[EN] 505N0042A02 - Supplier Process Audit Template DCS - Detailed

• Site conducted

  Select

• Supplier Name

• Supplier Number

• Location / Adress - Write the adress in the note field
  Address

• Audit Date

  Date

• Date and Result of last Audit at Supplier

• Audit Reason(s)

  Select Quality Performance Follow up audit New Product Development Change Control Frequent Supplier audit (Yearly, bi-yearly etc.) Based on Risk and criticality on product and process (single source, ATEX, PED. etc) New Supplier assessment - DCS

  • Quality Performance
  • Follow up audit
  • New Product Development
  • Change Control
  • Frequent Supplier audit (Yearly, bi-yearly etc.)
  • Based on Risk and criticality on product and process (single source, ATEX, PED. etc)
  • New Supplier assessment - DCS

• Lead Auditor / Prepared by

• Audit Team Members

• Supplier Representatives - Auditees

• Supplier Quality System Certification

  ISO 9001:2015

  IATF 16949:2016

  ISO14001:2015

  Others - specify

  NONE

• Danfoss Part/Product/code number including revision - including process(es)/technology(ies) audited at Supplier

• General Comments - Possible content can include: Details about audit reasons, evtl. Agenda (audit scope), Supplier specific information, Audit general comments and observations

• Strong Areas observed during Audit

• Risk Areas/Improvement Areas

• Timing for improvement plan

  Date

1. Generic Requirements - incl. Quality Management System topics, Supplier Quality Manual

• Has the supplier signed up on Danfoss.com for the Supplier Quality Manual automatic notification about changes made by Danfoss? and does the supplier accept and live up to the requirements?!

  Yes

  No

  N/A

• Are internal audits performed and are the results evaluated and used for improvement? Are findings closed without undue delay?

  Yes

  No

  N/A

• Management Commitment - Does supplier management show active commitment to quality and improvement? <br>- Quality Objectives <br>- Management Review<br>-> improvement actions Status and Follow up

  Yes

  No

  N/A

• Quality Management System Structure and suitability<br>- Procedures<br>- Document control<br>- Others

  Good

  Fair

  Poor

  N/A

2. Design and Development Change Control, Product Specification, Project Management - APQP

• Is a Design and development process established, implemented and maintained to ensure subsequent provision of products and services? - e.g. APQP<br>- The organization shall ensure that design and development outputs:<br>a) meet the input requirements;<br>b) are adequate for the subsequent processes for the provision of products and services;<br>c) include or reference monitoring and measuring requirements, as appropriate, and acceptance criteria;<br>d) specify the characteristics of the products and services that are essential for their intended purpose and their safe and proper provision.<br>The organization shall retain documented information on design and development outputs.

  Good

  Fair

  Poor

  N/A

• Is change control in place for all contract-, part- and process-specific documents

  Yes

  No

  N/A

• Are Special characteristics marked in all applicable cascaded quality planning documents

  Yes

  No

  N/A

• Are all serial parts approved by Danfoss?

  Yes

  No

  N/A

• Are all needed standards available and all customer specific requirements known?

  Yes

  No

  N/A

• Project management

  Yes

  No

  N/A

3. Purchased products and services Incl.: Supplier Management, Control of incoming goods

• Are Suppliers approved through a formal process, is there a suppliers performance-monitoring and development process established

  Yes

  No

  N/A

• Is a process in place to approve purchased goods? <br>- PPAP or similar

  Yes

  No

  N/A

• Are supplier processes audited? <br>- What is the audit trigger<br>- Planning<br>- Records

  Good

  Fair

  Poor

  N/A

• Is the quality of incoming material ensured by incoming inspection or other means?

  Yes

  No

  N/A

• Is there ensured a clear status for all incoming material in warehouse<br>- marking (non-conforming, status of inspection, etc.)<br>- area<br>- clean and organised.

  Good

  Fair

  Poor

  N/A

• Deployment of Danfoss Supplier Quality Manual requirements to next Tier Supplier level! (especially important on CMO or semi finished parts)

  Good

  Fair

  Poor

  N/A

4. Production Process - Product and process specifications, Planning, Product and process monitoring, 5S, Maintenance

• Is process well-defined and documented by e.g. flowcharts or operational routing?

  Yes

  No

  N/A

• Are Setup instruction, operator instructions, workmanship standards (SOP's) available for at least critical processes?<br>- Does initiating documents and/or operator instructions communicate all relevant information for process-setup and information about the product including specifications.<br>- Is there a good linkage between initiating documentation on process and product (As well with the product version)

  Yes

  No

  N/A

• Is a PFMEA prepared and is it following the defined process flow (PFD)?<br>- Are the risks properly scored (against defined scoring e.g. AIAG ref.)<br>- Are actions defined and progress ensured<br>- Are Special Characteristics identified<br>- Is the FMEA reviewed and Updated

  Yes

  No

  N/A

• Are manufacturing process KPIs/Targets defined? (e.g. PPM, Yield, ScrapRate)<br>- Is the process capable<br>- Is the performance regularly reviewed by appropriate statistical methodology<br>- Are actions taken and follow up ensured. (documentation, status and progress)

  Yes

  No

  N/A

• Product/process records / data analyzed in order to identify opportunity for improvement?

  Good

  Fair

  Poor

  N/A

• Has error-proofing, Automation&Robotics and/or other means and methods been implemented where appropriate?

  Yes

  No

  N/A

• Is Preventive and predictive maintenance ensured?<br>- Are procedures implemented for availability, identification and maintenance of tooling/fixtures?<br>- Are procedures implemented for preventive maintenance of process- and test equipment?<br>- Is the lifetime of tools, machinery and production equipment controlled and are preventive actions implemented?

  Yes

  No

  N/A

• Logistics - components and Production planning<br>- Is there a formalized process for receiving and processing Customers orders?<br>- What is the process for production and components planning? Forecast, Capacity vs. Load.

  Yes

  No

  N/A

• Are workstations clean and orderly? 5S implemented?

  Good

  Fair

  Poor

  N/A

5. Process Control, Material flow, traceability, identification and status

• Are in-process controls defined in a control plan or by similar means, and are inspections carried out according to e.g. control plan?<br>- Are the controls identified in FMEA incorporated in the Control Plan?<br>- Are Special Characteristics Identified and statistically controlled (SPC or 100% inspection)

  Yes

  No

  N/A

• How is line-clearance implemented -> how is it ensured that two similar productions are not mixed up. (one order system)

  Good

  Fair

  Poor

  N/A

• Is a procedure for first-off inspection implemented and are results documented?<br>Does the control plan include quantity, frequency, traceability, reaction plan and specification details? Are first off and last off inspections in place (mandatory requirement)?

  Yes

  No

  N/A

• Are machine/process settings identified, documented and controlled?

  Good

  Fair

  Poor

  N/A

• Is product identification and inspection status maintained through all stages of production, assembly, and delivery (e.g. by labelling, color-coding, accompanying documents)?

  Yes

  No

  N/A

• Is a process sign-off/final inspection implemented and are records traceable and readily available?

  Yes

  No

  N/A

6. Inspection and Testing - Calibration

• Is inspection and test equipment individually identified and listed and is the status clear(by identifier or system)?

  Yes

  No

  N/A

• Is inspection and test equipment handled, managed and stored in conditions avoiding damage, deterioration or other impact resulting in out of calibration condition?

  Yes

  No

  N/A

• Has all inspection and/or test equipment been calibrated according to traceable references/standards and are results formally documented and approved? <br>- approval and review is also required on visual aids/references available for attributive inspection.<br>- Is the validation of previous results ensured while measuring equipment is deviating from standard? - what actions are initiated if an equipment is found out of calibration condition?<br>

  Yes

  No

  N/A

• Has MSA been performed? -> minimum measurement equipment used for special characteristics or on Special customer requirement need a valid MSA?

  Select Yes No N/A

  • Yes
  • No
  • N/A

7. Competence and Training

• Do operator interviews indicate familiarity with parts and processes?

  Yes

  No

  N/A

• Is the responsibility and authority of the the process and product quality ensured in the Line?<br>- are operators / employees <br>- does operators/employees have an awareness of their impact to quality<br>- can operators relate to the meaningfulness of their work/activities

  Good

  Fair

  Poor

  N/A

• Are procedures for operator and supervisor training implemented and are records available?

  Yes

  No

  N/A

• Have employees received relevant training/courses and is documentation available?<br>- Is training done by operation or by technology?

  Yes

  No

  N/A

• Is a competence matrix used to identify skilled and minor skilled personal? Is matrix used also for development of competences and personal?

  Yes

  No

  N/A

8. Non-Conformities management -> Product and Process

• Is a process in place for recording of process deviations?

  Yes

  No

  N/A

• Is a process in place for the identification, handling and recording of nonconforming products?<br>- relevant for nonconformity handling of Customer, internal and supplier related non-conformities!

  Yes

  No

  N/A

• Is a process in place for handling and recording of nonconformities and complaints in a timely manner? <br>- Are corrective and preventive actions planned, documented, implemented, verified

  Yes

  No

  N/A

• Are problem-solving methods/models deployed (e.g. 8-D, six sigma)?

  Good

  Fair

  Poor

  N/A

• Is there a process in place to ensure control of reworked and conditionally accepted parts/processes?

  Yes

  No

  N/A

9. CoC Light - Health, Safety and Environment

• Has the supplier provided the employees with Personal protection Equipment (PPE) and are they used?<br>- PPE includes goggles, glasses, gloves, earplug, boots, and protective clothing it shall be available and used at factory cost.

  Yes

  No

  N/A

• Work safety established in all means, to protect workers from beeing harmed?<br>- emergency stops and shields<br>- electrical installations<br>- height, hot, and narrow /confined conditions<br>- Lifting<br>- Chemical exposure<br>- Safety during Maintenance - Including LOTO - Lock out Tag out

  Yes

  No

  N/A

• Factory emergency deployment <br>- eg. Fire Fighting equipment, emergency exits, 1st aid Kit, <br>Free for access, clearly marked, available and maintained?

  Yes

  No

  N/A

• Environmental work place conditions in all aspects - light, ventilation, temperature, etc.

  Yes

  No

  N/A

• Management of chemicals and hazardous material - Storage, disposal, Danfoss Negative list

  Yes

  No

  N/A