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How to give a root cause reply to this non-conformance on retention of records?

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qcdept

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Posted 22 September 2020 - 01:47 AM

Hi all, below are one of NC that i got during the audit, however the auditor was not satisfied with my corrective action because it doesnt fix the root cause. can anyone here help me with some ideas on how to answer the CA?

 

statement of non conformity 

Retention of food safety system records was not clearly defined in the procedure

 

Containment Action

Create retention period of the documents and keep it in the HACCP manual for reference

 

Root Cause

QA not aware with the retention period of keeping documents

 

 

Corrective action

Refer haccp standard  when preparing the documents

 

Regards

N

 

 



Charles.C

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Posted 22 September 2020 - 05:28 AM

Hi all, below are one of NC that i got during the audit, however the auditor was not satisfied with my corrective action because it doesnt fix the root cause. can anyone here help me with some ideas on how to answer the CA?

 

statement of non conformity 

Retention of food safety system records was not clearly defined in the procedure

 

Containment Action

Create retention period of the documents and keep it in the HACCP manual for reference

 

Root Cause

QA not aware with the retention period of keeping documents

 

 

Corrective action

Refer haccp standard  when preparing the documents

 

Regards

N

Hi qcdept,

 

Some clarification needed.

The criticism seems to imply a lack of specific information regarding retention times for documents ?, eg minimum 12 months retention time

 

If so, yr suggested CA does not yet answer the criticism ?.


Kind Regards,

 

Charles.C


qcdept

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Posted 22 September 2020 - 06:41 AM

Hi Charles,

 

auditor mention the CA should fix the root cause, in this case, my CA was " to refer haccp standard when preparing the document" ,it is not acceptable since the root cause for this NC was " QA not aware". how are we going to make QA aware? to refer standard is not tally with root cause.

 

I am planning to replace the  current CA  with " to give training to QA" however, i am the only person in this company that in charge for haccp document control and i already attend haccp awareness and IA training before. do you have any suggestion on this matter?

 

Thanks

N



qcdept

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Posted 22 September 2020 - 06:42 AM

Hi qcdept,

 

Some clarification needed.

The criticism seems to imply a lack of specific information regarding retention times for documents ?, eg minimum 12 months retention time

 

If so, yr suggested CA does not yet answer the criticism ?.

Hi Charles,

 

auditor mention the CA should fix the root cause, in this case, my CA was " to refer haccp standard when preparing the document" ,it is not acceptable since the root cause for this NC was " QA not aware". how are we going to make QA aware? to refer standard is not tally with root cause.

 

I am planning to replace the  current CA  with " to give training to QA" however, i am the only person in this company that in charge for haccp document control and i already attend haccp awareness and IA training before. do you have any suggestion on this matter?

 

Thanks

N



pHruit

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Posted 22 September 2020 - 07:42 AM

Are you responsible for all records relating to food safety systems?
Does some of the responsibility for this sit with e.g. production, and potentially also with logistics (e.g. goods in/out records that could be very relevant for recall/traceability purposes).
If your first corrective action addresses the specific element highlighted by Charles - e.g. you now have a documented procedure/standard that all records are retained for x months, then I'd potentially look at the second step of your CA being to augment this with training to the relevant people, and ensuring that there is a record of the training that you can share with the auditor as evidence. Obviously training yourself on a procedure you wrote seems a bit silly (although it wouldn't be the first time I've seen an auditor expect as much ;) ) but you can look at ways to broaden this out to (a) make it more plausible and (b) ensure that all of the necessary records and people really are covered.



Charles.C

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Posted 22 September 2020 - 07:44 AM

hi qcdept,

 

By "clarification" I meant  - 

 

(1) You have quoted the NC as -
 

 

Retention of food safety system records [RR] was not clearly defined in the procedure

(As I understand yr OP, the NC occurred in a haccp context, specifically the retention period of (haccp) records).

 

But what does the NC actually mean ? ie -

 

(i) What was yr stated  Procedure for RR ?

(ii) Why was the stated Procedure for RR considered by the auditor as insufficiently "clear" ?

 

(2) I agree yr auditor's comment that the CA should [ultimately] "fix the root cause," eg -

 

ISO22000 Def - corrective action - action to [a] eliminate the cause of a nonconformity  and [b] prevent recurrence.

( the [ ] are my own additions)

 

Frequently in practice, [a] tends to be rapid, eg crit.limit.failure and [b] tends to involve a "follow-up", eg RCA.

 

Required Responses (a,b) depend on the specific answers to (i,ii).


Edited by Charles.C, 22 September 2020 - 08:22 PM.
edited/re-stated

Kind Regards,

 

Charles.C


Hoosiersmoker

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Posted 24 September 2020 - 06:03 PM

Can you not just add "Food Safety System documents will be retained for no less than 3 years" or whatever the shelf life / expiration happens to be?



Charles.C

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Posted 25 September 2020 - 04:09 AM

Can you not just add "Food Safety System documents will be retained for no less than 3 years" or whatever the shelf life / expiration happens to be?

I agree but the OP seeks RCA.

 

hence my Post 6.


Kind Regards,

 

Charles.C




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