Documentation Review Practice

[qualityteam123]

Hello all.

I would like to gather some perspectives on the document review practice in your company. For non-QMS process related procedures (for example, inventory management, technical production steps, etc), does the Quality function review the procedure before allowing the procedure to be approved and made effective? If the Quality function review said procedures, what is the extent of the review?

Looking forward to this discussion.

 

[EdenG]

Hello,

The non-QMS processes perhaps have quality related functions to them e.g. Inventory management - Stock rotation / first-in-first out, this could be linked to inspection, influencing maybe how you ensure traceability to reports if your stock is mixed? Do you stamp parts etc.

The other question to ask is if it's not quality reviewing them who is? I guess the technical production steps procedure(s) should be made in accordance with the person performing that function most, likely as they're doing it under observation but with an open dialogue throughout about exactly what's going on where; The review if this approach is taken could be as simple as a getting another person (Ideally a capable 'alien') to run the procedure under observation again.

Some members of your quality team may be familiar with reviewing documentation, auditor trained or maintains the QMS - This person might have skills that lend themselves to this type of review...

Just my thoughts

Glen

 

[Tidge]

I would like to gather some perspectives on the document review practice in your company. For non-QMS process related procedures (for example, inventory management, technical production steps, etc), (1) does the Quality function review the procedure before allowing the procedure to be approved and made effective? (2) If the Quality function review said procedures, what is the extent of the review?

1) Yes.

2) Minimally, Quality makes sure that the documents were reviewed by the appropriate individuals and that the change order is constructed correctly.

As a long time quality reviewer of prints, drawings, specifications... I try to never inject my own evaluation of the content. However, if I have a question about something that doesn't appear correct, I do expect the appropriate reviewers to be able to explain what I see. Rarely, I have rejected a change to a document because it was clear that the assigned reviewer did an appropriate review. For example: the piece being released did not mate correctly with other pieces, or elements of the change's validation plan were not completed.

 

[Sidney Vianna]

Looking forward to this discussion.

The most sure-fire way to derail any quality system is to develop non-value added activities and bureaucracy. The workforce has this uncanny ability to smell muda in the process.

So, IF que quality function review adds any value to YOUR organization, do it. If it doesn’t, don’t.

 

[John Predmore]

I encourage having the Quality function review all new procedures and revisions. People being human beings, I often find other reviewers don't take the time to thoroughly review their assignment. I suspect that many reviewers (for example), knowing that only step 5 in a 10-step procedure was modified, will only review the language of step 5 and pay no attention to the rest of the lengthy document.

As a reviewer, I sometime discover inconsistencies were introduced in a document revision, such as a step 3.4 added but subsequent steps were incorrectly renumbered, or subsequent references to earlier steps are incorrect. Sometimes the Figure referenced "on page 4" is no longer on page 4 because of paragraphs added on page 3. I sometimes find settings or reference values cited are outdated or otherwise incorrect, because nobody checked when the document was in review. I try to refrain from commenting on other people's grammar or choice of words, but I sometimes find undefined use of jargon, or unnecessarily convoluted grammar or sentence structure, to be a potential source of confusion or inconsistency between operators.

As a Quality department person, I know that I don't design or manufacture product. In all humility, the way I bring value to the organization is by uncovering mistakes and proactively reducing the occurrence of human error. I make it my duty to carve out time when other reviewers may not (without unduly delaying document approval cycles). Avoiding human error is a legitimate quality department function. To address Sidney's point, the time spent in review of a document must be commensurate based on risk and the perceived likelihood of finding error.

 

[Ed Panek]

Depending on how siloed the processes are at your workplace, you could implement an item to your training form along the lines of "This document has been trained on and represents the current practice(s) involved in this process." Im thinking of an esoteric group that really only knows what they do. As the QA person you would not know if this is exactly what they do but the people in those weeds will let you know quickly.

Alternatively, Management Review has slides that address each group and have the minutes document something like "all relevant controlling documents have been reviewed by the owner(s) and found to be correct and relevant."

 

[Randy]

The most sure-fire way to derail any quality system is to develop non-value added activities and bureaucracy. The workforce has this uncanny ability to smell muda in the process.

So, IF que quality function review adds any value to YOUR organization, do it. If it doesn’t, don’t.

He's right, see it all the time the useless practice of reviewing something for the sake of reviewing something.

Press this equation into your memory bank, like many other subject specific professionals you might not have been made aware of it....

T + $$ (Time is equal to money) The time you spend doing stuff has to have some usefulness or it's a waste of resources and a drain on profitability or in other words no ROI (Return on Investment)

 

[Enghabashy]

* QC is core process , reviewing inspection , testing & the relevant QC documents & information only
**Quality Dept. should be independent from any process as the task , they are only responsible for inspection & testing -- as mostly management system & relevant operating manual -- but anyhow they can approve the documents if there' system requirement but should be independent from the reviewing -- the senior process owner may have the revising
***it's not appropriate to review some documents by Quality Dept-- as in-process /work instructions -etc-- . -- the processes could be submitted again for Quality audits ; any deviations /findings couldn't exclude Quality members for the results ---therefore the selecting independent auditors should away from QC & QA members -- accordingly -- Q Dept. should be independent for the effectively auditing processes -- the audits could cover recommendations & opportunities in management system-- hence it's useful tools for the improving process in future when Quality has more independent for sharing routine activities
*** some of non routine activities as products design could be covering QA / QC members in input/output --verifications --- it' as also the statement of design processes -- once validation & routine production initiated -- Q Dep't should be independent for any subsequent routine activities '

 

[Ed Panek]

He's right, see it all the time the useless practice of reviewing something for the sake of reviewing something.

Press this equation into your memory bank, like many other subject specific professionals you might not have been made aware of it....

T + $$ (Time is equal to money) The time you spend doing stuff has to have some usefulness or it's a waste of resources and a drain on profitability or in other words no ROI (Return on Investment)

Yes.

Things that need attention generally get attention. That's the nature of day-to-day work.

 

[FRA 2 FDA]

As @John Predmore state, I review all documents prior to release, not for content, but for the mundane things that no one else will bother to check. Do references to other documents check out? Is the part number used the correct one? etc. In addition, I ensure that there is continuity between all of our SOPs. Are all sections of the document present? Is the formatting correct? If we are switching from one logo/header/section format to another as documents are revised, did this document get switched over? Perhaps we will reach a point of work load where the value of my doing this is outweighed by the other tasks I have to get to and at that point I will probably no longer review every document prior to release. But for now, it has been valuable since I can fit it into my work load and I have frequently caught errors.