[ASK] API Q1 Ninth Edition, Section 5.4.5

#1
Hello guys,

Probably someone here has expertise on API Q1.
I have one question that still confusing me at long time after i read section 5.4.5 API Q1 of Ninth Edition.

At this section mentioned Design verification & Final Review,
"to ensure that the design and development outputs have met the design and development input requirements, design and development verification and a final review shall be conducted and documented"

what i confuse is the term is separated by "and", verification and final review, does it mean this section explaining there is two thing need to do ? not one ? due as in my first comprehension this section asked us to do only 1 thing, just design verification, comparing requirement in plan with our design in output, no more.

If yes, verification and final review is two different things, then what is the difference ?

Highly appreciated to someone that may give me an enlightenment about this.

Again, many thanks.
 
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jmech

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#2
The requirements for verification and final review in Q1 9th Edition 5.4.5 appear to be the results of awkwardly merging requirements previously in separate sections (Q1 8th Edition 7.3.4.1 and 7.3.5). In my experience, API auditors have checked that this was completed but did not go into great detail on whether verification and final review were performed together or separately.

The design verification (see definition in 3.1.10) and final review do not need to be conducted as completely separate activities, but they may be.

For example, one engineer may perform alternative calculations to confirm the accuracy of design results - this is a verification activity per the note in 3.1.10. Multiple verification activities may be appropriate for a single design, depending on the design complexity. A senior engineer or a group of engineers may review the results of the design and verification activities (such as the original and alternative calculations) as part of a final review.

For a simple design in a small organization, the design verification and final review could be completed as a combined activity by one engineer, as long as this meets the vague requirement in 5.4.4 that "Participants in such review(s) shall include representatives of functions concerned with the design and development stage(s) being reviewed."
 
#3
The requirements for verification and final review in Q1 9th Edition 5.4.5 appear to be the results of awkwardly merging requirements previously in separate sections (Q1 8th Edition 7.3.4.1 and 7.3.5). In my experience, API auditors have checked that this was completed but did not go into great detail on whether verification and final review were performed together or separately.

The design verification (see definition in 3.1.10) and final review do not need to be conducted as completely separate activities, but they may be.

For example, one engineer may perform alternative calculations to confirm the accuracy of design results - this is a verification activity per the note in 3.1.10. Multiple verification activities may be appropriate for a single design, depending on the design complexity. A senior engineer or a group of engineers may review the results of the design and verification activities (such as the original and alternative calculations) as part of a final review.

For a simple design in a small organization, the design verification and final review could be completed as a combined activity by one engineer, as long as this meets the vague requirement in 5.4.4 that "Participants in such review(s) shall include representatives of functions concerned with the design and development stage(s) being reviewed."
Very clear explanation sir, i really thanks to you.
So Design verification & Final Review may done in combined.

Design verification as 3.1.10 are one or more :

2.JPG

Then the final review in simple means is a proof that my superior has reviewed my design verification then as objective evidence get their signature in verification sheet right ?

Btw, is you or anyone here having sample of Design Verification & Final Review sheet ? i already searched in this forum and got nothing sir, very thanks if you have the example so i may compare with ours due we want to face the audit.

Additionally, i read again API Q1 ninth edition, and realized there is one statement pertaining with Final Review in section 5.4.1 Design and Development Planning, which in point e). The requirement for final review of the design (see 5.4.5).

1.JPG

Does it means, we have to list what things in Design Plan sheet that needed to review in Design Verification & Final Review ?

Before many thanks sir.
 

jmech

Trusted Information Resource
#4
Then the final review in simple means is a proof that my superior has reviewed my design verification then as objective evidence get their signature in verification sheet right ?
It can be as simple as that. In my experience, this has been enough.

Btw, is you or anyone here having sample of Design Verification & Final Review sheet ? i already searched in this forum and got nothing sir, very thanks if you have the example so i may compare with ours due we want to face the audit.
I'm not able to share one. As long as you cover the requirements in Q1, you should be fine. If you share yours, others might provide you with feedback.

Does it means, we have to list what things in Design Plan sheet that needed to review in Design Verification & Final Review ?
No. Your design procedure must identify the requirements for final review (i.e. "The final design must be reviewed"), not the contents of the review (i.e. "The final design review must include review of alternate calculations."). You can add more detail about the contents of the review, but then you open yourself up to a nonconformance if you do something different that would otherwise meet Q1 but doesn't meet your procedure.
 
#5
I'm not able to share one. As long as you cover the requirements in Q1, you should be fine. If you share yours, others might provide you with feedback.
Please find attacment for the sample sir, what your opinion about this format ? do this format not covered for final review as API Q1 regulation ?

Before many thanks
 

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