Design & Documentation of Control Systems and Procedures

[v9991]

How do you respond/act when you notice that
a) procedures are NOT-comprehensive, but implementation is adequate
vs
procedures are comprehensive BUT implementation is IN-adequate. (i.e., all the steps, parts, stages of procedure areimplemented but not effective)

b) documentation is NOT-comprehensive, but completed online.
vs
documentation is comprehensive, but NOT-completed online. (i.e., documentation is done after completing the activity, viz., end of activity, shift, batch etc)

& + clarify if you select the even options on the poll.

+ does the above perception change, when moving from industries which are self-regulated to regulated industries!

note :- ideal situation "comprehensive and effective systems" "comprehensive and online documentation" are always, anytime desirable, but we are in a state of flux, unless that is a very small team and products etc.,

 

[lk2012]

Hi,
I'd rather see a procedure that doesn't cover absolutely everything that's being done but the work and the system is being done 100%. Making additions/amendments to a document when everyone already knows what they're doing (and they're doing it right) is much better than having a fantastically written procedure that nobody follows and nobody cares about.
As for documentation completed online or post-process, I wouldn't worry about it too much as long as the documentation is completed within reasonable time and it doesn't affect the quality of the product / process.
Hope this helps
Lil

 

[v9991]

thank you for your response,

I'd rather see a procedure that doesn't cover absolutely everything that's being done but the work and the system is being done 100%.

I too agree, but taking an insider view, how do i be assured that across the teams, the procedure will be implemented in letter and spirit. because, as QA, i will be only seeing off the samples during the audit!!!
and with an outsider view, as an auditor, how to be sure that sample which is reviewed is representative of whole process, after all, i cannot be running through all exhausitve examples of all processes!!!

As for documentation completed online or post-process, I wouldn't worry about it too much as long as the documentation is completed within reasonable time and it doesn't affect the quality of the product / process.
Hope this helps
Lil

can you help me define the 'reasonable time'; any example or defenition or approach towards that.

thank you.

 

[v9991]

by the way, I tend to go with a comprehensive procedure, its like an track laid out, then its only to train-monitor-maintain the personnel for effective implementation. (this is particularly true for large teams, and otherwise, it will be more person dependent, i.e., unless it is enforced, it is there, otherwise it is lost!)

and on documentation account, no question about the completeness of records; but wrt online records your point is true &valid!,, we need to define that 'ratione time lag' which is considered online for relevant operations.

 

[pldey42]

I don't know what kind of industry the question refers to, but in the software industry I would not rely upon quality alone to check everything.

Software development typically includes generation of requirements specs, design docs, test specs and test records. We often build cross-checks into the process itself, calling them quality gates. So, for example, the requirements aren't approved until they've been reviewed - not by quality, but by the people who will use the document. They'll review the requirements against the template, maybe a checklist too. Ditto the design, even the code. So quality monitoring gets easier: we only need to check that the people doing the work are doing the detailed checks, and sample a few to assure ourselves it's going well.

So in short, my suggestion is to build cross-checks into the system so that quality only has to monitor the cross-checking. Extra effort for those doing the work, sure, but it's more efficient in the long run to find errors early. And cross checks can be cheap: think of those manufacturing lines where operators check the previous work was done correctly by inspecting the incoming work-piece against a photo of what it should look like.

Hope this helps,
Pat

 

[v9991]

I don't know what kind of industry the question refers to, but in the software industry I would not rely upon quality alone to check everything.

Software development typically includes generation of requirements specs, design docs, test specs and test records. We often build cross-checks into the process itself, calling them quality gates. So, for example, the requirements aren't approved until they've been reviewed - not by quality, but by the people who will use the document. They'll review the requirements against the template, maybe a checklist too. Ditto the design, even the code. So quality monitoring gets easier: we only need to check that the people doing the work are doing the detailed checks, and sample a few to assure ourselves it's going well.

So in short, my suggestion is to build cross-checks into the system so that quality only has to monitor the cross-checking. Extra effort for those doing the work, sure, but it's more efficient in the long run to find errors early. And cross checks can be cheap: think of those manufacturing lines where operators check the previous work was done correctly by inspecting the incoming work-piece against a photo of what it should look like.

Hope this helps,
Pat

Like I indicated, i work with regulated sector ( pharma); wherein QA is not only expected to check/cross-verify, its responsible for everything going right and accountable for anything gone wrong. (obviously, its patient,,health and more so from regulations stand point)

 

[John Broomfield]

Like I indicated, i work with regulated sector ( pharma); wherein QA is not only expected to check/cross-verify, its responsible for everything going right and accountable for anything gone wrong. (obviously, its patient,,health and more so from regulations stand point)

v9991,

If QA does all this, what are the non-QA managers doing in Pharma?

John

 

[v9991]

v9991,

If QA does all this, what are the non-QA managers doing in Pharma?

John

i didnt mean that "QA does all",

When i used word, "responsible", i meant line clearance and reviews at batch level, and including audits are process levels...
like for all critical steps, starting from dispensing(weights) till dispatch (product clearance); line clearance for all key steps is given by QA(QC),

and when i used the word "accountable", i meant coordination and collaboration for any failures, investigations, and audits, QA would be enabler-execution for ensuring they dont recur/successfully addressed..

note : !!! from management and regulatory point of view, its (almost)not a control untill the qa clears that...and since problem occurred after qa clearance! they are part of problem!!! (atleast thats how situation is (made to be) felt/perceived ~~~)

 

[John Broomfield]

v9991,

It sounds like pharma management has QA exactly where they want them.

A shield from any responsibility for getting their work right the first time.

And independence compromised when it comes to audit.

John

 

[John Broomfield]

v9991,

I chose:

Minimalist definition of the documented procedure implemented with an effective process in both letter and spirit.

My corrections reflect the fact that the process is the work and the procedure (documented and undocumented) is the specified way of carrying out the work.

John