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?