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