SOP for Analyst Qualification in Quality Control


1.0
Objective :
 To lay down a procedure for Training and Qualification of Quality Control Analyst.
2.0Scope :
 The scope of this document is to provide the procedure for Training and Qualification of Quality Control Analyst.
3.0Responsibility :
3.1Quality Control Personnel :
3.1.1To undergo Training and Qualification.
3.2Quality Control Head / Designee :
3.2.1To review and monitor the procedure for Training and Qualification of Quality Control Personnel.
5.0Procedure :
5.1Training shall be conducted by Manager / Designee for relevant core/ as per SOP, “Procedure for Training of Plant Personnel.
5.2Incase of SOP training the trainee shall be considered as ‘trained’ if analyst gets the qualifying score (> 80%) and should be evaluated through assessment questionnaire as per SOP, “Procedure for Training of Plant Personnel otherwise retraining shall be considered.
5.3Upon completion of training program, the new joinee shall undergo qualification process for all tests / techniques relevant to that area in which analyst is supposed to work.
5.4Based on the category to which the analyst belongs as per the discussion with the Head of Department, the tests in which the analyst shall be trained and qualified depending on the job responsibilities shall be identified.
5.5Non Complex Analytical Techniques are those for which a practical demonstration shall be provided by the trainer as per Annex – 1. As part of demonstration of these techniques, the Manager / Designee shall explain the test procedure to the analyst who is under training.
5.6Trainee shall enter the key learning points in the Analyst Qualification report.
5.7The details of the analytical techniques in which the analyst is trained and qualified shall be recorded in the current version of the “Analyst Qualification Record”,
5.8For complex analytical techniques the analyst shall be trained by Manager / Designee and key points of the analytical techniques shall be recorded by the trainer in “Analyst Qualification Record” during training.
5.9The analyst shall perform the test as per STP / Specification / GTP and qualification under the supervision of trainer and the qualification shall be verified as per the acceptance criteria.
5.10The trainer shall use the checklist provided in Annex – 3 to verify that the analyst undergoing qualification performs correct unit operations.        

5.11
Manager / Designee shall generate the Analyst Qualification Number (A.Q. No.) for each analyst as per procedure given below and this number shall be referred in analyst qualification raw data.
5.11.1AQXXYYY, Where AQ stands for Analyst qualification, XX denotes the last two digits of calendar year (20 for 2020) & YYY denotes the serial number.
5.11.2e.g. The Analyst qualification number for the first Analyst qualified in the year 2020 will be AQ20001
5.12For each analytical technique, the details such as “Name of Analytical Technique”, “Product” / “Material Name”, “Batch” / “Lot Number”, “A. R. Number” of the previous analysis shall be recorded in the “Analyst Qualification Register”.
5.13The details of analysis shall be recorded in the “Calculation Sheets” / “Test Data Sheets”. In case the qualification is performed on routine samples, the A.R. Number of the sample being analyzed shall also be recorded in the “Analyst Qualification Register” as a reference.
5.14The trainer shall review analytical results and consider the analyst as qualified, if the result of the test performed is complying with the acceptance criteria.
5.15Head of Department or his designee shall review the data of technique for which the analyst is under qualification and provide comments as “Qualified” or “Not Qualified” in the “Analyst Qualification Register”.
5.16At the beginning of every calendar year Manager / Designee shall prepare a schedule for re-training of relevant analytical techniques for each of the qualified personnel in the section in “Analytical technique Schedule”.
5.17The trainee shall be considered as trained only after the trainee qualifies as per the questionnaire.             
    5.18If the Analyst is having more than 2 years and above experience and have performed the similar analysis in previous organisation then depending upon the evaluation of previous experience and his expertise in the respective analytical technique, complex analytical technique need not be performed. In this case Analyst can directly put on the job by giving respective analysis of ongoing samples in presence of trained analyst and if the result meets the acceptance criteria then the analyst can be considered as Qualified Analyst.
 5.19Requalification of the Analyst shall be carried out if the analyst is absent for more than 60 working days.

6.0 Distribution :

This SOP (Controlled Copy) shall be distributed to Quality Control Department.

7.0 Annexures :

Annex-1 Non Complex Analytical Techniques for Qualification of Analyst

Annex-2 Complex Analytical Techniques for Qualification of Analyst

Annex-3 Checklist for Analyst Qualification.

8.0 Abbreviation :

Nil

9.0 Reference(s) :

Nil

10.0 SOP Revision History Record :

Revision No.Details for Revision(s) with Change Control No.Effective Date (Sign. / Date)

                                                               Annex-1

                           Non Complex Analytical Techniques for Qualification of Analyst

Sr. No.Analytical Technique
 1Description / Characteristics
 2Solubility of Solution
 3Appearance of Solution / Colour and Clarity of Solution
 4pH of Solution
 5Loss on Drying
 6Sulphated Ash
 7Residue on Ignition / Loss on Ignition
 8Heavy Metals
 9Limit tests such as Chloride, Sulphate, Nitrate, Lead, and Arsenic.
 10Bulk Density (Tapped / Untapped)
 11Distillation range
 12Melting Point
 13Sieve Analysis
 14Disintegration test
 15Friability
 16Thin Layer Chromatography
 17Preparation and Standardization of Volumetric solutions.
 18Determination of conductivity
 19Identification (FTIR, UV)

                                           Annexure-3    Checklist for Analyst Qualification                   
Name of the Analyst :
Product / Material/ Batch / Lot Number/ A. R.No.:
Test being performed:
Name of the Supervisor & Date:
Sr. No.ChecklistObservation     (Yes / No / NA)
 1Is the analyst using the correct analytical method for performing the analysis?  
 2Is the analyst using calibrated equipment / instrument for performing the analysis? 
 3Is the analyst using the correct working standard / reference standard? 
 4Is there evidence that the solutions/ reagents used during the analysis were within their validity period? 
 5Is it evident that the analyst is taking all the safety precautions? 
 6Is the analyst using the analytical balance correctly? 
 7Is the analyst using clean weighing accessories, like spatula, Butter paper, etc.? 
 8Is the solution prepared by the analyst labeled appropriately? 
 9Is the analyst using the correct glassware / reagents / chemicals / as mentioned in the analytical method? 
 10Is the analyst making concurrent documentation of the activity being performed? 
 11Are samples/ solutions stored appropriately during the analysis? 
Specific Observations for the Analytical Technique
    

Supervisor (Sign) & date:

One thought on “SOP for Analyst Qualification in Quality Control

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s