Process realization audit points
For the ISO 9001 & TS 16949 requirements, process realization process checklist points for audit are as under:
Are there sufficient instructions for operating machines and processes?
Who decides and how whether work instructions shall be established for a given process/workshop?
Are process parameters defined?
Interaction with operators to ensure the process, what should the settings be for various parameters in their processes, and how they know this? It there simple system to follow?
What are the bottom & higher limits for the parameters?
What should they do, and how, when a parameter goes over limit? As example: Temperatures of machine.
Who selects/specifies production line requirements, production supporting equipment & tooling?
Is equipment/tooling tested before it is used in production? Is there testing records are maintained?
Is tool having on monitored, and how it’s effective?
Are equipment checks and/or tool change intervals defined? What are the frequencies?
Is there a system for controlling the inventory of measuring/monitoring devices, list with identification, location, calibration status?
Is the inventory of measuring devices adequate to meet requirements of the monitoring/measurement program like inspections, tests, etc.?
Are there defined responsibilities for these activities? Are peoples are aware about its responsibilities, single activity’s responsibility given dual?
How requirements are documented, Procedures, work instruction or documented procedure?
Who is responsible for identifying processes requiring validation?
How is it determined what controls, validations and arrangements shall be required for each such process – criteria for review and approval?
Are process validation results recorded? Records are easily accessible for concern peoples?
Process required validation? If yes, are processes revalidated?
Select a sample of processes that require validation and investigate how these processes were validated, and whether this complies with requirements.
Are materials and products used in production uniquely identified while in storage, in staging areas, at work shop, etc?
Is the acceptance status identified? Acceptable status identified by responsible person?
Verify that for any product in production areas it is evident what the product is and whether it passed inspection and can be moved to the next processing stage or be dispatched to customer.
How is it determined what products require traceability, it should be comply requirements of customers, regulatory requirement, internal engineering or quality assurance requirements.
How are traceability requirements for specific products documented?
Where required, how is traceability recorded? Records are effective?
Review a sample of production records and verify the integrity of the traceability system.