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Title : QA Audit of Supplier/Subcontractor and his facilities
Page 1 of 14 Date: 07.10.2012 Auditor’s Signature: Project / Package:
Audited unit: HIDADA LTD. JEDDAH/KSA Tel: 0 503 964 609 (Wael Hassan) No. Questions Requirements / Reference
Comments / Results
FAC SYSTEM AUDIT ISO 9001:2008 Ques. 4 QUALITY MANAGEMENT SYSTEM 4.1 General requirements 1 Is the Quality system approved by the • Review of Certificate Accreditation Bodies such as LRQA,BV,DNV • Ref. Org. Chart etc.? • Review of Quality Manual Does the Org. Chart exist for QA/QC? • Scope of the quality Who does the Head/Manager of QA/QC management system Department report to? What activities are under and ouside the scope? (e.g. is the design work under the Is there any written Quality Manual prepared? scope of works? ) • Documented procedures or given references and Description of the interaction between processes 4.2 Documentation requirements 4.2.1 General
10..doc .00 .10.09.1 Management commitment Check that the commitment of the • Check if the management Subcontractor’s 116521441. • Document Control • Quality policy and quality • Internal audit objectives determined? • Control of nonconforming • Documented procedures product established? • Corrective action • Is there any Index Available • Preventive action for the Quality Procedures? • QC Inspection/Test Forms • Are the records required for the Quality Control implemented? 4...Revision no: Rev.2. 2 Questions Requirements / Reference Comments / Results 3 4 How is the quality management system Mandatory Quality Procedures: documented? Are the .2012 Title : QA Audit of Supplier/Subcontractor and his facilities Page 2 of 14 Date: 07. (Distribution documents of Internal and Matrix) External origin ? • Ensure that external documents are identified and • Is the control of documents their distribution controlled performed? • Prevent unintended use of obsolete documents and to apply suitable identification to them if they are retained 5 MANAGEMENT RESPONSIBILITY 5. JEDDAH/KSA Tel: 0 503 964 609 (Wael Hassan) No.3 Control of documents(DC System) Required procedure • Is there a procedure • Approval of the documents established for the Control prior to release and of the documents? Any Distribution to the responsible index prepared for personnel.2012 Auditor’s Signature: Project / Package: Audited unit: HIDADA LTD.
Revision no: Rev. including those needed to meet product requirements.1 Quality objectives How does top management ensure that the quality objectives.Referenced Standards etc. Comments / Results 5 5.2 Quality management system planning Do the Quality Plans (ITPs) prepared to cover Review of ITP index of variable works .10.4. How does the subcontractor manage the complaints and NCRs issued by TAL JV?(if applicable) 6 7 5.doc . with TAL JV. refer to the Q. JEDDAH/KSA Tel: 0 503 964 609 (Wael Hassan) No.2 Client focus How does the management ensure that the client’s requirements are determined and met? Review of Client/Client’s requirements under the shed light of specifications. Questions Management for QMS is in place? Requirements / Reference review meetings Have been held And if available. are established at relevant functions and levels within the subcontractor? 5.2012 Auditor’s Signature: Project / Package: Audited unit: HIDADA LTD.2012 Title : QA Audit of Supplier/Subcontractor and his facilities Page 3 of 14 Date: 07.4 Planning 5.15 for the review and Subcontractor’s 116521441. • Check if the Meetings that have been held both internally and as an external.09.4. Work Instructions. 10.00 . review of these minutes of meetings.(if all manufacturing/fabrication works as per it existing) has stated in the contract ? Pls.
Projenin başlangıcında onaylı iş programına bağlı olarak. kalite muayene ve deney noktalarını.5 Responsibility. 10.) • • • Are the opportunities for improvement assessed? What intervals are these meetings carried on? Are the need for changes of Subcontractor’s 116521441.Revision no: Rev.10.3 Internal communication How does subcontractor’s management ensure that appropriate communication processes are established within the subcontractor and that communication take place regarding the effectiveness of the quality management system 5. Requirements / Reference sampling of ITP prepared. deney ve muayenelerin sıklıklarını. Questions Not: ITP.Bulletins.Meeting etc. (such as Brochures. JEDDAH/KSA Tel: 0 503 964 609 (Wael Hassan) No.1 Responsibility and authority How does the management ensures that the responsibilities and authorities are defined and communicated within the subcontractor? 5. ölçme yöntemlerini. sorumlu süreçleri.5. adequacy and effectiveness? (Management Review Meetings) Task Management.6. sözleşme veya proje ile ilgili özel kalite uygulamalarını. kritik operasyon ve ürün özelliklerini. belirli bir malzeme. Internal Network. Comments / Results 8 9 10 5. Job Descriptions Are the Job Descriptions prepared and ready for the Key Personnel and other Main Staff exist in the organization? Sampling of Internal Communications tools and methods for ensuring the effectiveness of the QMS.00 .2012 Title : QA Audit of Supplier/Subcontractor and his facilities Page 4 of 14 Date: 07.09. hizmet. sorumluları belirlemek amacıyla yapılmalıdır.doc .6 Management review 5.5.1 General How does the management review the subcontractor’s quality management system at planned intervals to ensure its continuing suitability. authority and communication 5. kaynakları ve faaliyet sıralarını. Announcements.2012 Auditor’s Signature: Project / Package: Audited unit: HIDADA LTD.
To enhance client satisfaction by meeting client requirements (We can use as a reference the Client’s Requirements given in the Subcontractor’s 116521441.3 Review output Which decisions and actions are the outputs of the management review meetings? (if applicable) • Improvement of the effectiveness of the quality management system and its processes Improvement of product related to client requirements Resource needs Outputs of Management Review Meetings(MoM.00 .09.) Comments / Results • • • 12 6.2012 Auditor’s Signature: Project / Package: Audited unit: HIDADA LTD.6. including quality policy and quality objectives assessed? 11 5. 10. laboratory etc. Questions Requirements / Reference the system. tools. equipment.notifications etc.Revision no: Rev.10. RESOURCE MANAGEMENT 6. JEDDAH/KSA Tel: 0 503 964 609 (Wael Hassan) No.doc . for the execution of works ) • • To implement and maintain the quality management system and continious improvement and its effectiveness.1 Provision of resource How does the subcontractor determine and provide resources needed as per Contract? (Extracted from Contract Deliverables Such as the requirements of personnel.2012 Title : QA Audit of Supplier/Subcontractor and his facilities Page 5 of 14 Date: 07.
2012 Auditor’s Signature: Project / Package: Audited unit: HIDADA LTD.00 .2.10. Questions Requirements / Reference contract. awareness and training How does the subcontractor: • Determine the necessary competence for personnel performing Quality work affecting product quality? • Provide training or take other actions to satisfy these needs? • Maintain appropriate records of education.1 General How is it ensured that the personnel effecting product quality are competent on the basis of appropriate education.Revision no: Rev. 14 15 Subcontractor’s 116521441. training. JEDDAH/KSA Tel: 0 503 964 609 (Wael Hassan) No. The determination of Training needs of personnel. training.specs.2012 Title : QA Audit of Supplier/Subcontractor and his facilities Page 6 of 14 Date: 07. skills and experience? 7 PRODUCT REALIZATION 7.09.2 Competence. 10.) 6. skills and experience? 6.doc .2. Check if the Performance Management of the personnel has been maintained.1 Planning of product realization Is there an ITP established for the specific works undertaken ? What are the planned and developed processes for product realization with respect to: Comments / Results 13 • • • Review of Quality Personnel’s Qualification and Training Records.etc.2 Human Resource 6.
Revision no: Rev. the quality plan • Specific requirements could be in accordance with ISO 10005 : 2005 that provides guidelines for the development. validation.test reports.e. check lists of Quality works. 10. application and revision of quality plans. review.10.1 Determination of the requirements related to the product processes (Where practicle .2.codes etc. Standards. acceptance. • Subcontractor’s 116521441. Such as specs.Test schedules.The required tests and controls according to type of production. monitoring.00 . JEDDAH/KSA Tel: 0 503 964 609 (Wael Hassan) No.2 Client-related process 7. -Sampling of an ITP in accordance with the related reference docs. Comments / Results 16 The output of this planning shall be in a form of suitable for the subcontractor’s method of operations i.2012 Auditor’s Signature: Project / Package: Audited unit: HIDADA LTD. inspection and test activities specific to the product and the criteria for product acceptance? • Records needed to provide evidence that the realization processes and resulting product meet requirements? 7. -Sampling the inspection reports. documents and provide resources specific to the product? • Required verification. Material Data Sheets under use) Requirements / Reference -Review of ITPs.doc .2012 Title : QA Audit of Supplier/Subcontractor and his facilities Page 7 of 14 Date: 07. Below are the content of Quality Plan. Sampling the Subcontractor’s Method Statements.09. • Questions Establishment of the processes.
contracts or order handling including amendments? • Client feedback including client complaints? (Management of TAL JV’s NCRs.3 Client communication How does the subcontractor determine and implement the effective arrangements of communicating with client in relation to: • Product information? • Enquiries.2.1 Design and development planning Design Management Procedure Subcontractor’s 116521441.complaints. 18 7. related standards.) What are the subcontractor’s methods and tools for the Client relations? How they manage.2 Review of requirements related to the product -Check if the Client’s Specification exists related to the product that are planned to manufacture. legal/local regulatory requirements etc. terms and conditions. JEDDAH/KSA Tel: 0 503 964 609 (Wael Hassan) No.2012 Auditor’s Signature: Project / Package: Audited unit: HIDADA LTD.doc .instruction s if exists) 7.2012 Title : QA Audit of Supplier/Subcontractor and his facilities Page 8 of 14 Date: 07.3. Comments / Results 17 • The resources / references of product realisation related with the work undertaken and the Client’s instructions. 7. findings and observations.3 Design and development 7. respond.10.2.specification. Questions Requirements / Reference inspection & test plans . (Such as contract.00 . 10.act and verify the NCRs.09.Revision no: Rev.Inspection and test records. Check if the records available.
procedures.2 Purchasing information How is the purchasing information describing the product to be purchased with respect to: • Requirements for approval of product.1 Purchasing process Does the Purchasing(Procurement) procedure exist? How does the subcontractor evaluate and select suppliers?(prebid-prequalification of vendors/suppliers) How they approve the supplier? 7. Check if the appropriate information given for the product.4.Revision no: Rev. -Sampling of Purchase Order form. verification and validation that is appropriate to each stage? • The responsibilities and authorities for design and development? 7. JEDDAH/KSA Tel: 0 503 964 609 (Wael Hassan) No. Required to check the Procedure Note:The type and extent of evaluation applied to the supplier and the purchased product shall be dependent on the effect on the product realization or final product.2012 Auditor’s Signature: Project / Package: Audited unit: HIDADA LTD.2012 Title : QA Audit of Supplier/Subcontractor and his facilities Page 9 of 14 Date: 07.4 Purchasing 7.4.doc .10. Is there any Design Procedure issued? How has the subcontractor determined: • The design and development stages? • The review.00 . Subcontractor’s 116521441.09. 10. 19 Questions Is the Design work exist responsibility of Subcontractor? under the Requirements / Reference Comments / Results 20 21 22 If Yes.
6 Control of monitoring and measuring Check if the Calibration Procedure exist? devices Are the measuring equipments: • Records of the results shall • Calibrated and verified at be recorded.2012 Title : QA Audit of Supplier/Subcontractor and his facilities Page 10 of 14 Date: 07.4. specified intervals or prior to • The ability of computer use? software to satisfy the • Check if the company whom intended monitoring and has performed the calibration measuring application shall works.2012 Auditor’s Signature: Project / Package: Audited unit: HIDADA LTD.10. bear the accreditation be confirmed.doc .3 Verification of purchased product How does the subcontractor ensure that the purchased product meets specified purchase requirements? Check the Warehouse management.09. Questions processes and equipment 7. JEDDAH/KSA Tel: 0 503 964 609 (Wael Hassan) No. Ref. to Related procedure. Check how the material /equipment verification maintained? Requirements / Reference Comments / Results 23 The subcontractor shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier. 24 7.00 . 10.Revision no: Rev. from an international organization or local authorities? • Are the equipments adjusted or re-adjusted as necessary( if applicable)? Subcontractor’s 116521441.handling and preservation. Check if any procedure exist for the material receiving.
user opinion surveys.useful follow ups of the tests. and standards.00 . the statistics of defect rate(s). This shall include determination of applicable methods. JEDDAH/KSA Tel: 0 503 964 609 (Wael Hassan) No.doc .Revision no: Rev.client data on delivered product quality.2 Monitoring and measurement 25 8. masurement of product compliance with the specs. Internal Audits that may performed. Test the validity of previous measuring results when matrix. 10. indexes.2. compliments.2012 Auditor’s Signature: Project / Package: Audited unit: HIDADA LTD.10.09. ANALYSIS AND IMPROVEMENT 8.2 Internal audit Check if the Internal audit plan and audit schedule exists? Does the subcontractor conduct internal audits? Client satisfaction surveys. Calibration logs of measuring equipment maintained? How does the subcontractor assess and record Tracking and monitoring of test results. Check if any audit report 26 Subcontractor’s 116521441. and the extent of their use.1 Client satisfaction Is there a Client Satisfaction Survey done up to date? How does the subcontractor monitor the information relating to the client perception as to whether the subcontractor has met client requirements? 8. including statistical techniques.2. • Questions Requirements / Reference Comments / Results Identified to enable the calibration status to be determined? • Are the Calibration plans. the equipment is found not to conform to requirements? 8 MEASUREMENT. • • The methods for obtaining and using this information shall be determined.2012 Title : QA Audit of Supplier/Subcontractor and his facilities Page 11 of 14 Date: 07.
JEDDAH/KSA Tel: 0 503 964 609 (Wael Hassan) No.09. observation and improvement opportunity exist for the audit performed. Subcontractor’s 116521441. 10.doc . products? • Records shall indicate the • What are the actions to person(s) authorizing the eliminate the detected release of the product.Revision no: Rev. Comments / Results • 27 8. Check if any finding. (including client complaints) release or acceptance under • Determining the Root Causes concession by a relevant of nonconformities authority or the client? • Evaluating the need for actions to ensure that nonconformities do not recur • Determining and implementing action needed • Records of the results of action taken • Reviewing of corrective actions taken. Questions (if yes)At what intervals does this audits being conduct? Requirements / Reference exist.10.2012 Title : QA Audit of Supplier/Subcontractor and his facilities Page 12 of 14 Date: 07.2012 Auditor’s Signature: Project / Package: Audited unit: HIDADA LTD. nonconformity? • Reviewing nonconformities • Authorization of its use.00 .3 Control of nonconforming product Required to see the related procedure How does the subcontractor ensure that the Key features: product conforms the client’s requirements ? • Evidence of conformity with • Is there any procedure to the acceptance criteria shall manage the non-conforming be maintained.
Revision no: Rev.2012 Auditor’s Signature: Project / Package: Audited unit: HIDADA LTD. 8.1 Continual improvement Requirements / Reference Comments / Results 28 Records of the nature of nonconformities and any subsequent actions taken.5.2 Corrective action -Is there a procedure for Corrective Actions issued? -Sampling a Corrective action report. Questions 8.(if exists) -Are the Evaluation of the Root Causes of Non conformities exist? -Sampling of What precautions have been implemented up to date to Prevent the non- Subcontractor’s 116521441.2012 Title : QA Audit of Supplier/Subcontractor and his facilities Page 13 of 14 Date: 07. 10. collect and analyse appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made. it shall be subjected to the re-verification for demonstrate the conformity of the requirements.09. The analysis of data shall provide information relating to: • Client satisfaction • Conformity to product requirements • Characteristics and trends of process and products including opportunities for preventive actions • Statistical data Required to see the related procedure Key features: • Quality Manual • Audits(Internal/External) • Client’s inspections reports • NCRs • CARs 29 30 8.5.5 Improvement 8.4 Analysis of data How does the subcontractor determine.doc . including concessions obtained and shall be maintained.00 .10. When a nonconforming product is corrected. JEDDAH/KSA Tel: 0 503 964 609 (Wael Hassan) No.
09. Questions Requirements / Reference Comments / Results 31 conformances have been found? 8.00 . JEDDAH/KSA Tel: 0 503 964 609 (Wael Hassan) No.10.2012 Auditor’s Signature: Project / Package: Audited unit: HIDADA LTD.2012 Title : QA Audit of Supplier/Subcontractor and his facilities Page 14 of 14 Date: 07.Revision no: Rev.5. 10. occurrence?(review the procedure if exists) • Determining and -Sampling the Preventive Action reports.doc . implementing action needed • Records of the results of action taken • Reviewing corrective action taken Subcontractor’s 116521441.3 Preventive action Required to see the related procedure -How does the subcontractor determine the • Evaluating the need for action to eliminate the causes of potential actions to ensure that nonconformities in order to prevent their nonconformities do not recur.
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