4.3Estimation of Uncertainty
It is the uncertainty of the personnel performing the test, as a
personnels error it cannot be calculated in the form of numerical values
but estimated by determining the combined estimation of Repeatability
and Reproducibility through the test result.
ENTERPRISE Lab performs uncertainty of tests in the accreditation scope
as per the Quality Assurance Program. Furthermore, lab will perform
uncertainty each time when any of the following happens;
a. Amendment in the Test Method
b. Change in Lab Authorizations (addition / deletion of test performers
for particular test)
c. Calibration or recalibration of equipment
d. Allocation of new equipment for particular test
Please refer Procedure for Estimation of Uncertainty
5.0

ASSOCIATED DOCUMENTS & FORMATS

5.1Procedure for Estimation of Uncertainty

5.2PT Correspondence & Communication File
5.3Quality Assurance Program
5.4Quality Assurance Plan
5.5Replicate / Retesting Report
5.6 List of selected PT providers