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.