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Vendor Audits

  1. 1. Vendor Audits Audit Questionnaire Anand Subramaniam
  2. 2. <ul><li>“The man who rolls up his sleeves seldom loses his shirt.&quot; </li></ul><ul><ul><li>- Thomas Cowan </li></ul></ul>
  3. 3. Vendor Audits
  4. 4. Current Challenges <ul><li>Cost </li></ul><ul><li>Downtime </li></ul><ul><li>Cost rising </li></ul><ul><li>Extra equipment </li></ul><ul><li>Excessive capacity </li></ul><ul><li>Unplanned equipment </li></ul><ul><li>Communication </li></ul><ul><li>Poor customer / vendor relations </li></ul><ul><li>Delivery </li></ul><ul><li>Poor response </li></ul><ul><li>Premium freight </li></ul><ul><li>Missed shipments / deliveries </li></ul><ul><li>Inconsistent schedules </li></ul><ul><li>Inventory errors </li></ul><ul><li>Unrealistic forecasts </li></ul><ul><li>Lack of customer input concerning requirements </li></ul><ul><li>Engineering </li></ul><ul><li>Poor design control </li></ul><ul><li>Lack of cross-functional input </li></ul><ul><li>Uncontrolled changes </li></ul><ul><li>Engineering changes without process changes </li></ul><ul><li>Obsolete technology </li></ul><ul><li>Poor prototype quality / quality control </li></ul><ul><li>Unexpected cost increases </li></ul><ul><li>Poor management of requirements </li></ul><ul><li>Tolerance stack up not in +/- 3σ </li></ul><ul><li>Warranty issues due to design </li></ul><ul><li>Inventory </li></ul><ul><li>Additional material handling </li></ul><ul><li>Bottlenecks </li></ul><ul><li>Complex inventory management </li></ul><ul><li>High inventory levels </li></ul><ul><li>Large lot sizes </li></ul><ul><li>Long changeover </li></ul><ul><li>Long lead time </li></ul><ul><li>Unbalanced material flow </li></ul><ul><li>Labour </li></ul><ul><li>Excessive labor </li></ul><ul><li>Insufficient training </li></ul><ul><li>Poor layouts / unnecessary handling </li></ul><ul><li>Unbalanced operations </li></ul><ul><li>Unplanned overtime </li></ul><ul><li>Lack of employee involvement </li></ul><ul><li>Poor attendance </li></ul><ul><li>Quality </li></ul><ul><li>Excessive variation </li></ul><ul><li>Warranty cost </li></ul><ul><li>Incapable processes </li></ul><ul><li>Increased inspection </li></ul><ul><li>Safety </li></ul><ul><li>Safety </li></ul><ul><li>Accidents </li></ul><ul><li>Unsafe work Environment </li></ul>
  5. 5. Vendor Audit Audit Product Identification and Lot Traceability Document Control Design Control Process Control Purchase Contract Review Quality Systems Inspect & Test Calibration Non-conforming Product Control Handling, Packaging. Storage, Delivery Quality Records Vendor Quality Control
  6. 6. Product ID & Lot Traceability <ul><li>Are there procedures defining product identification requirements for all products? </li></ul><ul><li>Are in-stock and in-process materials properly identified and controlled? </li></ul><ul><li>Where traceability is a specified requirement, do individual products or batches have a unique identification? </li></ul><ul><li>Are assemblies properly marked and tracked through the assembly process to ensure no steps in the process flow are missed? </li></ul>
  7. 7. Quality Records <ul><li>Are there documented procedures for control of quality records? </li></ul><ul><li>Are all quality records identified, indexed, filed, collected, stored, maintained, and disposed after stated period? </li></ul><ul><li>Are quality records maintained to demonstrate achievement of the required quality and to demonstrate effective operation of the Quality System? </li></ul><ul><li>Are pertinent sub-contractor records included in the vendor quality records? </li></ul><ul><li>Are quality records maintained in such a way that they are readily retrievable? </li></ul><ul><li>Are quality records stored in such a way that deterioration is minimised and loss is prevented? </li></ul><ul><li>Have retention times of quality records been established & recorded? </li></ul><ul><li>Where agreed contractually, are quality records made available for evaluation by customers? </li></ul>
  8. 8. Inspection & Test <ul><li>Does the vendor utilise final inspection and testing? </li></ul><ul><li>Does the vendor utilise extended reliability testing? </li></ul><ul><li>Are there procedures that address product inspection and test status? </li></ul><ul><li>Are there documented procedures for defining inspection and test methods? </li></ul><ul><li>Does the inspection and test process assure outgoing products meet quality goals? </li></ul><ul><li>Does the vendor utilise outgoing product inspection and testing such as Out of Box Audits? </li></ul><ul><li>Does the vendor ensure that incoming product is not used or processed until it has been inspected and verified as conforming to specified requirements? </li></ul><ul><li>Does the vendor inspect, test and identify product as required by the quality plan or documented procedures? </li></ul><ul><li>Are there procedures and practices in place to assure product traceability through all stages of production? </li></ul><ul><li>Is the conformance or non-conformance of a product’s inspection or test status identified? (by markings, tags, inspection records, test software, physical location) </li></ul><ul><li>Does the system assure only material that has passed specified inspections or tests is utilised or sold? </li></ul><ul><li>Are there records which give evidence that the product has passed inspection and/or test with defined acceptance criteria? </li></ul>
  9. 9. Statistical Process Control (SPC) <ul><li>Is there a SPC training program? </li></ul><ul><li>Is the SPC training plan documented? </li></ul><ul><li>Are records of these activities maintained? </li></ul><ul><li>Are upper and lower limits used on control charts? </li></ul><ul><li>Are SPC training records for each employee maintained? </li></ul><ul><li>Have all relevant employees been trained according to the SPC training plan? </li></ul><ul><li>Are appropriate actions taken when the Cp/Cpk values are not meeting expectation? </li></ul><ul><li>Does the SPC training program include control chart theory and process capability analysis skills? </li></ul><ul><li>Are all critical processes and parameters under statistical control? (e.g., control chart, Cp/Cpk study) </li></ul><ul><li>Are out-of-control conditions noted on control charts, with causes investigated, and actions provided? </li></ul><ul><li>Are there work instructions defining the manner of production and installation for each process/station? </li></ul><ul><li>Do the work instructions clearly specify the machines, equipment, tools, fixtures, and program to be used? </li></ul><ul><li>Do the work instructions specify the materials to be used? (e.g., part number/name, assembly tools, inspection tools) </li></ul><ul><li>Do the work instructions indicate assembly specifications and machine setting? (e.g., solder temp, torque driver setting, and adjustment/test specifications) </li></ul><ul><li>Are quality documents (e.g., QC-flow/work instructions) revision controlled and approved by authorised personnel prior to issue? </li></ul><ul><li>When a process goes out-of-control and produces nonconforming product, are triggers defined and documented for the purpose of initiating a stop build, or stop shipment action? </li></ul><ul><li>Are requirements for preventive maintenance defined and documented for activities that can influence the product quality? </li></ul>
  10. 10. Quality System <ul><li>Are accurate training records maintained? </li></ul><ul><li>Are records maintained of management reviews? </li></ul><ul><li>Is there a system to disqualify and re-qualify personnel in a job function? </li></ul><ul><li>Have the procedures and work instructions been effectively implemented? </li></ul><ul><li>Do the internal quality audits verify effectiveness of the quality systems? </li></ul><ul><li>Does a system exist for determining which personnel are qualified for a job function? </li></ul><ul><li>Are the internal quality audits scheduled on the basis of the status and importance of the activity? </li></ul><ul><li>Are the internal audits and follow-up actions carried out in accordance with documented procedures? </li></ul><ul><li>Does the vendor carry out a comprehensive system of planned and documented internal quality audits? </li></ul><ul><li>Is there a system that identifies training requirements for all personnel affecting the quality of the product? </li></ul><ul><li>Has the vendor defined and documented its corporate quality policy, objectives and commitments to quality? </li></ul><ul><li>Has the vendor established and maintained a documented quality system including procedures and work instructions? </li></ul><ul><li>Do the internal quality audits verify compliance with quality objectives, customer/process requirements, and ISO elements? </li></ul><ul><li>Does the management personnel responsible for the area take timely corrective action on the deficiencies found by the audit? </li></ul><ul><li>Are procedures in place to ensure this quality policy is understood, implemented and maintained at all levels in the organisation? </li></ul><ul><li>Has the vendor defined the responsibility, authority and interrelation of all personnel who manage, perform and verify work that affects the quality of products, materials or services? </li></ul><ul><li>Has the vendor provided adequate resources for in-house verification activities such as inspection, testing, monitoring and review of processes and products? </li></ul><ul><li>Has the vendor appointed a management representative who has responsibility and authority for ensuring that a quality management system has been implemented and maintained? </li></ul><ul><li>Does the vendor conduct management reviews of the suitability and effectiveness of the quality management system at appropriate intervals? </li></ul>
  11. 11. Handling, Storage, Package, Delivery <ul><li>Are the materials issued according to FIFO? </li></ul><ul><li>Are all sensitive materials stored in anti-static containers? </li></ul><ul><li>Are the material control records maintained per the procedures defined? </li></ul><ul><li>Are there procedures for handling, storing, packaging & product delivery? </li></ul><ul><li>Are flammable, corrosive, and toxic materials properly stored & segregated? </li></ul><ul><li>Are temperature and humidity monitored in these storage areas on a regular basis? </li></ul><ul><li>Does the vendor provide methods and means of handling that prevent damage or deterioration? </li></ul><ul><li>Does the vendor provide secure storage areas to prevent damage or deterioration of product, pending use or delivery? </li></ul><ul><li>Is the condition of product in stock assessed at appropriate intervals in order to detect deterioration? </li></ul><ul><li>Does the vendor control packing, preservation and marking processes to ensure conformance to specified requirements? </li></ul><ul><li>Is there an arrangement for the protection of the quality of product after final inspection and test? </li></ul>
  12. 12. Purchasing <ul><li>Subcontractor process capability is assessed. </li></ul><ul><li>Purchasing works with a qualified subcontractors list. </li></ul><ul><li>Purchasing uses a subcontractor audit/certification process. </li></ul><ul><li>A vendor partnering program is in place with subcontractors </li></ul><ul><li>The subcontractor selection process and rating system is documented. </li></ul><ul><li>Purchasing maintains frequent communication with its subcontractors. </li></ul><ul><li>Purchasing involves its subcontractors early in the product design cycle. </li></ul><ul><li>Subcontractors are involved in the organisation's cycle time reduction programs and have their own cycle time reduction programs. </li></ul><ul><li>Subcontractors selection is based on Total Cost-of-Ownership decision making, not price. </li></ul><ul><li>Purchasing is familiar with the appropriate applications of dock-to-stock and just-in-time. </li></ul><ul><li>Reliability requirements (including reliability metrics, confidence levels and intended use conditions) are communicated in writing to all subcontractors? </li></ul><ul><li>Are there established procedures to ensure that products obtained from third parties conform to specifications? </li></ul>
  13. 13. Design Control <ul><li>Are the plans updated as the design evolves? </li></ul><ul><li>Are the records for design review properly documented and maintained? </li></ul><ul><li>Are obsolete design documents removed from production and general use? </li></ul><ul><li>Can the design verification establish that design output meet the design input? </li></ul><ul><li>Are the design and verification activities planned and assigned to qualified personnel? </li></ul><ul><li>Are there plans that identify the responsibility for each design and development activity? </li></ul><ul><li>Is there a requirement to verify the product meets design specifications prior to mass production? </li></ul><ul><li>Are there procedures to control and verify the design of the product to ensure it is meeting all requirements? </li></ul><ul><li>Are organisational and technical interfaces between different groups identified, documented, transmitted and reviewed regularly? </li></ul><ul><li>Are design input requirements relating to the product identified, documented and reviewed for adequacy? </li></ul><ul><li>Is there a procedure for resolving incomplete or conflicting requirements with those responsible for drawing up the requirements? </li></ul><ul><li>Are design outputs documented and expressed in terms of requirements, calculations and analyses? </li></ul><ul><li>Has the design verification been planned, established, documented and assigned to competent personnel? </li></ul><ul><li>Are there procedures for the identification, documentation, review and approval of all changes and modifications? </li></ul>
  14. 14. Contract Review <ul><li>Are such procedures reviewed to ensure that: </li></ul><ul><ul><li>Contract requirements are adequately defined and documented. </li></ul></ul><ul><ul><li>Contract requirements that differ from those in tender are resolved. </li></ul></ul><ul><ul><li>The vendor has the capability to meet the contractual requirements. </li></ul></ul><ul><li>Are process capabilities part of the contract review process? </li></ul><ul><li>Are there established procedures for contract review? (i.e. product specifications and quality requirements) </li></ul><ul><li>Are there established procedures for new product introduction / transfer? (e.g., established work instructions, documentation checklist, equipment checklist, conduct pilot run, pre-production) </li></ul><ul><li>Are the warrantee return policies document and included as part of the contract review process? </li></ul>
  15. 15. Doc. Control / Engineering Changes <ul><li>Does the vendor have established and documented procedures for: </li></ul><ul><ul><li>Quality Manual? </li></ul></ul><ul><ul><li>Design documents and technical drawings? </li></ul></ul><ul><ul><li>Process control documents? </li></ul></ul><ul><ul><li>Work instructions? </li></ul></ul><ul><ul><li>Audit documents? </li></ul></ul><ul><li>Is there a procedure to govern engineering changes? </li></ul><ul><li>Is there a system to verify the effectiveness of engineering changes? </li></ul><ul><li>Is there a system to ensure engineering change notifications are being implemented? </li></ul><ul><li>Do these procedures ensure that pertinent documents are available to personnel at all locations? </li></ul><ul><li>Do these procedures ensure that all obsolete documents are promptly removed from all points of issue or use? </li></ul><ul><li>Are quality documents reviewed and approved for adequacy by authorised personnel prior to issue? </li></ul><ul><li>Are engineering changes reviewed and approved by authorised personnel prior to implementation? </li></ul><ul><li>Are the engineering change notifications distributed to all affected functional areas once approved? </li></ul>
  16. 16. Control of Non-conforming Product <ul><li>Is failure analysis performed on product returned? </li></ul><ul><li>Are all corrective actions and results documented? </li></ul><ul><li>Is there a system to track status of corrective action requests? </li></ul><ul><li>Are the criteria/guidelines for materials disposition defined? </li></ul><ul><li>Are the RMA records kept according to the defined retention period? </li></ul><ul><li>Does the corrective action request include short term/preventive action? </li></ul><ul><li>Are there documented procedures for control of nonconforming material? </li></ul><ul><li>Is a corrective action request issued in the event a unit fails reliability test? </li></ul><ul><li>Is the corrective action report reviewed and approved by relevant authorities? </li></ul><ul><li>Is there a requirement to issue a Closed Loop Corrective Action (CLCA) for RMA? </li></ul><ul><li>Are corrective actions monitored for effectiveness in preventing similar non-conformance? </li></ul><ul><li>Is action taken when progress/implementation of improvement actions is not satisfactory? </li></ul><ul><li>Are the contents of the responses/corrective actions appropriate to prevent future occurrences? </li></ul><ul><li>Is the responsibility and authority to review/approve disposition of nonconforming materials defined? </li></ul><ul><li>Is there a system to feedback failure analysis and action items to relevant departments (including mfg site)? </li></ul><ul><li>Is there a procedure to review the disposition of nonconforming material? ( RTV, scrap, rework) </li></ul><ul><li>Are all necessary details included in the corrective action request (P/N, lot #, inspection date, lot size, sample size, reject qty, etc.)? </li></ul><ul><li>Does the corrective action request include long term/root cause action? If defect is vendor related, is there any system to feedback for actions? </li></ul>
  17. 17. Vendor Quality Control <ul><li>Does the report include verification of: </li></ul><ul><ul><li>Quality documents? </li></ul></ul><ul><ul><li>Process control parameters/documents? </li></ul></ul><ul><ul><li>Condition of manufacturing equipment and tooling? </li></ul></ul><ul><ul><li>Critical parameters/dimensions? (including capability index) </li></ul></ul><ul><ul><li>Traceability of tooling #, and manufacturing site? </li></ul></ul><ul><ul><li>Inspection/test yield? </li></ul></ul><ul><li>Are up-to-date records kept of acceptable/approved subcontractors? </li></ul><ul><li>Does the vendor ensure that the subcontractors' quality system controls are effective? </li></ul><ul><li>Does the vendor have procedures to ensure that purchased product conforms to specified requirements? </li></ul><ul><li>Are subcontractors selected on the basis of their ability to meet subcontract requirements, including quality requirements? </li></ul><ul><li>Are the records for subcontractor approval properly maintained and kept according to the defined retention period? </li></ul><ul><li>Does the vendor review and approve purchasing documents for adequacy of specified requirements prior to release? </li></ul><ul><li>Is the customer allowed to verify at source, or upon receipt, that purchased product conformed to specified requirements? </li></ul><ul><li>Is there a procedure for part qualification? (i.e. tooling qualification, inspection method, inspection quantity, etc.) </li></ul><ul><li>Are Inspections conducted in a production environment to ensure requirements are met prior to mass production? </li></ul>
  18. 18. Calibration <ul><li>Is equipment verified or re-calibrated at appropriate intervals? </li></ul><ul><li>Are there documented procedures for control of inspection, measuring and test equipment? </li></ul><ul><li>Is there an official approval control system for all equipment to determine accuracy and precision? </li></ul><ul><li>Are devices that are exempt from inspection clearly marked as such? </li></ul><ul><li>Are the reference devices (standard equipment) used for base-point calibrations (0 point, maker's scale, etc.) correctly stored, managed and calibrated to Industry standards? </li></ul><ul><li>Is an appropriate method set up for storing measuring equipment, tools and jigs? </li></ul><ul><li>Are measuring and test equipment re-calibrated when found not meeting the requirement? </li></ul><ul><li>Is there a process for dispositioning product that has been built / tested with equipment found to be out of calibration? </li></ul>
  19. 19. <ul><li>“Good order is the foundation of all things.&quot; </li></ul><ul><ul><li>- Edmund Burke </li></ul></ul>
  20. 20. <ul><li>Good Luck </li></ul><ul><li>http://www.linkedin.com/in/anandsubramaniam </li></ul>

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