4.2.4 (b) requires that controlled documents that are required by the quality system be reviewed and updated as necessary and re-approved.

Engineering Standards in my organization are controlled documents required by the quality system, but have no periodic review time. All other documents in our QMS are looked at every 2-5 years to ensure that they remain current.

Our Engineering manager maintains "Any changes are handled with a formal change notice process and then reissued. Again no reviews are done or required after the design has been developed. The ISO standards do not require it."

As these documents are used to purchase components, manufacture product and package product, it seems to me that a periodic proactive review is needed to ensure that the standards remain consistent with design and manufacturing changes and external industry standards.

As a side note, our internal employee corrective/preventive action process identifies 6-8 errors per year on these standards.

Comments, please?

4.2.4 (b) requires that controlled documents that are required by the quality system be reviewed and updated as necessary and re-approved.

Engineering Standards in my organization are controlled documents required by the quality system, but have no periodic review time. All other documents in our QMS are looked at every 2-5 years to ensure that they remain current.

Our Engineering manager maintains "Any changes are handled with a formal change notice process and then reissued. Again no reviews are done or required after the design has been developed. The ISO standards do not require it."

As these documents are used to purchase components, manufacture product and package product, it seems to me that a periodic proactive review is needed to ensure that the standards remain consistent with design and manufacturing changes and external industry standards.

As a side note, our internal employee corrective/preventive action process identifies 6-8 errors per year on these standards.

Comments, please?

What's an "engineering standard"? Something developed in-house, or something like an ASTM or SAE standard? If it's the former case, are we talking about product-specific standards, or general standards that are used for all (or most) products?

Engineering Standards are created by our Engineering Dept. and fall into several categories.
1. Raw material specifications, often based on Industry Standards;
2. Product processing How tos, like: How to Heat Treat a certain grade of Steel, or how to perform a stamping operation; (again, sometimes case don industry standards)
3. Determination of product conformance, like visual inspection criteria;
4. Directions for finished product packaging to prevent damage.

Does that explain it better?

Engineering Standards are created by our Engineering Dept. and fall into several categories.
1. Raw material specifications, often based on Industry Standards;
2. Product processing How tos, like: How to Heat Treat a certain grade of Steel, or how to perform a stamping operation; (again, sometimes case don industry standards)
3. Determination of product conformance, like visual inspection criteria;
4. Directions for finished product packaging to prevent damage.

Does that explain it better?

Yes. :D

A lot depends on how many documents there are--if there are hundreds of them (or even thousands), review of all of them periodically might not be practical. It might be helpful to get rid of some of them. For example, there's almost never a need for having your own material standards because there are published standards that cover the requirements adequately. Your #2 and #3 categories fit better in the idea of work instructions (it seems) and thus those should probably be reviewed on a regular basis, perhaps as part of internal audits. #4 (packaging specifications) shouldn't need to be reviewed once it's established that the specified packaging is adequate, imo.

Actually it's 4.2.3..... b) to review and update as necessary and re-approve documents,..... (in ISO 9001:2008 & 9001:2000, 4.2.4 doesn't have any lower case requirements)

And the key phrase is "as necessary", so the answer could be yes or could be no.....

It just depends on when and why it may become necessary.....

Our Engineering manager maintains "Any changes are handled with a formal change notice process and then reissued. Again no reviews are done or required after the design has been developed. The ISO standards do not require it."
The first sentence sounds fine... but the 2nd seems to contradict it! As for the 3rd - I'm not sure what he means there - can you explain?

As these documents are used to purchase components, manufacture product and package product, it seems to me that a periodic proactive review is needed to ensure that the standards remain consistent with design and manufacturing changes and external industry standards.

I would have thought it reasonably important to make sure that the documents are up to date - but the degree of risk involved, as well as practicality (eg, numbers of docs must be factors)

our internal employee corrective/preventive action process identifies 6-8 errors per year on these standards.
How serious are the errors? What are the costs, effects, impacts? (real or potential)?

I agree with Randy. It depends on wether the interested parties consider it necessary.

Randy, I understand your point. My problem is that I'm not getting any rationale for why it isn't necessary. As an auditor, would you accept the answer "it isn't necessary" without having a reason?

The only thing I've heard is, "there's too many documents" and "no other engineering group in the comapny is doing this".

Neither seem like real valid reasons to me.

I'd like to see any document over 10 or 15 years old be reviewed, no matter what it relates to, because time changes things. For example, there are references in the Engineering Standards to industry standards that have been withdrawn or replaced. There are standards for products we no longer make and raw materials we no longer buy.

On the other hand, if I'm being too strict in my interpretation, that's good to know also.

Randy, I understand your point. My problem is that I'm not getting any rationale for why it isn't necessary. As an auditor, would you accept the answer "it isn't necessary" without having a reason?

The only thing I've heard is, "there's too many documents" and "no other engineering group in the comapny is doing this".

Neither seem like real valid reasons to me.

I'd like to see any document over 10 or 15 years old be reviewed, no matter what it relates to, because time changes things. For example, there are references in the Engineering Standards to industry standards that have been withdrawn or replaced. There are standards for products we no longer make and raw materials we no longer buy.

On the other hand, if I'm being too strict in my interpretation, that's good to know also.


How often is the US Constitution reviewed and/or revised? Only when it's been necessary. It's over 200 years old and still works doesn't it? (Rhetorically speaking) As long as it's working why review it?

How often is the US Constitution reviewed and/or revised? Only when it's been necessary. It's over 200 years old and still works doesn't it? (Rhetorically speaking) As long as it's working why review it?

The Constitution is under constant review. Ever hear of these folks?

http://i575.photobucket.com/albums/ss194/jimwynne/current_supreme_court_justices.jpg

:lol:

Of course, they're down to one woman now... :notme:

As a side note, our internal employee corrective/preventive action process identifies 6-8 errors per year on these standards.
Comments, please?


How serious are the errors? What are the costs, effects, impacts? (real or potential)?
Are the errors due to the documents themselves, or misuse/disuse of them that could be eliminated by changing the documents?
Insofar as rationale for not reviewing the documents is concerned, you might want to ask the engineering manager how he would answer a CB auditor when asked about it.

The first sentence sounds fine... but the 2nd seems to contradict it! As for the 3rd - I'm not sure what he means there - can you explain?


I would have thought it reasonably important to make sure that the documents are up to date - but the degree of risk involved, as well as practicality (eg, numbers of docs must be factors)


How serious are the errors? What are the costs, effects, impacts? (real or potential)?

I've got a situation where our Engineering management folks are reading the ISO document and because it doesn't specifically spell out what documents are involved, they assume it is not a requirement for them.

I]I agree. That's why I've proposed editing the list to documents over 10 years old, but that is 95% of our standards. I get uncomfortable when I see documents of that age, because lots of things that could impact those standards have changed. For example, 10 years ago we weren't buying Asian steel, and some of our US specs are not common to Asia. [/I]

Some real, some potential. For example, We had to update our packaging standard because we had a series of damage claims that forced us to relook at the size and weight of parts going into certain boxes.

I don't understand why raw material specifications, product processing instructions, visual inspection criteria, and finished product packaging instructions woild not be reviewed. Do they ever change?

I would especially think these need to be reviewed since they are the intial inputs into the product realization processes.

To make sure I understand this, are you saying that the engineering inputs supporting all subesquent proceses are not reviewed ever?

I don't understand why raw material specifications, product processing instructions, visual inspection criteria, and finished product packaging instructions woild not be reviewed. Do they ever change?

I would especially think these need to be reviewed since they are the intial inputs into the product realization processes.

To make sure I understand this, are you saying that the engineering inputs supporting all subesquent proceses are not reviewed ever?

Clarification: these aren't the specifications or the work instructions, these are the standards on which those items are based.

And yes, they are never reviewed.

This morning I took a look at the first 4 material standards in the book. Two of them referenced industry standards that no longer exist. That kinda makes them worthless as the baseline, in my opinion.

The Constitution is under constant review. Ever hear of these folks?

They don't review the Constitution, they review the applicability of it to specific situations of their choosing, within their timeframe. I learned that when I studied Constitutional Law

And yeah, I've heard of those folks.

"these aren't the specifications or the work instructions, these are the standards on which those items are based."

Notice that I clearly stated those documents are an input into the tools used in the product realization processes. Think process approach - input, process, output.

To me, the quoted statement above is all the justification I would need to decide that those documents need to be reviewed. How would an organization expect the work instructions to be effective if they are based on information that is outdated?

"Too many documents" and "no one else is doing it in our organization" are unforntunate justifications to not knowing what the current specifications are.

What was the direct and indirect cost of the series of damage claims? Too bad that dollar amount wasn't applied to keeping specifications current and known and preventing problems instead of reacting to customer complaints.

Let's say you did review the standards, what would you learn? If your audit only showed that they have been in existence for a period of time, would that mean anything to the quality system? Now if you reviewed the standards and then found objective evidence that one or more standards were causing quality problems that would be a meaningful finding.

Bill Pflanz

"these aren't the specifications or the work instructions, these are the standards on which those items are based."

How would an organization expect the work instructions to be effective if they are based on information that is outdated?[/quote]

Yes, how would they? How do they? And - do they in fact? (Actually I hadn't realised you were talking about internal standards - I'd thought you meant external ones.)

If the standards that are used as an input aren't ever reviewed, how on earth is it possible to be sure that they remain accurate and relevant (as opposed to presumably having been determined to be so at a particular point in time)?

""Too many documents" and "no one else is doing it in our organization" are unforntunate justifications to not knowing what the current specifications are.

Too many - does this mean that if there were only, say, 20 of them? 5? 50? (pick a number), then they would be reviewed? The argument of 'too many' is a justification, not a good reason. That's a specious argument.

As for 'no one else is doing it', spare me. It's the kind of argument children use on their parents (no one else's mother/father makes them do this). I'd have expected better from engineers.

""What was the direct and indirect cost of the series of damage claims? Too bad that dollar amount wasn't applied to keeping specifications current and known and preventing problems instead of reacting to customer complaints.

If your engineer is getting that from reading the 9001 Standard, he/they are misunderstanding the difference between reading a generic as opposed to a specific Standard. Most Standards are very specific. 9001 isn't.

In my industry and experience, our ES's are referenced on the drawings as applicable to the product. The ES is an integral part of the product development process and are reviewed or developed when the products are being developed, or possibly later in the product life if there are failures. Reviewing for review sake is not efficient in my opinion. If a product is developed with a specific ES and is in the market for several years with no issues what is the value in reviewing the ES?? I an updated model of the product is developed, you would review the ES to ensure it is applicable and appropriate and move on with changes or not...System approach.