Document Review Frequency

[Leslie M]

TS 16949 and ISO 9001:2000 say:

4.2.3 Control of documents
Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4.
A documented procedure shall be established to define the controls needed
a) to approve documents for adequacy prior to issue,
b) to review and update as necessary and re-approve documents,

Is there any required review frequency? How do you determine a review frequency?

 

[Wes Bucey]

Welcome to the Cove, Leslie!

I see by your profile you are a student (as are we all) and you ask a common question by folks who tend to think of ISO Standards as "prescriptive" rather than "descriptive."

If you are clear about what makes a record a special kind of document, let's proceed from there. If not, let us know and we'll backtrack.

In general, a record is an unchangeable 'proof" that a certain activity was performed. Obviously, if it is to act as proof, it can't be changed. However, there is a finite life of utility and value to most records. That finite life may range from minutes to centuries, depending on the value to future generations of the information contained in the record. For the most part, though, those records have an equivalent of a "statute of limitations" after which no one expects the records to be of any use.

In normal practice, an organization sets a tentative date for a "review" of the record to see if it still retains value to keep in storage or whether it may be destroyed and discarded. Sometimes, new events happen during the initial storage period which makes it important to retain the record past its initial "stale date."

In most cases, the decision to delete or extend the holding period for a record should have some intelligent input at the review time versus a mindless purge based on date alone.

In the case of a document which is a plan or an instruction (blueprints, work instructions, etc.), the document is always subject to "revision" based on new information or requirements which may come to light. This revision time table is on a case by case basis and subject to many internal and external influences ranging from customer needs, to competition, to government regulation. Organizations faced with a need to revise a plan or instruction document have a series of activities and involved personnel to draft potential changes, check them for applicability and "doability" then to approve the revision and finally, to publish the revision to all pertinent parties and to withdraw all previous obsolete documents.

Simple examples:
Record: Inspection record for a production run of a product with an expected useful life of 6 months on top of a shelf life of 2 years (a ballpoint pen refill for example) might be retained for three years after production date before review prior to discarding. For something more complicated, consider radiation exposure records. There is a central database for sending reports (see https://www.eh.doe.gov/rems/) and special record keeping requirements. All of these are subject to change as Science provides new information about ways to use existing records.

Work Instruction Document: Work instruction for inspection, maintenance, repair, and replacement of clutches on dock jeeps which becomes obsolete once the organization changes to a fleet of automatic transmission dock jeeps. Another work instruction that might have an infinite life is the work instruction for bill of materials and methods for mixing Coca Cola syrup.

 

[Leslie M]

Hi, and thanks for the welcome. I appreciate the detailed response.

How about procedures. Is there any required review frequency or cycle or how do you approach review of procedures - such as level 2 and level 3 procedures / work instructions?

 

[Wes Bucey]

Hi, and thanks for the welcome. I appreciate the detailed response.

How about procedures. Is there any required review frequency or cycle or how do you approach review of procedures - such as level 2 and level 3 procedures / work instructions?

All plans and instructions documents are reviewed on a regular basis as part of "management review" wherein the underlying "processes" are reviewed quarterly or annually by an auditing team which makes suggestions about whether the process is being performed as planned, NOT performed as planned, or suggestions for improvement. Management reviews the audit and makes decisions about leaving the underlying documents which control the processes (procedures and work instructions) as they are or revising them. If they choose revising, they appoint an individual or a team to investigate and create a revision which then goes through an approval process before being adopted. Approval process varies in complexity according to the process and the organization.

 

[Mike S.]

We had an ISO consultant once who almost insisted we implement a 1 year review period for every level 1,2,& 3 document in the QMS because, he said, registrars he deals with usually require that. I say that's bullhockey, but I'm just a QM, not a consultant.

Wes' idea is one way to do it. A fixed review period is another way to do it. And another way to do it is to say the documents are reviewed by the original approving authority whenever he/she feels it is necessary based on how often the document is used, feedback from the users of the document, and his/her knowledge of the process and any changes that may have taken place in it. Whatever way works best for you. JMO.

 

[Wes Bucey]

We had an ISO consultant once who almost insisted we implement a 1 year review period for every level 1,2,& 3 document in the QMS because, he said, registrars he deals with usually require that. I say that's bullhockey, but I'm just a QM, not a consultant.

Wes' idea is one way to do it. A fixed review period is another way to do it. And another way to do it is to say the documents are reviewed by the original approving authority whenever he/she feels it is necessary based on how often the document is used, feedback from the users of the document, and his/her knowledge of the process and any changes that may have taken place in it. Whatever way works best for you. JMO.

Mike is correct in that each organization is ultimately responsible for creating a review process that works for the organization. That said, "ad hoc" changes (revisions) to documents may occur whenever there is a perceived need, regardless of the formal review schedule, but every organization, as a matter of course, should review all its documents on a regular basis (months or years) to determine if they are obsolete, redundant, need revision, or are fine as is.

 

[RoxaneB]

We subscribe to the "once a year" philosophy that many other's do, as well. It is, however, subject to change if that is what we want.

All documents are reviewed at least once annually. Our document control software looks at the release date and compares it to today's date. If the release date and today's date = 364 days, then an email is automatically sent to the document authors indicating that the document is due for review.

Basically, what this means is that if I haven't touched a document since September 25 (today being Sept. 24), then tonight an email will be sent to my inbox saying that my document is due for review. If however, the document was released September 25, but I made some changes and the next revision was released November 9, then the clock would reset to trigger the review email prompt for November 8.

 

[Wes Bucey]

We subscribe to the "once a year" philosophy that many other's do, as well. It is, however, subject to change if that is what we want.

All documents are reviewed at least once annually. Our document control software looks at the release date and compares it to today's date. If the release date and today's date = 364 days, then an email is automatically sent to the document authors indicating that the document is due for review.

Basically, what this means is that if I haven't touched a document since September 25 (today being Sept. 24), then tonight an email will be sent to my inbox saying that my document is due for review. If however, the document was released September 25, but I made some changes and the next revision was released November 9, then the clock would reset to trigger the review email prompt for November 8.

Excellent use of the power of the computer to deal with minutiae combined with the power of the internet to communicate!

 

[Douglas E. Purdy]

How do you Re-Approve?

Okay, you review the document annually since it's last revision or it's original issuance. How do you show that it has been re-approved?

Thanks,
Doug

 

[RoxaneB]

Okay, you review the document annually since it's last revision or it's original issuance. How do you show that it has been re-approved?

Thanks,
Doug

Hmmm...let's try a little story about the life cycle of a document...at least up to, and including, the whole review process. I'll not discuss the process for rendering a document obsolete.

Chapter 1 - The idea is formed...

4 different crews making 4 different pots of coffee. I like Crew A's the best, but Crew C has some interesting ideas. Crews B and D make sludge, making me think I've joined the Navy by accident.

So, we decide to standardize the way coffee is made. Working together, we come up with what is the Best Demonstrated Practice of making coffee. This is entered into our document control software and saved.

Being a draft document, it is as Revision 0 - meaning it has never been approved or released.

A few more tweeks are made to perfect the document and it is sent for approval. It is approved and released on September 29, 2003. This Revision 1.

Chapter 2 - The first year...

For a year, coffee is perfect. We are all wide awake when we do our jobs, without feeling as if somone has punched a hole in our stomachs. Nothing is changed to the document.

Being the Document Author of WI-0123 "Making Fantasic Coffee!", on September 28, 2004, the document control software acknowledges that a year has gone by since this document was approved and released. It sends an email to my inbox informing me that, being the good Document Author that I am, I need to review this document and verify that the process is still applicable.

I look it over and, if necessary, get some input from other people. We all agree it is good.

I hit the "Document Review" button and, in the electronic history section of the Document, a new line is entered saying that on September 30 (because I decided to take a few days to get input from a few people) the review was done. No changes made to the document.

All is good. We're still on Revision 1.

Chapter 3 - Where the heck are we buying coffee from?!?!

In November of 2004, our coffee grinds change and we must change our standardized process. It's like we're getting concentrated grinds or something and less coffee must be added.

I put WI-0123 into modification and make the changes. On November 10, 2004, WI-0123 Revision 2 is approved and released.

The clock is reset for reviewing.

The electronic history sections shows the dates that I entered the document into modification, submitted for approval, as well as the dates of approval and release.

Chapter 4 - The reset clock...

November 9, 2005 comes around and the document has not be revised since we made the modification to adjust for the new grinds. I get to work to find an email in my inbox saying that I need to review the document.

I want to make sure that nothing else has changed and I take 5 days to review it. On November 14, 2005, I hit the Document Review button.

Chapter 5 - The ongoing saga of reviewing...

No changes for a year...last reviewed November 14, 2005. On November 13, 2006, I find an email indicating the document has not been reviewed for a year...guess what I do?

The End