Information

  • Audit Title

  • Document No.

  • Client / Site

  • Conducted on

  • Prepared by

  • Location
  • Personnel

  • Enter the unique number for this audit taken from the schedule in IsoXpress.

WHAT WAS AUDITED

  • Name of personnel spoken to.

  • What Standard was used as reference in this Internal Audit?

  • What process and department were audit?

Section 1: SAFETY – Does the employee’s or department supervision understand safety needs and requirements? ISO Ref: OHSAS18001

  • 1.1. Do you have safety controls in place? What are they?

  • 1.2. How are there implemented?

  • 1.3. DO YOU HAVE ANY SAFETY IMPROVEMENTS THAT YOU FEEL ARE REQUIRED?

  • 1.4. Is there a risk assessment for the task you are doing?

  • 1.5. Have you read & signed off on the risk assessment?

  • 1.6. Where are the risk assessments kept?

  • 1.7. Is there an SOP in the area? Where is it located?

  • 1.8. Are you fully aware of the SOP’s content?<br>

  • 1.9. Have all the pre-start check been completed on equipment?

  • 1.10. Have you been trained in the task you are doing?

  • 1.11. To what level have you been trained?

  • 1.12. Is there training instructions?

  • 1.13. Are there training records? Where are they kept? Matrix?

  • 1.14. Is there maintenance on equipment that you use? How often?

  • 1.15. Is this in IsoXpress (Maintenance and Calibration Module)?

  • 1.16. Are there chemical in the area and what are they?

  • 1.17. Is there a MSDS from chemicals used here?

  • 1.18. Where is the MSDS kept?

  • 1.19. Is the MSDS up to date?

  • 1.20. What areas are you responsible for

  • 1.21. Are the areas clean according to housekeeping (5S) standards?

  • 1.22. Do you isolate equipment? How? Electrical safety checks?

  • 1.23. Have you been trained in the correct way to isolate?

  • 1.24. Are you aware of fire, explosion & fire extinguishers?

  • 1.25. Are you aware of the evacuation procedure?

  • 1.26. Are you full aware of safe manual handling techniques? RSI

  • 1.27. Are you aware of gas safety? Pre-start checks?

  • 1.28. What do you do if you have an incident or accident?

  • 1.29. When should you report an incident or accident?

  • 1.30. What do you do if someone has an incident or accident?

  • 1.31. Are you fully aware of the PPE requirements on site?

  • 1.32. Would you say something if you see and unsafe act?

  • 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.

  • CLOSING COMMENTS:

  • Count all the "YES" answers and move the slider to the corresponding number.

Section 2: CUSTOMER FOCUS (ISO 9001:2008 Ref 5.2 & 8.2.1)

  • 2.1. Do you know the customer’s needs & requirements?

  • 2.2. By what means? By whom?

  • 2.3. Does a meeting take place to discuss customer requirements?

  • 2.4. Do you have process documents related to customer satisfaction?

  • 2.5. Are personnel fully aware of the customer requirements?<br>

  • 2.6. Do you use Drawing and Order Confirmation?<br>

  • 2.7. Is the system capable of delivering customer satisfaction?<br>

  • 2.8. How do you know if the customer is satisfied?<br>

  • 2.9. Is the customer notified in relation to system failures?<br>

  • 2.10. Is there new customer opportunities?<br>

  • 2.11. Is there customer loyalty?<br>

  • 2.12. Does the company give feedback to its customers?

  • 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.

  • CLOSING COMMENTS:

  • Count all the "YES" answers and move the slider to the corresponding number.

Section 3: LEADERSHIP - Objectives and Targets. Recent changes explained to employees.

  • 3.1. What are you trying to achieve? The direction of your section!<br>High quality, Low cost, to be competitive, Delivery targets

  • 3.2. Are they displayed on the Mini Business Board?

  • 3.3. Has there been any change in the business that may affect any process controls – Shop floor personnel – Management

  • 3.4. Have you been trained in the new process?

  • 3.5. Training and Skills Matrix updated?

  • 3.6. Do you have clear objectives that are been achieved?

  • 3.7. Do you have a quality policy, and where is it located?

  • 3.8. Are objectives & targets being achieved and recorded?

  • 3.9. Are employees kept in the loop, Section changes - Feedback?

  • 3.10. Are employees fully aware of their responsibilities?

  • 3.11. Are employees motivated, when changes occurs?

  • 3.12. Are all employees aware of continual improvement?

  • 3.13. Are targets recorded, displayed and reviewed.

  • 3.14. Do employees have a PD? If so, when was it last reviewed?

  • 3.15. Do employees / Customers complain about quality? If so, what are they?

  • 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.

  • CLOSING COMMENTS:

  • Count all the "YES" answers and move the slider to the corresponding number.

Section 4: INVOLVEMENT OF PEOPLE.

  • 4.1. Are people communicated to on a daily bases to any changes in the Safety or Quality system or other requirements?

  • 4.2. How does communication occur?

  • 4.3. Do people have the resources to carry out their duties efficiently?

  • 4.4. Have all employees been competently trained in all skills they required?

  • 4.5. Are they any training work instructions available

  • 4.6. Are training work instructions controlled?

  • 4.6. Are training work instructions controlled?

  • 4.7. Do you have a training and skills matrix? If so where are they kept?

  • 4.8. Are there training records and sign offs?

  • 4.9. Are training records stored and where? Are they easily accessible?

  • 4.10. Have all the activities been carried out by the responsible people?

  • 4.11. Are their skills used to maximize potential & contribute ideas to lower costs?

  • 4.12. Is these cost Value adding downstream or upstream?

  • 4.13. How do employees communicate their improvement ideas?

  • 4.14. Do all employees take fully responsibility & are accountable for their actions?

  • 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.

  • CLOSING COMMENTS:

  • Count all the "YES" answers and move the slider to the corresponding number.

Section 5: PROCESS APPROACH: (CONTROLS, INFORMATION FLOW & EVIDENCE AND DOCUMENTATION)

  • 5.1. Is there control over documentation?

  • 5.2. Who controls the documents? Are they easily accessible?

  • 5.3. Are Work Instruction generated and controlled by IsoXpress?

  • 5.4. Have work instructions been reviewed in the past year?

  • 5.5. Are controls defined by work instructions or Production Packs?

  • 5.6. Are customer requirements placed in the production packs?

  • 5.7. Are peoples responsibilities defined and communicated to?

  • 5.8. Is the process capable of delivering customer requirements?

  • 5.9. Do you know the capability of your manufacturing system?

  • 5.10. Have you full control over your manufacturing system?

  • 5.11. Are changes to the customer requirements communicated? How?

  • 5.12. Are effective use of resources used to reduce cost?

  • 5.13. Are cost reduction been achieved?

  • 5.14. Is there an acceptance and the rejection criteria?

  • 5.15. Does the acceptance & rejection have controls & checkpoints?

  • 5.16. Do you have an Inspection and Test Plan?

  • 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.

  • CLOSING COMMENTS:

  • Count all the "YES" answers and move the slider to the corresponding number.

Section 6: SYSTEM APPROACH TO MANAGEMENT (INPUTS & OUTPUTS)

  • 6.1. What customer requirements triggers the process?

  • 6.2. What are your inputs? Customer Orders/Production job packs.

  • 6.3. Do you have service agreement and when was it last reviewed?

  • 6.4. Are all service agreements available?

  • 6.5. Are all inputs & output addressed and controlled?

  • 6.6. Do you have checks points and have they been recorded?

  • 6.7. Are added value & downstream activities controlled?

  • 6.8. Is the section achieving its objectives efficiently?

  • 6.9. Have cost savings (IF ANY) been recorded?

  • 6.10. How are employees trained to use the improvement tools? (LEAN MANUFACTURING)

  • 6.11. Have all specifications been achieved before despatching?

  • 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.

  • CLOSING COMMENTS:

  • Count all the "YES" answers and move the slider to the corresponding number.

Section 7: CONTINUAL IMPROVEMENT (Recent Corrective Actions and Internal Audits - Past 12 Months)

  • 7.1. Is there a system for continual improvement?<br>

  • 7.2. Do personnel know how to raise a Corrective Action (CAR)?<br>

  • 7.3. Are there certain areas targeted for improvement? <br>

  • 7.4. Are improvements recorded, costed and monitored?<br>

  • 7.5. Does the section embrace new opportunities?<br>

  • 7.6. Are there difficulties to change in the work environment?<br>

  • 7.7. Is changes in a work process explained with clarity? <br>

  • 7.8. How are non-conforming products identified?<br>

  • 7.9. Do you have a quarantine area? <br>

  • 7.10. Are corrective actions raised, costed and closed off?<br>

  • 7.11. Have all corrective action been closed off in a timely manner?<br>

  • 7.12. Are there non-conforming trends?<br>

  • 7.13. What is the largest complaint category & is it been addressed?<br>

  • 7.14. Are people trained in the prevention of complaints?<br>

  • 7.15. Have all effective QA Checks been conducted and recorded? <br>

  • 7.16. Do you have calibrated system and is it maintained?<br>

  • 7.17. Are check sheets generated for critical equipment?<br>

  • 7.18. Do you know of any failures in the process at the moment? <br>

  • 7.19. Does management know?<br>

  • 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.

  • CLOSING COMMENTS:

  • Count all the "YES" answers and move the slider to the corresponding number.

Section 8: FACTUAL APPROACH TO DECISION MAKING

  • 8.1. How do you analyse production and process KPI’s?

  • 8.2. Are they displayed and were?

  • 8.3. Is root cause analysis use for determining a problem?

  • 8.4. How does this happen?

  • 8.5. Is the section fully aware of the importance of quality and cost?

  • 8.6. Do you have the ability to defend decisions on specific information?

  • 8.7. Is the data ready available from the works data system?

  • 8.8. Is the section ensuring quality objectives are consistent and are achieved in an orderly manner?

  • 8.9. Are existing work instructions or technical specifications effective in the training of personnel?

  • 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.

  • CLOSING COMMENTS:

  • Count all the "YES" answers and move the slider to the corresponding number.

Section 8: MUTUALLY BENEFICIAL SUPPLIER RELATIONSHIPS

  • 9.1. Do you have an approved supplier list?

  • 9.2. Do you conduct audits on customers and suppliers?

  • 9.3. Do you evaluate/re-evaluate your suppliers?

  • 9.4. Have you had any safety or quality issues from any of your suppliers?

  • 9.5. Are customers issues recorded into the works CAR system?

  • 9.6. Do you give feedback on quality issues to your customers?

  • 9.7. Do your customers welcome feedback from issues raised?

  • 9.8. Does the business benefit from customer feedback?

  • 9.9. Is supplier communication effective?

  • 9.10. Must you inspect all material that arrives form your customers or suppliers?

  • 9.11. Do you trust your suppliers & customers?

  • 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.

  • CLOSING COMMENTS:

  • Count all the "YES" answers and move the slider to the corresponding number.

OBSERVATIONS

  • What was seen, specific reference to evidence

DISCREPANCIES

  • Describe any discrepancies witnessed

AUDIT SIGN OFF

  • Select the date by which this audit was completed

  • Name Signature of auditee

  • Name and Signature of Auditor

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