Manufacturing Process Audit - Pro QC International

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!!!!!Manufacturing Process Audit!* Example Report *North America 1-815-344-1252Latin America 52-1-333-2010712Europe & Middle-East 49-8122-552 9590Asia & Asia Pacific 886-2-2832-2990Emailinfo@proqc.comwww.proqc.com

Manufacturing Process AuditRev.GUIDELINES2PURPOSE: Audit scores are rarely understood outside of the quality organization or the auditing company. This auditis based on defined criteria for each element assessed. Scoring is based upon the suppliers ability to meet all of therequirements of this audit, plus any specific requirements of the client. The audit focuses on the manufacturingprocess and its related supporting functions. The intent of the Process Audit is to provide the client with informationuseful in making sourcing decisions and reducing associated risks.CLIENT CHECKLIST - PROCESS CHECKLIST: Either a client checklist or a product/process checklist may beincluded with the audit. The auditor will review the questions and use the responses to score questions in the survey.SCORING:Scores are assigned based on what is done for the Pro QC client regardless of what is done for other clients. Forexample, if control plans are developed for other clients but not for the Pro QC client, the score must be NC. Scoringmust be explained to the supplier at the opening meeting.Complies with the Requirements CImprovement Needed INon-Conformance Found NCN/A Does Not ApplyGUIDELINE FOR SCORING CONFORMANCE:Each question is assessed for conformance to the requirements of ISO 9001, and the auditors knowledge of theproduct and/or process This must be clear to the supplier at the opening meeting.Complies with Requirements - has objective evidence to support the question, AND- has a written procedure (when required).Improvement Needed - has objective evidence but procedure needs improvement.- has objective evidence, but no written procedure.- has written procedure, but is lacking some objective evidence to support the question.Non-Conformance - No objective evidence to support the question (regardless of the procedure).- Lacking some objective evidence and no written procedure.AUDIT REPORT:- Scope of the Audit- Recommendations- Strengths of the Supplier's Quality System and Manufacturing Process- Opportunities for Improvement (Weaknesses in the Supplier's Quality System and/or Manufacturing Process)RESULTS REVIEW WITH SUPPLIER:The auditor should review the audit results with the supplier, but cannot provide the supplier a copy of the audit. Theaudit is the property of the client.CORRECTIVE ACTIONS:It is recommended that the client request a corrective action (improvement plan) based on the results of the audit. Theimprovement plan should include the following:- Detailed description of action plan.- Name of the person responsible for the improvement activity.- Date when the improvement will be completed.

Manufacturing Process AuditRev.SUMMARY2Supplier NameAudit DateReport PPLIER'S INFORMATIONNAME :CLIENT'S INFORMATIONNAME :XXXXXXXXXXXXXXXXXXXXXXXADDRESS : XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXCITY : XXXXXXXXXXXXXXXXXXXXXXXCOUNTRY : XXXXXXXXXXXXXXXXXXXXXXXPHONE : XXXXXXXXXXXXXXXXXXXXXXXFAX : ESS : XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXCITY : XXXXXXXXXXXXXXXXXXXXXXXCOUNTRY : XXXXXXXXXXXXXXXXXXXXXXXPHONE : XXXXXXXXXXXXXXXXXXXXXXXFAX : XXXXXXXXXXXXXXXXXXXXXXXSUPPLIER'S PERSONNEL XXXXXPRO QC PERSONNEL .Mr./Mrs.Scope ail:XXXXXXXXXXXXXXXXXXXFactory Profile, Manufacturing Process AuditAUDIT RESULTSCategoryNb. Ques.%Complies with Requirements ( C )2466.7%Improvement Needed ( I )38.3%Not-compliant with Requirements (NC)925.0%Not Applicable (N/A)625.0%%8.3%%66.7%%36RECOMMENDATIONSThe process is effective. You could start or continue business with this supplier.The process is acceptable, with minor nonconformities. YOU could use thissupplier, and keep pushing for improvements.The process has several major issues noted. You could temporally use this supplier andrequest immediate corrective action in case of long-term business.There are serious major issues noted with this supplier that could impact in your business.The better solution will be to source for another supplier.

Manufacturing Process AuditRev.AUDIT REPORT2Supplier NameXXXXXXXXXXXXXXXXXXXXXXXAudit DateReport No.XX/XX/XXXXIEC00000372HScope of Audit:To evaluate the factory's production control process and identify risk areas and opportunities for improvement by predicting failureopportunities within the manufacturing, and related processes.Summary/Recommendations:1. The supplier is a middle size foundry with a long history. Supplier is ISO9001 certified. See photo 29 for reference.2. The founding equipments are acceptable. Arc furnaces, automatic molding machines and core making machines included. Seephotos 11, 12 & 13 for reference.3. The supplier can do chemical analysis and mechanical property testing. See photos 15, 16, 17 & 18 for reference.4. The supplier has machining & heat treat capability. See photos 6, 7 & 8 for reference.5. The supplier has the founding experience of similar parts to 8100370, 8100371 & 8100372. See photos 4 and 5 for reference.6. When the audit was performed, the client's parts had not been produced. This audit did not focus on client's parts, but onsimilar castings.7. For MTC issued by BAM, see photo 28.Strengths:1. Good founding equipment and heat treat capability.2. Sufficient test equipment, chemical analysis and mechanical property test machine.3. Founding experience of similar part.Opportunities for Improvement:1. Sub-supplier approval and evaluation program should be developed.2. More detailed quality control plan or inspection instruction for all parts should be developed. Significant characteristics shouldbe identified.3. The on-time delivery should be monitored. The statistics and objective of on-time delivery should be developed.

Manufacturing Process AuditRev.AUDIT CHECKLIST2Supplier NameAudit DateReport No.XXXXXXXXXXXXXXXXXXXXXXXXX/XX/XXXXIEC00000372HC Complies with the requirements, I Improvement Needed, NC Not Complies, N/A Not ApplicableQUESTIONNAIREFINDINGSSCORESECTION 1 - TECHNICAL DOCUMENTATIONDoes the supplier have all of the required technical documentationnecessary to the part or product being reviewed? Examples includedrawings, specifications, material charts, regulations, reference samples,CAD Data, etc.The drawings and specifications have been received bythe supplier. The technical engineers are now reviewingall of the documents.CThe technical documentation for the part, product, or component beingreviewed may include and not limited to:- Drawings- Specifications/standards for material, testing, and laboratory, etc.What is the supplier's document control program, and is it effectivelyimplemented?There is a very detailed file control program.All the documents are well controlled by a specificperson.The supplier shall have a document control program. The program mustensure:- Proper revision level- Distribution of new revision- Control of obsolete documents- Records retentionHow are significant characteristics selected, classified and identified?CNo significant characteristics were selected andidentified. The supplier always checks all of thecharacteristics equally.The supplier must have a method to identify significant product andprocess characteristics. The characteristics shall be visible in all technicaldocumentation (flow chart, control plan, work Instruction, etc.).When the technical documentation supplied by the customer does notindicate the existence of significant characteristics, the supplier’s personnelshall be trained and able to identify those characteristics important to thecustomer or product by means of techniques such as process FMEA’s,DOE, knowledge of their processes, and/or knowledge of how the productis used. At a minimum, the supplier must select characteristics that affectclose tolerances, fit, function, finish, reliability, durability or characteristicsaffected by their manufacturing process and process parameters.Are the required technical documents available at the workstation?NCThere are working instructions at all workstations.See photo 21 for reference.CThe required technical documentation shall be available at the workstationsand/or easily accessible without disrupting the work activity.SECTION 2 - CONTROLS AND TESTS ON PURCHASED PARTSIs there a list of qualified sub-suppliers? What is the supplier's program toapprove new sub-suppliers for business?- The supplier must have a list of approved sub-suppliers they canpurchase raw material or services from.- The supplier must have a procedure that describes how new subsuppliers are approved. This includes: Criteria for evaluating new sub-suppliers Rules for issuing purchase orders based on the sub-supplier'sperformance Specification of purchase data to send to the sub-supplier Acceptance/verification criteria for the purchased parts, raw material, etc Rules for how to handling of non-conforming parts receivedNOTE: The auditor must record the names of sub-suppliers reviewed.There is no sub-supplier list, and no approval programfor new sub-suppliers.NC

Manufacturing Process AuditRev.AUDIT CHECKLIST2Supplier NameAudit DateReport No.XXXXXXXXXXXXXXXXXXXXXXXXX/XX/XXXXIEC00000372HC Complies with the requirements, I Improvement Needed, NC Not Complies, N/A Not ApplicableQUESTIONNAIREFINDINGSSCOREThe sub-suppliers' performances were evaluated.How is sub-supplier performance evaluated using the information gatheredfor the receiving inspection function?- The supplier must have a procedure to monitor the performance of theirsub-suppliers. Performance metrics should include:- On-Time-Delivery- Quality of delivered parts - Parts Per Million or Shipment rejects should beused- Effectiveness of corrective actions- There should be established objectives for each metric with action planswhen objectives are not met- The supplier must be able to work with the sub-suppliers in terms of:- auditing the sub-supplier for each new product/ process- analysis of Control Plans for new or modified parts- analysis and monitoring of the improvement plans following a nonconformanceNOTE: The auditor must record the names of sub-suppliers reviewed.If a sub-supplier is not approved, what prevention controls are used toensure the conformity of the supplied product and/or raw material?When it is necessary to purchase from non-qualified sub-suppliers that donot satisfy the requirements of elements 2.1, effective controls, using anadequate sampling plan, shall be used in both the I\incoming inspectionarea and during the manufacturing process to prevent/block the use of nonconforming parts or raw material. Whenever possible, this should includethe use of statistical controls on the product.NCEach lot of incoming material was inspected beforebeing accepted.For example, the factory will do chemical analysis onevery incoming lot of pig iron.See photo 27 for ref.CNOTE: How is this applied? Must see examples.NOTE: Is the sampling plan based on C 0? Please document here.How does the supplier control the quality of incoming material / rawmaterial that is not subject to controls by receiving inspection?- Selected types of material/raw material may not be subject to controls atreceiving inspection, such as:- Sheet metal- Bar stock- Plastic raw material- The supplier must receive documentation/certification with results ofinspection and tests for each delivered lot. e.g. chemical analysis, physicalanalysis, conformance reports.- The supplier should verify the results reported on the 'certifications' by anindependent laboratory. Minimum of annually.How does the supplier inspect and approve purchased product/materialprior to its being used for the product being audited? Examples includedimensional, fit and function approval.First, the supplier will review the certificates of allincoming materials. Next, the supplier will verify theresults on the certificate by sending the material to anindependent lab.CThe supplier failed to show MTC from sub-suppliers.The supplier explained they would do a chemicalanalysis on every lot of incoming pig iron.I

Manufacturing Process AuditRev.AUDIT CHECKLIST2Supplier NameAudit DateReport e supplier failed to show MTC from sub-suppliers.The supplierthey wouldchemicalC Complies with the requirements, I Improvement Needed,NC explainedNot Complies,N/A doNota Applicableanalysis on every lot of incoming pig iron.QUESTIONNAIREFINDINGS- Before starting production, the supplier shall receive and approvesamples submitted by the sub-supplier. The samples for part approval mustbe:- Manufactured from the actual production tooling- Checked for conformity to the specifications- And is compatible with the suppliers’ processes and use on thecustomers’ final product- The part approval must verify the conformity of the material to thetechnical specification.- When a part is obtained from multiple molds, dies or multi-cavityequipment, each mold/die/cavity shall be identified in a permanent way onthe part. A separate sampling shall be provided for each in order to carryout separate dimensional controls. This shall also be required for parts ofthe same size but different features (color, hardness, embossing, etc.).- If the approval is granted via deviation, this shall be temporary and shallindicate the quantity or the valid time period.- Deviation on characteristics that may affect the fit or functionality of thecomponent as seen by the customer shall be authorized in advance by thecu

The audit focuses on the manufacturing process and its related supporting functions. The intent of the Process Audit is to provide the client with information useful in making sourcing decisions and reducing associated risks. CLIENT CHECKLIST - PROCESS CHECKLIST: Either a client checklist or a product/process checklist may be included with the audit. The auditor will review the questions and File Size: 2MBPage Count: 25People also search foraiag process control planmanufacturing process audit templateprocess audit pdfmanufacturing process audit checklist pdfiso process audit worksheet exampleprocess audit template