Review complete, no changes needed - When a Procedure is due for a periodic review?

K

kennypa

#1
Hello all,
Currently document control is not electronic.
Quick question.
When a Procedure is due for a periodic review:
Who should review it? Everyone intially involved?
If no change is needed:
Does it have to receive new signatures?
Do new controlled copies have to be distributed?
(our new plan may be to stamp controlled copies with an expiration date, equal to the required review date, so I assume new copies should be distributed for that reason)
Does the re-distribution warrant a new revision number?

Assuming we decide not to stamp our controlled copies with an expiration date, and we add a "Reviewed by" signature section to the procedure format, could we just have the master copy signed as "reviewed with no changes needed" and file back in our master copy file cabinet?

Sorry, I take back that part above about this being a quick question. Thank you everyone for your help. Ken
 
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D

David Hartman

#2
At a former employer we used to track the review by, and review completed dates in the master document index (also included release date, and current revision or date).
 
D

ddunn

#3
I have always proved "periodic review" of documents the the internal audit process. The periodic internal audit includes a review of documents by both the auditor and the auditee.

If a document doesn't change, don't touch it. No new signatures, no new copies, no stamps.

Do not stamp controlled copies with an expiration date. This will cause more work tracking those dates.

Remember - KEEP IT SIMPLE
 

SteelMaiden

Super Moderator
Trusted Information Resource
#4
ddhartma said:
At a former employer we used to track the review by, and review completed dates in the master document index (also included release date, and current revision or date).
This method works well. You can then report on any doucments that are "outside" your defined review period and send a notice to the owner (or whomever does your review) to let you know if there are any changes needed. Document the date reviewed, who did it and your are good to go.
 

Helmut Jilling

Auditor / Consultant
#5
kenfagan said:
Hello all,
Currently document control is not electronic.
Quick question.
When a Procedure is due for a periodic review:
Who should review it? Everyone intially involved?
If no change is needed:
Does it have to receive new signatures?
Do new controlled copies have to be distributed?
(our new plan may be to stamp controlled copies with an expiration date, equal to the required review date, so I assume new copies should be distributed for that reason)
Does the re-distribution warrant a new revision number?

Assuming we decide not to stamp our controlled copies with an expiration date, and we add a "Reviewed by" signature section to the procedure format, could we just have the master copy signed as "reviewed with no changes needed" and file back in our master copy file cabinet?

Sorry, I take back that part above about this being a quick question. Thank you everyone for your help. Ken

Your questions are all beyond the scope of ISO requirements. In other words, you may choose how you approach these details. ISO does not dictate the methods to this level of detail.

Therefore, while it is good to know what your peers do, but decide what the purpose of these activities are for, and find a simple clear way to meet your needs. It will be different for different companies.
 
O

ob1con

#6
Use internal audit

:applause:

I agree with DDunn, use your internal audit process as your periodic review. By putting an "expiry" or "fresh before" date on your procedures you are making more work than necessary. Use the audit to prove the procedure is still applicable or redundant. If found to be no longer applicable, notify the auditee and the responsible process owner to make the necessary changes. More appropriately, if it is not broke, do not fix it!! Review for the sake of ISO is not a good review for the company. Make it applicable, practical and simple to follow and that will ensure the company actually benefits from a QMS. Use your master document list as a method of control and notification of need for change due to audit or even corrective actions.>
 
D

David Hartman

#7
ob1con said:
:applause:

I agree with DDunn, use your internal audit process as your periodic review. By putting an "expiry" or "fresh before" date on your procedures you are making more work than necessary. Use the audit to prove the procedure is still applicable or redundant. If found to be no longer applicable, notify the auditee and the responsible process owner to make the necessary changes. More appropriately, if it is not broke, do not fix it!! Review for the sake of ISO is not a good review for the company. Make it applicable, practical and simple to follow and that will ensure the company actually benefits from a QMS. Use your master document list as a method of control and notification of need for change due to audit or even corrective actions.>
Not trying to be argumentative, just presenting a different perspective. If your tracked your processes for review via the master index (not the documents themselves) then you have a chance of being proactive with any changes that need to be made, rather than waiting for the internal auditor to catch these problems. Not only that but an audit is merely a sample, taken at a specific moment in time and may not catch all of the changes that may need to be made.

Another perspective: Perhaps the onus should be on ensuring the processes are updated as changes are being made, then your internal audit could result in corrective action for this deficiency if an outdated process is discovered.
 

Helmut Jilling

Auditor / Consultant
#8
ddhartma said:
...Another perspective: Perhaps the onus should be on ensuring the processes are updated as changes are being made, then your internal audit could result in corrective action for this deficiency if an outdated process is discovered.

I think this is the key. We must stop changing the processes without reviewing and changing the documents that CONTROL the process.

If a builder changes the master bathroom, he will do so by changing the drawings and documents controlling that part of the construction.
 

SteelMaiden

Super Moderator
Trusted Information Resource
#9
Yes, why wait until it is found in an audit? Then it becomes a nonconformance, and the name of the game is continual IMPROVEMENT. We look at all documents that have had no revisions in the past three years. If they are still good, so be it. If they are not needed, we delete them. If they need changes, we change them.
 
D

ddunn

#10
SteelMaiden said:
Yes, why wait until it is found in an audit? Then it becomes a nonconformance, and the name of the game is continual IMPROVEMENT. We look at all documents that have had no revisions in the past three years. If they are still good, so be it. If they are not needed, we delete them. If they need changes, we change them.
Please understand. I only use the audit process to prove "periodic review" of documents. Documents are in fact under constant review by the originators and users. This comes from ownership of the processes and the desire throughout the entire company to make the system effective, efficient and profitable.

If there are problems with periodic review and improvement of the documentation the real problem would seem to be pride in ownership. This is a different issue that may require a whole different approach to the Quality Management System.
 
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