Tackling Clause 6.1 in ISO 9001 can be structured by using
Ishikawa's fishbone diagram. You can 'reverse engineer' it to create a
framework for a simple risk approach.
Ishikawa discovered
that most non-conformances typically have their 'root cause' in one or
more of these four areas:
- People
(he called this category Man).
This relates to clauses 7.1.2 and 7.2. Do our employees have the skills
they need to reduce risks associated with their responsibilities?
- Method
This category will be in all areas of your system, but if you focus on
clause 8, Operations, you'll be mitigating risks in a critical area. Are
we monitoring our process and improving them?
- Machine
Look for risks throughout your
infrastructure (Clause 7.1.3) and prioritize them. Is our machinery aging?
Is our internet fast enough for us?
- Milieu
This is your 'Work environment'
(Clause 7.1.4). Have we created an environment that keeps risk to a
minimum? Are we monitoring our culture and fostering engagement? Are we
listening to our employees?
We've added
'customer' on our table in the SimplifyISO platform and don't forget inputs,
either - 'garbage
in' raises risks every time!
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