Importance of Written Procedures in ISO 9001:2015

[robertwalker]

Since ISO 9001 is so big on processes, should a repair procedure be specified so the same procedure is used in each case of rework?
I am a pretty new Quality Manager and I work for a company that makes fiberglass reinforced pipe, we had a procedure in place that specifically dictated how to do rework for each defect type. The process engineer went out of spec and backed a repair technique that doesn't match our documented rework procedure.

I have no problem with the new procedure, but I asked him to amend the specification to reflect his new way of of reworking defects. He basically refused, left the documented repair procedure the same, and added to the specification, "If a different method of repair is to be used, Process Engineering should be consulted for approval". So we have a procedure that tells how to make the rework, implying that this is the way the repair is to be done, but a caveat in there that basically they can do it however he pleases.
I'm interested in the take on this from the standpoint of Quality Managers and engineers alike.

Thanks

 

[Michael_M]

Re: Importance of written procedures.

If the different process is used, can you trace it back to the person who did the approval? Do you have any evidence that the new method was approved and the new method made conforming parts?

Having the ability to alter the process by a knowledgeable person should be good so long as you have something that traces the approval and acceptance. This would allow you to use better/improved processes as they come up.

 

[robertwalker]

Re: Importance of written procedures.

It can be traced to him because he wrote and approved the spec i guess. No testing was done on the new method. It basically leaves it up in the air, any rework technique used,QC has to go get approval from engineering as to whether or not the repair is ok.

 

[howste]

Re: Importance of written procedures.

Welcome to the forums, Robert!


Since we're talking about ISO 9001:

8.5.6 Control of Changes

The organization shall review and control changes for production or service provision, to the extent necessary to ensure continuing conformity with requirements.

The organization shall retain documented information describing the results of the review of changes, the person(s) authorizing the change, and any necessary actions arising from the review.

8.7 Control of nonconforming outputs

8.7.1 ...Conformity to the requirements shall be verified when nonconforming outputs are corrected.

Per the requirements, this is the wrong answer:

No testing was done on the new method.

 

[robertwalker]

Re: Importance of written procedures.

Thank you howste, that pretty much sums it up I think!

 

[Sidney Vianna]

Re: Importance of written procedures.

No testing was done on the new method.

Can you clarify this statement? Do you mean that no testing was done to validate the repair technique? Or no test was done on the repaired pipe, AFTER repair? or neither?

 

[robertwalker]

Re: Importance of written procedures.

No testing was done to verify the repair technique, and no test was done on the repaired pipe after repair either. It is a very low pressure system, so I'm not that concerned about the repair, I have no problem with the repair, I believe the repair technique should be an approved technique though, especially since we have a technique stated in our repair specification. So in essence what we have is a spec saying repair the defect this way, and the defect is repaired a different way, and a new line in the specification saying any different repairs must be approved by engineering.

 

[Pancho]

Re: Importance of written procedures.

No testing was done to verify the repair technique, and no test was done on the repaired pipe after repair either. It is a very low pressure system, so I'm not that concerned about the repair, I have no problem with the repair, I believe the repair technique should be an approved technique though, especially since we have a technique stated in our repair specification. So in essence what we have is a spec saying repair the defect this way, and the defect is repaired a different way, and a new line in the specification saying any different repairs must be approved by engineering.

Assuming no testing or other verification is really needed, then your process engineer's single-sentence shortcut allows the repair process to accommodate variation at his discretion. That is certainly easier than thinking about how to modify the procedure to accommodate the new possible repair. But it shortchanges your organization because knowledge is not being captured and because discretion is often the source of problems.

Even without the engineer's cooperation, you can still improve your system. You have that one new engineer-approved example of repair. Document it. I'd add pictures or description of his alternate repair method as a second acceptable repair for the particular non-conformity, with a provision that reads something like this: "Here is a second possible repair method for this condition (it should be used only with the process engineer's approval)." You can even leave in the procedure, after that second repair method, his more open qualifier (allowing even other methods). Chances are that when he sees the new version of the procedure he himself will improve it.

Maybe you can't override the discretion he feels he needs. But you should always capture as much knowledge as possible into your QMS. And encourage your team to do the same. Maybe a knowledge capture policy would convince him and others to pitch in?

 

[robertwalker]

Re: Importance of written procedures.

Thanks for your input Pancho, that all sounds great except for the engineer telling me that the DPI's (detailed process instructions) are HIS, and he will be the only one to modify them. He told me all Quality was concerned about was visual appearance and I should "move on". Maybe on this one, that is what I should do.

 

[howste]

Re: Importance of written procedures.

...fiberglass reinforced pipe...

...It is a very low pressure system, so I'm not that concerned about the repair...

...all Quality was concerned about was visual appearance...

I tend to use the definitions in ISO 9000 to interpret questions here. You said that there are defects (nonconformity related to an intended or specified use) that are being repaired (action on a nonconforming product... to make it acceptable for the intended use). This makes it sound like there are functional problems with the product that would require testing (determination according to requirements for a specific intended use or application) to verify conformity. If the visual appearance is the only requirement then they wouldn't be considered defects and a visual verification (confirmation, through the provision of objective evidence, that specified requirements have been fulfilled) after rework (action on a nonconforming product... to make it conform to the requirements) may be acceptable.

What's the purpose of the fiberglass reinforcement? What's the actual specification that needs to be met - visual or functional? Should Quality only be concerned with appearance, or are there bigger issues here? Of course we don't want to make a mountain out of a molehill if it's a non-issue, but we also don't want to ignore a functional problem if it exists.