ISO 9001:2015 8.5.6 and 7.5.3 Document Control Questions

Devin A

Involved In Discussions
#1
Hello, I pretty much got thrown in the deep end here. I took over the quality department in our machine shop when our quality tech left for another job and our quality manager got laid off. I had no previous experience in quality and now we have an ISO 9001:2015 surveillance audit coming up. I'm struggling to wrap my head around a few of the requirements and I would love some direction from those of you more experienced and knowledgeable than I am in this so I can hopefully salvage this situation.

8.5.6 Control of changes:
Does this apply to all changes to all controlled documents? If no, what does it apply to? If it is not all controlled documents then my interpretation would be anything directly related to the process like work instructions. Is any documentation required for the change outside of a log with the specifics mentioned in the clause? For example, do we need a "document change request form" to be filed and kept? Or just a log of the results?

7.5.3 Control of documented information
Specifically the retention part. Do we need a document retention log of sorts to show what documents we're retaining and for how long?

I would really appreciate any input. Trying to learn this stuff on the fly on such a short time frame is frying my brain.
 
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Mikey324

Quite Involved in Discussions
#2
Good morning.
8.5.6 is about control of changes. This in general is about changes that could impact the product/process. changes to die height, shots per minute, a new shift, etc. The standard says you shall retain documented information describing the results, who approved/authorized, and any resulting actions. An process change log could work, just whatever would be of the most value to your company.

7.5.3
How do you control your documented information? Do you have a master list, or similar format. So you know you are always using the latest and greatest version of whatever the information may be? As for retention, I'm sure you retain records for production inspection data. You will want to keep that for a set amount of time, company standard or to meet customer/state/federal requirements. Since you dont want to keep this forever, you will have a retention time (maybe kept on a master list of records??). You can state how long you retain, and the disposal method in one place.

i hope this helps. we were all new once. You will get it in no time.
 

Devin A

Involved In Discussions
#3
Good morning.
8.5.6 is about control of changes. This in general is about changes that could impact the product/process. changes to die height, shots per minute, a new shift, etc. The standard says you shall retain documented information describing the results, who approved/authorized, and any resulting actions. An process change log could work, just whatever would be of the most value to your company.

7.5.3
How do you control your documented information? Do you have a master list, or similar format. So you know you are always using the latest and greatest version of whatever the information may be? As for retention, I'm sure you retain records for production inspection data. You will want to keep that for a set amount of time, company standard or to meet customer/state/federal requirements. Since you dont want to keep this forever, you will have a retention time (maybe kept on a master list of records??). You can state how long you retain, and the disposal method in one place.

i hope this helps. we were all new once. You will get it in no time.
Thank you very much for the reply. So 8.5.6 is referring to process changes rather than document changes? That makes my life easier!

Also for 7.5.3 we are using a master document list that keeps track of rev level etc. Are we required to have it documented in there (or anywhere) the retention period for certain documents? Or can it just be a general thing in a procedure or policy? Like, for instance, something vaguely along the lines of "records will be retained for a minimum of 2 years before being disposed, unless otherwise required by customer request or state/federal requirements.". If we can use something like this I feel it would be ideal for our small shop as it keeps us from being artificially restrained and we can do as we need.
 
#4
8.5.6 Control of changes:
Does this apply to all changes to all controlled documents? If no, what does it apply to? If it is not all controlled documents then my interpretation would be anything directly related to the process like work instructions. Is any documentation required for the change outside of a log with the specifics mentioned in the clause? For example, do we need a "document change request form" to be filed and kept? Or just a log of the results?
No, it's not about document change control which is looked after elsewhere. The fundamental reason for change control in section 8 is that, once you've defined a process, put in place objectives, controls and measurement/monitoring, things shouldn't be allowed to change in an uncontrolled/unapproved manner. Yes, it does affect documents at some time, but that's incidental.
Thank you very much for the reply. So 8.5.6 is referring to process changes rather than document changes? That makes my life easier!

Also for 7.5.3 we are using a master document list that keeps track of rev level etc. Are we required to have it documented in there (or anywhere) the retention period for certain documents? Or can it just be a general thing in a procedure or policy? Like, for instance, something vaguely along the lines of "records will be retained for a minimum of 2 years before being disposed, unless otherwise required by customer request or state/federal requirements.". If we can use something like this I feel it would be ideal for our small shop as it keeps us from being artificially restrained and we can do as we need.
I'd suggest that you make certain that it's records of things being done which you are retaining for 2 + years, not anything which is a document. If you are ISO 9001:2015, your CB may expect you to keep certain records for the 3 year certification cycle - check your contract. It is fine to simply state the minimum retention and who decides when and how to dispose of them - or not!
 

Mikey324

Quite Involved in Discussions
#5
Thank you very much for the reply. So 8.5.6 is referring to process changes rather than document changes? That makes my life easier!

Also for 7.5.3 we are using a master document list that keeps track of rev level etc. Are we required to have it documented in there (or anywhere) the retention period for certain documents? Or can it just be a general thing in a procedure or policy? Like, for instance, something vaguely along the lines of "records will be retained for a minimum of 2 years before being disposed, unless otherwise required by customer request or state/federal requirements.". If we can use something like this I feel it would be ideal for our small shop as it keeps us from being artificially restrained and we can do as we need.
I have my retention times listed on the master list, along with disposal methods. For me, that makes it very easy to explain during an audit. Also, as i get older, it makes it easier to remember how to follow my own rules!!
We have different retention times for different records. Some are customer based (see if you have any CSR's for retention time), some are not. For example, daily PM records are not kept as long as inspection records or PPAP documentation. It all depends on the use of the document. You want to meet the requirements, but you also want to do what works best and adds value to your company. If you have to look through 3 or 4 documents to find a retention time, you are losing money in wasted time. Again, as i get older, i prefer it to be simple one stop shopping!
 

Devin A

Involved In Discussions
#6
No, it's not about document change control which is looked after elsewhere.
Is there a specific clause for document change control? I'll start flipping through my manual as soon as I have a chance and see if I can find it.

And again, thank you all for replying. I really appreciate the help. This stuff is way above my experience.. Not to mention pay grade haha
 

Mikey324

Quite Involved in Discussions
#7
Is there a specific clause for document change control? I'll start flipping through my manual as soon as I have a chance and see if I can find it.

And again, thank you all for replying. I really appreciate the help. This stuff is way above my experience.. Not to mention pay grade haha
This is what i like about this forum.

As for a specific clause for document changes, check 7.5.2, creating and updating
 

KimGr

Involved In Discussions
#8
We have a more general table of retention times in our Record Retention SOP by type of document. If you need a time saver, this could be an option for you. You may want to add disposal depending on the type of work you do. I'm attaching a snapshot of the top of the procedure. I have a general disposal statement at the end of the SOP.
 

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Devin A

Involved In Discussions
#9
You guys are lifesavers. Maybe I'll actually get the hang of this haha. We're going through our procedures now and trimming them where we're needlessly limiting ourselves without benefit. As for record retention we went extremely vague on timeframes, basically stating that we consider any requirements as "minimums" and will retain them beyond that as long as we feel the need. of course more yadda yadda about responsible person disposing of them and keeping them legible and indexed in a nice way etc. Worded a little more elegantly of course, but you get the idea! I'm sure I'll be pestering you guys with more questions before audit time comes. You rock!
 

KimGr

Involved In Discussions
#10
You guys are lifesavers. Maybe I'll actually get the hang of this haha. We're going through our procedures now and trimming them where we're needlessly limiting ourselves without benefit. As for record retention we went extremely vague on timeframes, basically stating that we consider any requirements as "minimums" and will retain them beyond that as long as we feel the need. of course more yadda yadda about responsible person disposing of them and keeping them legible and indexed in a nice way etc. Worded a little more elegantly of course, but you get the idea! I'm sure I'll be pestering you guys with more questions before audit time comes. You rock!
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!
 
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