SOP for the Corrective and Prevention Action for non-conforming results

OBJECTIVE: To lay down the procedure for the Corrective and Prevention Action for non- conforming results in total microbial count in water samples

SCOPE: This sop “Corrective and Prevention Action for non-conforming results” is applicable to the utility department and all the production department

RESPONSIBILITY: Microbiologist

Head – Microbiology

Head – Production Block

Head Engineering and Utility

ACCOUNTABILITY

Head-Quality Assurance.

PROCEDURE: for Corrective and Prevention Action for non-conforming results

• On observation of out-of-limit results in Total Microbial Count in water samples collected from water generation and distribution systems, the microbiologist shall inform Head Microbiology.
• Head Microbiology shall check the corresponding negative control. If negative control shows microbial growth, the investigation shall be carried out for the reason for the failure of the negative control test and all test results shall be invalidated.
• If negative control shows no microbial growth in media, HOD Microbiology shall create the CORRECTIVE AND PREVENTIVE ACTION REQUEST  (C-PAR) FORM  as per Annexure – I and he/she shall record the initiation in a log book given in Annexure-II
• HOD Microbiology department shall start the identification of microbial colonies in the medium to evaluate the origin of the contamination.
• The sr. number of the C-PAR form shall be generated from the log book and shall be written as below:
• WATM/ block code (e.g. A, B, etc) / last two-digit code of the current year/ sr. number beginning from 001
• Example: WATM/A/23/001-002-003 and so on. The number shows the 1st non-conforming result in the microbial limit test in a given water sample gathered from the water system of Production department Block A in the year 2023  

Related: SOP for Analytical reports and raw data for correctness

HOD Microbiology has a right to categorize the failure as 1. critical,2. major and minor as per Appendix-I

• HOD microbiology shall mail the C-PAR form to the HOD QA after reporting the failure results, and the past history of any failure that is happened before in the system.
• HOD QA shall assess the failure report and shall write the quick action required as per Appendix 1.
• HOD QA shall authorize a team for investigation consisting of one microbiologist, one production person, one Engg., and one Quality Assurance member and shall report the name of the investigation team in C-PAR form.
• The C-PAR form shall be mailed to the HOD Production / HOD Engineering and Utility to take immediate action as reported in the C-PAR form.
• The investigation team shall carry out the investigation based on the facts and shall prepare the report as per Annexure-III. The investigation report along with the C-PAR form after repoerting immediate action and investigation report summary shall be given to HOD QA.
• If the investigation shows an error in the water system following will be proceedings: Head QA along with Head operation shall decide the corrective and /or preventive action to take to prevent the recurrence of failure.
• Recommended CAPA shall be written in the C-PAR form and shall be sent to HOD Production to take CAPA Sampling shall be done from all the user points departments for one to two weeks after assesing corrective action.
• The results of water samples collected after taking corrective and/or preventive action shall be evaluated for the effect of the action taken.
• On getting satisfactory results in water monitoring results, Head QA shall close the CPAR form.
• If the investigation shows no error in the water system, the following will be the proceeding: No preventive action shall be taken for an inconclusive minor and major failure. In case of inconclusive critical failure, the frequency of sanitization of the complete water system shall be increased.
• Sampling shall be done from all the user points for  one to two week
• On getting satisfactory results in resamples, Head QA shall close the CPAR form.
• The release of the Tbalets batches, which had used the water for production failing in microbial action limit, shall be hold till the final investigation and shall be rejected in case the investigation ends inconclusive or investigation results indicate that microbial quality of water that is used in product is affected.

ABBREVIATIONS

CCR-Change Control Request

QA-Quality Assurance

ANNEXURE

Annexure-I-Corrective and Preventive action request form

Annexure-II-Initiation Log

Annexure-III-Investigation report