Handling Out of specification result in water sample
This Document describes (Standard Operating procedure) SOP for handling of out of specification result in water sample
SOP for handling of out of specification result in water sample.
I. Purpose & Scope:
- To lay down the procedure for Handling of Out of Specification result in Water Sample.
- This Standard operating procedure is applicable for the Handling of Out of Specification result in Water Sample
II. Responsibilities:
- All Quality control personnel shall be responsible to follow and implement this SOP i.e. Handling of Out of Specification result in Water Sample
III : Introduction and Procedural Part:
Procedure for Handling of Out of Specification result in Water Sample :
- On observation of out of specification results in the microbial count of the water samples, the Microbiologist shall inform to Head of Quality control.
- Head of Quality control shall check the corresponding results along with documents. If Media plate of water shows any type of contamination or Negative control plate shows microbial growth, investigation shall be carried out to find the reason for the failure of negative control test and all tests shall be invalidated.
- Then Head of Quality control shall initiate the ‘Water failure investigation and Corrective and Preventive Form’. Refer Annexure I.
- Generate the water failure Serial number and shall be written as follows; WATF/Block Code (CEPHA for Cephalosporin block)/ last two digit of Year/Serial number start from 001. Example: WATF/CEPHA/15/001, This number indicate the first nonconforming result of water sample collected from CEPHA block water system in the year 2015.
- After initiating the number, fill the failure result details of water sample in the form.
Perform the laboratory investigation, investigate the following parameters for Out of Specification result in Water Sample:
- Procedure: Ensure that the correct method followed for analysis. Ensure the correct sampling procedure is followed for sampling.
- Equipment/Accessories: Ensure the correct or calibrated instrument used for analysis. Ensure the sterilization load of accessories as per validated cycle, temperature condition of area.
- Media: Media used for analysis should pass Growth promotion test, storage condition and expiry should be confirmed. Check the media for any physical appearance.
- Culture: Culture used during analysis should be authentic. Ensure the all cultures used are free from contamination.
- Personnel: Ensure the proper training of Microbiologist. Personnel hygiene of analyst should be checked.
- After laboratory investigation, Head of Quality control shall send the form to Head QA for further action.
- Head QA shall evaluate the failure and write the immediate action required in the form and prepare the investigation team consisting of Microbiologist/QC Person, production person, engineering person and one QA person.
If investigation shows the error in water generation system following actions shall be taken :
- Send form to Production department and engineering/utility department for its comment on failure.
- Take the comments of Head QA and Head of Operation on form .They shall decide the Corrective and Preventive actions to be taken with respect to failure.
- Perform the sanitization of complete water system. In case of critical failure, the frequency of sanitization of complete water system shall be increased.
- Recommended Corrective and / or Preventive action shall be written in the Form and shall send to Engineering department/Production to take corrective and preventive action.
- Sampling and analysis shall be done from all the user points for one to two weeks after taking corrective action.
- The result of water sample collected after taking corrective and preventive action shall be evaluated for the effect of action taken.
- On getting satisfactory result of water monitoring, Head QA shall close the Form.
IV:Annexure :
Annexure I: Water failure Investigation, Corrective and Preventive Form.
Annexure– I
Water failure Investigation, Corrective and Preventive Form.
| Failure Result | |
| Sample point Location | |
| Sampling point Number | |
| Date of sampling | |
| Parameter | |
| Specification | |
| Observed Value | |
| Name of analyst | |
| Laboratory investigation and its result | ||
| Parameter | Investigation | Remark |
| Procedure | ||
| Equipment/Accessories | ||
| Media | ||
| Culture | ||
| Personnel | ||
| Conclusion of Laboratory Investigation
|
|
|
| Initiated By Head of Department
|
Name | Signature | Date |
| Immediate action taken by user department
|
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Annexure- I
Water failure Investigation, Corrective and Preventive Form.
| Investigation Team | |||
| Department | Name | Signature | Date |
| Q.C/ Microbiology | |||
| Production | |||
| Engineering Department | |||
| QA | |||
| Engineering Department Comment :
|
|||
| Department | Name | Signature | Date |
| Head Engineering | |||
| Production Department Comment :
|
|||
| Department | Name | Signature | Date |
| Head Production | |||
| Recommendation of Corrective / Preventive Action | |||
| Name | Signature | Date | |
| Approved By | |||
| Head QA
|
|||
| Authorized By | |||
| GM (Operation) |
|
|
|
Annexure- I
Water failure Investigation, Corrective and Preventive Form.
| Corrective / Preventive Action Taken | |||
|
|
|||
| Name | Signature | Date | |
| Head Engineering | |||
| Head Production | |||
| Closing of CAPA Form | |||
| The water samples shows result within specification for consecutive three days after taking action | Yes / No / Not Applicable | ||
| Name | Signature | Date | |
| Head QA | |||
Note : Handling of Out of Specification result in Water Sample shall be performed as per above standard operating procedures.
