ISO 9001:2015 8.5.6 and 7.5.3 Document Control Questions

[Devin A]

Sounds like you are on the right track! Just make sure that your minimum retention times work for your toughest customer contract. We are mostly medical which is why we have the 15 years. Good luck!

Thankfully at this time we have no retention requirements from customers, but we do cover that topic in our procedure! We're mostly automotive but supply to the people supplying the big companies. Now, another quick question about document control, is a document change request form / document change log strictly required for documents that wouldn't really fall under 8.5.6? Having trouble thinking of a quick example off the top of my head, but something that doesn't directly impact production. We track revision level, date, and all that good stuff on the document itself with a link to it on our Master Document List database.

 

[KimGr]

That's a little tough without an example. SOPs and work instructions have to have evidence of approval by relevant parties. We have electronic approval routes in our document control software so we avoid forms for our non-manufacturing documents. Does that help?

 

[Devin A]

That's a little tough without an example. SOPs and work instructions have to have evidence of approval by relevant parties. We have electronic approval routes in our document control software so we avoid forms for our non-manufacturing documents. Does that help?

It does help. We have a header for all documents that states document number, rev level and date, author, who it was approved by, and the title. Would this be sufficient for the requirement? Perhaps an example could be adding a footnote to a daily maintenance sheet for a machine that just gives information rather than changing how they perform the maintenance? We would still update rev level and date for this, but would we be required to have any further log?

 

[KimGr]

Yes to the header as long as the approval parties are the same when you change it (by title at least) and as for the maintenance, is the footnote more of a note on what went on during maintenance vs how to do it? If so, that's more of a record than a document control issue. I would just initial and date the entry.

 

[Devin A]

Again hard to think of a good example, but it wouldn't be something filled out on it. more of like maybe.. "Caution: this part is hot" or something. Something that would be added to the document without changing how it's done.

 

[KimGr]

Safest thing would be to write permission to do that into your SOP. Certain types of changes require more approval than others. You could call an A change vs a B change. A affects product quality and requires approval before implementation (risk). B does not affect product quality and can be approved by a qualified operator (no risk). Please ignore my grammar. I am only half way into my first cup of coffee.

 

[Devin A]

We're a very small shop and only two of us have permissions to alter documents so perhaps we can use that to our advantage. Maybe something along the lines of changes needing to be approved by Vice President OR Quality dude(me ;D). Would that being in our procedures allow me to alter documents and my own approval be enough? And don't worry, I fully understand! I've been coming in early to prepare for this audit. I'm used to my cozy 7:30-4, m-f haha.

 

[KimGr]

Yes, that should work. Those are my hours too (normally). We just opened a second plant this past year and have our ISO 9001 audit next Wednesday. It's weird for me because although most of our stuff is medical we are IATF certified for our automotive customers at the main location. I have to dial back the requirements so I'm not overdoing it. It's been a little bit of a challenge mentally. LOL

 

[Devin A]

Wonderful, I want to make my life as easy as possible so if I can make changes on the fly without having to run every small change by the Vice President that'd be wonderful. Hopefully after this audit I can earn the title of quality manager instead of just having the responsibilities ;P I still have a WHOLE lot to learn obviously, but I'd say given the circumstances I'm winging it pretty well! ISO requirements weren't kept up well after the quality manager was laid off so we're playing a fun game of "what can we do to pass this by the skin on our teeth.." For example, our last management review meeting was 12-5-2017. So we're just going to state that our planned interval is annually. BOOM! Now our procedures explain why there isn't one for 2018 yet!
We cover many of the topics during our weekly production meetings, but we don't have records of this which as far as I'm aware, are required.

I really can't thank you enough for all this help. I'm sure there will be many more questions to come if you're willing to keep answering haha!

 

[KimGr]

I don't mind at all. Sounds like you are on the right track. Make sure that the VP is ready to talk about risks, metrics and business conditions. If the auditor feels like you are managing your risks and your customers are satisfied that's half the battle!