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

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DP561

Just tried to PM you but I'm being told I can't PM anyone until I have 5 or more posts to my name. I'll post a few more and then re attempt to PM you.

Thanks.
 
D

DP561

However, he is in the middle of revising them from 8th edition to 9th edition. He has said he will post his revisions as he does them.[/QUOTE]
Marc,

Am I doing something wrong? (I'm a bit of a dinosaur with IT), another invalid thread when I clicked on your link?
 
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DP561

Hi All,

There are various thoughts on how to lay out the Q1 (ninth edition) QM, that is, either an exact replica of the Q1 or in your own words.

What's wrong with using the Q1 template, is it frowned upon by the API auditors? I would think it makes things easier for them with regards to referencing etc. when they are carrying out an audit. As long as the manual then refers to the companies procedures which are in their own words.

I should mention that we are working from a blank canvas as we don't have a current "working" manual only a draft API Q1.

Any thoughts, or even better, first hand experience.

Thanks
 
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DP561

Hi All,

Another question.

How do API auditors view companies bringing in a non API auditor to carry out a pre API audit??
 
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wywy2020

Hi all,

Appreciate if anyone can share on below subject:
1. Risk assessment
2. Contigency plan
3. Management of change

Is there a standard way of doing it or any best practice that any big company is introducing?

thank you in advance.
 
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qhsemeneger

Hi Nick, will be API Audit in our organization in the middle of April, right now I am prepare MoC , data analysis and Tractability procedure. Do you have any draft procedures regarding to mentioned header for to compliance?

Thanks in advance,
Orkhan
 
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Puck81

We are also switching from ISO9001 system to the API q1. We are weak on the addition ...management of change, contingency planning, & risk assessment. I've seen some samples and have helped some, but on management of change, do you have each relevant manager "manage" and control their own areas..i.e. HR handles key personnel/organizational changes, quality mgr handles changes to the system etc? IF so would you create a work instruction for each area describing how you would manage it or am I way off base.
 
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pjgary

Hi All,

There are various thoughts on how to lay out the Q1 (ninth edition) QM, that is, either an exact replica of the Q1 or in your own words.

What's wrong with using the Q1 template, is it frowned upon by the API auditors? I would think it makes things easier for them with regards to referencing etc. when they are carrying out an audit. As long as the manual then refers to the companies procedures which are in their own words.

I should mention that we are working from a blank canvas as we don't have a current "working" manual only a draft API Q1.

Any thoughts, or even better, first hand experience.

Thanks

I've only ever dealt with 1 API auditor. He was very impressed with what he had and called it "one of the best I've ever seen". My Quality Systems Manual pretty much mirrors the API Spec. This is what is required; this is WHAT we must do. It doesn't make sense to go fancy with that in my opinion. However, my Quality Procedures Manual and all associated forms and documents are HOW we carry out the WHAT. That is something that must be tailored to your operation.

What is required of you is the same thing required for all of us; the requirement or spec does not change from company to company. What is does change is how each company goes about fulfilling the specification, or executing it. Your procedures should accurately describe the practices with which you fulfill, meet, or exceed what is required.

Note-- be careful with some of the language you use. There is a difference in May vs Shall, or Required vs Recommended, or Annually vs Continuously or As Needed.

Don't paint yourself in a corner. If you say "this is what we do" in your procedure, you better do it, otherwise you might be meeting API specifications and requirements, but not your own, which will be a finding all the same.

If you say you evaluate all employees every month, now you have to have a papertrail for that proving it. I have on a few of my preventative maintenance forms "operators must perform pre-use inspections prior to every shift; document Once per week at a minimum" -- so instead of having to make sure I can prove they are performing this inspection every day as I require, I only have to show documentation of it once a week.

Simple but true phrase - Say what you do, & do what you say. Q1 is so vague and broad. Your procedures should narrow it down to the way you do it. But dont make it so narrow that you create a paper monster that will be impossible to maintain.
 
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pjgary

Hi All,

Another question.

How do API auditors view companies bringing in a non API auditor to carry out a pre API audit??

They've got no problem with it, but you better know the requirements and perform the audit with him, because they've seen too many examples of companies that hire consultants and outside auditors who completely whiffed on ___, and guess what, that consultant isn't the one dealing with the reprocussions. Its good to have someone outside take a look, but its better to understand a) what is being asked for, b) how do we say we do that, c) how do we prove we do that, and d) does does our WHAT and HOW fulfill and match?

If you go through the 9th edition audit form, you can see point for point this is what they are looking for. If you saved your conformity matrix, that's a great resource because now you instantly see where everything in your system matches API.

Everything clicks in your mind once you perform an internal audit. Thats when the light goes on and you understand all of the process (assuming you've not done one yet and are new to this). The internal audit will be your greatest learning tool
 
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Chingibadshah

Dear Sirs,

Greetings & great work by you all forum people's!:)

Mr.PJ Gary & Irshad Khan.

I'm new to this subject & API certification, had some doubts & queries related to API SPEC Q1 9th edition.

Our firm is small group with only 10-12 employees a part from this 1 person is performing 2-3 departments work for all procedures & forms,we are now heading for API certifications soon.

I want to seek some help/guidance from you people for following points as:
1) What is the pre-requisite for API SPEC Q1 certification?
2) Whether it is good for our firm to go head with this employee strength?
3) What should i do for getting better knowledge & get the proper work done as per the standard requirements?
4) What will be the approximate time for preparing & maintaining the records as per available resources?
5)All my superior's are putting pressure on me for doing the multiple tasking work for documentation.

Please, I need your guidance & assistance w.r.t this so that i can prepare myself with all records updated.
Your Detailed & Elaborated response would be highly appreciated.

:thanks:

Best Wishes,

Chingibadshah
 
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