QMS / QSR - Reference to Framework - Templates - Procedures for Medical Devices

[v9991]

QMS :- quality management system
QSR :- quality system regulations.

Is there an equivalent reference or document to provide outline various QMS / QSR processed involved for compliance to 21 CFR part 820 or ISO 13485. for medical device!!!

WHO has published such a useful repository for drug product.
http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/

http://www.who.int/medicines/areas/quality_safety/quality_assurance/QualityAssurancePharmVol2.pdf

http://apps.who.int/iris/bitstream/10665/64465/1/WHO_VSQ_97.01.pdf

etc .,

 

[v9991]

wonder if 'restricting' or controlling the templates-formats really have any meaning!

it is proved time&again that real value IS IN spirit+extent of implementation of QMS.
i.e., having SOP alone just does not yield the expected and required benefit.
viz., we might include the 5-why tools; or fish-bone diagram as formats in the SOPs, but real benefit will only be yielded WHEN&ONCE they are applied to fullest extent!


This perception is backed by examples of FDA 483s and warning letters to some of the established 'companies' in the market. ( infact, i am unable to say it as leaders ,
* as standards are not uniform......and
* they are quite a spectrum of requirements/practices for any given procedure!!! ( noted an simple 5d format vs detailed 3-stage handling of incident procedures across organizations! )
* atleast there is little consensus on QMS requirements .., apart from the ISPE, PDA like organizations which focus on highly specific topics;
vs
though this comment/observation is from outside, compare above ispe/pda initiatives to the standards of qualifications procedures followed by automotive industry from supplier qualification, MSA published by industry consortiums!)
* let alone the interpretation and implementation of standards by the regulatory agencies! ( barring the recent effort to share the audit observations, and joint audits being performed across agencies)

in one line,
what do we really gain by making the sops-templates-formats available in general ( atleast generic ones!_
or
is there a place-group which really makes the qms templates-formats available for free access!!!

Anyways, on note of forward looking.... its time to embrace a representation similar to that of SEI-CMM ...
this is nicely demonstrated in the SEI-CMM levels of software development!!!... which is in itself definition of process
Level 1 – Initial: Company has no standard process for software development. Nor does it have a project-tracking system that enables developers to predict costs or finish dates with any accuracy.
Level 2 – Managed: Company has installed basic software management processes and controls. But there is no consistency or coordination among different groups.
Level 3 – Defined: Company has pulled together a standard set of processes and controls for the entire organization so that developers can move between projects more easily and customers can begin to get consistency from different groups.
Level 4 – Quantitatively Managed: In addition to implementing standard processes, company has installed systems to measure the quality of those processes across all projects.
Level 5 – Optimizing: Company has accomplished all of the above and can now begin to see patterns in performance over time, so it can tweak its processes in order to improve productivity and reduce defects in software development across the entire organization.

 

[Marc]

Re: wonder if 'restricting' or controlling the templates-formats really have any mean

Problem 1 is the goal posts tend to change over the years.

Problem 2 is that technology and software is changing so fast that once (for example in CMMI) a company is at level 5 it finds its self back at level 2.

 

[Marcelo]

I'm not sure what you exactly expect with the second post (but I don't know of any group creating and making available medical devices QMS templates), but here are some food for thought:

- Templates are only as good as the person using them. If you know what you are doing, a template can help you begin something not from scratch. If you do not know what you are doing, no template will help you.

- I always use "templates" (in fact, the last iteration of a template from my last client) in a client to show the idea of something, but in the end his/her document is always so different from the "template" that calling it a template is a misnomer (but I know how to use all of them so it's no problem for me guiding the client in creating the correct document for his/her use).

- in the case of QMS templates, most templates that I see are not "procedure templates", but a mix of very different stuff. A procedure is "a specified way to carry out an activity or a process", meaning, they should be simply the set-by step of an activity for example (with related stuff required for the performance of the activity). Most templates I see are a mix of a procedure with a specification (detailing requirements), but are a bad specification, because they define the requirements of the standard and not the requirements of the related activity. This makes no sense at all. So in fact, in my opinion, most are simply bad templates. No wonder people have no idea how to use them

 

[v9991]

but here are some food for thought:

- Templates are only as good as the person using them. If you know what you are doing, a template can help you begin something not from scratch. If you do not know what you are doing, no template will help you.

- I always use "templates" (in fact, the last iteration of a template from my last client) in a client to show the idea of something, but in the end his/her document is always so different from the "template" that calling it a template is a misnomer (but I know how to use all of them so it's no problem for me guiding the client in creating the correct document for his/her use).

- in the case of QMS templates, most templates that I see are not "procedure templates", but a mix of very different stuff. A procedure is "a specified way to carry out an activity or a process", meaning, they should be simply the set-by step of an activity for example (with related stuff required for the performance of the activity). Most templates I see are a mix of a procedure with a specification (detailing requirements), but are a bad specification, because they define the requirements of the standard and not the requirements of the related activity. This makes no sense at all. So in fact, in my opinion, most are simply bad templates. No wonder people have no idea how to use them :-P

I'm not sure what you exactly expect with the second post (but I don't know of any group creating and making available medical devices QMS templates),

why are standards (requirements-expectations) soooo much cryptic? what stops them from being atleast to have appendix/annexures which are indicative of what they could look like. (viz., even you mentioned each implementation would lead to highly specific/customized form for each template, and each iteraction evolves it in some ways... )

in one line,
1) like WHO has come up with certain form/templates for cGMPs , is there equivalent such forms/templates for Devices
2) since anyways its going to be evolved and customized to specific needs, what is stopping from these forms being available (in one form or another)!

 

[Ronen E]

why are standards (requirements-expectations) soooo much cryptic?

In my opinion they aren't.

Further, what do you think 90% of the enterprises would have done if ISO, for instance, released a standard template?... Exactly - they would have adopted it as-is, investing as little as possible thought and resources in actually adjusting them so that the goals of having a QMS could be effectively met. There are privately-created templates circulating in the market, and too many times I've seen systems which are thoughtless duplicates of such templates, sitting there gathering dust and adding near zero value.

(Please forgive my cynicism)

 

[v9991]

In my opinion they aren't.

...
(Please forgive my cynicism)

And in fact, I share your cynicism, (if not more )

BUT, not withstanding what most of them are doing;....
I really think what WHO did is really commendable.,!!! and it puts most common options in place and a very good starting point. (as opined by Marcelo Atunes )

on other hand, it might also be putting off same guys... as they are interpreted every time in different ways by different persons (even auditors! ....between agencies/authorities!!!)

we have got people who can deal with certain complex technologies and processes; but when it comes to quality/compliance processes, they treat it as if its alien thing!!! ( personnel include at different levels and across functions!!!)

for personnel who might be on border/interested....not having templates is putting them off.... { what they say is that, it took hundreds of year to bring wheels under for travelling baggage!!! ...u see what i am saying.... templates are there...few evolved., some times i wonder, how long it took our existing templates to be here; and i surely see that they require to evolve to address not just future requirements but to support organizational maturity in implementing/adopting/executing those processes!!!)

and the point is...while each constituent require certain different aspects to overcome....the above context is to find a solution at the genesis. i.e., definition level of requirements-framework etc., (extend/better the guidance same )

 

[Ronen E]

I don't know the WHO templates but since drugs and medical devices are not that far apart, they can be used as an origin template for a medical devices QMS.

 

[v9991]

I don't know the WHO templates but since drugs and medical devices are not that far apart, they can be used as an origin template for a medical devices QMS.

AGREE..., and i am looking for specifically the templates for (i acknowledge the same during earlier one of the discussion)

• 
  [*]820.20 Management Responsibility
  [*]820.30 Design Controls
  [*]820.100 Corrective and Preventive Action

 

[Ronen E]

AGREE..., and i am looking for specifically the templates for (i acknowledge the same during earlier one of the discussion)

• 
  [*]820.20 Management Responsibility
  [*]820.30 Design Controls
  [*]820.100 Corrective and Preventive Action

Don't the WHO QMS templates address management responsibility, design controls (ie how to develop products etc.) and CAPA? Not at all? :mg:

Either way, in the thread you linked to you already received plenty of guidance and resources to support developing compliant systems in the above fields - with or without templates.