INTERNAL AUDIT CHECKLIST

Transcription

1 DOCUMENT INFORMATION / RECORDS CONTROL 7.5 P-4.2, rev 1 WHAT INFORMATION DO YOU USE TO DO YOUR JOB? Make a copy of the master list to check off as you go or save them up to check at one time or your documents may be readily available online and therefore no list is used, ie. Controlled information. WI 7.5 (line 28 and 61) Inspection p/n 439, form 1, rev 1 not online, obsolete after you verify (line 29) Current Lead Time sheet (line 16) P-4.2, NOTE: THIS COULD BE DOCUMENT CONTROL OR 8.1 PRODUCTION PLANNING OR 8.2 CONTRACT REVIEW, BUT YOU ARE AUDITING PRODUCTION. I WOULD TEND TO PUT IT UNDER DOCUMENT CONTROL, IE. ELECTRONIC CONTROL ON THE SERVER. ASSESS IF ALL THE INFORMATION NEEDED TO DO JOB IS AVAILABLE. CONSIDER HOW FORMAL ON-THE-JOB TRAINING IS VERSUS TRAINING FROM DOCUMENTED WORK INSTRUCTIONS. ARE THEIR ANY NEGATIVE TRENDS THAT WOULD INDICATE CURRENT METHODS NEED IMPROVEMENT? Production work instruction does exist and appears to be adequate. ASSESS HOW THIS IS CONTROLLED, HOW OFTEN DOES IT CHANGE AND IS THERE A CHANCE THAT IT WOULD BE CHANGED NOT GET UPDATED? Operators do not use the Lead Time Sheet but Production provides the information to be distributed. Los like it has been updated at least 3-4 times so far this year. Information to be controlled. IDENTIFY RECORDS THAT ARE AN OUTPUT FROM THIS PROCESS. HOW LONG ARE THEY TO BE KEPT (RECORD RETENTION SCHEDULE)? Make a copy of the list to check off as you go or save them up to check at one time or records may be completely electronic and then it is managed by Information Technology. Inspection records current year plus 1 Calibration records 3 years ASSESS IF THERE WERE ANY PROCESS CHANGES THAT WOULD HAVE CHANGED THE RECORDS. ANY NEW RECORDS OR OBSOLETE RECORDS? None at this time. 1 -see above

2 LEADERSHIP AND COMMITMENT 5.2/7.3 P-5.1, HOW HAS THE QUALITY POLICY BEEN COMMUNICATED? Sam was aware of policy and training records observed. (line 28). IF CONTRACTORS ARE WORKING ON-SITE IS IT AVAILABLE TO THEM? Maintenance uses contractors for planned outages. (line 84) ASSESS THE EVIDENCE OF TRAINING RECORDS. CONSIDER THE FEASIBIITY AND CONSEQUENCES OF CONTRACTORS TRAINING RECORDS. These contractors will need some training such as safety and environmental training if bringing any chemicals on-site. You can do the training onsite and maintain records, or contractually require the subcontractor to perform the training and they maintain the records. Records would be available upon request. They are performing maintenance activities so wouldn t require any quality policy and objectives training. 5.1/6.2/7.3 P-5.1, WHAT ARE THE RELEVANT QUALITY OBJECTIVES FOR THIS PROCESS? On-time delivery Claims < 1% sales Downtime 5% 5.1/7.3 ASSESS THE EVIDENCE THAT INDIVIDUALS HAVE BEEN MADE AWARE OF THESE OBJECTIVES AND THEIR PERFORMANCE. ARE THEY AVAILABLE TO CONTRACTORS? Operator said objectives were posted in lunch room (line 59) COMPARE THE GOAL VERSUS CURRENT PERFORMANCE. IF GOAL IS NOT BEING MET, HAS A DOCUMENTED ACTION PLAN BEEN INITIATED? On-time delivery - no Claims < 1% c/a issued (line 23) Downtime - yes WHAT KIND OF PROGRESS HAS BEEN MADE TOWARDS ACHIEVING THIS PLAN? On-time delivery action plan was not documented (line 9) 2

3 5.1.2 P-5.1, EVIDENCE OF CUSTOMER FOCUS? Customer requirements are well known by employees. ASSESS COMMUNICATION OF CUSTOMER PERFORMANCE, INCLUDING ANY COMPLAINTS. The Operator you spe to was aware of the 439 p/n complaint. Check the lunch room which was said to have the Quality Policy posted. It may have management objectives posted and customer feedback regularly posted. Make more inquiries to other employees if they ever lo at the board. 5.3 P-5.1, HOW HAVE RESPONSIBILITES AND AUTHORITIES ASSIGNED? Work instruction WI 7.5 denotes responsibilities. ARE THERE ANY CHANGES, IF SO HAVE THEY BEEN REFLECTED IN DOCUMENTATION? None observed RESOURCES 7.2 P-6.2, HOW DO YOU QUALIFY PERSONNEL (DIRECT OR CONTRACT EMPLOYEES)? 7.2 d) A training matrix is used to train on the required work instructions. (line 73) Nonconformities are tracked by employee for competency. (line 75) Quality performs monthly process audits but Mike does not receive results. (line 76) ASSESS TRAINING RECORDS AND VERIFY ANY NEW EMPLOYEES OR EMPLOYEES THAT HAVE CHANGED POSITION Mike Spencer Sam Lesniak (you loed it up) (line 52) Jim Anderson / obs 3

4 WORKING ENVIRONMENT observe ASSESS THE WORK AREA AND ITS CONDITION FOR BEING CONDUCIVE TO PRODUCING/CONDUCTING CONFORMING PRODUCT OR SERVICE, ie. Physical factors - Lighting, hygiene, noise Housekeeping was good. Lighting was adequate for inspection. Equipment guards were in place and Operators wearing PPE. IMPROVEMENT/CORRECTIVE ACTIONS 9.2.2/10.2 P-8.5, P-8.5, P-8.5, 10.3 P-8.5, WI 7.5 VERIFY PREVIOUS INTERNAL AUDIT NONCONFORMANCES. ASSESS ACTIONS TAKEN AND THEIR EFFECTIVENESS. None at this time, first audit. VERIFY ANY OPEN AND/OR CLOSED CUSTOMER COMPLAINTS. ASSESS ACTIONS TAKEN AND THEIR EFFECTIVENESS. 439 corrective action verified at production line and operators are aware of complaint. (line 38) New tooling work order for 439 (line 26) VERIFY ANY INTERNAL CORRECTIVE ACTIONS, IF ANY? ASSESS ACTIONS TAKEN AND THEIR EFFECTIVENESS. Could review the corrective action log and sample implementation, but only verified for on-time delivery but no internal corrective action issued. VERIFY ANY CONTINUAL IMPROVEMENT PROJECTS. ASSESS THEIR PROGRESS. Did not audit Production WORK INSTRUCTION BEING FOLLOWED? You can create more detailed questions or use a copy of the work instruction as your checklist and to take notes. Paperwork completed as required See dna f) WI 7.5 DOES THIS PROCESS INVOLVE ANY PRODUCT CHARACTERISTICS THAT CANNOT BE VERIFIED, SUCH AS WELDING OR HEAT TREATING? Typically this has already been established but wanted to provide meaning. None at this time. N/A 4

5 8.5.2 WI 7.5 PRODUCT IDENTITY MAINTAINED AT THE WORKSTATION? You can create more detailed questions or use a copy of the work instruction as your checklist and to take notes. Yes, router is signed off and parts identified. RAW MATERIAL/COMPONENT LOT NUMBERS MAINTAINED AT THE WORKSTATION, IF REQUIRED? Not required as per the work instruction. N/A WI 7.5 DOES THIS PROCESS INVOLVE ANY CUSTOMER SUPPLIED PRODUCT, IE. CONTAINERS, COMPONENTS? IF SO HOW IS IT CONTROLLED? Typically this has already been established but wanted to provide meaning. None at this time. N/A DOES THIS PROCESS INVOLVE ANY EXTERNAL PROVIDER S PRODUCT, IE. CONSIGNMENT COMPONENTS? IF SO HOW IS IT CONTROLLED? None at this time WI 7.5 ARE THERE ANY PACKAGING REQUIREMENTS AT THIS WORK STATION AND ARE THEY BEING FOLLOWED? You can create more detailed questions or use a copy of the work instruction as your checklist and to take notes. Observed operator placing parts into in-process basket as required by the work instruction. No other special requirements. 8.6 WI-7.5, Form 1 PARTS INSPECTED ACCORDING TO CUSTOMER REQUIREMENTS? You can create more detailed questions or use a copy of the work instruction as your checklist and to take notes. Yes, p/n 439, 100% at this time (line 36) 8.7 WI 7.5 WHAT DO YOU DO WHEN NONCONFORMING PRODUCT IS FOUND? Sam said he would stop the press and notify his Supervisor. He would put a red tag on completed product baskets. (line 49) 5

6 Calibration / WI 7.6, Rev 7 INSPECTION EQUIPMENT CALIBRATED? Micrometer #101 calibration sticker (line 38) # finding 7.1.6/ 7.5 WI-7.1, Rev 3 A 3-decimal place micrometer would not be capable of measuring a tolerance of.001. You can verify with a capability study. Also, equipment should be calibrated to 1/10 of its tightest tolerance, therefore a 4-decimal place micrometer is needed. extra credit!! ARE QUALITY PLANNING DOCUMENTS (OUTPUT) DONE ACCORDING TO CUSTOMER REQUIREMENTS? You can create more detailed questions or use a copy of the work instruction as your checklist and to take notes. Yes, p/n 545 rev WI-7.1, Rev 3 ARE PART CHANGES ADEQUATELY REVIEWED ACCORDING TO PROCEDURES? Material Spec change reviewed, or could note here from 7.5 6