Do Engineering Standards require periodic review? ISO 9001 4.2.4 (b)

[RosieA]

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?

 

[Jim Wynne]

Re: Do Engineering Standards require periodic review?

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?

 

[RosieA]

Re: Do Engineering Standards require periodic review?

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?

 

[Jim Wynne]

Re: Do Engineering Standards require periodic review?

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.

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.

 

[Randy]

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.....

 

[JaneB]

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)?

 

[Saizi]

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

 

[RosieA]

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]

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?

 

[Jim Wynne]

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?