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Score of 0
A lapse in discipline or control during implementation, which does not indicate a system breakdown.
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Score of 1
Can be potential problems, risks, inefficiences, or failure to apply best practices. A situation, where, in the opinion of the auditor, clarification or improvement is appropriate.
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Score of 2
Processes have been defined and consistently applied and documented, leading to a reliable system to ensure compliance and performance
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Major Finding
an absence or ineffective implementation of a required system element, or a group of minor findings within an element, indicating inadequate implementation of the system.
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How to check if quality policy is understood?
Interview 6 people from different areas
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How to prove quality objectives
Ask employees to show you where objectives are
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Section 4, 5 Sections
- 1. QMS-policy in place
- 2. Mgmt Responsibility-objectives
- 3. Organization Capability-Competency
- 4. Documents-Revision control
- 5. Control of Records-procedure on how to store docs
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How to check training (4)
- 1. 3 people who affect quality
- 2. Training records
- 3. Date of training
- 4. Trainer
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What to check for doc control (4)
- 1. legible
- 2. retrievable
- 3. prevent damage
- 4. Retention time defined
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Approximate number of questions
450
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Section 5
Product Realization
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How to audit approved supplier list of supplier (3)
- 1. Location
- 2. Scope of services
- 3. Method of approval
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How to check "verification of purchased products"
List 3 completed receiving inspection documents (at least one elastomer)
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