• Scope of the audit

  • Date of Audit

  • Name/Signature of auditee

  • Name/Signature of auditor

  • Names/Positions of people involved in the audit as necessary

1. People (Communication)

  • Look for evidence of: Team Talks, Notices Boards (check information is up to date and relevent), KPI graphs, or departmental performance figures, information regarding performance of the QMS/EMS/H&S system (such as accidents, scrap, complaints, OTIF etc)

  • Is there evidence of communication within the department? (describe/photograph) (Please ensure you write down, or photograph serial numbers, reference numbers, order numbers etc to ensure that the audit is repeatable)

  • Compliance Level

  • Action required

  • By Whom?

  • By When?

  • Follow up - has action been taken and to a satisfactory level? (enter details)

  • Date Verified

  • Name/Signature of Verifier

2. People (Competence and Capability)

  • Look for examples of young persons, pregnant workers (H&S issues), evidence of employees having undergone induction training, quality and environmental and HSE awareness training, and training for the specific task(s) they are perrforming. Competency can be based on education, training, skills and.or experience. Look for evidence of records or training - are they suitable and sufficient. Are there issues with understanding (eg language barriers of disability). Is there evidence of stress or violent behaviour.. Is there evidence of unsafe or environmentally unsound behaviour or practice. Is there evidence of lack of competence or capability affecting product quality or customer service. Is there evidence of ongoing performance appraisal for all persons within the department or area being audited? Is there adequate supervision?

  • Are personnel performing work which could impact on customer service, or the product competent and capable? (describe/photograph)

  • Compliance Level

  • Action required

  • By Whom?

  • By When?

  • Follow up - has action been taken and to a satisfactory level? (enter details)

  • Date Verified

  • Name/Signature of Verifier

3. People (Responsibility and Authority)

  • Is it clear what each person's responsibility and authority level is? (is there evidence of decisions not being made or tasks not being done, because no-one is quite sure who's job it is?). Are the roles clearly defined and documented with a job profile, and if not, how are people informed about their responsibilities and authority levels - are budgetary responsibilities clear?

  • Is responsibility and Authority Clearly Defined?

  • Compliance Level

  • Action required

  • By Whom?

  • By When?

  • Follow up - has action been taken and to a satisfactory level? (enter details)

  • Date Verified

  • Name/Signature of Verifier

4. Materials (COSHH)

  • Look for chemicals that are in use, including use of Local Exhaust Ventilation. Check that the chemicals are properly labelled, are listed in the COSHH register, and are used in a safe manner (using the PPE that is recommended) Check for signs of use of water which may be stale or contain bacteria (such as cooling water) and for signs of water spray

  • Are all chemicals in use suitably controlled?

  • Compliance Level

  • Action required

  • By Whom?

  • By When?

  • Follow up - has action been taken and to a satisfactory level? (enter details)

  • Date Verified

  • Name/Signature of Verifier

5. Materials (Identification and traceability)

  • Check materials in use (components, raw materials, products etc) are clearly identified in terms of their status and traceability and what they are for (eg supplier, batch number, part number, inspection and test status if applicable. For example tapes on stillages, inspection labels, non-conformance tape and accompanying NCR label etc)

  • Are all Materials in use suitably identified and traceable?

  • Compliance Level

  • Action required

  • By Whom?

  • By When?

  • Follow up - has action been taken and to a satisfactory level? (enter details)

  • Date Verified

  • Name/Signature of Verifier

6. Materials (Safe Storage)

  • Check material(s) storage. Is it safe (not exceeding working loads for shelving and safely and suitably stacked - e.g. stability and load distribution), is it free from spills and leaks (eg granules on the floor), secondary contained as needed, is packing in good condition (damaged boxes etc). Is storage such that it prevents damage or deterioration to the item(s) concerned? Does the material(s) in use have a limited shelf life such that it could deteriorate and not function properly (for example seals/gaskets or cements etc)

  • Are all Materials stored safely?

  • Compliance Level

  • Action required

  • By Whom?

  • By When?

  • Follow up - has action been taken and to a satisfactory level? (enter details)

  • Date Verified

  • Name/Signature of Verifier

7. Materials (Hazards)

  • Do any of the material(s) used present a hazard (Environmental, or Health and Safety)? For example a hazard to aquatic life, or dust or explosive risk

  • Do any materials present an environmental or H&S Hazard?

  • Compliance Level

  • Action required

  • By Whom?

  • By When?

  • Follow up - has action been taken and to a satisfactory level? (enter details)

  • Date Verified

  • Name/Signature of Verifier

8. Materials (Conformity and Capability)

  • is there any evidence that material(s) in use do not conform to requirements and could affect product quality. Is tooling in good condition, clean, with vents cleared etc - preventive maintenance etc. Is it identified as non-conforming?

  • Do all material(s) in use conform to requirements?

  • Compliance Level

  • Action required

  • By Whom?

  • By When?

  • Follow up - has action been taken and to a satisfactory level? (enter details)

  • Date Verified

  • Name/Signature of Verifier

9. Equipment (Accuracy and capability)

  • Is equipment and machinery in use suitable for it's intended purpose, calibrated to ensure it's accuracy as necessary (if used to validate product quality, or measure environmental emissions or levels, or measure H&S performance). Is equipment's performance repeatable to ensure reliability of the process. Are resistance meters in cell correctly set, and is there a record of this being conducted

  • Is equipment and machinery in use suitable, calibrated and capable?

  • Compliance Level

  • Action required

  • By Whom?

  • By When?

  • Follow up - has action been taken and to a satisfactory level? (enter details)

  • Date Verified

  • Name/Signature of Verifier

10. Equipment (Safety)

  • Has equipment in use been assessed for PUWER compliance, has it been tested if necessary (for example PAT testing for portable appliances). Has equipment undergone appropriate statutory examinations if necessary (for example lifting equipment, cranes, eyebolts, slings etc - colour coded - FLT's, electrical panels, moulding machines etc). Is all equipment in use suitably guarded (with the need to use a tool to remove) to prevent access to dangerous parts of machinery.. Are all electrical cabinets and other high voltage sources locked to prevent unauthorised access? check condition of hand tools etc

  • Is equipment and machinery in use safe?

  • Compliance Level

  • Action required

  • By Whom?

  • By When?

  • Follow up - has action been taken and to a satisfactory level? (enter details)

  • Date Verified

  • Name/Signature of Verifier

11. Equipment (Condition)

  • Is equipment in use in good condition (no exposed wires, broken casings, accessibility to dangerous parts through broken or damaged guards. Is equipment in a condition to ensure good and reliable quality of output. Is secondary containment free from rainwater and spillages etc. If necessary is equipment regularly serviced or preventive maintenance applied to prevent deterioration. Is equipment stored such that it prevents deterioration or damage?

  • Is equipment in good, serviceable condition, with suitable storage?

  • Compliance Level

  • Action required

  • By Whom?

  • By When?

  • Follow up - has action been taken and to a satisfactory level? (enter details)

  • Date Verified

  • Name/Signature of Verifier

12. Equipment (Training and Authorisation)

  • Are personnel using equipment suitably trained or authorised to use such equipment (for example Fork Lift Trucks, Ladders, changing of grinding wheels, lifting etc). Do records demonstrate that personnel have been trained to operate the process, for the reasons of quality, environmental implications and health and safety implications.

  • Is all equipment used by suitably trained and authorised personnel?

  • Compliance Level

  • Action required

  • By Whom?

  • By When?

  • Follow up - has action been taken and to a satisfactory level? (enter details)

  • Date Verified

  • Name/Signature of Verifier

13. Environment (Infrastructure of the building)

  • Are there issues with building infrastructure, such as floor or wall condition - is there damage or deterioration to the building fabric (especially to any part of the building identified as asbestos). Are floors free of holes, or uneven surfaces? Is the area water and dust free and a reasonable temperature? is the temperature, humidity and other environmental conditions such that it prevents poor quality or deterioration of quality

  • Are there issues with the infrastructure?

  • Compliance Level

  • Action required

  • By Whom?

  • By When?

  • Follow up - has action been taken and to a satisfactory level? (enter details)

  • Date Verified

  • Name/Signature of Verifier

14. Environment (Access and Egress and ergonomics)

  • Is there free access and egress to the area being audited? Are fire exits clear? are there constraints to carrying out tasks due to space or ergonomics of the process?

  • Is there sufficient access and egress to the work areas? are there issues with the ergonomics of the work area?

  • Compliance Level

  • Action required

  • By Whom?

  • By When?

  • Follow up - has action been taken and to a satisfactory level? (enter details)

  • Date Verified

  • Name/Signature of Verifier

15. Environment (Waste, Energy and Emissions)

  • Are wastes from the process properly segregated and managed. Are recyclable wastes (card board, plastics, metal etc) and hazardous wastes (oil contaminated) for example, disposed of in the correct containers. Are personnel clear on the correct disposal points. Is equipment turned off when not in use? Is there any evidence of emissions during the process?

  • Are wastes, energy, and emissions properly managed?

  • Compliance Level

  • Action required

  • By Whom?

  • By When?

  • Follow up - has action been taken and to a satisfactory level? (enter details)

  • Date Verified

  • Name/Signature of Verifier

16. Environment (Storage/Racking)

  • Is storage and racking suitable for the load and safe? (Check that racking is marked clearly with the Safe Working Load, is secure so it cannot topple over, and it properly loaded (for example heavy items and lighter items are distributed such that risks from manual handling are minimised and stability of the storage is maintained. Ensure the storage is stable (i.e. items are not likely to fall off shelves. Check for unsuitable storage - for example wooden pallets used to support a load greater than their capacity (or condition)

  • Is storage and racking suitably managed?

  • Compliance Level

  • Action required

  • By Whom?

  • By When?

  • Follow up - has action been taken and to a satisfactory level? (enter details)

  • Date Verified

  • Name/Signature of Verifier

17. Environment (Fire Hazard)

  • Is there any fire hazard in the area (for example flammable chemicals in use, cardboard/wood or other flammable materials stored in such a way that they may cause a fire (eg against a hot surface). Is there any source of ignition in the area (such as welding or brazing or heaters). Is there evidence of blocked cooling ventilation on equipment?. Has a fire risk assessment been conducted in the area/department?

  • Is there any fire hazard?

  • Compliance Level

  • Action required

  • By Whom?

  • By When?

  • Follow up - has action been taken and to a satisfactory level? (enter details)

  • Date Verified

  • Name/Signature of Verifier

18. Process (Change management)

  • If there is change in the department, is the integrity of the department processes/procedures maintained? look for tasks not being carried out because someone is no longer in the department, changes in priority because of change of leadership or responsibility, or new manufacturing processes/departmental processes being implemented with associated learning curves

  • Have there been any changes in the department/area being audited, and what impact has it had?

  • Compliance Level

  • Action required

  • By Whom?

  • By When?

  • Follow up - has action been taken and to a satisfactory level? (enter details)

  • Date Verified

  • Name/Signature of Verifier

19. Process (monitoring and measurement of product)

  • Are quality objectives and quality requirements defined for the product (for example quality plans, specifications, work instructions, quality alerts). Are the required verification, validation and monitoring, measurement, inspection and test activities specific to the product carried out correctly. Are there suitable records of such inspections and tests? is the person responsible for the checks clearly indicated. Check for appropriate testing (for example batch release measurement and testing, process verification testing and, if necessary, type/approvals testing). Check also for approval status (if for example an approval mark is being added to a product, is there evidence of that product being approved?) Are the results of measurements and tests suitably analysed looking for trends, and possibly indicating the need for increased or decreased levels of activity)

  • Are all relevant checks and measurements being undertaken and suitably analysed?

  • Compliance Level

  • Action required

  • By Whom?

  • By When?

  • Follow up - has action been taken and to a satisfactory level? (enter details)

  • Date Verified

  • Name/Signature of Verifier

20. Process (Legal/Standards Compliance)

  • Is the legislation/standard/specification to which the process must comply known, documented and available? is the legislation (if applicable) recorded within the legal register? Consider hazardous processes, for example work in confined spaces, working at height, compliance to gas standards for example, LOLER, Risk Assessments etc

  • Is appropriate legislation or standards/specifications known? is it available? is it complied with?

  • Compliance Level

  • Action required

  • By Whom?

  • By When?

  • Follow up - has action been taken and to a satisfactory level? (enter details)

  • Date Verified

  • Name/Signature of Verifier

21. Process (Documentation)

  • is the process suitability documented via process flow chart, work instruction, standard operation, specification sheet, quality, environmental or H&S alert, booklet etc. If not documented, is the person performing the process suitably trained and/or experienced (or supervised/monitored). Are all documents controlled in such a way that changes are identified, the document is issue numbered and dated and is approved prior to issue. Are documents legible and identifiable? Are documents of external origin (such as customer drawings or specifications) suitably controlled? Is there evidence of controlled conditions being outside if allowable tolerances?

  • Who is the supplier and customer to the department/process being audited? how is it ensured that the requirements of the customer are satisfied and the supplier supplies what is required to perform the task properly?

  • Is process suitably documented and is input/output clearly defined?

  • Compliance Level

  • Action required

  • By Whom?

  • By When?

  • Follow up - has action been taken and to a satisfactory level? (enter details)

  • Date Verified

  • Name/Signature of Verifier

22. Process (Measurement)

  • What are the key process measures? Are these displayed? (for example KPI's, departmental charts or graphs)? if so, is there improvement? if not what actions are being taken to improve things? Is data generated analysed looking for trends and the need for action to improve (for example number of near misses/accidents, test results, audits, product measurements etc)

  • Are key process measures defined, measured and communicated? do they demonstrate improvement?

  • Compliance Level

  • Action required

  • By Whom?

  • By When?

  • Follow up - has action been taken and to a satisfactory level? (enter details)

  • Date Verified

  • Name/Signature of Verifier

23. Process (Risk Assessment/Aspects Evaluation)

  • Are the process(es) being undertaken risk assessed? (examples of risk assessments are: General, Task Specific, Manual Handling, COSHH, PUWER, VDU, Explosive atmospheres, young or pregnant workers, noise, fire etc) - See C23 in the H&S management system - are there any outstanding actions from such assessments?

  • Are the process(es) being undertaken covered by the environmental aspects evaluation? (see EM-01 and the aspects database)

  • Are there suitable risk assessments? and are activities covered in the environmental aspects evaluation? are actions from such dealt with?

  • Compliance Level

  • Action required

  • By Whom?

  • By When?

  • Follow up - has action been taken and to a satisfactory level? (enter details)

  • Date Verified

  • Name/Signature of Verifier

24. Process (Data and Records)

  • Are all data and records created as part of the process suitably controlled? (backed up, suitably stored, with clearly documented disposal and retention periods) - Identify the records within the audit, and ensure they are covered within the quality records process (P15c) (eg master condition sheets, tool build records etc) - if things change from Innoge system - how it is controlled?

  • Are all records suitably controlled?

  • Compliance Level

  • Action required

  • By Whom?

  • By When?

  • Follow up - has action been taken and to a satisfactory level? (enter details)

  • Date Verified

  • Name/Signature of Verifier

25. Process (Non-conformance/Corrective/Preventive Action)

  • When the process goes wrong - and results in non-conformance or rework etc - is action taken to resolve the issue, root cause analysis, and finally corrective action to resolve the root cause. Additionally, is such failure analysed and improved as well as applying preventive measures proactively? How are tooling issues managed (for example tool damage where tooling needs to be repaired? or where vents just need to be cleaned - how do we apply this to other tooling?)

  • Is there a robust process for dealing with non-conformance in the area being audited?

  • Compliance Level

  • Action required

  • By Whom?

  • By When?

  • Follow up - has action been taken and to a satisfactory level? (enter details)

  • Date Verified

  • Name/Signature of Verifier

26. Process (Identification and Traceability)

  • During the process, is the status of the outputs of the process (whether it be product or documentation) clear, as well as identifiable so it is clear what it is, and what needs to happen to it? (interaction with syscon for example, when does job end, how do they plan what's next?)

  • Are all inputs and outputs clearly identified? Including the status of such inputs and outputs?

  • Compliance Level

  • Action required

  • By Whom?

  • By When?

  • Follow up - has action been taken and to a satisfactory level? (enter details)

  • Date Verified

  • Name/Signature of Verifier

27. Process (PPE)

  • Are all personnel wearing PPE required for the process (take note of signs and process requirements to identify whether people should be wearing hearing protection, eye protection etc) Are people suitably trained and made aware of how to use the PPE? is the PPE suitable for it's intended purpose (for example dust mask being used for solvent use)

  • Is PPE being worn where required? and is it suitable and being correctly used?

  • Compliance Level

  • Action required

  • By Whom?

  • By When?

  • Follow up - has action been taken and to a satisfactory level? (enter details)

  • Date Verified

  • Name/Signature of Verifier

28. Process (Unsafe Acts/Conditions and Accidents)

  • Have there been any Unsafe acts or conditions raised in the area in the last 6 months? have there been any accidents in the area in the last 6 months? Are there any outstanding actions from surveys and audits from external bodies? (such as owen david, SGS, BSi etc) if so, has action been taken to resolve the problem(s). Has there been any Notification to the HSE of dangerous occurrence - do personnel know the process for accidents and near misses?

  • Have there been accidents or near misses related to the process. If so, what action(s) have been taken?

  • Compliance Level

  • Action required

  • By Whom?

  • By When?

  • Follow up - has action been taken and to a satisfactory level? (enter details)

  • Date Verified

  • Name/Signature of Verifier

29. Process (Emergency)

  • Is there evidence of emergency preparedness - spills kits, fire extinguishers, fire exits, knowledge of the emergency plan, knowledge of what to do in the event of fire, spill, accident?

  • Is there suitable emergency preparedness?

  • Compliance Level

  • Action required

  • By Whom?

  • By When?

  • Follow up - has action been taken and to a satisfactory level? (enter details)

  • Date Verified

  • Name/Signature of Verifier

30. Process (Outsourcing)

  • Are any processes or parts of process outsourced? if so, how are these controlled to ensure compliance to customer requirements, environmental compliance etc. If these outsourced activities are carried out on our premises, is the contractor managed through permits to work etc (see C05) - also ensuring that the contractor complies with environmental requirements such as waste, discharges, emissions etc. How do we confirm the quality of the outsourced operation? how is the outsourced activity approved and controlled? - eg tooling manufacture and repair, engraving pads etc

  • Is anything outsourced? if so how is it controlled?

  • Compliance Level

  • Action required

  • By Whom?

  • By When?

  • Follow up - has action been taken and to a satisfactory level? (enter details)

  • Date Verified

  • Name/Signature of Verifier

Process Specific Questions (Based on process flows, and ISO 9001/14001/18001 requirements for the department)

31. Condition sheets and specification sheets

  • Is the specification sheet for the specific job on the machine (and only this job)? Is the condition sheet on the machine? (check the quality records for any problems and look for amendments being recorded). Do the machine conditions match the condition sheet? Is the condition sheet for this run the only condition sheet on the machine?

  • Are condition sheets and specifications etc properly controlled and removed from previous run?

  • Compliance Level

  • Action required

  • By Whom?

  • By When?

  • Follow up - has action been taken and to a satisfactory level? (enter details)

  • Date Verified

  • Name/Signature of Verifier

32. Scrap and downtime

  • Is scrap and downtime being booked on syscon (and is purge and other scrap being recorded?) Are the downtime reason codes correct? Is scrap clearly identified? Is purge correctly disposed of? How is this monitored and measured?

  • Is all scrap and downtime being properly managed?

  • Compliance Level

  • Action required

  • By Whom?

  • By When?

  • Follow up - has action been taken and to a satisfactory level? (enter details)

  • Date Verified

  • Name/Signature of Verifier

33. Raw material

  • Is the correct raw material in use? (check by following pipework through silo/drier/feed connection) is the batch number correctly recorded on the startup sheet (i.e. the batch in use ties into the batch showing on the submission sheet).

  • Is the correct material in use?

  • Compliance Level

  • Action required

  • By Whom?

  • By When?

  • Follow up - has action been taken and to a satisfactory level? (enter details)

  • Date Verified

  • Name/Signature of Verifier

34. Identification and traceability

  • Are date clocks correctly set? Are they legible are date stampers correctly set (on start)

  • Is product suitably identified (what it is, and its status) and traceable? (tapping tees and moulding)

  • Compliance Level

  • Action required

  • By Whom?

  • By When?

  • Follow up - has action been taken and to a satisfactory level? (enter details)

  • Date Verified

  • Name/Signature of Verifier

35. Hot Sizing process

  • How does this work, and what is the current status of this process? How do we ensure products not covered are added in? How do we manage it if we change machine, or use an alternative tool?

  • Does the hot sizing process work effectively?

  • Compliance Level

  • Action required

  • By Whom?

  • By When?

  • Follow up - has action been taken and to a satisfactory level? (enter details)

  • Date Verified

  • Name/Signature of Verifier

36. How are "projects" managed (eg SDR 17 wall section, new engraving pads etc)

  • How do long term projects get managed to ensure that they are completed in a timely manner

  • Are long term projects effectively managed?

  • Compliance Level

  • Action required

  • By Whom?

  • By When?

  • Follow up - has action been taken and to a satisfactory level? (enter details)

  • Date Verified

  • Name/Signature of Verifier

37. Are all wastes and tools removed from the press after toolfitting?

  • Check a few recently changed running machines to ensure that previous condition sheets, specs, tools, purge etc are cleared from the machine?

  • Are wastes/tools/documentation etc removed after change?

  • Compliance Level

  • Action required

  • By Whom?

  • By When?

  • Follow up - has action been taken and to a satisfactory level? (enter details)

  • Date Verified

  • Name/Signature of Verifier

38. How is the master condition sheet system managed?

  • How are master condition sheets created, if not available, managed for different machines (if running on more than one) and for different tools

  • Is the master condition sheet process managed properly?

  • Compliance Level

  • Action required

  • By Whom?

  • By When?

  • Follow up - has action been taken and to a satisfactory level? (enter details)

  • Date Verified

  • Name/Signature of Verifier

39. How is the tool build verified and controlled? (see process)

  • Process describes verifying the tool build prior to setting out to change, how is this done? Check a tool build on the database and confirm actual build is correct

  • Is tool build management done effectively?

  • Compliance Level

  • Action required

  • By Whom?

  • By When?

  • Follow up - has action been taken and to a satisfactory level? (enter details)

  • Date Verified

  • Name/Signature of Verifier

40. Do machine conditions reflect that on the condition sheet?

  • Check a couple of machines and see if the conditions as set in the machine, are the same as the condition sheet. Are amendments made recorded?

  • Are conditions correctly recorded?

  • Compliance Level

  • Action required

  • By Whom?

  • By When?

  • Follow up - has action been taken and to a satisfactory level? (enter details)

  • Date Verified

  • Name/Signature of Verifier

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