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  Post Number #17  
Old 28th February 2014, 05:57 PM
Irshad Khan

Total Posts: 27
Re: API Q1 9th Edition - My Experiences (A Diary)

Hi Amanda,

I started with writing the new procedures first and then I was halfway in tweaking the old procedures when the Audit showed up. Read the standard word by word and line by line and address every requirement. If you are in US attend 9th edition training with API in Houston which our auditor told us is very helpful.
You have got limited time ahead, so gear up your efforts as you will have to submit conformity matrix 3 months down the road and believe me there is a lot of work, specially when you are stuck interpreting something.
If I can help with anything it will be my great pleasure!
Good Luck.
Irshad Khan
Thank You to Irshad Khan for your informative Post and/or Attachment!

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  Post Number #18  
Old 28th February 2014, 06:11 PM
Marc's Avatar

Total Posts: 26,666
Thumbs up Re: API Q1 9th Edition - My Experiences (A Diary)

In Reply to Parent Post by Irshad Khan View Post

Dear Amanda,

We have an upcoming audit and I will answer your question after Feb 28. Thanks for contacting.
Any feedback will be appreciated! Thanks!
  Post Number #19  
Old 28th February 2014, 06:31 PM

Total Posts: 21
Re: API Q1 9th Edition - My Experiences (A Diary)

I myself am just starting this task. We just passed our Stage 2 audit for API Q1 8th and ISO Registration/Certification. Only had 1 finding- I didn't clearly define the exact method we would use for the disposition of records (i.e.- shredding), but instead said that "records shall be destroyed in a manner that permanently prevents future retrieval"

It was nit pick, but only took 5 minutes to fix.

Anyways, I have a buddy who was supposed to hook me up with his revised manual, but now he wants $2000 grand for it. That's not happening. We pretty much had the same manual for 8th edition, the only thing that was different was the Company Logo and mine excluded 7.3 (design & development). For 9th edition, he did a total revision-- he renumbered and reformatted his entire QMS. He works for a bigger company and doesn't have to do everything I have to do; in other words, he has time to do just that.

I am the Quality Manager at a small company that has only been around for less than 2 years. I built this system from scratch-- and the API auditor told us during the exit meeting that in almost 30 years of performing audits on companies big and small, ours was the best he has seen. Very high complement to get in front of the top brass.

However, in addition to being the Quality Manager, I am also the only Quality Inspector. I don't have the time to reformat and renumber my QMS to the layout of 9th edition. I've been to the class in Houston put on by Ed Durant, I have the conformity matrix and all the necessary tools I need to revise everything, I just lack the time. It will get done, but it will be done the quickest and easiest way I can do it without redoing everything. It will take me a few months.

We have till June 1 to be in conformance with API Q1 9th. This entails not only having your QMS revised, but all the new procedures in place and running. Prior to submitting the conformity matrix, everyone is also required to do an internal audit on everything you are saying to have changed/implemented.

I started in May with nothing, and it took till February to build the current system and have everyone on board, doing everything required. I have from now till June 1 to repeat the process for 9th. It's going to be a bitch, pardon my french.

Once I am done with it, I will gladly upload it to this site for anyone to have or use as a template free of charge. In fact, if anyone wants any procedure, policy, or manual for the 8th edition, email me by "blind" email in my profile and I'll give it to you. Everything I have is super organized, simple but effective. The Auditor was very very impressed. Ask and you shall receive. I probably want be done with everything for the 9th edition until its just about too late for you to use it if you also have the June 1 deadline, but for guys building from scratch, it will be here after June.

If anyone wants to pay my buddy for his 9th edition that is already done, email me and I'll give you his contact information.
Thank You to pjgary for your informative Post and/or Attachment!
  Post Number #20  
Old 28th February 2014, 06:33 PM
Marc's Avatar

Total Posts: 26,666
Re: API Q1 9th Edition - My Experiences (A Diary)

Ummmm, WoW! Thanks!
  Post Number #21  
Old 3rd March 2014, 10:18 AM
Charles Osenbaugh

Total Posts: 3
Re: API Q1 9th Edition - My Experiences (A Diary)

We're beginning the API Q1 process. There's a clause hopefully some of you can offer some feedback. Final Inspection and Testing
"Personnel other than those who performed or directly supervised the production of the product shall perform final acceptance inspection at planned stages of the product realization process."
Q: Can both direct supervisors (MFG and Final Testing) report to the same Manager? I read this as acceptable, probably unavoidable at small companies. Anyone have any experiences? Maybe OFI's?
Thanks in advance
  Post Number #22  
Old 3rd March 2014, 11:43 AM
Irshad Khan

Total Posts: 27
Re: API Q1 9th Edition - My Experiences (A Diary)

Hi Gary,

Thanks for such an awesome post. Your post has one very eye opening requirement of Internal Audit. I thought the same but my manager told me that it is for new applicant only, so I let it go and had no plan to do it before submitting the conformity matrix.
Is internal Audit required on the whole system or the changes that we have made as per 9th Ed?

Last edited by Irshad Khan; 3rd March 2014 at 03:33 PM.
  Post Number #23  
Old 3rd March 2014, 06:01 PM

Total Posts: 21
Re: API Q1 9th Edition - My Experiences (A Diary)

Just on the changes. I took a highligher and basically found the 86 or so areas on conformity matrix that were additions, and if you read it closely, under on you will see a box that says "QMS Processes audited before claiming performance to specification"

Basically, if you are applying for the first time, this will mean everything. If you have already passed a stage 2 audit and are certified/registered, then you only have to internal audit the areas you have made changes to before submitting the matrix.

I've asked API if we had to fill out the entire matrix, or just the blue additions, and was told we have to fill all of it out because "it will help the auditor be more efficient" when he comes the next time you are up"

As for final inspection, small companies have personnel who wear multiple hats. Just make sure the person performing final inspection/release of product 1- have a yearly eye exam where the pupils get dialated, 2) make sure that person (s) with the eye exam have a QC/QA inspector job description & competence statement & appropriate training in their employee record, 3) the person (s) who fulfill #1 & #2 should be the ONLY signature on your traceability/router with authority to release product.

It would not be a great idea to have the job description of "production supervisor" as well as "quality inspector/manager" in the same folder, because just as you can't audit your own work, you should not release your own work. A simple fix would be to change the "production supervisor" title or remove it from the folder.

Our salesman/purchasing officer has to get a yearly eye exam for personal reason. So we use that as a second person with "product release" authority for the instances where I go on vacation or to a Dr or __. He's got qc inspector job description in his employee folder, and the results of his eye exam as well.

On our job description form, directly under the title is a paragraph that says "I, ____ hereby certify ___ as competent to perform his duties in the capacity of ___, through his previous training and our OJT.

So that one form covers both job description and competence.

We have an additional form called "employee's previous training/qualifications" where a new empolyee lists all his previous training and qualifications from other companies-- in this way we can say Joe smo was trained, just not by us, but we concur that he knows his stuff.
Thank You to pjgary for your informative Post and/or Attachment!
  Post Number #24  
Old 4th March 2014, 01:06 PM
Irshad Khan

Total Posts: 27
Re: API Q1 9th Edition - My Experiences (A Diary)

This is absolutely great and I really appreciate the value that you are adding to this forum.
Would you please explain the requirement of Risk A & M and Contingency Planning. I wrote a procedure for Risk A & M and then did Risk Assessment on Facility, Key Equipment, Supplier Performance, Delivery of NC product and availability of Competent personnel. I used a very simple and basic Risk matrix.
I do not understand the last two that is delivery of NC Product and availability of Competent personnel. Our auditor just asked if we did Risk assessment on each employee?
Is this going to be something like this or a general approach should work.
Regarding delivery of NC product I can hardly mention other than that we have alternate suppliers.
Your explanation regarding Risk A & M and Contingency Planning will be greatly appreciated by all readers.
Irshad Khan

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