Title Page

  • Site conducted

  • Supplier Name

  • Supplier Number

  • Location / Adress - Write the adress in the note field
  • Audit Date

  • Date and Result of last Audit at Supplier

  • Audit Reason(s)

  • Lead Auditor / Prepared by

  • Audit Team Members

  • Supplier Representatives - Auditees

  • Supplier Quality System Certification

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

Audit Sumary

  • 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

Questionaire

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?!

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

  • 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

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

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.

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

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

  • Are all serial parts approved by Danfoss?

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

  • Project management

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

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

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

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

  • 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.

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

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?

  • 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)

  • 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

  • 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)

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

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

  • 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?

  • 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.

  • Are workstations clean and orderly? 5S implemented?

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)

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

  • 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)?

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

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

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

6. Inspection and Testing - Calibration

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

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

  • 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>

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

7. Competence and Training

  • Do operator interviews indicate familiarity with parts and processes?

  • 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

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

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

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

8. Non-Conformities management -> Product and Process

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

  • 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!

  • 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

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

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

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.

  • 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

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

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

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

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