Should procedures have a "revise by" or "expiration" date?

11 Replies

Should procedures have a "revise by" or "expiration" date?

Posted by Thomas Ohrbom on Dec 24, 2018 2:04 am

Hi, I have been a quality manager for a few years now, and I have setup and maintained management systems (and obtained ISO 9001 and ISO 14001 certifications) at several companies.
Previously I have never seen the need to enforce a "revise by" date or to set an expiration date on documents in the management system. I am now at a new company, and I have started work on introducing a management system (the reason I have been hired), and management here is already requesting that we enforce a strict policy of expiration dates on all documents in the management system.

I would like to hear your experiences and recommendations on this. Thanks!
Quality Manager Bertel O. Steen AS, Oslo, Norway

Re: Should procedures have a "revise by" or "expiration" date?

Posted by Joseph Brzoska on Dec 24, 2018 8:34 am

As a quality manager for a small company and having to wear a number of hats, I find that having an expiration date a good rule.  You are forced to review documents and records on a continuing basis.  I've decided to have a requirement to review these documents every 3 years.  Seems to work for me.  Using this guide, I've had the opportunity to remove old documents that no longer are used or are not necessary especially for the newer version of ISO.

Re: Should procedures have a "revise by" or "expiration" date?

Posted by Daniel Zrymiak on Dec 24, 2018 2:42 pm

The content and context of the procedures and organization should define its validity and lifespan.  If the procedures describe a process that has not changed over time, then it could be sustained for a longer period than one describing a shifting process in a dynamic organization.  

In this context, I would like the impartial, professional opinion about the document control practices within ASQ.  If you examine the processes at this location, you will find some that have not been updated since 1997.  I personally think that 21 years is too long to leave a policy or procedure unchanged, particularly if there have been several significant organizational changes.
https://asq.org/about-asq/how-we-do-it/pnp-f
 

Re: Should procedures have a "revise by" or "expiration" date?

Posted by Imran Rana on Dec 24, 2018 8:45 pm

The procedures and other policies are generally revised at 3-5 years span, working with organizations of all type/size i have  witnessed advantages of revising documents, as due to customer, market and regulatory changes businesses found the need to revise SOPs. So,our management systems are required to be flexible to adopt on going changes which are everywhere if we keenly observe.

Re: Should procedures have a "revise by" or "expiration" date?

Posted by Jeremiah Genest on Dec 24, 2018 8:58 pm

In the pharmaceutical and medical device industries (and similar) periodic review requirements is a requirement based on a host of different regulations and guidances.

like everything, this should be based on risk. A master production record is on a different cycle than a component specification. The 3-5 year range mentioned by others is fairly standard.

Re: Should procedures have a "revise by" or "expiration" date?

Posted by Roberto Tahan on Dec 26, 2018 9:49 am

It is not mandatory, but as companies change over time, it forces us to keep the procedures up to date. So, establishing a review date is a good preventative practice.

Re: Should procedures have a "revise by" or "expiration" date?

Posted by Thomas Ohrbom on Dec 28, 2018 4:13 am

Thank you for the replies, guys. You seem to be more or less on the same page, all of you. And what you suggest is not that far from what I practised. Even if I have not previously set at revise by date on procedures, I have always ended up reviewing all documents at least once in a three year cycle, as I've always practised internal reviews of all processes at least once per three years.

I think now that I will setup a system where I set a default "life span" of a revision to three years, and update this at every revision,. I'll leave this date as a hidden metadata only available to the document owner, process owner and myself.

Then I'll set up a monitoring process and a document report listing the current status, with warnings on anything nearing end of life (let's say three months or less).

Cheers!
Quality Manager Bertel O. Steen AS, Oslo, Norway

Re: Should procedures have a "revise by" or "expiration" date?

Posted by Kaiwen Cheng on Dec 31, 2018 9:25 am

Thomas,
It appears that you have received sufficient inputs for your decision.  That's great and I want to offer one more piece of suggestions.

The "revise by" or "expiration" date by itself does not generate enough benefits.  The practice I had in our organization/corporation is driving that dates with the internal audit program.  Our idea on the quality document itself is "procedures are the documentation of the best practices known during that period of time".  The focus shall be on the validity of the best practice itself.  Therefore, the document has no need to be revised if we have proven it is fit with the purpose.

As you can see, the key point is on auditing the processes to see if it still meet the needs or requirements.  Procedures are the complementary elements for the program, not the focus.  The "revise by" date is in fact the due date of internal audit program of each procedures.  I have seen many companies taken the "don't fix if it ain't broke" approach, but if there is a lack of structured internal audit program then how would we know if it is broke?  

My encouragement is thinking about what a "revise by" date is for.  We quality managers sometime think we know all the processes and chosen to "review" the procedures on our own which is a bad practice.  My lesson learned is that a robust internal audit program is a critical
driver to ensure Quality Management System to be trusted by all functions. 

Hope my suggestion is beneficial and Happy New Year!

Kaiwen Cheng, Owner, KC Business Consulting, LLC
https://www.kcbcweb.com

Re: Should procedures have a "revise by" or "expiration" date?

Posted by Thomas Ohrbom on Jan 1, 2019 11:50 pm

Kaiwen Cheng,
thank you, I fully agree. When I wrote "internal reviews" in my previous post, I did actually mean to write "internal audits". You did described it more eloquently than I did though.

Happy new year!
Quality Manager Bertel O. Steen AS, Oslo, Norway

Re: Should procedures have a "revise by" or "expiration" date?

Posted by Kaiwen Cheng on Jan 2, 2019 8:44 am

Thomas, you are welcome and thank you for providing a good subject for discussion.  

Kaiwen, https://www.kcbcweb.com
 

Re: Should procedures have a "revise by" or "expiration" date?

Posted by Sophie Gooch on Jul 23, 2019 5:17 am

The "change by" or "lapse" date without anyone else does not create enough advantages. The training I had in our association/partnership is driving that dates with the inner review program. Our thought on the quality record itself is "methodology is the documentation of the prescribed procedures known during that timeframe". The emphasis will be on the legitimacy of the best practice itself. In this manner, the record has no should be amended on the off chance that we have demonstrated it is fit with the reason.


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Re: Should procedures have a "revise by" or "expiration" date?

Posted by Caroline Cook on Sep 4, 2019 4:11 pm

Per our laboratory accreditation, we're required to put documents on an annual or biennial periodic review cycle. Our document management system has a workflow that automatically puts it in the cycle. It will notify within 30 days of the periodic review date that the document is coming up for review. We do annual for policies and biennial for most procedures. It may seem frequent, but I find that smaller, more frequent reviews generally eliminate the need to have to completely overhaul the content of a very old document. In some cases, no revisions are needed at the time of periodic review, but at least we've recorded with a date that the content is still valid.