Procedure equals a process?

[Marc]

The word procedure no longer exists in the standard

This discussion started with respect to AS9100 and has changed/moved to @Weeder 's post relating to MEDDEV. Is this the "standard" you are referring to, or AS9100, @Big Jim ?

 

[Big Jim]

Yes, I'm referring to AS9100D. It is also true of ISO 9001:2015, the standard that AS9100D is based on.

 

[Weeder]

This discussion started with respect to AS9100 and has changed/moved to @Weeder 's post relating to MEDDEV. Is this the "standard" you are referring to, or AS9100, @Big Jim ?

Sorry Marc, I am referring to the MEDDEV and I did not notice the original discussion was AS9100.

 

[Weeder]

Forced to write procedures for everything?

Where is this specified as a requirement?

These days our standards and auditors of systems and processes recognize the usefulness of undocumented procedures arising from training, competence and shared organizational beliefs and knowledge.

The old rule of document the system to the extent necessary for effective planning and control did lead to a lot of over documentation but much of that is disappearing as users find that the upkeep of many documents added cost but no value. Long may that continue.

These days system developers start with the process and the people doing the work. Respecting them as experts in what they do instead of acting as representatives of the “we know best department”. Consequently, the employees feel they own the system and are more enthusiastic about improving it as and where necessary.

But I am intrigued by your claim that you feel forced to write procedures for everything.

Kindly explain.

Thanks John,

What I mean by forced is that the auditor is always asking where is your procedure for vigilance, technical documentation, unannounced audits, clinical evaluation, etc. I am not saying we should operate without procedures, what I am saying is many times the MEDDEV guidance and other documents already contain the process/procedure/steps and you don't have to reiterate them in your own company procedures. For example, when asked about vigilance procedure, it should be enough if we have a statement in our quality manual that says we follow the MEDDEV 2.12-1. Same thing goes for others. There are time when you may have to tailor some items to suit your product but generally those guidance are enough.

As you mentioned, the upkeep of such documents is just an added burden on companies (specially the small ones) and adds no value. Many times it just seems like an academic exercise to write these procedures. The regulations are often verbose and do a poor job of keeping things simple. Other than to please the auditor, I find little value in documenting such procedures/processes.

 

[John Broomfield]

If the relevant parts of MEDDEV are cited by your policy and made available to the employees planning the work, resourcing the work, doing the work and monitoring the work and the workers combined with MEDDEV are competent then you could reasonably claim that MEDDEV is part of the documented parts of your management system.

It is however rare for an external document to accurately refer to the job titles of each person completing a task specified by said document. But this may be resolved by a documented matrix (or router) showing which of your job titles implements each of the MEDDEV clauses.

It may still need your documented instructions and forms to supplement MEDDEV.

Naturally, even if this sounds well and good in theory you and your colleagues will validate this change as effective. Also, be prepared to show how your training process responds to upcoming changes with updated verifications of competence.

To keep us on topic, please note that the process is the work whereas the procedure is the specified way of carrying out the work.

 

[Weeder]

If the relevant parts of MEDDEV are cited by your policy and made available to the employees planning the work, resourcing the work, doing the work and monitoring the work and the workers combined with MEDDEV are competent then you could reasonably claim that MEDDEV is part of the documented parts of your management system.

It is however rare for an external document to accurately refer to the job titles of each person completing a task specified by said document. But this may be resolved by a documented matrix (or router) showing which of your job titles implements each of the MEDDEV clauses.

It may still need your documented instructions and forms to supplement MEDDEV.

Naturally, even if this sounds well and good in theory you and your colleagues will validate this change as effective. Also, be prepared to show how your training process responds to upcoming changes with updated verifications of competence.

To keep us on topic, please note that the process is the work whereas the procedure is the specified way of carrying out the work.

Thanks John, That makes a lot of sense and I think I am going to use that approach. Using the MEDDEV for the bulk of the information and then tailoring it to our particular needs and the other issues you pointed out.