API Q1 9th Edition - My Experiences (A Diary)

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Aussie99

Hi,
Has anybody here been audited by API to Q1 9th edition yet?
If so, could you describe any comments and/or criticisms related to the new requirements for Risk Management and Change Management you may have received?
I think it'll be a learning curve for them (the auditors) over the first six to twelve months as well as us (the facilities), when it comes to the 9th.

We are a very small facility (6 - 8 people) and have our audit starting on the 10th of June, scheduled over three days.

It's going to be interesting. :cfingers:
 
B

bluepagen

Good Luck on your Audit. I too am anxious to see how it goes and the extent to which the auditors dig for the details. Again, Good Luck.
 
A

Aussie99

OK.........API audit to Q1 9th edition all done. Ended up with 5 AARs. Overall I was fairly pleased with the result. Our auditor was extremely thorough and in my opinion far more well versed in the requirements than the auditor we have had for the previous three audits. He was also extremely professional and took the time to explain his findings in a pleasant and well mannered way. (Something extremely lacking in previous audits).

No AAR's relating to MOC or Risk Management, however we did receive a concern for not having fully implemented the Risk Management procedures. We have a risk register which has only been partly populated. I was up front with the auditor and showed him what we'd done, plus we had already scheduled a Management Meeting for the 18th of June where one of the agenda items is to discuss the full implementation of the process. He accepted this and issued his findings as a concern only. He was happy with our documentation and paperwork which we have developed for the processes (MOC and Risk Management).
Just as an aside, we included our Contingency planning as part of the risk assessment process and included the contingency plan for each risk inside the risk register and he was happy with that.

2 x AARs related to our efforts to streamline things over the last year or so where we tried to simplify a lot of our processes, but came a little unstuck on the initial evaluation of critical suppliers, and also on the documentation relating to training effectiveness. So we have a bit of work to do in those areas.

A minor AAR relating to monitoring of the work environment in our gauge room where we do some internal calibrations, and another relating to annual stocktake of consumables. Minor fixes required here.

At the end of the day, I think your audit results are going to depend a lot on the individual auditor. I inherited a system in a state of disrepair well over a year ago. The previous audit, (which was held in the second week of my employment) resulted in AARs being given for work and processes outside the scope of Q1. At the time I was too green to burn, (I'm still a long way from the professional I'd like to be), and didn't know any different, and previous audits showed similar customs, so I assumed it they were relevant. The responses offered up by my General Manager to API resulted in the suspension of our certifications. After a year of solid effort, we are close now to regaining these, assuming successful closure of the issues raised in our most recent audit.

The last year for me has been a massive learning curve, and I have a long way to go. Ideally I'd like to get to the US to do some training in Q1 9th edition, (not on offer in Australia), but at this point in time, it's just not possible.

One point our auditor made, was just how much of a monster Q1 has become, and although he appreciated the massive amount of work we'd put in over the last twelve months, he did reinforce just how much work would be required to maintain and improve the system moving forward, with our limited resources. We are a very small company, and activity has been minimal, so time will tell.

I would imagine most people would already have their documentation developed for all Q1 9th edition processes by now (given the conformity matrix's were due in two weeks ago) but if I can help by posting some, let me know. I didn't post any previously as I thought, given my limited experience, they may not be up to scratch. Most of my stuff is just a blend of documents that I've found on here (Elsmar) or on google anyway.

Which leads me to me next point..................I would like to thank all those who have previously posted, and continue to post documents, and have also offered up their generous advice in so many different areas. Your assistance has been immeasurable.
 
I

Irshad Khan

Hello Aussie,
Congratulations! It is good to know that your audit went well. 5 AARs are just normal which always provide an opportunity for improvement.
Would greatly appreciate if you can share MOC and Risk Management Procedure and how you have integrated Contingency Planning into Risk Assessment.
Hope to hear from you soon!
Irshad Khan.
 
A

Aussie99

Hello Aussie,
Congratulations! It is good to know that your audit went well. 5 AARs are just normal which always provide an opportunity for improvement.
Would greatly appreciate if you can share MOC and Risk Management Procedure and how you have integrated Contingency Planning into Risk Assessment.
Hope to hear from you soon!
Irshad Khan.

See attached Irshad.
Wont suit everybody, but hope these help:).
 

Attachments

  • Risk Management & MOC docs.zip
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radica

Congratulation Aussie!!!
Can you please share your purchasing procedure. I am stuck with determination of criticality of the activities or product (5.6.1.1 a requirement) and I would like to know how did you respond to the above request.

Thank you in advance.
 

Confussed

Involved In Discussions
Thats great your efforts paid off. Question weere the documents you shared with everyone. also used by Engineering for design plans for a monogram certification also?
 
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Aussie99

Hi Confussed..........we have an exemption from design, as per this quote from our Quality Manual:

"###### produces and/or repairs product to customer specified requirements and/or specifications such as engineering drawings, product samples for reverse engineering, industry standards and technical orders. The customer's design responsible function has already developed, reviewed, verified and validated their design and has complete control of design changes. If at any point ###### wishes to suggest changes for improvements to product, the customer's design responsible function is notified in order to review, validate and authorise and changes".

We handed back our Monogram licenses some years ago. Our clients expressed no interest in us holding the Monogram licenses, so we didn't see any point spending time and money on them.
 
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