1- Process (activity or set of inter-related activities)?

  • Where & how is the process defined?πŸ“˜

  • Who is the owner of the process?πŸ“˜

  • Where is the process located and how does it relate to other processes?πŸ“˜

  • Details

2- Inputs (internal requirements, external requirements, quality risks)?

  • What are the inputs? πŸ“˜

  • Where do they come from? πŸ“˜

  • How many are there? πŸ“˜

  • What are the quality risks? πŸ“˜

  • How are customer requirements determined and planned for? πŸ“˜

  • Details

3- Outputs (including records)?

  • What are the outputs? πŸ“˜

  • Where does it go? πŸ“˜

  • Who is the customer (maybe internal)? πŸ“˜

  • What other processes are linked? πŸ“˜

  • What records are required? πŸ“˜

  • Where do you put the record? πŸ“˜

  • What do you do if output is non conforming? πŸ“˜

  • Details

4- Safety & Health requirements (Significant Risks & Hazards)?

  • What are the significant safety risks and hazards? πŸ“˜

  • How are they ranked/evaluated? πŸ“˜

  • Are they placed in any priority/ranked? πŸ“˜

  • What controls are in place? πŸ“˜

  • Are they routine / non-routine? πŸ“˜

  • We're changes evaluated for risks & hazards? πŸ“˜

  • Details

5- Environmental requirements (Significant Environmental Aspects)?

  • What are the significant environmental aspects and impacts? πŸ“˜

  • How are they ranked/evaluated for significance? πŸ“˜

  • What controls are in place? πŸ“˜

  • Were changes evaluated for impact? πŸ“˜

  • What are the documented procedures to control these? πŸ“˜

  • Details

6- Resources (raw materials, equipment, infrastructure, hardware, software)?

  • What raw materials, equipment, parts, tools, materials, hardware and/or software are needed for the process? πŸ“˜

  • Are the resources adequate for the process? πŸ“˜

  • Are the resources adequately maintained? πŸ“˜

  • Is there adequate infrastructure? πŸ“˜

  • Are there any repeat issues? πŸ“˜

  • Are they available when needed? πŸ“˜

  • Is calibration/verification required? πŸ“˜

  • Are there any resources issues or concerns? πŸ“˜

  • Details

7- Responsible parties (roles, responsibilities, competences/skills/training)?

  • Who participates in this process (who is responsible)? πŸ“˜

  • How are responsibilities & authorities defined and communicated? πŸ“˜

  • How are participants competence determined? πŸ“˜

  • What training is included/required? πŸ“˜

  • What training records are maintained? πŸ“˜

  • How is training effectiveness determined? πŸ“˜

  • What documented training procedures applies? πŸ“˜

  • How is one trained to understand the impact to the customer, safety, health and/or environment if not followed as prescribed? πŸ“˜

  • Who maintains training records? πŸ“˜

  • What environmental aspects are associated with this process? πŸ“˜

  • What safety risks and hazards are associated with this process? πŸ“˜

  • Details

8- Operational Controls (methods/procedures/instructions/techniques)?

  • How do you know what to do? πŸ“˜

  • How do you stay safe through this process? πŸ“˜

  • How do you keep the environment safe through this process? πŸ“˜

  • How do you ensure that we meet customer requirements? πŸ“˜

  • Are the procedures and instructions clear enough for you to complete your tasks? πŸ“˜

  • Is the information in the document correct (does practice match procedure)? πŸ“˜

  • How do you know you have the current revision? πŸ“˜

  • How do you know if the document has been properly approved? πŸ“˜

  • How do you get the document? πŸ“˜

  • What other information is required for this process? πŸ“˜

  • Are documentation of external origin used? How are they controlled? πŸ“˜

  • Policy - Quality, environmental, health and safety? πŸ“˜

  • How does the Policy impact you and your work? πŸ“˜

  • Emergencies - what do you do? πŸ“˜

  • Is the process Value Added? πŸ“˜

  • Details

9- Metrics (Key performance indicators, measurements, analysis, & continual improvement)?

  • What are the key performance indicators for this process? πŸ“˜

  • How is this measured? πŸ“˜

  • How do you know if the process is on target (it's trend)? πŸ“˜

  • What do we do if the measure doesn't meet target? πŸ“˜

  • What do we do if the process is out of control? πŸ“˜

  • What type of data analysis do you do? πŸ“˜

  • How has this process continually improved? πŸ“˜

  • What could we do to make this process more effective? πŸ“˜

  • Details

  • Audit Summary Report

  • Document MasterπŸ”‘
    πŸ“˜ = Reference Only

  • Lead Auditor

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