Key Process Audit Checklist Record answers and notes on blank turtle diagrams or audit checklist or note page

Transcription

1 What machines, equipment, software, and materials are used to do this process? Are there adequate resources? Is the equipment maintained and supported? Are there gauges that require calibration? What Inputs are required to do this process? Are these good and correct? What comes from internal and external customers? Any legal or regulatory requirements? What measurement or performance indicators exist? What monitoring or measuring is there? How is the performance and trends? What goals are there? Any customer feedback? How effective is the process? Are employees and management aware of negative trends and is anything being done? What is the Process being audited? Observe all aspects of the process being done. Ask questions about how the process gets done by the people doing the process. Who is the Process Owner? What role, responsibility and authority? Collect documents looked at, it s number and revision date. Verify against master documents. Any obsolete documents in use? Are all documents used for production controlled? Are documents populated and signed as required? Who is involved with this process? (Departments and job functions) What training and skills are required? Any special skills, certifications or training needs? What records of training exist? What Outputs come out of this process? What gets delivered to internal and external customers? What current records and historical evidence can you see to prove effectiveness of the process? Are records adequate per plan? What procedures or work instructions exist for this process? Get copies of all appropriate documentation and review. Do the people clearly demonstrate that they can do their jobs per the documented procedures and work instructions? What other Processes does this one link to or interact with? What examples can be followed into other processes? Follow audit trails from this process into other processes to assure the linkage, sequence and interaction are working as intended. What are the applicable ISO 9001 clauses that affect this process?. Key Process Audit Checklist Record answers and notes on blank turtle diagrams or audit checklist or note page List people audited and verify training and competency records: Verify records against the jobs you saw them performing 2010 simpleque Inc. All Rights Reserved 249 S. Garber Dr., Tipp City, OH

2 Audit Checklists for Support and Management Processes Please note that checklists for support and management processes will be more old school checklists that use questions following the specific clause of the ISO standard (possible examples of support and management processes are: management review, internal audits, HR/training, corrective action, preventive action, document control, record control). Additional questions should be added to review document control, records, training, etc., but expect more traditional checklists that follow the ISO clause and requirements. The Key Process Audit Checklist is not applicable for support and management processes.

3 People Interviewed (Shift): Auditors: 8.2 What is monitored, measured and reported for this production process? Select a process and look at the performance data. Copy the data or record a summary here Are there any negative trends or bad performance against goals? 8.5 If yes, what is being done for continual improvement? 1

4 Are there any customer problems, scorecards, negative feedback or high reject rates? Is there any specific part number or customer that should be used for audit samples due to poor performance? 5.5 Are appropriate employees aware of any recent customer problems? 2

5 7.5 Get a copy of the work instructions for the production process or part number being observed and audited. Watch and see if the work instruction matches exactly what is being done in production. Get a copy of the traveler and routers. Are they being followed? Note any discrepancies between documentation. 6.2 Has the operator been trained on the job you are observing them perform? What records exist for the training? 3

6 4.2 Are all necessary documents available in production? Work order, checklists, visual cards, routers, etc. List all the documents and their revision levels. Are all the documents the most recent version? 4.2 Look at records from the last time this part was run. Can the records be found? Were production records properly filled out and completed? Evaluate records from multiple shifts. 4

7 7.5 Look at raw material being used. Is there adequate identification and traceability to a lot (if required)? 7.5 Is purchased part lot traceability information being carried forward to production records? 8.3 Is any scrap properly handled and identified? 5

8 8.3 Are there any examples of nonconforming product or rework? 8.3 Is this material properly identified? 8.3 Is the procedure for nonconforming or rework material being followed? 6

9 7.5 Evaluate preventive maintenance records for the machines being observed or audited. What preventive maintenance was supposed to have been completed? What preventive maintenance has been completed? 4.2 Are preventive maintenance records complete? 7

10 Are there any deviations or exceptions in the production process? Is the deviation process and procedure being followed? How long is the deviation for, or for how many parts? When did the deviation start? When is it supposed to end? Is the deviation still open? 8.3 Is the customer involved and have they approved the deviation, if appropriate? 8

11 7.6 Record information from any measurement gauges or test equipment. 7.6 Check to see that gauge calibrations are up to date and that calibration records are maintained. 8.2 Are measurement records complete for any inspections that are supposed to be recorded? 8.2 Are any measurements out of spec? If yes, what was done? Is this per procedure? 9

12 Were there any targets for productivity and effectiveness? What is OEE versus the goal? What is scrap versus the goal? What is PPM versus the goal? What is process capability versus the goal? What is the standard time or rates versus the goal? Are operators aware of bad performance or negative trends? 8.5 Is anything being done to make improvements in areas that aren t performing as planned? 10

13 6.1 Observe the work environment and equipment. Are there adequate resources (space, equipment, and people) to do the job as planned? Is the work environment appropriate, clean and safe? 11

14 Add your own supplemental questions: 12