700 Supplier Audit

Audit Information

• Document No.

• Audit Title

• Client / Site

• Conducted on

  Date

• Prepared by

• Location
  Address

• Personnel

Incoming goods + WH

• Identity and essential properties of incoming goods are verified<br>(Incoming inspection or by certificate)

  Yes

  No

  N/A

• Environmental conditions of WH are suitable<br>(T, %rH, storing position...)

  Yes

  No

  N/A

• Shelf life control, FIFO

  Yes

  No

  N/A

• Management of quarantined or blocked material

  Yes

  No

  N/A

Manufacturing & shop floor

• Observation of the work place<br>- organized, tidy/clean, clear<br> (Floor, walls, corners, ...)<br><br>

  100

  80

  60

  40

  0

• Transport, storage and handling of material is suitable

  100

  80

  60

  40

  0

• non-conforming material is adequtely identified, sgregated and dispositioned?

  100

  80

  60

  40

  0

• Production equipment is state of the art

  Yes

  No

  N/A

• Production equipment is well maintained

  Yes

  No

  N/A

• 4 Is there evidence of appropriate operator training?

  Yes

  No

  N/A

• 10 Is personal safety equipment provided?

  Yes

  No

  N/A

• Are work instructions (appropriate and complete) provided at all work stations?

  Yes

  No

  N/A

• 3 Are special characteristics appropriately controlled at the operation(s) that produce them?

  Yes

  No

  N/A

Maintenance

• A suitable maintenance program is in place<br>- preventive (schedule for machines)<br>- predictive<br>- analysis of machine down time

  100

  80

  60

  40

  0

• - stock of critical replacement parts<br>spare parts are readily available to maintain the key machinery and equipment?

  100

  80

  60

  40

  0

• - personell/ resources

  100

  80

  60

  40

  0

Test equipment

• The test equipment is suitable for monitoring the quality requirements<br>Kind of equipment

  100

  80

  60

  40

  0

• 15 Does the supplier maintain effective calibration of test and measurement equipment used, e.g., production, quality assurance?

  Yes

  No

  N/A

• Calibration of test equipment - by akkredited external lab? - calibration records available

Packaging + logistics

Quality system

• The QM system is defined, described and documented

  100

  80

  60

  40

  0

• MR are conducted<br>- regularly as defined<br>- containing all required in- and outputs<br>- with focus on the suitability/effectiveness of QM system<br>- it is used effectively as steeing instrument

  100

  80

  60

  40

  0

• KPI are used effectively as steering instrument<br>- which quality related KPI are focussed

  Yes

  No

  N/A

• 9 does the supplier document responsibilities and authority?

  Yes

  No

  N/A

• Is CIP implemented effectively?<br>process for capturing and deploying lessons learned?<br><br>Projects/examples?

  100

  80

  60

  40

  0

• 24 Does the supplier have an end-of-life management process, e.g. controlled ramp-down, to protect customer quality and schedules?

  Yes

  No

  N/A

• A procedue for monitoring customer satisfaction is defined and implemented<br>- regularly<br>- following actions

  Yes

  No

  N/A

• 11 Does the supplier have an efective document control system, e.g., document revision status readily available?

  Yes

  No

  N/A

• 13 Does the supplier have appropriate product verification activities from receiving through product realization and shipping, including material identification?

  Yes

  No

  N/A

• 19 Are mistake-proofing and error-proofing provisions effectively used to control Special Characteristics and ensure product integrity?

  Yes

  No

  N/A

• 11 Is there linkage between the design record, DFMEA/PFMEA,Control plan, and Operator Instructions, e.g., special characteristics are identified by the supplier, effective and unterstandable controls are specified fo affectd operators to use?

  Yes

  No

  N/A

• 9 Does the suplier demonstrate effective use of FMEA, e.g., DFMEA/PFMEA quantifies risk, identifies special chacteristic for use in the Control Plan, takes action to reduce ongoing risk, uses appropriate criteria to calculate risk, e.g., severity?

  Yes

  No

  N/A

• 2 Are special characteristics identified?

  Yes

  No

  N/A

• 10 Does the supplier demonstrate conformance to requirements specified or reerenced in the control plan?

  Yes

  No

  N/A

Purchasing + supplier handling

• Only reliable sources/ sub-suppliers are used.

  Yes

  No

  N/A

• Controls are in place for sub- suppliers, e.g. assessment metrics

  Yes

  No

  N/A

Process control

• 17 Does the supplier have experience using AIAG core tool documents, e.g., MSA, SPC, APQP, FMEA, PPAP?

  Yes

  No

  N/A

• 6 Is process capability and performance maintained at levels originally approved by the customer PPAP?

  Yes

  No

  N/A

• 14 Does the supplier comply with acceptable measurement system analysis, e.g. measurement uncertainty is known?

  Yes

  No

  N/A

• 16 Does the supplier effectivey use statistical methods, addressing both variable and attributive data, as applicable, for process control?

  Yes

  No

  N/A

• 1 Does the supplier demonstrate an understanding of Process Validation?

  Yes

  No

  N/A

• 20 Does the supplier have an effective problem solving process, e.g., AIAG CQI-10?

  Yes

  No

  N/A

Testing

• 13 Is performance testing that includes, as appropriate, life, durability, and reliability, tracked for timely completion and conformance?

  Yes

  No

  N/A

Internal audits

• An effective internal audit system is in place<br>

  Yes

  No

  N/A

Competence & Training

• Competence/ technical knowledge to ensure a stable product design or to adapt products according to customer requirement is available

  Yes

  No

  N/A

• Human resources are selected based on education, training, experience, and/or requirements?

  Yes

  No

  N/A

• Skill and competency requirements are identified and trained if necessary

  Yes

  No

  N/A

• The quality awareness of the employees is obvious <br>and it is further enhanced

  100

  80

  60

  40

  0

Product development

• 7 Does the supplier have experience developing effective DFMEA?

  Yes

  No

  N/A

• 6 Does the supplier hae experience with approriate design evaluation tools, e.g., FEA, HALT, CAE, simulation?

  Yes

  No

  N/A

• 9 Are formal documented design reviews by the appropriate functions conducted at appropriate stages of design per a design plan?

  Yes

  No

  N/A

• 5 Does the supplier demonstrate effective design validation?

  Yes

  No

  N/A

• 15 Are technical reviews completed to address all open issues?

  Yes

  No

  N/A

Technical capabilities

• Can MSP guarantee a complete traceability of raw material and components?

• Do you have regular internal audits? How is your internal auditors’ qualification? Do you have regular Management review meetings?

• Does MSP have Design- and Process-FMEA for this product? Which are the “special characteristics”?

• 8 What is the suppliers on-time delivery percentage for production and service parts for the last 2 years?

• 6 Does the facility build tooling in house? <br>If so, what percentage?<br><br>7 Does the facility refurbish tools in house?

  Yes

  No

  N/A

LOGISTICS

• Logistics information

  Off

  On

• 3 What are the average days of finished product inventory on hand?

• 1 What are the different modes of transportation used to ship product?

• 2 Is the supplier capable of EDI?

  Yes

  No

  N/A

• 4 Does the facility use a pull system inventory management with FIFO?

  Yes

  No

  N/A

• Other

Zusammenarbeit mit tesa

• facility's language capabilities

Capacity, legal, capability, financial reliability

• Capacity information

  Off

  On

• 1 How long has the facility been in the business thay are quoting?

• 2 What products or services does the facility manufacture?

• 4 What impact would have the quoted business on the capacity? (Tesa share of business / bottle neck situation)

• 18 Is there a business continuity plan in place in the event of disaster?

  Yes

  No

  N/A