(Subcontractor) QMS Audit Checklist ISO 9001_2008 Rev 0

of 13Revision no:Rev.00 , 10.09.2012

Title : QA Audit of Supplier/Subcontractor and his facilities Date: 07.10.2012 Auditor’s Signature:

Audited unit: HIDADA LTD. JEDDAH/KSA Tel: 0 503 964 609 (Wael Hassan)

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No. Questions Requirements / Reference Comments / Results

FACQues.

SYSTEM AUDIT ISO 9001:2008

4 QUALITY MANAGEMENT SYSTEM4.1 General requirements

1 Is the Quality system approved by the Accreditation Bodies such as LRQA,BV,DNV etc.?Does the Org. Chart exist for QA/QC?

Who does the Head/Manager of QA/QC Department report to?

Is there any written Quality Manual prepared?

Review of Certificate Ref. Org. Chart Review of Quality Manual

Scope of the quality management systemWhat activities are under and ouside the scope? (e.g. is the design work under the scope of works? )

Documented procedures or given references and Description of the interaction between processes

4.2 Documentation requirements4.2.1 General

Subcontractor’s document.doc




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2 How is the quality management system documented? Are the .... Quality policy and quality objectives

determined? Documented procedures established? Is there any Index Available for the

Quality Procedures? Are the records required for the Quality

Control implemented?

Mandatory Quality Procedures: Document Control Internal audit Control of nonconforming product Corrective action Preventive action QC Inspection/Test Forms

4.2.3 Control of documents(DC System) Required procedure3 Is there a procedure established for the

Control of the documents? Any index prepared for documents of Internal and External origin ?

Is the control of documents performed?

Approval of the documents prior to release and Distribution to the responsible personnel. (Distribution Matrix)

Ensure that external documents are identified and their distribution controlled

Prevent unintended use of obsolete documents and to apply suitable identification to them if they are retained

5 MANAGEMENT RESPONSIBILITY5.1 Management commitment

4 Check that the commitment of the Management for QMS is in place?

Check if the management review meetingsHave been held And if available, review of these minutes of meetings.

Check if the Meetings that have been held both internally and as an external, with TAL





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JV.

5.2 Client focus5 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, Work Instructions,Referenced Standards etc.How does the subcontractor manage the complaints and NCRs issued by TAL JV?(if applicable)

5.4 Planning5.4.1 Quality objectives

6 How does top management ensure that the quality objectives, including those needed to meet product requirements, are established at relevant functions and levels within the subcontractor?5.4.2 Quality management system planning

7 Do the Quality Plans (ITPs) prepared to cover all manufacturing/fabrication works as per it has stated in the contract ? Not: ITP, Projenin başlangıcında onaylı iş programına bağlı olarak, b elirli bir malzeme, hizmet, sözleşme veya proje ile ilgili özel kalite uygulamalarını, kritik operasyon ve ürün özelliklerini, kalite muayene ve deney noktalarını, deney ve muayenelerin sıklıklarını, ölçme

Review of ITP index of variable works .(if existing)Pls. refer to the Q.15 for the review and sampling of ITP prepared.





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yöntemlerini, sorumlu süreçleri, kaynakları ve faaliyet sıralarını, sorumluları belirlemek amacıyla yapılmalıdır.

5.5 Responsibility, authority and communication

Task Management, Job Descriptions

5.5.1 Responsibility and authority8 How does the management ensures that the

responsibilities and authorities are defined and communicated within the subcontractor?

Are the Job Descriptions prepared and ready for the Key Personnel and other Main Staff exist in the organization?

5.5.3 Internal communication9 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

Sampling of Internal Communications tools and methods for ensuring the effectiveness of the QMS. (such as Brochures,Bulletins, Announcements, Internal Network,Meeting etc.)

5.6 Management review5.6.1 General

10 How does the management review the subcontractor’s quality management system at planned intervals to ensure its continuing suitability, adequacy and effectiveness? (Management Review Meetings)

Are the opportunities for improvement assessed?

What intervals are these meetings carried on?

Are the need for changes of the system, including quality policy and quality objectives assessed?

5.6.3 Review output





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11 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,notifications etc.)6. RESOURCE MANAGEMENT6.1 Provision of resource

12 How does the subcontractor determine and provide resources needed as per Contract?(Extracted from Contract Deliverables Such as the requirements of personnel, tools, equipment, laboratory etc. for the execution of works )

To implement and maintain the quality management system and continious improvement and its effectiveness.

To enhance client satisfaction by meeting client requirements (We can use as a reference the Client’s Requirements given in the contract,specs,etc.)

6.2 Human Resource6.2.1 General

13 How is it ensured that the personnel effecting product quality are competent on the basis of appropriate education, training, skills and experience?

Review of Quality Personnel’s Qualification and Training Records.

The determination of Training needs of personnel.

6.2.2 Competence, awareness and training14 How does the subcontractor: Check if the Performance Management of





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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, training, skills and experience?

the personnel has been maintained.

7 PRODUCT REALIZATION7.1 Planning of product realization

15 Is there an ITP established for the specific works undertaken ?What are the planned and developed processes for product realization with respect to: Establishment of the processes, documents

and provide resources specific to the product?

Required verification, validation, monitoring, 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?

-Review of ITPs,Test schedules,The required tests and controls according to type of production.

-Sampling of an ITP in accordance with the related reference docs. Such as specs. Standards,codes etc.

-Sampling the inspection reports,test reports, check lists of Quality works.

7.2 Client-related process16 7.2.1 Determination of the requirements

related to the product processes (Where The output of this planning shall be in a

form of suitable for the subcontractor’s





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practicle , Sampling the Subcontractor’s Method Statements, Material Data Sheets under use)

method of operations i.e. the quality plan Specific requirements could be in

accordance with ISO 10005 : 2005 that provides guidelines for the development, review, acceptance, application and revision of quality plans.Below are the content of Quality Plan;inspection & test plans ,Inspection and test records.

7.2.2 Review of requirements related to the product

17 -Check if the Client’s Specification exists related to the product that are planned to manufacture.

The resources / references of product realisation related with the work undertaken and the Client’s instructions, terms and conditions. (Such as contract,specification, related standards, legal/local regulatory requirements etc.)

7.2.3 Client communication18 How does the subcontractor determine and

implement the effective arrangements of communicating with client in relation to: Product information? Enquiries, contracts or order handling

including amendments? Client feedback including client

What are the subcontractor’s methods and tools for the Client relations? How they manage, respond,act and verify the NCRs, findings and observations.Check if the records available.





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complaints? (Management of TAL JV’s NCRs,complaints,instructions if exists)

7.3 Design and development7.3.1 Design and development planning Design Management Procedure

19 Is the Design work exist under the responsibility of Subcontractor?

If Yes;Is there any Design Procedure issued?How has the subcontractor determined: The design and development stages? The review, verification and validation that

is appropriate to each stage? The responsibilities and authorities for

design and development?7.4 Purchasing7.4.1 Purchasing process Required to check the Procedure

20 Does the Purchasing(Procurement) procedure exist?

21 How does the subcontractor evaluate and select suppliers?(prebid-prequalification of vendors/suppliers)How they approve the supplier?

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.

7.4.2 Purchasing information





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22 How is the purchasing information describing the product to be purchased with respect to: Requirements for approval of product,

procedures, processes and equipment

-Sampling of Purchase Order form.Check if the appropriate information given for the product.

7.4.3 Verification of purchased product23 How does the subcontractor ensure that the

purchased product meets specified purchase requirements?

The subcontractor shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier.

Check the Warehouse management.Check how the material /equipment verification maintained?

Ref. to Related procedure.Check if any procedure exist for the material receiving,handling and preservation.

7.6 Control of monitoring and measuring devices

Check if the Calibration Procedure exist?

24 Are the measuring equipments: Calibrated and verified at specified intervals

or prior to use? Check if the company whom has performed

the calibration works, bear the accreditation from an international organization or local authorities?

Are the equipments adjusted or re-adjusted as necessary( if applicable)?

Records of the results shall be recorded. The ability of computer software to satisfy

the intended monitoring and measuring application shall be confirmed.





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Identified to enable the calibration status to be determined?

Are the Calibration plans, Calibration logs of measuring equipment maintained?

How does the subcontractor assess and record the validity of previous measuring results when the equipment is found not to conform to requirements?

Tracking and monitoring of test results. Test matrix, indexes,useful follow ups of the tests.

8 MEASUREMENT, ANALYSIS AND IMPROVEMENT8.2 Monitoring and measurement

25 8.2.1 Client satisfactionIs there a Client Satisfaction Survey done up to date?

Client satisfaction surveys,client data on delivered product quality, user opinion surveys, compliments.

How does the subcontractor monitor the information relating to the client perception as to whether the subcontractor has met client requirements?

This shall include determination of applicable methods, including statistical techniques, and the extent of their use. Internal Audits that may performed, the statistics of defect rate(s), masurement of product compliance with the specs. and standards.

8.2.2 Internal audit26 Check if the Internal audit plan and audit

schedule exists?Does the subcontractor conduct internal audits?

The methods for obtaining and using this information shall be determined.

Check if any audit report exist. Check if any finding, observation and





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(if yes)At what intervals does this audits being conduct?

improvement opportunity exist for the audit performed.

8.3 Control of nonconforming product Required to see the related procedure27 How does the subcontractor ensure that the

product conforms the client’s requirements ? Is there any procedure to manage the non-

conforming products? What are the actions to eliminate the

detected nonconformity? Authorization of its use, release or

acceptance under concession by a relevant authority or the client?

Key features: Evidence of conformity with the acceptance

criteria shall be maintained. Records shall indicate the person(s)

authorizing the release of the product. Reviewing nonconformities (including client

complaints) Determining the Root Causes of

nonconformities 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.

8.4 Analysis of data28 How does the subcontractor determine, 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.

Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained and shall be maintained.

When a nonconforming product is corrected, it shall be subjected to the re-verification for





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demonstrate the conformity of the requirements.

8.5 Improvement29 8.5.1 Continual improvement 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 data8.5.2 Corrective action Required to see the related procedure

30 -Is there a procedure for Corrective Actions issued?-Sampling a Corrective action report.(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-conformances have been found?

Key features: Quality Manual Audits(Internal/External) Client’s inspections reports NCRs CARs

8.5.3 Preventive action Required to see the related procedure31 -How does the subcontractor determine the

action to eliminate the causes of potential nonconformities in order to prevent their occurrence?(review the procedure if exists)-Sampling the Preventive Action reports.

Evaluating the need for actions to ensure that nonconformities do not recur.

Determining and implementing action needed

Records of the results of action taken





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Reviewing corrective action taken


(Subcontractor) QMS Audit Checklist ISO 9001_2008 Rev 0

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