Manufacturing procedure / work instruction depth

James

Involved In Discussions
#1
Hello friends

I wondered if anyone could give an example of the level of detail required for Manufacturing procedures / work instructions? How 'high level' can these be to meet 13485 / MDR requirements?
We manufacture class 1 devices (but mainly accessories for devices), and the components used are quite diverse, based on a clinicians requirements (such as different combinations of foam fillers and coverings). Accessory requirements will be written in a drawing sheet produced by a clinician. These may not necessarily constitute 'custom made' accessories; they may for example be a postural support for a wheelchair that has been designed to meet a particular patients' needs, but could 'technically' be used by someone else.

Does anyone have a good example of a clinical device or accessory manufacturing procedure?

Many thanks

James
 
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yodon

Staff member
Super Moderator
#2
You need to ensure that the product made meets specifications. You need to consider the complexity of the work and the culture of the operators. If you have highly-skilled folks that can do the job perfectly every time with just a drawing, you could arguably not need any work instructions (a bit facetious since there may be test points / QA checks along the way that probably need some instruction but hopefully you get the point).

(Your production / post-production monitoring activities should give you a clue as to whether the procedures / instructions are sufficient and effective.)
 

John C. Abnet

Teacher, sensei, kennari
#3
level of detail required for Manufacturing procedures / work instructions? How 'high level' can these be to meet 13485 / MDR requirements?
Good day @Jamesv ;
Be careful not to build documentation based on what you might think the auditor "needs". (i.e. "...to meet 13485...") .
Ask/work with your teams to see what level of detail your organization needs to ensure...
1- Conforming work
2- Repeatable/standardized work.
3- Sustainability if/when key members of your team leave the organization.

If the system/documentation constructed is only done so to "meet 13485/MDR requirements", then the system and documents will likely be a burden for someone to simply maintain instead of a tool that will benefit your organization.

Hope this helps.
Be well.
 

James

Involved In Discussions
#4
If the system/documentation constructed is only done so to "meet 13485/MDR requirements", then the system and documents will likely be a burden for someone to simply maintain instead of a tool that will benefit your organization.
Thanks, thats a helpful perspective. I've not documented manufacturing-based procedures before, only service based. I'm struggling to apply the principles in a meaningful way. Based on the objective of ensuring
1- Conforming work
2- Repeatable/standardized work.
3- Sustainability if/when key members of your team leave the organization.
we could arguably have a very high-level manufacturing procedure that specifies that the item will be manufactured in accordance with the design specifications and technical file, by a competent technician.

We could then have 'good practice' work instructions that are maintained by the workshop that are not mandatory, but give guidance on the general manufacturing principles and approach for different groups of products. These help to ensure sustainability through having documented 'instructions'for how groups of products can be manufactured. Different technicians might take a different approach to manufacturing an item, but crucially, as long as what is manufactured meets the problem / intended aim of the product, the way in which this is achieved can vary?

We also have occasions where the person making the product also designs it. In this instance, they dont do an actual drawing of what they are going to build, its a mental image / conceptualisation that they make. They take photos of the product at the end, and it is signed off as meeting clinician and patient approval at the end. This is a pragmatic approach in my view, but does it meet requirements?
 

John C. Abnet

Teacher, sensei, kennari
#5
Good day @Jamesv ;
Obviously only you and your organization know what is best for your situation. I, however, generally council companies to consider (similar to what you described), ....
1- Procedures (which are limited on text) and simply identify WHO does WHAT and WHEN. These can be extremely helpful to ensure that the corporate intent is SUSTAINED if/when there is turnover in the organization.
2- Work Instructions (which, WHEN required are filled with the detail necessary) to ensure standardized work specific to HOW a job is to be done.

Example:
If the corporate intent is that the ADMINISTRATOR (who) will MAKE COFFEE (what) every MORNING (when), then a procedure can help sustain that intent and a work instruction is likely not needed. However, if instead of "make coffee" the procedure says "start the reactor", then a significant work instruction/training curriculum is likely needed !

Hope this helps.
Be well.
 

James

Involved In Discussions
#6
Thanks @John C. Abnet

Can work instructions be semi-vague in relation to HOW we get there, as long as we get there consistently? Eg, a step like - 'engineer considers job requirements and selects cutting tools necessary for cutting out specified materials'?
 

John C. Abnet

Teacher, sensei, kennari
#7
Can work instructions be semi-vague in
Good evening @Jamesv

They can be as detailed or "semi-vague" as you and your organization wishes. They should serve your organization and its people and only your organization and its people can determine how much detail that requires. I would council that IF a work instruction is required, then that would prompt me to lean towards more detail instead of less.

The standard only mentions certain required procedures (the terms "procedure", "work instruction", etc... are not necessarily common from organization to organization) and is very specific on which "procedures" are required and which "procedures" are required if/then.

Hope this helps.
Be well
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#10
Thanks @John C. Abnet

Can work instructions be semi-vague in relation to HOW we get there, as long as we get there consistently? Eg, a step like - 'engineer considers job requirements and selects cutting tools necessary for cutting out specified materials'?
I see nothing wrong with that statement... but as an auditor I might then ask "how does the engineer know what tool is appropriate?" At which point you would produce training records or other qualification of the engineer.

So, as has been stated, write the work instructions to suit your business - not to suit what an auditor might ask for.

I've always taken these on a case by case basis for each work instruction... sometimes you can leave things open, sometimes you need to be exact.
Fit the situation.
 
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