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Documented process vs procedure and product safety

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Guest user Created:   Sep 19, 2017 Last commented:   Sep 19, 2017

Documented process vs procedure and product safety

What is the difference between documented process and procedure? What are the requirements in Product safety? Does we need to maintain any procedure?
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IATF 16949 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

IATF 16949 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Strahinja Stojanovic Sep 19, 2017

Answer:

Documented process is just another way to require documented procedure. It only allows you to document the process in any way you find the most suitable and that is through flowchart, quality plan or any other way, but the essence is the same.

Clause 4.4.1.2 titled Product Safety requires a documented process (procedure) for the management of product safety. This clause defines 13 normative elements that must be included in the documented product safety process. These 13 requirements include identification of product safety characteristics, inclusion of safety characteristics with approvals in design and process FMEA’s, control of safety characteristics at the point of manufacturer with documentation in control plans with specific reaction plans, and defined responsibilities for product safety management including the definition of an escalation process and flow of information, inc luding top management, and customer notification. Additionally, those personnel involved in product safety related processes will have specific training.
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Sep 18, 2017

Sep 18, 2017

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