SOP for Qualifying Quality Control Personnel

OBJECTIVE

To lay down a procedure for qualifying quality control personnel.

SCOPE

This standard operating procedure covers the training and qualification of all laboratory technical personnel.

RESPONSIBILITY

Departmental Head/Trainee.

PROCEDURE

• Training shall be conducted by a QC executive / the head and the effectiveness of the training shall be evaluated through oral questions. The trainee shall be considered as trained only after qualifies as per the acceptance criteria given in the questionnaire.
• Details of the above training shall be recorded in the individual’s training card.
• Based on the category to which the analyst belongs (“with prior experience/ without prior experience”), as per the discussion with the head of the department, the tests in which the analyst shall be trained and qualified depending on the job responsibilities shall be identified.
• The qualification of the analyst on relevant analytical techniques shall be carried out as per annexure-1 attached and for Non Complex analytical techniques shall be carried out as per annexure-2 attached.

• The trainer shall record key points of the analytical technique in the analyst qualification record during the above training.
• The effectiveness of training shall be assessed through an oral questionnaire. The trainee shall be considered as a trainee only after the trainee qualifies as per the acceptance criteria.
• In the analyst register, the trainer shall summarize whether the observation analyst is qualified or not qualified.
• If not qualified, then the relevant steps indicated in the flow chart attached shall be followed.
• The details of the analytical techniques in which the analyst is trained and qualified shall be recorded in the analyst qualification record. as per annexure-3 attached.
• The analyst shall perform the test as per the STP/Specification/GTP, under the trainer's supervision. The qualification shall be verified as per the acceptance criteria as per annexure -4 attached.
• The trainer shall use the checklist provided as per annexure-5 attached, and verify whether the analyst undergoing qualification performs all unit operations as per the standard procedure/requirement.
• In case the analyst is found not following correct unit operations while performing the analysis on a pre-approved sample, the test shall be repeated completely or only those steps where the unit operations were not correctly followed and all details shall be recorded in the analyst qualification register without raising a non-quality impacting incident report.

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• For each analytical technique, the details such as the name of the analytical technique, product/material name, and batch/lot number. A.R.No. of the previous analysis shall be recorded in the analyst qualification register.

• The details of the analysis shall be recorded in the qualification sheets/ Records of analysis in case the qualification is performed on routine samples. The AR.No. of the sample being analyzed shall also be recorded in the analyst qualification register as a reference.
• The trainer shall review analytical results and consider the analyst as qualified if the result of the test performed complies with the acceptance criteria.
• In case the analyst is being qualified on the routine sample if the sample fails to meet the specification limits an OOS shall be raised.
• OOS investigation shall be conducted as detailed in the SOP.
• The head of the department or his designee shall review the data of the technique for which the analyst is under qualification and provide comments as qualified or not qualified in the analyst qualification register.
• If the analyst is qualified for an analytical technique listed in a group of analyst qualification records, shall be considered qualified for other analytical techniques listed in the same group.
• The details of analytical techniques in which the analyst is qualified shall be recorded in the analyst qualification record.
• For Microbial Analyst qualification: The following tests will be conducted to qualify the Trainee microbiologist.

Tests	Acceptance criteria
TBC	Shall comply with the specification. Both the results should be within 30 cfu/ml or gm difference.
TFC	Shall comply with Specification.
Pathogens	Shall comply with Specification.
Water Analysis	Shall comply with Specification.

• For Packing material analyst qualification: The following tests will be conducted to qualify the Trainee.

Pack Materials	Tests	Acceptance criteria
Labels Cartons Shippers	Dimensions Grammage  Color Text matter	To comply with Specifications.
Bottles	Various Dimensions	To comply with Specifications.

FREQUENCY

As and when analyst qualification is done.

ANNEXURE

Annexure - 1: Flow chart.

Annexure - 2: Non-complex analytical techniques for qualification of analysis.

Annexure - 3: Analyst qualification record.

Annexure - 4: Complex analytical techniques for qualification of analysts.

Annexure - 5: Checklist for the analytical qualification

ABBREVIATIONS

QC: Quality Control

QA: Quality Assurance

SOP: Standard Operating Procedure

REVISION HISTORY

Nil

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