General Information

Auditor information (Mandatory)

  • Auditor (Name and sign)

  • Position:

  • Handicare Business Unit:

  • Please add Additional auditors

  • Auditor
  • Auditor (Name and sign)

  • Position:

  • Handicare Business Unit:

Supplier Details: (Mandatory)

  • General information (Supplied products, structure, financials, capacity etc)

  • General Photographs of site and products

  • Which certifications does the supplier hold?

  • List other certifications held by the supplier

  • Number of employees:

  • Quality contact name

  • Position

  • Email and phone contact details

  • Shift pattern:

  • Are there any previous 8d or other issues raised on this supplier? Add details/photos as necessary

  • Add details of previous issues from supplier (including 8d references if available)

  • Are there tools and/or jigs/fixtures needed as part of the process? (Add details and photos if available)

  • Describe tooling/jigs or fixtures ownership if known (paid for by Handicare/amortised in part cost or paid for by supplier for example. )

  • Notes

Auditee details: (name/position)

  • Auditee details (all people involved in the audit)

  • Persons audited :
  • Name:

  • Position:

  • Picture of Business card (if appropriate)

Quality Management

Question 1 (Mandatory)

  • Guidance: Look at the quality management systems in place at the supplier. Are such a management systems based on established and recognised standards such as ISO 9001 or TS 16949. Use the camera to capture a copy of the certificates for management systems which are audited by a third party body and are duly certified If no certification then select "other" and explain that the management systems are not certified

  • Does the supplier have an established quality management system in place? (Enter details below and add photographs as necessary)
    Add additional actions in notes

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Question 2

  • Is the quality management system based on a standard? (Enter details below and add photographs as necessary)

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Question 3

  • Guidance: Look at the last audit report and examine any observations or nonconformities and look at the timescale to resolve

  • Is the last audit report conducted by the certified external body available for viewing? (Enter details below and add photographs as necessary)

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Question 4

  • Guidance: Look at a few internal audit reports and examine any observations or nonconformities and look at the timescale and effectiveness to resolve

  • Is there an internal system audit program in place? (Enter details below and add photographs as necessary)

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Question 5 (Mandatory)

  • Guidance: What are the communication methods relating to measurement of performance - for example notice boards, whiteboards, KPI graphs etc

  • Are actual quality results and key performance indicators (KPI's) measured and communicated to all personnel on a regular basis? (Enter details below and add photographs as necessary)

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Question 6 (Mandatory)

  • Guidance: The system should involve specification verification for every new manufacturing order

  • Is there a system in place to document and register customer specifications and ensure that these specifications are always used and kept up-to-date? (Enter details below and add photographs as necessary)

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Question 7

  • Guidance: The system should review and identify changed specifications to ensure they are achievable and all elements are properly addressed such as communication, production documents, packaging, communications etc. Items must only be modified with prior authorisation of Handicare.

  • Is there a clear product modification system? (Enter details below and add photographs as necessary)

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Question 8 (Mandatory)

  • Guidance: The system should review complaints and ensure that appropriate corrective action is taken using an approach such as 8d. Confirm that complaints from Handicare i(f the supplier is a current supplier) have been progressed appropriately

  • Is there a system in place to handle customer complaints? (Enter details below and add photographs as necessary)

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Question 9

  • Guidance: Review a sample of the suppliers corrective actions and check effectiveness of problem-solving with quality monitoring and check the control plan has been updated as necessary

  • Are there effective problem-solving techniques in use such as 8d or PDCA ? (Enter details below and add photographs as necessary)

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Question 10 (Mandatory)

  • Guidance: Consider the accuracy and capability of the measuring equipment or test equipment being used to measure product quality. Have gauge R&R studies been carried out for example?

  • Is the available measuring equipment sufficient to measure the produced items effectively and accurately? (Enter details below and add photographs as necessary)

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Question 11

  • Guidance: When considering the calibration process: is calibration traceable to internationally recognised standards - and is equipment suitably traceable with appropriate serial numbers etc and clearly identified to calibration certificates and equipment (such as slip gauges) used for calibration. Are calibration frequency is at a suitable interval?

  • Has an adequate calibration programme being implemented? (Enter details below and add photographs as necessary)

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Question 12 (Mandatory)

  • Guidance: Statistical techniques might include SPC on the production line, process capability monitoring (CP/CPK) especially where this data is supplied as part of a PPAP.
    Production capability is an extremely important (and valuable) part of ensuring consistent quality of supply compared to the approved samples. Look for evidence of this being carried out routinely.

  • Are statistical techniques used by the supplier? (Enter details below and add photographs as necessary)

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Question 13

  • Guidance: identify whether the supplier is capable of carrying out ISIR and PPAP submissions in accordance with customer requirements

  • Is there a procedure in place to ensure that ISIR and PPAP submissions are carried out in accordance with customer requirements? (Enter details below and add photographs as necessary)

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Question 14 (Mandatory)

  • Guidance: How does the supplier maintain their records. Are they secure, accessible, indexed and legible? Is the data from such records readily retrievable? (especially in the case of emergency)

  • Are all records and data completed and stored in an effective manner and is the data accessible any time (Enter details below and add photographs as necessary)r

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Pre-Production

Question 15

  • Guidance: Ensure that good document control is applied such as removing obsolete documents from point of use and ensuring internal reference documents (such as SOPs) refer to the correct issue and include relevant elements of the new drawing

  • Are all the latest customer drawings and specifications internally approved and distributed in a controlled manner? (Enter details below and add photographs as necessary)

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Question 16 (Mandatory)

  • Guidance: Look at how revisions are handled and communicated to ensure operational documents are updated and ensure revisions are incorporated into the product or process (for example an ECN process)

  • Is there a procedure to control revisions on specifications? (Enter details below and add photographs as necessary)

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Question 17

  • Guidance: Check how running changes are controlled - how is it ensured that engineering issues are finalised before actual production takes place?

  • Are open engineering issues addressed with an appropriate action plan? (Enter details below and add photographs as necessary)

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Question 18

  • Guidance: For new tooling, check if there are records and measuring/approval forms. Is the process well documented? (Are trials conducted? And are process capability studies carried out to validate)

  • Are clear procedures and containment plans on tooling approval and first product approval (ISIR procedures) in place? (Enter details below and add photographs as necessary)

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Question 19 (Mandatory)

  • Check the procedures for release product for production - is there a defined quality plan, standard operations, first off inspection, in process inspection, end of line tests, process monitoring for things like tool wear, process fluctuations etc created? This should include DFMEA and PFMEA

  • Are there procedures for releasing the product foe production? (Enter details below and add photographs as necessary)

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Question 20

  • Guidance: Process flow should be well documented, if not for the individual product, then for general production processes

  • Is the process flow well documented for each product? (Enter details below and add photographs as necessary)

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Question 21 (Mandatory)

  • Guidance: Has a process FMEA been conducted and has a control plan been developed based on the PFMEA which includes acceptance criteria and procedures for rejects?

    The control plan should include product controls (dimensions, appearance, performance etc) or process controls (machine settings for example) and work instructions/standard operations procedures for all critical to quality elements

  • Has a process FMEA (PFMEA) been condcted, and has the output from this been implemented into a control plan? (Enter details below and add photographs as necessary)

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Question 22 (Mandatory)

  • Guidance: Confirm that suitable and sufficient process equipment, test or measuring equipment or tooling/jigs and fixtures has been identified and purchased - such equipment necessary to enable the production process to be carried out effectively and to ensure that the product specification requirements are achieved.

    Has it been agreed who owns the equipment, owns the rights to the design, pays for maintenance costs (both breakdown and preventive), who covers insurance losses (fire for example), and the life expectancy and forecasted output rates ?

  • Is suitable and sufficient equipment and machinery available? (Enter details below and add photographs as necessary)

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Question 23 (Mandatory)

  • Guidance: is there a planned preventive maintenance plan available to ensure that the process equipment continues to achieve it's process capability. This should include maintenance activities on jigs, fixtures and tooling

  • Is there a documented maintenance plan, and is it being complied with? (Enter details below and add photographs as necessary)

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Question 24

  • Guidance: Check that the the item being supplied is part of the company's core competency or portfolio. If not, then detail what the supplier's core compentency is.

  • Is the core competence of the company in line with the part category (Enter details below and add photographs as necessary)

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Purchase

Question 25 (Mandatory)

  • Guidance: Check how their suppliers and subcontractors are approved (including approval criteria, sub-supplier audits. sub-supplier corrective action requests, KPI's Material specifications, important dimensions and tolerances, restricted substances etc.)

  • Is there an effective sub-supplier approval /control process in place?
    (Enter details below and add photographs as necessary)

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Question 26

  • Guidance: Have all purchased components, materials and services from sub-suppliers been approved by the supplier through a formal process? Check initial samples reports for each component and material.

  • Is there a robust process for approval of purchased items and subcontract processes?
    (Enter details below and add photographs as necessary)

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Question 27

  • Guidance: In case of sub-contracting, was the sub-supplier process audited, and does the sub-supplier deliver a conformance report? Look for evidence in forms or reports.

  • Are sub-contractors and sub-suppliers audited and controlled? (Enter details below and add photographs as necessary)

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Question 28 (Mandatory)

  • Guidance: How are purchased items or sub-contracted processes validated upon receipt? Look for evidence in checking instructions, forms and records. Customer supplied products must be handled as any other supplier.

  • Is there a robust process for verification of received items? (Enter details below and add photographs as necessary)

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Question 29

  • Guidance: How are materials (and jigs/fixtures/checking equipment) identified to avoid inadvertant mix ups. Check item number., revision, quantity, etc

  • Are materials (and jigs/fixtures/checking equipment) clearly identified? (Enter details below and add photographs as necessary)

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Production

Question 30

  • Guidance: Check that all personnel are suitably and sufficiently trained and certified for their assigned function. This is especially important where the correct operation of the process is reliant on specific skills - for example welding. Check that the supplier has a process to ensure that only competent personnel are working in the specified job role. Are competencies defined in a clear training plan? and are skills gaps identified and being addresses?

  • Are all personnel carrying out tasks related to the supplied product competent / qualified? (Enter details below and add photographs as necessary)

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Question 31

  • Guidance: Check that there is an effective identification and traceability system in place from raw materials through to finished product.

    Check that it is possible to trace from raw material/ component deliveries through to customer deliveries, material certificates. goods inwards control where this is a requirement.

    Check that records of approval are kept by batch/serial number. Check that it would be possible for the supplier to track back through their process in the event of problems

  • Are all critical items suitably identified and traceable through the production process to delivery (Enter details below and add photographs as necessary)

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Question 32

  • Guidance: check first off production acceptance to a clear quality plan, standards operation procedures, work instructions or visual samples (either first off from this production or against initial approved golden sample depending on process) ,

    Ensure all tests are done to allow product to start running

    Check all records are done and check and that the process is stabilised before accepting production as good

    Check that the product is checked at a suitable repeat intervals (for example batch change of materials, time, shift/operator change restart after significant pause in production or restart after breakdown etc)

  • Do procedures for production start up of a new production batch ensure that the process is stabilised and the product meets requirements fully before accepting and packing the product (Enter details below and add photographs as necessary)

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Question 33 (Mandatory)

  • Guidance: Check that appropriate standard operations or work instructions are available for production and tooling, and that they are known by operators (and are attached to machines where necessary)
    Check that they are in compliance with product requirements/control plans. Do they adequately detail how to perform the operations and what to inspect? Is there clear evidence that the instructions have been checked on latest revision prior to production issue

  • Is production documentation available to operators? (such as standard operations) (Enter details below and add photographs as necessary)

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Question 34 (Mandatory)

  • Guidance: Check that appropriate inspections are being performed during the production process (both in terms of measurements and process monitoring such as machine conditions).

    Check the methods and requirements for these inspections are clear and are known by operators

  • Are appropriate measurements and checks being made during production? (Enter details below and add photographs as necessary)

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Question 35 (Mandatory)

  • Guidance: Check that the inspection status of the product is clearly identified at all stages of the production process to ensure that only inspected and released products are used in the production process or dispatched to the customer.

    Is it clear what the parts are by part number and/or description to avoid using the wrong parts

  • Does the supplier ensure that parts are clearly identified as to their status so that only good parts are used or despatched and is it clear what the product actually is to avoid mix ups (Enter details below and add photographs as necessary)

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Question 36 (Mandatory)

  • Guidance: Check to ensure all critical process characteristics are monitored during the process (Such as machine conditions, software settings, temperatures, pressures etc)

  • Are all critical process parameters monitored during the production process?
    (Enter details below and add photographs as necessary)

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Question 37 (Mandatory)

  • Guidance: Ensure that rejected material and or components are clearly segregated from good production. Check that containers are clearly marked/ identified for easy identification, including part labeling.

  • Is non-conforming product kept segregated from good production? (Enter details below and add photographs as necessary)

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Question 38 (Mandatory)

  • Guidance: Check that there are records and appropriate checks on reworked products and that traceability of reworked products is maintained and communicated to the customer

  • Is there a robust proess for reworked products? (Enter details below and add photographs as necessary)

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Question 39

  • Guidance: Check how the process is monitored for effectiveness. How are changes to improve the process implemented? Use of yield or scrap performance charts, SPC charts, Pareto charts, process capability studies, kaizen events, 5s, feedback to engineering are examples of improvements and monitoring activities

  • Is there a method for process monitoring and improvement? (Enter details below and add photographs as necessary)

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Question 40

  • Guidance: Check the sample standard for incoming and final inspection, such as sample size and sample frequency? Is there of AQL or other established sample check system

  • Is there a methodology for defining sample sizes for incoming and in-process verification? (Enter details below and add photographs as necessary)

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Logistics

Question 41

  • Guidance: Check the process for verification and control of order intake to ensure that it can be achieved (sales order/production planning)

  • Is there a process for how order intake is controlled to ensure it can be achieved? (Enter details below and add photographs as necessary)

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Question 42 (Mandatory)

  • Guidance: Check that the supplier works on a first in - first out (FIFO) stock rotation system to ensure sequential use of batches of parts
    Check how they monitor dates and control sequence of usage

  • Does the supplier work on a FIFO system to ensure sequential use of batches of parts? (Enter details below and add photographs as necessary)

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Question 43

  • Guidance: is the supplier using labelling or marking specified by their customer

  • Are finished goods properly identified according to customer requirements? (Enter details below and add photographs as necessary)

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Question 44 (Mandatory)

  • Guidance: Check methods of storage of components and finished goods to ensure no damage, contamination or deterioration occurs.

    For example check rubber components, and adhesives for age and condition, metal components for rusting/oxidation, contamination due to dust, dirt or oil etc and look for the potential for items to fall from where they are stored and be damaged.

  • Are storage methods for components and finished goods suitable? (Enter details below and add photographs as necessary)

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Question 45

  • Guidance: Check transport and handling methods, both internally and through external transport for suitability to prevent damage or deterioration of product.

  • Are appropriate measures taken to protect materials/ products during transport to Handicare and internally (Enter details below and add photographs as necessary)

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Question 46

  • Guidance: Ensure that there is a process for recording what batches or serial numbers have been despatched and that it is effective.

  • How is tracebility of finished products controlled? (Enter details below and add photographs as necessary)

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Health and Safety

Question 47

  • Guidance: Check that there is a robust health and safety policy, that it is well communicated and that employees are aware of it. Ensure such a policy is regularly reviewed. Is it obviously implemented?

  • Is there a Health & Safety policy available? (Enter details below and add photographs as necessary)

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Question 48

  • Guidance: Check the machines are properly guarded, that employees are wearing suitable PPE (such as eye protection, hearing protection, local exhaust ventilation, protection of the head and feet etc)

  • Are adequate personal protection measures available and in use for employees? (Enter details below and add photographs as necessary)

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Question 49

  • Guidance: Ensure that there are appropriate safety warnings where relevent to identify specific hazards to employees

  • Are warning signs present? (Enter details below and add photographs as necessary)

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Question 50

  • Guidance: Look for evidence of housekeeping policies, such as 5s. And look for general good housekeeping, such as lack of oil, or swarf on the floor for example, good storage, clean walls, building in good repair etc

  • Is the production environment clean and tidy? (Enter details below and add photographs as necessary)

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Question 51

  • Guidance: Check emergency procedures for both internal and external personnel - check areas such as: evacuation in case of fire, pollution/spills etc.

  • Is there a robust emergency plan? (Enter details below and add photographs as necessary)

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Environment

Question 52

  • Guidance: Check that there is a robust environmental policy, that it is well communicated and that employees are aware of it. Ensure such a policy is regularly reviewed. Is it obviously implemented?

  • Is there a Environmental policy available? (Enter details below and add photographs as necessary)

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Question 53

  • Guidance: Look for waste segregation, identification and minimisation policies and containers/signs etc. Are waste containers regularly emptied, not mixed or contaminated etc.

  • Is there evidence of a policy of waste segregation, minimisation and recycling? (Enter details below and add photographs as necessary)

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Question 54

  • Guidance: Is a system in place to document/register and fulfill customer specific enviroment related requirements?
    For example, any records, procedures for purchase, chemicals and sub contractors production methods.

  • Are customer specific environmental concerns controlled? (Enter details below and add photographs as necessary)

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Question 55

  • Guidance: Is the supplier aware of the environmental (and health and safety) legislation that applies in the country of operation. Are there attempts to comply with such legislation?

  • Is there a system in place to check that local environmental regulations are met? (Enter details below and add photographs as necessary)

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Overall score

Score (take score from each section) - (Mandatory)

  • A) Quality management Score:

  • B) Pre-Production Score:

  • C) Purchase score

  • D) Production Score:

  • E) Logistics score:

  • GLOBAL SCORE = (A + B + C + D + E)/5

Additional scores (not included in global score)

  • F) Health and Safety

  • G) Environment

Supplier rating: (Mandatory)

  • Supplier Rating:

Actions

  • Actions

  • action number
  • Action required?

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