Title Page
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Site conducted
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Conducted on
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Prepared by
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Location
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Department
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Individual
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Process - Process map, flow chart, process description
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Where & How is the process defined?
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Who is the process owner?
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What are the most important steps to completing this process?
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What are the controls and Checks points? Are they logged and analyzed
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Inputs - Customer requirement, specifications, scheduled, documents, materials, regulatory and legal requirements
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What are the process inputs?
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Supporting Document
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Where do they come from?
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How are cusotmer requirements determined and planned for?
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Are there Legal or Regulatory requirements to consider?
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Supporting Document
Outputs - Traceable product or service, inspection records, completed work orders, maintenance records.
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What are the Outputs
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Supporting Document
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Where do they go?
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Who is your customer?
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What records are required ?
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Where do you put the record?
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What do you do if output in nonconforming?
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Supporting Document
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Resources - Approved Suppliers and Supplier Evaluation (Other Resources)
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Who are your Approved Suppliers and how are they Evaluated
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How are they selected? (Type of service; historical records that show capability and performance)
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Are there any requirements for your critical suppliers? (Vendor Survey Form - VSURV)
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Upon completion of evaluations, are there any documents that show results and classifies suppliers? (Approved, Provisional, Not Approved)
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Show proof
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Do you have any new suppliers that have been automatically approved?
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Show proof
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Are there any vendors on your Approved Supplier List that are not considered critical?
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Explain
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Are there any other critical resources? (Resources - Maintenance, preventive, calibration,<br>and other details of machine, materials, computer<br>systems used by the process)
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List
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Are the resources adequate for the process?
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Explain
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Are they adequately maintained?
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Explain
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Are there any resource issues or concerns?
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Explain
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What is the retention policy?
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Where are they stored?
Personnel - Defined roles and responsibilities, requirements for required skills, competence criteria, consequences if procedures are not followed, records of training, etc.
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Who participates in this process?
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How are responsibilities & authorities defined and communicated?
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How is competency defined?
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What training is required?
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What training records are maintained?
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How is training effectiveness determined?
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Who maintains training records?
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How is the process executed - Process controls, procedures, work instructions, methods, control plans
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How do you know what to do?
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How do you ensure that we meet customer requirements?
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Are your procedures and instructions clear enough for your to complete your task?
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Is the information in the document correct (does procedure match practice)?
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How do you know you have the current revision?
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How do you know if the document has been properly approved?
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How do you get the document
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What other information is required for this process?
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What is our Policy
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How does this policy impact your work?
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General Observation/Conversation/OFI
