"Method" vs "Process" - Differences

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Mark Meer

Trusted Information Resource
#32
Did you mean no documented procedures?
Or no procedures documented to the extent necessary for effective control?
I don't want to misrepresent what Bev is describing, but it appears like we are talking about "an absolute minimum amount of method and process documentation", which is laudable.
Hypothetically, you could envision a company with no process documentation at all, but whose records/data indicate everything is functioning perfectly. How many auditors would be ok with this? Notwithstanding any requirements within the audit scope that explicitly call for procedures, auditors should technically be fine with this, assuming interviews with personnel indicate that appropriate control is maintained.
However, in my experience, how auditors react to novelty is uncertain and increases chances of increased scrutiny and having to contest (perceived) non-conformances. Uncertainty is undesirable for our business, and there is certainly a risk-assessment of the potential regulatory & certification headaches of adopting novel, undocumented approaches that weighs in favour of the documented approach.

As an aside, the same goes for recognized/harmonized/concensus testing standards. Technically you are free to go "off script" and develop your own tests - but if your business depends on the outcome of an FDA review, it can be a huge risk to deviate from status quo (unfortunately).
 

John Broomfield

Staff member
Super Moderator
#33
Regulations may specify use of documented procedures whereas ISO 9001 has evolved to specify whatever is necessary for processes to be effective. Consequently an FDA auditor may feel very uncomfortable auditing a process without the support of a documented procedure.

But as auditees, should we be documenting procedures just to pass an ISO 9001 audit?

Better for every member of the process team to be able to explain what the process is meant to achieve, how it works, how it is monitored, what to do if it goes wrong, who is involved and what other processes interact with it.
 

Mark Meer

Trusted Information Resource
#34
Great discussion re: merits of procedures! Given that this is a bit tangential to the OP topic of this thread, I thought it might be worth spinning out a dedicated thread to continue discussion of this topic specifically. Started a new thread here.
 
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