Supplier audit

Template Information

Handicare (version 2.2 - 7th november 2015)

Category: manufacturing

Template Questions

  • Auditor (Name and sign)
  • Position:
  • Auditor information (Mandatory)
  • Please add Additional auditors
  • General information (Supplied products, structure, financials, capacity etc)
  • General Photographs of site and products
  • Which certifications does the supplier hold?
  • Number of employees:
  • Quality contact name
  • Position
  • Email and phone contact details
  • Shift pattern:
  • Supplier Details: (Mandatory)
  • Notes
  • Auditee details (all people involved in the audit)
  • Name:
  • Picture of Business card (if appropriate)
  • Guidance: Look at the quality management systems in place at the supplier. Are such a management syst
  • Question 1 (Mandatory)
  • Action summary
  • Question 2
  • Guidance: Look at the last audit report and examine any observations or nonconformities and look at t
  • Question 3
  • Guidance: Look at a few internal audit reports and examine any observations or nonconformities and lo
  • Question 4
  • Guidance: What are the communication methods relating to measurement of performance - for example not
  • Question 5 (Mandatory)
  • Guidance: The system should involve specification verification for every new manufacturing order
  • Question 6 (Mandatory)
  • Guidance: The system should review and identify changed specifications to ensure they are achievable
  • Question 7
  • Guidance: The system should review complaints and ensure that appropriate corrective action is taken
  • Question 8 (Mandatory)
  • Guidance: Review a sample of the suppliers corrective actions and check effectiveness of problem-solv
  • Question 9
  • Guidance: Consider the accuracy and capability of the measuring equipment or test equipment being use
  • Question 10 (Mandatory)
  • Guidance: When considering the calibration process: is calibration traceable to internationally recog
  • Question 11
  • Guidance: Statistical techniques might include SPC on the production line, process capability monitor
  • Question 12 (Mandatory)
  • Guidance: identify whether the supplier is capable of carrying out ISIR and PPAP submissions in accor
  • Question 13
  • Guidance: How does the supplier maintain their records. Are they secure, accessible, indexed and legi
  • Question 14 (Mandatory)
  • Guidance: Ensure that good document control is applied such as removing obsolete documents from point
  • Question 15
  • Guidance: Look at how revisions are handled and communicated to ensure operational documents are upda
  • Question 16 (Mandatory)
  • Guidance: Check how running changes are controlled - how is it ensured that engineering issues are fi
  • Question 17
  • Guidance: For new tooling, check if there are records and measuring/approval forms. Is the process we
  • Question 18
  • Check the procedures for release product for production - is there a defined quality plan, standard o
  • Question 19 (Mandatory)
  • Guidance: Process flow should be well documented, if not for the individual product, then for general
  • Question 20
  • Guidance: Has a process FMEA been conducted and has a control plan been developed based on the PFMEA
  • Question 21 (Mandatory)
  • Guidance: Confirm that suitable and sufficient process equipment, test or measuring equipment or tool
  • Question 22 (Mandatory)
  • Guidance: is there a planned preventive maintenance plan available to ensure that the process equipme
  • Question 23 (Mandatory)
  • Guidance: Check that the the item being supplied is part of the company's core competency or portfoli
  • Question 24
  • Guidance: Check how their suppliers and subcontractors are approved (including approval criteria, sub
  • Question 25 (Mandatory)
  • Guidance: Have all purchased components, materials and services from sub-suppliers been approved by t
  • Question 26
  • Guidance: In case of sub-contracting, was the sub-supplier process audited, and does the sub-supplier
  • Question 27
  • Guidance: How are purchased items or sub-contracted processes validated upon receipt? Look for eviden
  • Question 28 (Mandatory)
  • Guidance: How are materials (and jigs/fixtures/checking equipment) identified to avoid inadvertant mi
  • Question 29
  • Guidance: Check that all personnel are suitably and sufficiently trained and certified for their assi
  • Question 30
  • Guidance: Check that there is an effective identification and traceability system in place from raw m
  • Question 31
  • Guidance: check first off production acceptance to a clear quality plan, standards operation procedur
  • Question 32
  • Guidance: Check that appropriate standard operations or work instructions are available for productio
  • Question 33 (Mandatory)
  • Guidance: Check that appropriate inspections are being performed during the production process (both
  • Question 34 (Mandatory)
  • Guidance: Check that the inspection status of the product is clearly identified at all stages of the
  • Question 35 (Mandatory)
  • Guidance: Check to ensure all critical process characteristics are monitored during the process (Such
  • Question 36 (Mandatory)
  • Guidance: Ensure that rejected material and or components are clearly segregated from good production
  • Question 37 (Mandatory)
  • Guidance: Check that there are records and appropriate checks on reworked products and that traceabil
  • Question 38 (Mandatory)
  • Guidance: Check how the process is monitored for effectiveness. How are changes to improve the proces
  • Question 39
  • Guidance: Check the sample standard for incoming and final inspection, such as sample size and sample
  • Question 40
  • Guidance: Check the process for verification and control of order intake to ensure that it can be ach
  • Question 41
  • Guidance: Check that the supplier works on a first in - first out (FIFO) stock rotation system to ens
  • Question 42 (Mandatory)
  • Guidance: is the supplier using labelling or marking specified by their customer
  • Question 43
  • Guidance: Check methods of storage of components and finished goods to ensure no damage, contaminatio
  • Question 44 (Mandatory)
  • Guidance: Check transport and handling methods, both internally and through external transport for su
  • Question 45
  • Guidance: Ensure that there is a process for recording what batches or serial numbers have been despa
  • Question 46
  • Guidance: Check that there is a robust health and safety policy, that it is well communicated and tha
  • Question 47
  • Guidance: Check the machines are properly guarded, that employees are wearing suitable PPE (such as e
  • Question 48
  • Guidance: Ensure that there are appropriate safety warnings where relevent to identify specific hazar
  • Question 49
  • Guidance: Look for evidence of housekeeping policies, such as 5s. And look for general good housekeep
  • Question 50
  • Guidance: Check emergency procedures for both internal and external personnel - check areas such as:
  • Question 51
  • Guidance: Check that there is a robust environmental policy, that it is well communicated and that em
  • Question 52
  • Guidance: Look for waste segregation, identification and minimisation policies and containers/signs e
  • Question 53
  • Guidance: Is a system in place to document/register and fulfill customer specific enviroment related
  • Question 54
  • Guidance: Is the supplier aware of the environmental (and health and safety) legislation that applies
  • Question 55
  • 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
  • F) Health and Safety
  • G) Environment
  • Supplier rating: (Mandatory)
  • Actions
  • Action required?