QMS Manual / Procedure re-write & Internal Audits

[Gil R.]

Hello,
I've taken over the Quality Manager position for an Aluminum Die Casting company. One of the first things I noticed was the QM and all Procedures were "overwritten" (redundant and too much information). It should be noted I took over in April (2023) with a recertification audit date in mid May (yes, one month to prepare!). We made it through, however the auditor told me he's mentioned several times that our Procedures, if left as-is, are going to eventually bite us in the back side.
I have already re-written the QM, and wondering if I should do a systems audit while I rewrite the Procedures. Our current IA's are "Process" based, however since they need revising, I'm trying to determine my best course of action. I've never been in this situation, hence, I am seeking some guidance here. Thank you for any input you can provide! - Gil

 

[Big Jim]

Unfortunately, it is very common for the procedures to be overwritten. The simpler you keep things while still making sure you have the structure you need to have an effective system, the better off you are. Keep in mind that AS9100 only requires written procedures for two topics, control of nonconforming outputs and nonconformity and corrective actions.

A well written quality manual could cover all you need. I have helped many companies trim up their documentation. You would probably benefit from using a consultant that can help you trim things up.

 

[JonnyB]

I am in a very similar position, although the issue I have is that the documentation doesnt seem to be have been updated much in the last 10 years - since the company first got certified. Any updates that have taken place in that time were just sentences or paragraphs stuck to the end of the document. The result is an entire catalogue of procedures and processes that either do not reflect actual working practices, or in some cases, just do not make any sense.
My approach (and currently on going) has been to do the following:
1. Create a map of all existing documentation (recording the links between them so that I know which documents are affected by any updates or changes)
2. Working through AS9100 (and ISO 14001) clause by clause and identifying two conditions:
- How we currently "meet" the requirement (I am using historical audit reports (internal and external) and the content of all the documents I have read to answer this) and,
- What a refined (and rationalized) version of what we have might look like (this is my target system)
3. Sit down with process owners and department heads and mark up where the existing procedures need amending
4. Create drafts of new processes (using the map initially made to capture changes required in other documents as a result of the parent document changing)
5. Review all other existing and interlinked documentation for content
6. Identify any significant changes i feel need to be made and present this to the rest of the management team (as a representation of how the entire management system will operate in accordance with the standard)

Once I am finished reviewing all the interlinked documents I should be able to swap them out, almost in bulk - I am not too worried about the effect of this because all I should be doing is bringing the documentation in line with how everybody works anyway.

I will also be updating our internal audit procedure - for the last ten years, almost every audit is copied and pasted from the year before and there have been a total of 2 non-conformances found in that time... It is worth noting that all of the audits completed in that time were system audits directly against the clauses of the standard. Its fairly obvious to me that I need a different type of audit to capture the fact that the procedures are not well written.

TLDR; I am in a similar position. I had to do a system audit in type - but a very extensive one - and moving forwards will be relying much more on process audits to identify the type of issues you have found.

 

[Sidney Vianna]

2. Working through AS9100 (and ISO 14001) clause by clause and identifying two conditions:
- How we currently "meet" the requirement (I am using historical audit reports (internal and external) and the content of all the documents I have read to answer this) and,
- What a refined (and rationalized) version of what we have might look like (this is my target system)
3. Sit down with process owners and department heads and mark up where the existing procedures need amending

It has been over two decades since ISO 9001 attempted to de-emphasize "procedures" and have people focus on processes. Documentation, such as procedures, is nothing more than a resource and component of process definition. I am glad you mentioned process owners and focus on processes in your post. Few people "responsible" for steering, maintaining and developing the quality system in their respective organizations ever have that epiphany; they keep mistakenly focusing on documents as they are an end in itself.

 

[Rich Shippy]

I have been in these take-over situations a few times as well. The flow diagrams of the processes become your best friends when trying to unravel some of these messes people have created. It also makes it much easier for the process owners to reference required activities.

 

[Rob_Kellock]

My preferred method would be to document how your processes and your system meets the requirements of each clause of the relevant standard.

If at the end of the review you have gaps then you know you need to fill those gaps. If you have documents or processes over then you know you have either redundancy or processes that aren't required by the standards and you can decide what you do with those. The finished review can then be maintained as a live record which you update as your system and processes change or the requirements change.