Information
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Audit Title
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Document No.
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Client / Site
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Conducted on
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Prepared by
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Location
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Personnel
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Enter the unique number for this audit taken from the schedule in IsoXpress.
WHAT WAS AUDITED
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Name of personnel spoken to.
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What Standard was used as reference in this Internal Audit?
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What process and department were audit?
Section 1: SAFETY – Does the employee’s or department supervision understand safety needs and requirements? ISO Ref: OHSAS18001
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1.1. Do you have safety controls in place? What are they?
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1.2. How are there implemented?
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1.3. DO YOU HAVE ANY SAFETY IMPROVEMENTS THAT YOU FEEL ARE REQUIRED?
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1.4. Is there a risk assessment for the task you are doing?
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1.5. Have you read & signed off on the risk assessment?
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1.6. Where are the risk assessments kept?
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1.7. Is there an SOP in the area? Where is it located?
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1.8. Are you fully aware of the SOP’s content?<br>
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1.9. Have all the pre-start check been completed on equipment?
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1.10. Have you been trained in the task you are doing?
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1.11. To what level have you been trained?
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1.12. Is there training instructions?
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1.13. Are there training records? Where are they kept? Matrix?
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1.14. Is there maintenance on equipment that you use? How often?
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1.15. Is this in IsoXpress (Maintenance and Calibration Module)?
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1.16. Are there chemical in the area and what are they?
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1.17. Is there a MSDS from chemicals used here?
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1.18. Where is the MSDS kept?
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1.19. Is the MSDS up to date?
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1.20. What areas are you responsible for
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1.21. Are the areas clean according to housekeeping (5S) standards?
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1.22. Do you isolate equipment? How? Electrical safety checks?
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1.23. Have you been trained in the correct way to isolate?
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1.24. Are you aware of fire, explosion & fire extinguishers?
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1.25. Are you aware of the evacuation procedure?
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1.26. Are you full aware of safe manual handling techniques? RSI
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1.27. Are you aware of gas safety? Pre-start checks?
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1.28. What do you do if you have an incident or accident?
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1.29. When should you report an incident or accident?
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1.30. What do you do if someone has an incident or accident?
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1.31. Are you fully aware of the PPE requirements on site?
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1.32. Would you say something if you see and unsafe act?
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Opportunity For Improvement (OFI) or Area Of Concern (AOC) - AOC must be address by opening a Corrective Action Report (CAR)! Remember to record the CAR number. OFI's should be discussed at Operation Meetings.
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CLOSING COMMENTS:
Section 2: CUSTOMER FOCUS (ISO 9001:2008 Ref 5.2 & 8.2.1)
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2.1. Do you know the customer’s needs & requirements?
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2.2. By what means? By whom?
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2.3. Does a meeting take place to discuss customer requirements?
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2.4. Do you have process documents related to customer satisfaction?
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2.5. Are personnel fully aware of the customer requirements?<br>
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2.6. Do you use Drawing and Order Confirmation?<br>
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2.7. Is the system capable of delivering customer satisfaction?<br>
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2.8. How do you know if the customer is satisfied?<br>
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2.9. Is the customer notified in relation to system failures?<br>
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2.10. Is there new customer opportunities?<br>
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2.11. Is there customer loyalty?<br>
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2.12. Does the company give feedback to its customers?
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Opportunity For Improvement (OFI) or Area Of Concern (AOC) - AOC must be address by opening a Corrective Action Report (CAR)! Remember to record the CAR number. OFI's should be discussed at Operation Meetings.
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CLOSING COMMENTS:
Section 3: LEADERSHIP - Objectives and Targets. Recent changes explained to employees.
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3.1. What are you trying to achieve? The direction of your section!<br>High quality, Low cost, to be competitive, Delivery targets
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3.2. Are they displayed on the Mini Business Board?
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3.3. Has there been any change in the business that may affect any process controls – Shop floor personnel – Management
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3.4. Have you been trained in the new process?
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3.5. Training and Skills Matrix updated?
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3.6. Do you have clear objectives that are been achieved?
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3.7. Do you have a quality policy, and where is it located?
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3.8. Are objectives & targets being achieved and recorded?
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3.9. Are employees kept in the loop, Section changes - Feedback?
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3.10. Are employees fully aware of their responsibilities?
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3.11. Are employees motivated, when changes occurs?
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3.12. Are all employees aware of continual improvement?
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3.13. Are targets recorded, displayed and reviewed.
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3.14. Do employees have a PD? If so, when was it last reviewed?
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3.15. Do employees / Customers complain about quality? If so, what are they?
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Opportunity For Improvement (OFI) or Area Of Concern (AOC) - AOC must be address by opening a Corrective Action Report (CAR)! Remember to record the CAR number. OFI's should be discussed at Operation Meetings.
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CLOSING COMMENTS:
Section 4: INVOLVEMENT OF PEOPLE.
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4.1. Are people communicated to on a daily bases to any changes in the Safety or Quality system or other requirements?
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4.2. How does communication occur?
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4.3. Do people have the resources to carry out their duties efficiently?
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4.4. Have all employees been competently trained in all skills they required?
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4.5. Are they any training work instructions available
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4.6. Are training work instructions controlled?
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4.6. Are training work instructions controlled?
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4.7. Do you have a training and skills matrix? If so where are they kept?
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4.8. Are there training records and sign offs?
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4.9. Are training records stored and where? Are they easily accessible?
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4.10. Have all the activities been carried out by the responsible people?
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4.11. Are their skills used to maximize potential & contribute ideas to lower costs?
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4.12. Is these cost Value adding downstream or upstream?
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4.13. How do employees communicate their improvement ideas?
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4.14. Do all employees take fully responsibility & are accountable for their actions?
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Opportunity For Improvement (OFI) or Area Of Concern (AOC) - AOC must be address by opening a Corrective Action Report (CAR)! Remember to record the CAR number. OFI's should be discussed at Operation Meetings.
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CLOSING COMMENTS:
Section 5: PROCESS APPROACH: (CONTROLS, INFORMATION FLOW & EVIDENCE AND DOCUMENTATION)
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5.1. Is there control over documentation?
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5.2. Who controls the documents? Are they easily accessible?
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5.3. Are Work Instruction generated and controlled by IsoXpress?
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5.4. Have work instructions been reviewed in the past year?
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5.5. Are controls defined by work instructions or Production Packs?
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5.6. Are customer requirements placed in the production packs?
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5.7. Are peoples responsibilities defined and communicated to?
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5.8. Is the process capable of delivering customer requirements?
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5.9. Do you know the capability of your manufacturing system?
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5.10. Have you full control over your manufacturing system?
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5.11. Are changes to the customer requirements communicated? How?
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5.12. Are effective use of resources used to reduce cost?
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5.13. Are cost reduction been achieved?
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5.14. Is there an acceptance and the rejection criteria?
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5.15. Does the acceptance & rejection have controls & checkpoints?
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5.16. Do you have an Inspection and Test Plan?
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Opportunity For Improvement (OFI) or Area Of Concern (AOC) - AOC must be address by opening a Corrective Action Report (CAR)! Remember to record the CAR number. OFI's should be discussed at Operation Meetings.
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CLOSING COMMENTS:
Section 6: SYSTEM APPROACH TO MANAGEMENT (INPUTS & OUTPUTS)
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6.1. What customer requirements triggers the process?
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6.2. What are your inputs? Customer Orders/Production job packs.
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6.3. Do you have service agreement and when was it last reviewed?
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6.4. Are all service agreements available?
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6.5. Are all inputs & output addressed and controlled?
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6.6. Do you have checks points and have they been recorded?
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6.7. Are added value & downstream activities controlled?
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6.8. Is the section achieving its objectives efficiently?
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6.9. Have cost savings (IF ANY) been recorded?
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6.10. How are employees trained to use the improvement tools? (LEAN MANUFACTURING)
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6.11. Have all specifications been achieved before despatching?
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Opportunity For Improvement (OFI) or Area Of Concern (AOC) - AOC must be address by opening a Corrective Action Report (CAR)! Remember to record the CAR number. OFI's should be discussed at Operation Meetings.
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CLOSING COMMENTS:
Section 7: CONTINUAL IMPROVEMENT (Recent Corrective Actions and Internal Audits - Past 12 Months)
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7.1. Is there a system for continual improvement?<br>
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7.2. Do personnel know how to raise a Corrective Action (CAR)?<br>
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7.3. Are there certain areas targeted for improvement? <br>
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7.4. Are improvements recorded, costed and monitored?<br>
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7.5. Does the section embrace new opportunities?<br>
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7.6. Are there difficulties to change in the work environment?<br>
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7.7. Is changes in a work process explained with clarity? <br>
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7.8. How are non-conforming products identified?<br>
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7.9. Do you have a quarantine area? <br>
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7.10. Are corrective actions raised, costed and closed off?<br>
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7.11. Have all corrective action been closed off in a timely manner?<br>
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7.12. Are there non-conforming trends?<br>
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7.13. What is the largest complaint category & is it been addressed?<br>
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7.14. Are people trained in the prevention of complaints?<br>
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7.15. Have all effective QA Checks been conducted and recorded? <br>
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7.16. Do you have calibrated system and is it maintained?<br>
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7.17. Are check sheets generated for critical equipment?<br>
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7.18. Do you know of any failures in the process at the moment? <br>
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7.19. Does management know?<br>
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Opportunity For Improvement (OFI) or Area Of Concern (AOC) - AOC must be address by opening a Corrective Action Report (CAR)! Remember to record the CAR number. OFI's should be discussed at Operation Meetings.
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CLOSING COMMENTS:
Section 8: FACTUAL APPROACH TO DECISION MAKING
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8.1. How do you analyse production and process KPI’s?
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8.2. Are they displayed and were?
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8.3. Is root cause analysis use for determining a problem?
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8.4. How does this happen?
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8.5. Is the section fully aware of the importance of quality and cost?
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8.6. Do you have the ability to defend decisions on specific information?
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8.7. Is the data ready available from the works data system?
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8.8. Is the section ensuring quality objectives are consistent and are achieved in an orderly manner?
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8.9. Are existing work instructions or technical specifications effective in the training of personnel?
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Opportunity For Improvement (OFI) or Area Of Concern (AOC) - AOC must be address by opening a Corrective Action Report (CAR)! Remember to record the CAR number. OFI's should be discussed at Operation Meetings.
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CLOSING COMMENTS:
Section 8: MUTUALLY BENEFICIAL SUPPLIER RELATIONSHIPS
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9.1. Do you have an approved supplier list?
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9.2. Do you conduct audits on customers and suppliers?
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9.3. Do you evaluate/re-evaluate your suppliers?
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9.4. Have you had any safety or quality issues from any of your suppliers?
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9.5. Are customers issues recorded into the works CAR system?
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9.6. Do you give feedback on quality issues to your customers?
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9.7. Do your customers welcome feedback from issues raised?
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9.8. Does the business benefit from customer feedback?
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9.9. Is supplier communication effective?
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9.10. Must you inspect all material that arrives form your customers or suppliers?
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9.11. Do you trust your suppliers & customers?
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Opportunity For Improvement (OFI) or Area Of Concern (AOC) - AOC must be address by opening a Corrective Action Report (CAR)! Remember to record the CAR number. OFI's should be discussed at Operation Meetings.
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CLOSING COMMENTS:
OBSERVATIONS
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What was seen, specific reference to evidence
DISCREPANCIES
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Describe any discrepancies witnessed
AUDIT SIGN OFF
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Select the date by which this audit was completed
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Name Signature of auditee
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Name and Signature of Auditor