Documentation structure - Do I need Work Instructions?

James

Involved In Discussions
#11
however that with regard to "quality indicators," it's almost always a mistake to believe that if you change the name of a thing, the nature of it will change. They're still instructions.
Actually, I didn't want them to be detailed instructions, but indicators of quality relating to each device family. So - I'm changing the name to make sense. We make things, and I don't want to be overly prescriptive about how we do that, albeit we make things consistently. However, what's more important is what 'quality' looks like for each device family.
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#12
Change all the names as you like. What ever works in your company. You write the definition(s) of documents and what they are supposed to do.
what's more important is what 'quality' looks like for each device family.
I'm not sure what you mean by "...what quality looks like...".
 

James

Involved In Discussions
#13
I'm not sure what you mean by "...what quality looks like...".
Really as the document name suggests.. I don't want to spell out how devices need to be made as we can demonstrate technician competence and we'd we writing these for no good reason. We can specify what high quality conforming product in that family looks like though / what best practice should be applied to manufacturing steps (countersunk screws are flush with wooden surfaces; linisher used on sawn edges, which are checked prior to covering, etc)
 

James

Involved In Discussions
#15
What is your market? Is it strictly in the EU?
Its only the UK, so not the EU (new UK legislation will replace the MDR, but the new Medical Device Bill will inevitably look very similar). We make low risk devices (mainly accessories for wheelchairs); we will also be operating under a Health Institution Exemption
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#17
But please - Seriously - Do explain how it is 'archaic' and it's negative aspects. And, what is a better way to show in a simple graphic the relationship of documents in a company.
Manuals - who read them? Useless documents in the overwhelming majority of cases; so much so that even the TC 176 stop invoking the requirement for a quality manual.

In general terms we have to realize that documentation, in any shape, form and media serves no other purpose ( I am talking about documentation other than records here) to assist with process definition and control. The world is always evolving and more and more processes are being automated, digitally-controlled where applications are very self intuitive and mistake proofing is built-in the software.

Layers of documents just confuse the workforce and documents must be lean and to the point. A pyramid approach to documentation, in my experience, is a relic of Mil-I and Mil-Q days and belong in the past. The real goal is effective process deployment and documentation should be recognized just as a component of that objective.
 

John Broomfield

Staff member
Super Moderator
#18
Indeed.

Processes that are being automated and digitally-controlled operate strictly in accordance with documented procedures.

No need to repeat that documentation in any QMS.
 

James

Involved In Discussions
#19
Indeed.

Processes that are being automated and digitally-controlled operate strictly in accordance with documented procedures.

No need to repeat that documentation in any QMS.
I agree with this point entirely, but I'm not sure that the pyramid duplicates documentation, it just describes a way of structuring and organizing documentation, which makes it more relevant to staff IMHO. For example, the mandated top level quality manual is a very lean document of around 15 pages, which 'delegates' much of its required content to 2nd level procedures. Where more detail is required to complete a process, the individual procedures delegate these to a 3rd level detailed work instruction. Records on the 4th level are used to demonstrate evidence of activity.

Thanks

James
 

John Predmore

Trusted Information Resource
#20
I watched a video 30+ years ago, I think it was James Womack, author of Lean Thinking, who compared the game of American football to the game of European futbol, which Americans know as soccer.

The objective in both games is similar, to advance the ball down the field against the opposing team. In American football, the play proceeds in disjointed "downs", with lots of pauses and resets between plays, using a memorized play-book and each player on the team has a specialized role as a blocker or pass receiver, etc. The game of futbol/soccer appears to a football fan to be more chaotic, where players appear to have more flexibility, more autonomy, and the play proceeds without pauses for planning, without any apparent central coordination.

I offer this contrast as an analogy in discussion of detailed work instructions versus relying on the judgement and competence of workers to get the job done efficiently and expeditiously. Both football and futbol players are "trained" skilled athletes, both know what Success looks like, but the futbol/soccer player is more consistent with the definition of Lean in the modern era.
 
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