General Help

  • Take photographs or sketch to help clarify any issues you identify as required in each section. Don't forget to record the good points as well.

    You must select compliance level from the options:

    OK = Satisfactory (It is working effectively and reliably)
    NCR = Non-Conforming (It is NOT working effectively)
    OBS = Observation (there may be a slight deviation but generally is working well)
    OFI = Opportunity for Improvement (ideas that could make it better than it is)
    N/A = Not Applicable (this question does not apply to the area being audited)

  • Please ensure you write down, or photograph: serial numbers, reference numbers, order numbers etc to ensure that the audit is repeatable

  • In order to allow typing information against a question, tap on the text of the question to open the text input box

People Issues

  • OK = Satisfactory (It is working effectively and reliably)
    NCR = Non-Conforming (It is NOT working effectively)
    OBS = Observation (there may be a slight deviation but generally is working well)
    OFI = Opportunity for Improvement (ideas that could make it better than it is)
    N/A = Not Applicable (this question does not apply to the area being audited

1. People issues (communication)

  • Is there evidence of communication within the department? (Describe/photograph)

  • Guidance:

    Look for evidence of: team talks, noticeboards, (check information is up to date and relevant), KPI graphs, departmental performance figures, information regarding the performance of the quality management system, environmental management system, or health and safety management system (such as accidents, scrap, complaints, OTIF, etc)

  • Action(s) required:
    you must also identify who is responsible for the action(s)

  • Action(s)
  • Action

  • Responsibility:

  • Has action been taken to address the action, and to a satisfactory level?

  • Verified by

2. People Issues (competence and capability)

  • Are personnel performing work which could impact on the customer, service, health and safety, or the environment, competent and capable?

  • Guidance:

    Look for examples of Young persons (Under 18 years of age) and pregnant workers (health and safety concerns). These two groups are especially at risk. Young persons because of inexperience and immaturity and pregnancy can affect ability to carry out certain tasks safely (for example manual handling)

    Look for evidence of employees having undergone induction training, quality, environmental and health and safety awareness training, and training for the specific tasks they are performing.

    Look especially for tasks which require specific skills or qualification such as driving fork lift trucks, changing grinding wheels, measuring or testing product etc.

    Competency can be based on education, training, skills, and/or experience. Look for evidence of records of training - are they suitable and sufficient? Are there issues with understanding (for example language barriers). Is there evidence of stress or violent behaviour? is there evidence of unsafe or environmentally unsound behaviour or practice?

    Are any of the workers disabled or otherwise disadvantaged in performing the task(s)?

    Is there evidence of lack of competence or capability affecting product quality or customer service? Is there evidence of ongoing performance appraisal on persons within the department or area being audited? Is there adequate supervision?

  • Action(s) required:
    you must also identify who is responsible for the action(s)

  • Action(s)
  • Action

  • Responsibility:

  • Has action been taken to address the action, and to a satisfactory level?

  • Verified by

3. People Issues (responsibility and authority)

  • Is responsibility and authority clearly defined?

  • Guidance:

    Is it clear what each person's responsibility and authority level is? (Is there evidence of decisions not being made or tasks not been done, because no one is quite sure whose job it is?).

    Are the roles clearly defined and documented within a job profile, and if not, how are people informed about their responsibilities and authority levels? Are budgetary levels and responsibilities clear?
    Is it clear who is responsible for the release of product? (ref batch release, non-conformance etc)

  • Action(s) required:
    you must also identify who is responsible for the action(s)

  • Action(s)
  • Action

  • Responsibility:

  • Has action been taken to address the action, and to a satisfactory level?

  • Verified by

Material Issues

  • OK = Satisfactory (It is working effectively and reliably)
    NCR = Non-Conforming (It is NOT working effectively)
    OBS = Observation (there may be a slight deviation but generally is working well)
    OFI = Opportunity for Improvement (ideas that could make it better than it is)
    N/A = Not Applicable (this question does not apply to the area being audited

1. Materials (Hazards)

  • Are all chemicals in use on the COSHH register and suitably identified controlled to minimise H&S or Environmetal issues? Describe/photograph)

  • Guidance:

    Look for Toxic, Irritant, Sensitising, Corrosive or Carcinogenic chemicals that are in use (including the use of local exhaust ventilation). Check that chemicals are properly labelled (or otherwise identified so it is clear what the contents are and what the corresponding hazards are)

    Check that they 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 might be stale or contain bacteria (such as cooling water) and for signs of water spray in air (Legionella risk)

    Look for environmental hazards also, for example use of oils, chemicals hazardous to aquatic life and materials that can cause dust or fume with the resultant risk of explosion, fire or problems with inhalation.

  • Action(s) required:
    you must also identify who is responsible for the action(s)

  • Action(s)
  • Action

  • Responsibility:

  • Has action been taken to address the action, and to a satisfactory level?

  • Verified by

2. Materials (Safe Storage)

  • Are all materials stored in a safe manner? (Describe/photograph)

  • Guidance:

    Check all material(s) storage. Is it safe? (not exceeding safe working loads for shelving, and safely and suitably stacked - for example stability and load distribution)

    Is storage free from spills and leaks (for example granules on the floor)?
    Is it secondary contained as needed?
    Is packing in good condition (damaged boxes etc)?
    Is storage such that it prevents damage or deterioration to the items concerned?
    Does the material in use have a limited shelf life such that it could deteriorate and not function properly (for example seals/gaskets, cement etc) ?

  • Action(s) required:
    you must also identify who is responsible for the action(s)

  • Action(s)
  • Action

  • Responsibility:

  • Has action been taken to address the action, and to a satisfactory level?

  • Verified by

Equipment issues

  • OK = Satisfactory (It is working effectively and reliably)
    NCR = Non-Conforming (It is NOT working effectively)
    OBS = Observation (there may be a slight deviation but generally is working well)
    OFI = Opportunity for Improvement (ideas that could make it better than it is)
    N/A = Not Applicable (this question does not apply to the area being audited

1. Equipment (Accuracy and capability)

  • Is equipment and machinery in use; suitable, calibrated and capable? (Describe/photograph)

  • Guidance:

    Is equipment and machinery in use suitable for its intended purpose and calibrated to ensure accuracy as necessary (if used to validate product quality, or measure environmental emissions or levels, or measure health and safety performance)?

    Is equipment's performance consistently repeatable to ensure reliability of the process?

    Examine measuring instruments, test equipment such as MFi Machine, CMM etc

  • Action(s) required:
    you must also identify who is responsible for the action(s)

  • Action(s)
  • Action

  • Responsibility:

  • Has action been taken to address the action, and to a satisfactory level?

  • Verified by

2. Equipment (Safety and effectiveness)

  • Is equipment and machinery in use safe? (Describe/photograph)

  • Guidance:

    Has equipment and machinery that is in use been assessed for PUWER (Provision and use of work equipment regulations) compliance? (For example, bandsaw, CMM, x-ray machine etc)

    Has equipment or machinery been tested as necessary (for example PAT testing on portable appliances)?

    Is all equipment or machinery in use suitably guarded, (with the need to use a tool to remove that guard), to prevent access to the dangerous parts of machinery? (eg bandsaw, xray machine, CMM etc)

    Are all electrical cabinets and other high-voltage sources locked to prevent unauthorised access?

    Any sign of unsafe equipment?

    Look for examples where equipment or machinery has deteriorated due to lack of maintenance or attention, for example, missing or damaged guards, damaged casings, or cables, secondary containment full of rainwater, deterioration of bunds etc.

    Look for examples where such deterioration could result in the efficiency or the capability of the equipment or machinery being compromised (eg rusty or damaged measuring equipment)

  • Action(s) required:
    you must also identify who is responsible for the action(s)

  • Action(s)
  • Action

  • Responsibility:

  • Has action been taken to address the action, and to a satisfactory level?

  • Verified by

3. Equipment (Training and authorisation)

  • Is all equipment and machinery used by suitably trained and authorised personnel? Describe/photograph)

  • Guidance:

    Are personnel using equipment suitably trained or authorised to use such equipment (for example forklift trucks, ladders, changing grinding wheels etc)?
    Check personnel are capable of using things like test and measuring equipment correctly

    Do records demonstrate that personal have been trained to operate the process or equipment for the reasons of quality, environmental implications and health and safety implications.

    Check, for example, qualification for RPS (Radiation Protection Supervisor), operation of CMM, MFi machine etc

  • Action(s) required:
    you must also identify who is responsible for the action(s)

  • Action(s)
  • Action

  • Responsibility:

  • Has action been taken to address the action, and to a satisfactory level?

  • Verified by

Environment issues

  • OK = Satisfactory (It is working effectively and reliably)
    NCR = Non-Conforming (It is NOT working effectively)
    OBS = Observation (there may be a slight deviation but generally is working well)
    OFI = Opportunity for Improvement (ideas that could make it better than it is)
    N/A = Not Applicable (this question does not apply to the area being audited

1. Environment (Infrastructure of the building and environmental conditions)

  • Are there issues with the building infrastructure or environmental conditions? Describe/photograph)

  • Guidance:

    Is there evidence of unsafe structural elements of the building (e.g. walls, doors, windows, floor etc)? For example, is the floor level and free from damage, obstruction, or slip/trip hazards.

    Are the walls/windows/doorframes, secure and free from elements which could fall off or fail to operate? (For example falling brickwork)

    Look for areas which could potentially be asbestos, look at the condition. If in doubt, refer to the asbestos survey information. Typically asbestos can be used to lag pipework, or cover pipework but it can also be used for the fabric of the building.

    If you believe there is asbestos in the vicinity which potentially is damaged, you should immediately report this to the maintenance supervisor.

    Is the "in process", or storage temperature, humidity, or other environmental conditions such that it prevents poor quality or deterioration of quality? (For example rusting, moisture condensation etc)

  • Action(s) required:
    you must also identify who is responsible for the action(s)

  • Action(s)
  • Action

  • Responsibility:

  • Has action been taken to address the action, and to a satisfactory level?

  • Verified by

2. Environment (access and egress and ergonomics)

  • Is there sufficient access and egress to the work areas? Are there issues with the ergonomics in the work area?(Describe/photograph)

  • Guidance:

    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?

  • Action(s) required:
    you must also identify who is responsible for the action(s)

  • Action(s)
  • Action

  • Responsibility:

  • Has action been taken to address the action, and to a satisfactory level?

  • Verified by

3. Environment (waste, energy and emissions)

  • Are wastes, energy, and emissions properly managed? (Describe/photograph)

  • Guidance:

    Are wastes from the process properly segregated and managed? Are recyclable wastes (cardboard, 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?

  • Action(s) required:
    you must also identify who is responsible for the action(s)

  • Action(s)
  • Action

  • Responsibility:

  • Has action been taken to address the action, and to a satisfactory level?

  • Verified by

4. Environment (Storage/racking)

  • Is storage/racking suitably managed? (Describe/photograph)

  • Guidance:

    Is storage and racking suitable for the load and safe? (Check racking is marked clearly with the safe working load, is secure so it cannot topple over, and it is properly loaded) ?

    Are legs of racking protected from damage?

    Ensure that heavy and light items are distributed such that the risks of manual handling are minimised and the stability of the storage is maintained

    Ensure that storage is properly stacked/located (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 warrants.

  • Action(s) required:
    you must also identify who is responsible for the action(s)

  • Action(s)
  • Action

  • Responsibility:

  • Has action been taken to address the action, and to a satisfactory level?

  • Verified by

5. Environment (Fire Hazard)

  • Is there any risk of fire? (Describe/photograph)

  • Guidance:

    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 of fire - such as against a hot surface)?

    Is there any source of ignition in the area (such as welding, brazing or heaters)?

    Is the evidence of blocked cooling systems or ventilation on equipment?

    Has a fire risk assessment been conducted in the area/department?

  • Action(s) required:
    you must also identify who is responsible for the action(s)

  • Action(s)
  • Action

  • Responsibility:

  • Has action been taken to address the action, and to a satisfactory level?

  • Verified by

Process Issues

  • OK = Satisfactory (It is working effectively and reliably)
    NCR = Non-Conforming (It is NOT working effectively)
    OBS = Observation (there may be a slight deviation but generally is working well)
    OFI = Opportunity for Improvement (ideas that could make it better than it is)
    N/A = Not Applicable (this question does not apply to the area being audited

1. Process (change management)

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

  • Guidance:

    If there is change in the department, is the integrity of department procedures/processes maintained?

    Look for tasks not been 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.

  • Action(s) required:
    you must also identify who is responsible for the action(s)

  • Action(s)
  • Action

  • Responsibility:

  • Has action been taken to address the action, and to a satisfactory level?

  • Verified by

2. Process (Monitoring measurement of product)

  • Are all relevant checks and measurements being undertaken and suitably analysed?(Describe/photograph)

  • Guidance:

    Are quality objectives and quality requirements defined for the product or process (for example quality plans, product specifications, work instructions, quality alerts etc). How do the quality engineers know what they need to check? ("things to look for" for example)

    Are the required verification, validation, monitoring, measurement, inspection and test activities specific to the product carried out correctly? (for example, dimensional checks, visual checks, batch release checks etc)

    Are there suitable records of such inspections and tests?

    Is the person responsible for the checks clearly identified?

    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 the product being approved?) . How do the quality engineers verify that marked product is actually approved?

    Are the results of measurements and tests suitably analysed looking for trends, and possibly indicating need for increased or decreased levels of activity?

  • Action(s) required:
    you must also identify who is responsible for the action(s)

  • Action(s)
  • Action

  • Responsibility:

  • Has action been taken to address the action, and to a satisfactory level?

  • Verified by

3. Process (Legal/standards compliance)

  • Are applicable legislation or standards/specifications known? Are they available? Are they complied with?(Describe/photograph)

  • Guidance:

    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 working in confined spaces, working at height, compliance to gas standards, transport requirements (hazardous chemicals for example)

    Consider items such as CEN standards, approvals requirements, etc)

  • Action(s) required:
    you must also identify who is responsible for the action(s)

  • Action(s)
  • Action

  • Responsibility:

  • Has action been taken to address the action, and to a satisfactory level?

  • Verified by

4. Process (documentation)

  • Is the process suitably documented and is the input/output clearly defined? (Describe/photograph)

  • Guidance:

    Is the process suitably documented via a process flow chart, work instruction, standard operation, specification sheet, quality, environmental or health and safety 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 having an issue/revision number and date, and is it approved prior to issue?

    Are documents legible and identifiable?

    Are documents of external origin (such as customer drawings/specifications) suitably controlled?

    Applicable processes are the p07 series of process flows on the intranet and the appropriate quality plans at the rear of the management sytems index

  • Action(s) required:
    you must also identify who is responsible for the action(s)

  • Action(s)
  • Action

  • Responsibility:

  • Has action been taken to address the action, and to a satisfactory level?

  • Verified by

5. Process (measurement)

  • Are key processes measured, analysed, communicated and do they demonstrate appropriate improvement? (Describe/photograph)

  • Guidance:

    What are the key process measures?
    Are these displayed? (For example KPI's, departmental charts or graphs etc)? If so, is there improvement noted? if not what actions of being taken to improve things? For example on time delivery, service complaints (eg incorrect quantity or item)

    Is data generated and analysed looking for trends and the need for action to improve (for example number of near misses/accidents, non-conformities, audits etc)?

  • Action(s) required:
    you must also identify who is responsible for the action(s)

  • Action(s)
  • Action

  • Responsibility:

  • Has action been taken to address the action, and to a satisfactory level?

  • Verified by

6. Process (Risk assessment/aspects evaluation)

  • Are there suitable risk assessments? And are activities covered in environmental aspect evaluation? Are actions from such assessments dealt with? (Describe/photograph)

  • Guidance:

    Are processes being undertaken risk assessed? (Examples of risk assessment are: general, task specific, manual handling, COSHH, PUWER, VDU, explosive atmosphere, young or pregnant workers, noise, fire etc (see section c23 in the health and safety management system)

    Are there any outstanding actions from any such assessments?

    Are the processes being undertaken covered by the environmental aspect evaluation if applicable? (See EM-01 - and the environmental aspects evaluation database - in the environmental management system)

  • Action(s) required:
    you must also identify who is responsible for the action(s)

  • Action(s)
  • Action

  • Responsibility:

  • Has action been taken to address the action, and to a satisfactory level?

  • Verified by

7. Process (Data and records)

  • Are all data records suitably controlled? (Describe/photograph)

  • Guidance:

    Are all data and records, created as part of the process, suitably controlled? (Identified, backed up and suitably stored, with clearly documented disposal and retention periods)

    The control of records should include electronic records as well as paper records.

    Identify the records kept during the audit, and ensure that they are properly controlled

  • Action(s) required:
    you must also identify who is responsible for the action(s)

  • Action(s)
  • Action

  • Responsibility:

  • Has action been taken to address the action, and to a satisfactory level?

  • Verified by

8. Process (Non-conformance/rework/corrective/preventive action)

  • Is there a robust process for dealing with non- conformance in the area being audited? (Describe/photograph)

  • Guidance:

    When the process goes wrong - and results in nonconformance - is action taken to resolve the issue in terms of documenting the problem, disposal action being taken (scrap, rework etc), containment action (making sure the customers not receive the problem), root cause analysis, and finally corrective action to resolve the root cause?

    Additionally, is such failure analysed and improved upon, as well as applying preventive measures proactively?

    Is there any evidence that materials in use do not conform to requirements and could affect quality (for example rusty, dimensionally non-compliant, visually non-compliant, deteriorating, etc). If so, are they clearly identified as nonconforming, with appropriate action identified?

    Is the product being produced compliant to the specification? For example labels (including barcode labels for example) visual appearance, type of product/material, engraving/stamping etc (check also compliance against any quality alerts, etc). If the product is non-compliant, is the product being bonded pending a decision?

    Is rework being managed effectively? how is this managed? is there a count of scrap/good production? How do the operators (or whomever is carrying out sorting/rework) know what to look for? Are the quality department aware of rework/sorting going on? has it been verified as acceptable?

  • Action(s) required:
    you must also identify who is responsible for the action(s)

  • Action(s)
  • Action

  • Responsibility:

  • Has action been taken to address the action, and to a satisfactory level?

  • Verified by

9. Process (Identification and traceability)

  • Are all products and items clearly identified and traceable? (Describe/photograph)

  • Guidance:

    During the process, is the status of the output of the process (whether it be product or documentation), clear?

    Check materials (components, products etc) are clearly identified in terms of their status and traceability and what they are for (e.g. supplier, batch number, part number, inspection and test status etc) - is this information recorded on quality records, and does it match the actual?

    if product is held, is it identifiable, such that it is clear what it is, and what needs to happen to it next?

    Identification and traceability would include things such as; part numbers, operator stamps, batch numbers, works order numbers, purchase order numbers, material batch numbers etc

  • Action(s) required:
    you must also identify who is responsible for the action(s)

  • Action(s)
  • Action

  • Responsibility:

  • Has action been taken to address the action, and to a satisfactory level?

  • Verified by

10. Process (PPE - Personal protective equipment)

  • Is a PPE being worn when required? Is it suitable and being correctly used? (Describe/photograph)

  • Guidance:

    Are all personnel wearing PPE which is 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 PPE suitable for its intended purpose (for example a dust mask being used for solvent use, cotton gloves for oil etc)?

  • Action(s) required:
    you must also identify who is responsible for the action(s)

  • Action(s)
  • Action

  • Responsibility:

  • Has action been taken to address the action, and to a satisfactory level?

  • Verified by

11. Process (unsafe acts/conditions and accidents)

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

  • Guidance:

    Have there been any health and safety, environmental, or quality concerns raised in the area in the last six months? Have there been any accidents in the area in the last six 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 problems?

    Has there been any notification to the HSE of any dangerous occurrence?

  • Action(s) required:
    you must also identify who is responsible for the action(s)

  • Action(s)
  • Action

  • Responsibility:

  • Has action been taken to address the action, and to a satisfactory level?

  • Verified by

12. Process (Emergency)

  • Is there suitable emergency preparedness?(Describe/photograph)

  • Guidance:

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

    Is all emergency equipment in operational condition (e.g. spill kits full, spill mats available, bunds not full of water, fire extinguishers not discharged etc)?

  • Action(s) required:
    you must also identify who is responsible for the action(s)

  • Action(s)
  • Action

  • Responsibility:

  • Has action been taken to address the action, and to a satisfactory level?

  • Verified by

13. Process (Outsourcing)

  • Is anything outsourced? if so how is it controlled? (Describe/photograph)

  • Guidance:

    Are any processes or parts of processes outsourced? If so how are these controlled to ensure compliance to customer requirements, environmental compliance, health and safety compliance, etc)? (Example might be calibration, machining to dimensions, and subsequent verification of those dimensions for example)

    If these outsourced activities are carried out on our premises, is the contractor managed through permits to work etc (See C05). (eg visitors to repair xray machine, CMM for example)

    How do we ensure that contractors working on our premises comply with environmental requirements (such a waste, discharges, emissions etc), or health and safety requirements (such as PUWER, working at height etc).

    How do we confirm the quality of the outsourced operation? (eg sub-contract machining requiring 4 hourly dimensional checks)

    How is the outsourced activity approved and controlled?

  • Action(s) required:
    you must also identify who is responsible for the action(s)

  • Action(s)
  • Action

  • Responsibility:

  • Has action been taken to address the action, and to a satisfactory level?

  • Verified by

Specific department or process questions

  • OK = Satisfactory (It is working effectively and reliably)
    NCR = Non-Conforming (It is NOT working effectively)
    OBS = Observation (there may be a slight deviation but generally is working well)
    OFI = Opportunity for Improvement (ideas that could make it better than it is)
    N/A = Not Applicable (this question does not apply to the area being audited

Process specific questions based on the process flows and ISO requirements

1. Material Batch Changes

  • How are material batch changes managed?

  • Guidance:

    How does the requirement to create a new works order for material batch changes get managed? How is the material change notified, how does the change to the works order impact on the quality control process and records and batch release?

  • Action(s) required:
    you must also identify who is responsible for the action(s)

  • Action(s)
  • Action

  • Responsibility:

  • Has action been taken to address the action, and to a satisfactory level?

  • Verified by

2. Specifications

  • How are specifications created? Where does the information come from?

  • Guidance:

    How is the creation of specifications managed? In terms of source information? Verification of correct date, ensuring appropriate marking information is available (eg approvals etc), as well as verification of things like fusion and cooling times as engraved, or within the bar code.?

  • Action(s) required:
    you must also identify who is responsible for the action(s)

  • Action(s)
  • Action

  • Responsibility:

  • Has action been taken to address the action, and to a satisfactory level?

  • Verified by

3. Rejected product

  • How is product rejected by quality control managed?

  • Guidance:

    how is the count of product rejected by quality control due to test failure, or back checking notified to ensure
    a) correct stock of the finished item
    b) correct stock of the component parts such as bags, boxes, cutters etc

  • Action(s) required:
    you must also identify who is responsible for the action(s)

  • Action(s)
  • Action

  • Responsibility:

  • Has action been taken to address the action, and to a satisfactory level?

  • Verified by

4. Process and product audits

  • Is the production process audited by the quality engineers? Are product audits conducted?

  • Guidance:

    Do the quality engineers audit the production process for issues such as:

    missing condition sheets, missing specifications, BOM, Labels, Boxes etc from previous runs or previous shifts etc?

    Is action taken to resolve the issues identified?

  • Action(s) required:
    you must also identify who is responsible for the action(s)

  • Action(s)
  • Action

  • Responsibility:

  • Has action been taken to address the action, and to a satisfactory level?

  • Verified by

5. Test failure

  • what happens in the event of test failure (eg 170 hour stress crack test)?

  • Guidance:

    If the sample put on to 170 test fails part way through the run, what is the process to ensure

    a) stock is segregated? (look at things like auto freeze of stock for example)
    b) how do we retest? Are sufficient samples taken to validate that the initial failure has been isolated? (was it an early submission? is it a problem during the run?

  • Action(s) required:
    you must also identify who is responsible for the action(s)

  • Action(s)
  • Action

  • Responsibility:

  • Has action been taken to address the action, and to a satisfactory level?

  • Verified by

Additional Checks

Additional checks performed

  • Additional check details

  • Conforms?

  • Action(s) required:
    you must also identify who is responsible for the action(s)

  • Action(s)
  • Action

  • Responsibility:

  • Has action been taken to address the action, and to a satisfactory level?

  • Verified by

  • Additional check details

  • Conforms?

  • Action(s) required:
    you must also identify who is responsible for the action(s)

  • Action(s)
  • Action

  • Responsibility:

  • Has action been taken to address the action, and to a satisfactory level?

  • Verified by

  • Additional check details

  • Conforms?

  • Action(s) required:
    you must also identify who is responsible for the action(s)

  • Action(s)
  • Action

  • Responsibility:

  • Has action been taken to address the action, and to a satisfactory level?

  • Verified by

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