Can Extent of Documentation differ due to the Competence of Personnel?

Clause 4.2.1 Note 1 of ISO 13485:2003 states that "the extent of the quality management documentation can differ from one organization to another due to a) the size of the organization and the type of activities,
b) the complexity of processes and their interactions, and
c) the competence of personnel."

I wonder how the competence of personnel relates to the extent of the documentation.. does less competent personnel need more detailed documentation? Or is it the other way around and can more competent personnel handle more extensive documentation?

Does anyone have an idea what is the reasoning behind this point and why it is in the norm? I asked our auditor last week and he did not have a direct answer.

Thanks!

Sometimes organizations use MORE simplified documents- pictures, cartoons, etc. to avoid confusing workers who may have vocabulary or literacy problems in the language used by bosses in the organization.

I've seen industrial settings for mentally challenged folks that get along well with a combination of simple documents and instructions combined with individualized training and frequent evaluation of the adequacy of documents and training.

This point is in the standard, because of the diversity of companies in the medical devices industry. There are companies like "one man shows". and companies like multicorporate enterprises. It is obvious that things in bigger companies must be written down to work the same way around the world (one goal of QM). But a single person does not need to have special procedures for everything.

Regards,

phloQS

Size and complexity are pretty straightforward, but competency seems to me to be varying from individual to individual and changing over time. It doesn't make sene to me to base the extent of the documentation on such a changing factor. I have to admit that this doesn't have much impact in practice but I was just wondering why it is mentioned in the norm. As Wes' comment shows, the interpretation can go in two directions and therefore it can always be used to defend either an overly simple or an overly complicated documentation..

This is a good point to ponder !
The Information marked as “NOTE” is for guidance in understanding or clarifying and the same notes are exisiting in ISO 9001 as well.
It is true this can lead to any direction but it is same for points 1 and 2, since in a dynamic situation we can expect changes in these two as well.
The idea of these notes is to bring in diversity (if needed) and making documentation easily understandable to all employees within the organisation (and to other external stakeholders). without compromising in compliance to the requirements of the standard. It may be noted that "notes" are not NORM (requirement / standard).

What my question boils down to:
Larger organization -> logically requires more extensive documentation
More complex product/process -> logically requires more extensive documentation
More competent personnel -> ??

A case can be made that more competent personnel can 'handle' more extensive documentation, but also that they don't need a lot of documentation because they are already competent. But as mentioned earlier, competency is also partly a function of the documentation..

Maybe this note should be read as a warning not to blindly copy an existing quality system from another organization, which would be a silly idea anyway.

Thanks for the feedback everyone!

What my question boils down to:
Larger organization -> logically requires more extensive documentation
More complex product/process -> logically requires more extensive documentation
More competent personnel -> ??

Click to expand...

No, need not be this way
It depends upon the maturity levels of the organization and no two will be same and no two will be as smart.
Take a case of a big organization with a complex process. You are inclined to find the extent of documentation to be extensive.
No, A photo copier machine is assembled by one person and he knows all the parts and sequence to the correct details. Very less documentation.
Such a photo copier machine can also be assembled in a conveyor line with several people building the product as the conveyor moves and each stage has needed work instructions (documentation). The extent of documentation is vast here.
So in response to your subject :

Can Extent of Documentation differ due to the Competence of Personnel?

Click to expand...

YES

You have to remember that competency can be gained through appropriate education, training, skills, and experience.

If the company has been around awhile and has a large number of veterans then the overall experience level of the company will be high and will require less documentation as these individuals will know what needs to be done and pass that along to the younger generation. As for a start up or a relocated company the overall experience will be very low which will require more documentation to fall back on.

Our company relocated 9 years ago. After the relocation they feverish pumped out flowcharts and work instructions. Now several years later, our work force has matured and the over documentation is less necessary and some what of a burden.

When hiring new personnel, if the time is taken and the right money is offered you may get applicants that already have high skill sets and educated in the field in which they are hired for and they will require less documentation of how to perform their job.

That's my take on documenting to account for competency.


Steve

One of the main problem in this discussion, in my opinion, is that people forgot one simple thing - what is the purpose of the documentation and how it fits systemically in my QMS.

For example, the QMS generally expects that people perform theirs tasks correctly.

This can be solved in some ways

1 - detailed procedures to be followed - because of this, requirements for personnel can be somewhat "low" because they will always need to read and follow exactly what is written. In this case, the purpose of the documentation is to be a mandatory checklist to be followed.

2 - a generic procedure, let´s say, a general flowchart - because there´s already a "high" requirement for personnel. If you require that you personal is a PHD in the subject he´s dealing with, why would you need very detailed procedures? The guy already know because you required him to know. In this case, the objective of the documentation could be to be a reminder of the general flow of the process.

If the effectiveness of the proces is obtained by 1, 2 or any other solution related to competence and documentation, things would be ok.

You can also read more on this general approach on Introduction and support package: Guidance on the documentation requirements of ISO 9001:2008

In many of the organizations that we work with, we see different levels of instructions for "expert" and "novice" operators. These differences typically revolve around best practices, e.g., soldering, crimping, etc. Managed in an appropriate way,e.g., via electronic deployment, these two different sets of instructions can be presented in an appropriate fashion to the two different groups. Novice employees see all of the details while expert employees only see the high-level steps. Presentation can depend on assigned skill level.The thought process here is that the standard work will include all of the critical steps but doesn't include best practices for "expert" employees. The Instruction might read "solder the 9-conductor wire to the D-connector based on the wiring diagram" for the expert while the novice might get step x step and visuals showing how a wire is to be stripped, inserted, fluxed and soldered.