Production Audit Checklist

Production Audit Checklist

 

Production Audit Checklist

  • Are adequate product specification like drawing, spare part list, mathematical data, statistical data, production samples etc.. Are available to production personnel?

  • Where all the specifications are in used is updated and approved?

  • Interview production personnel and ask how they know what to make and what the requirements are for workmanship standards appearance, precision, surface quality of product etc..

  • Are there sufficient work instructions for operating machines / equipment and processes?

  • What is the method to decide of criteria? How and who are establish criteria? Whether work instruction / standard operating systems shell be established for the given process /work place?

  • All the process parameters, speed of the machine, temperature, required pressure are defined?

  • Interact with operators for the settings for the various parameters, how parameters are adjust? And how they know this?

  • What is up stream & download stream limits of the parameters? And what this the limits are bounded? Is there any method used for it? The method is verified?

  • In case of the parameters are cross over the limits how they are handle? Is there any method of controlling? Which method is used for controlling? Control parameters should be measurable.

  • What is the process of choose specific equipment and supporting tools? How the equipment and tooling is test for the production lines? Is tool wear monitored, and how?

  • In the production line, equipments inspection and tools change process are done as frequency defined?

  • Is there a system for controlling the inventory of measuring/monitoring devices? All the measuring and monitoring devices are identified? Calibrated? What is the frequency of the calibration? Is there records are available?

  • Is the inventory of measuring devices adequate to meet requirements of the monitoring/measurement program?

  • Are there defined responsibilities for these activities?

  • Is the procedures / work instruction / standard operating systems / sign boards / precaution notes etc.. Requirements are documented? Deployed at place?

  • Is the responsibility assign for the identification processes and requiring validation?

  • Who are authorized personnel to determine controls, validation, arrangement and approvals?

  • All the process validation and re-validation process records, documents, evidence are recorded?

  • Sampling plan is available with production department? How the sample process plan designed? How it validated?

  • Is there mentioned if the sample are failed on testing that what is the process for it?

  • Are materials and products used in production uniquely identified while in storage, in staging areas, at work stations, etc?

  • Acceptance status is identified? How established acceptance criteria?

  • 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? How are traceability requirements for specific products documented? Where required, how is traceability recorded?

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