Qualitest InternationalAUDIT CHECKLIST

NO ELEMENT 4.1 MANAGEMENT RESPONSIBILITY FINDINGS

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What are your duties and responsibility in this department?

Do you have a documented job description?

May I see your organizational structure

Are you aware of the Quality Policy? Can you explain the Quality Policy.

What are the scope, responsibility and authority of your function to ensure product or service quality or to achieve the corporate quality objective?

How can you contribute or support for the success and implementation of this policy?

Do you have department goals? Explain the concept is this relevant to the Quality Policy?

Do you conduct verification activities such as verification of resources and personnel? How Explain?

Do you have an existing policies and objectives in your own department relevant to the Quality Policy

NO Element 4.2 Quality System FINDINGS

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What are your processes in this department? What are your transactions in performing your job? How do you perform your activities?

Do you have a documented procedure for this transactions/activities?

How will you ensure that all of this procedures are effectively implemented and being followed at all levels in your department?

Do you have a Quality Plan? Can you explain how the requirements for quality can be met?

How do you perform the following activities?- The preparation of the Quality Plan- The identification and acquisition of any controls, processing,

equipment, (including inspection and test equipment) fixtures, resources and skills that may be needed to achieve the required quality?

- Ensuring the compatibility of design, the production process, installation, servicing, inspection and test procedures and the applicable documentation.

- The updating of quality control, inspection and testing techniques, including the development of new instrumentation

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NO ELEMENT 4.2 QUALITY SYSTEM FINDINGS

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- The identification of any measurement requirement involving the capability that exceeds the known state of the art, in sufficient time for the needed capability to be developed.

- The identification of suitable verification at appropriate stages in the realization of the product.

- The clarification of standards of acceptability for all features and requirements, including those which contain a subjective element.

Does the Quality Plan define:?a) The objectives to be defined (e.g. characteristics or

specifications, uniformity, effectiveness, aesthetics, cycle time, cost, natural resources, utilization, yield, and dependability.

b) The steps in the process that constitute the operating practice of the organization (a flowchart or similar diagram can be used to demonstrate elements of the process).

c) The specific allocation of responsibilities, authority and resources during the different phases of the project.

d) The specific documented procedures and instruction appliede) Suitable testing, inspection, examination and audit programs at

appropriate stages.f) A documented procedure for changes and modifications in a

quality plan that project proceed.g) A method of measuring the achievement of the quality

objectives.

NO Element 4.3 Contract Review FINDINGS

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Do you perform submission of tender? If so, How?, explain the process, Is this found on your relevant procedures, Do you conduct tender review before submission? If so,explain. How do you handle acceptance of a contract or order. Explain the process steps.

Do you accept verbal means of order? If so, explain how do conduct contract review?

How do you handle amendments to a contract? Explain the process.

Who are responsible for the contract review? Explain the role of each member.

Do you have a contract review procedure? Does the procedure contain the following features?a) All interested parties have an opportunity to review to review

the contract.b) A checklist or some other means is available for reviewers to verify that they have reviewed and understood the requirements of the contract.c) A method is available for reviewers to question the

requirement of the contract and to have their questions addressed.

Qualitest InternationalAUDIT CHECKLIST

NO ELEMENT 4.3 CONTRACT REVIEW FINDINGS

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d) If appropriate, a draft quality plan is developed to havean understanding of how to implement the contract successfully.

e) There is a provision for reviews in the event that the contract is changed.

May I see records of contract review. Does the records maintain and adequate.

NO Element 4.5 Document and Data Control FINDINGS

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Who is responsible for document and dataa) Approvalb) Issuancec) Distributiond) Administratione) Removal of obsolete copiesExplain how being done?

Do you have a masterlist of documents identifying all controlled documents and its current status and location?

How will you ensure that pertinent issues of appropriate documents are available at all locations where essential operations are performed?

How will you ensure that invalid and/or obsolete documents are promptly removed from all points of issue or use, or otherwise assured against unintended use?

Can you discuss the methods of control for document and data changes at the stage of preparation, handling, issuance and recording of changes.

Do you have unique identification for internal and external documents? By what means?

What is the importance of documentation review during revision?

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NO ELEMENT 4.6 PURCHASING FINDINGS

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Do you conduct evaluation of subcontractor? Explain how. On what basis? How often on what interval?Example:- a review of previous performance in supplying similar

products, process .or services.- A satisfactory assessment to an appropriate quality system

standard by a body considered to be competent for the purpose.- An assessment of the subcontractor by the supplier to an

appropriate quality system standards.

How will ensure that purchased, subcontracted products (including services) conform to specified requirements?Such as:- assessment and selection of subcontractor- clear and unambiguous specification of the purchaser

requirements- the performance of suitable verification- inspection procedure

On what type and extent of control are you exercising over subcontractors?

Does the existing system establish an effective working relationship and feedback system with each subcontractor? Does the existing quality system for purchasing includes:- the applicable issue of specifications, drawings, purchase

documents and other technical data- selection of acceptable subcontractor- agreement on quality assurance- agreement on verification method- provisions for settlement of disputes- receiving inspection procedure- receiving controls- receiving quality records

Does the purchasing documents contains clear description of the products ordered and requirements.Including:- the type, class, grade or other precise identification- the title or other positive identification, and applicable issues of

specifications, drawings, process requirements, inspection, and other relevant technical data, including requirements for approval or qualification of product, procedures, process equipment and personnel

Who is responsible for the review and approval of purchasing product

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AUDIT CHECKLIST

NO ELEMENT 4.6 PURCHASING FINDINGS

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How do you perform selection of acceptable subcontractors? Describe the methods used to establish capabilityEx:- on-site evaluation of subcontractors capability and/or quality

system- evaluation of product sample- past history and test results of similar products- published experience of other users.

Do you have a clear agreement with subcontractors for the assurance of products supplied such as any of the following?- reliance on the subcontractors quality system- submission of specified inspection/test data and process control

records with shipment- 100 % inspection and testing by the subcontractor- implementation of a formal quality system by the subcon- periodic evaluation of subcon quality practices by the

organization or third party- In-house receiving inspection or sorting

Do you have an agreement with subcontractors regarding the verification methods of purchased products. If so, does the purchasing documents specify the verification arrangements and the method of product release?

Do you have an agreement for customer for customer verification of subcontracted product. If so, is this specified in the contract?

Do you have provisions for settlement of disputes with subcon regarding quality? Explain, Is there provision for dealing for both routine and non-routine matters? Does the system contains provision of improved communication channels between the organization and the subcon onmatters affecting quality?

Does the quality records relating to purchasing maintained? Does the records maintain has identification for the purpose of traceablity?

NOElement 4.8 PRODUCT IDENTIFICATION &

TRACEABILITYFINDINGS

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How do you implement a product identification and traceability system?

Does the product traceability has the ability to trace the history, application, location of an item or activity by means of recorded identification?

Does the identification of product appropriate (legible, durable) and maintained throughout the process, from receipt and during all stages of production, delivery and installation?

Qualitest InternationalAUDIT CHECKLIST

NOELEMENT 4.8 PRODUCT IDENTIFICATION &

TRACEABILITYFINDINGS

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Does the materials or product contains unique identification from the time of initial receipt, to delivery and installation at the final destination?

Does the identification in accordance with the documented procedures and recorded?

Does the existing system is capable of identifying a particular product in the event that a recall or special inspection becomes necessary?

NO Element 4.9 PROCESS CONTROL FINDINGS

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Do you have a plan for your production processes which directly affect quality?

What are those processes or product characteristics that can have a significant effect on product quality? Please can you identify?

How will you ensure that these critical processes affecting quality are carried out under control conditions?Does the controlled conditions includes the following:- documented procedures defining the manner of production,

installation and servicing, where the absence of such procedures could adversely affect quality

- use of suitable production, installation, and servicing equipment and a suitable working environment

- compliance with reference standards/codes, quality plans, and/or documented procedures

- monitoring and control of suitable process parameters and product characteristics

- the approval of processes and equipment as appropriate- criteria for workmanship, which shall be stipulated in the

clearest practical manner (e.g. written standards, representative samples or illustration)

- suitable maintenance of equipment to ensure continuing process capability

Does the planning of process ensure that those proceed under controlled conditions in the specified manner and sequence?

Does the controlled conditions includes appropriate control for materials, approved production, installation and servicing equipment, documented procedure or quality plans computer software, reference standards codes, suitable approval of process and personnel, as well as associated supplies, utilities and environments?

Does the operation of processes specified to the necessary extent by the documented work instructions? Do you conduct process capability studies? What verification

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method being used?

AUDIT CHECKLIST

NO ELEMENT 4.9 PROCESS CONTROL FINDINGS

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Does the verification of process include material, equipment, computer system and software, procedures and personnel?

Do you conduct verification of process variables? Where does the verification depends on? ( in-process product characteristics or final product characteristics)

Do all in-process and final verifications planned and specified? Is this documented including test and inspection procedures for each quality characteristics to be checked, specify equipment to perform such test and checks and the specified requirements and workmanship criteria?

How will you distinguish finished product characteristics from measurable in-process characteristics? Does the process qualified in advance by test to make sure that the process can meet the specified requirements.

Do you have a documented procedures/instructions of the common practice being applied in the operations?

Does the procedure/instructions describe the criteria for determining satisfactory work completion and conformity to specification and standard of good workmanship?

Does the workmanship criteria is stipulated in the clearest practical manner by written standards, illustrations and/or representative samples?

Are you employing the use of statistical process control, control charts and statistical sampling procedures and plans for process control explain?

Does the monitoring of control and processes relates directly to finished product specifications or to internal requirements?

Does the existing system/procedures contains appropriate methods for cleaning, preserving and the details of packaging including moisture elimination, cushioning, blocking and crating?

Does important product quality characteristics, auxiliary materials and utilities, such as water, compressed air, electrical power and chemicals used for processing controlled and verified periodically to ensure uniformity of effects on the process?

Does environmental conditions, such as temperature, humidity and cleanliness important to product quality is controlled and verified thru specified appropriate limits?

MATERIAL CONTROLa) Does all materials and parts conform to specified requirements

before being introduced into a process

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AUDIT CHECKLIST

NO ELEMENT 4.9 PROCESS CONTROL FINDINGS

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b) Does all in-process product including that in-process inventory stockrooms are appropriately stored, segregated, handled and preserved to maintain its suitability?

c) Does special consideration given to shelf-life and deterioration control, including assessment of product in stock at appropriate intervals?

Does all equipment, including fixed machinery, jigs, fixtures tooling, templates, patterns, and gauges proved for accuracy prior to use?

Does all equipment appropriately stored and adequately protected between use, and verified or calibrated at appropriate intervals to ensure that requirements concerning accuracy, trueness and precision are fulfilled?

Do you have a preventive maintenance program to ensure continued process capability?

Does process variables monitored, controlled and verified at appropriate frequencies to ensure- the accuracy and variability of equipment used- the skills capability and knowledge of the operators- the accuracy of measurement results and data used to control

the process- process environment and other factors affecting quality, such

as time, temperature and pressure- appropriate documentation of process variables, equipment and

personnel

When, how or in what point in time you determine that there is a process deficiency?

In case, it is apparent only after the product is finished or in use; do you conduct process pre-qualification(validation) to ensure process capability and control of all criteria variables during process operation?

Does the verification status of process output identified such as unverified, conforming or nonconforming including the organizational unit responsible for the verification?

Does the identification suitable such as stamps, tags, notation or inspection records that accompany the product , or by computer entry or physical location?

Who is responsible for the authorization of process change. Do you seek customer approval for the change (where necessary)?

In case of design changes, does all changes to production tooling or equipment materials or processes documented and

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communicated? Is this covered in the procedure?

AUDIT CHECKLIST

NO ELEMENT 4.9 PROCESS CONTROL FINDINGS

31 Does the product evaluated after any changes to verify that the change instituted had the desired effect upon product quality?

NO Element 4.10 INSPECTION AND TESTING FINDINGS

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Does the activities for inspection and testing are in accordance with the quality plan or documented procedures?

RECEIVING INSPECTION AND TESTINGa) Does all incoming products, materials, parts is not used or

processed until it has been inspected or otherwise verified as conforming to specified requirements?

b) Does appropriate actions carried-out in the event of non conformities? How?

c) Where incoming product is released for urgent production purposes prior to verification; does the product positively identified and recorded in order to permit immediate recall and replacement in the event of nonconformity? Note: Items should only be released subject to recall if:

- an objective evaluation of quality status and solution of nonconformities can still be implemented

- correction of nonconformities cannot compromise the quality of adjacent, attached or incorporated items

d) Does the procedure define the responsibility and authority of personnel who may allow incoming products to be used without prior demonstration of conformance?

e) Does the procedure define how such product(s) will be positively identified and controlled in the event that subsequent inspection finds nonconformities?

IN-PROCESS INSPECTION AND TESTINGa) Does the product is hold until required inspection and tests

have been completed or necessary reports have been received and verified except when product is released under positive-recall procedures.

b) Does the inspection and test allows the early recognition of nonconformities and timely disposition of the nonconforming items?

c) Do you apply statistical control techniques to identify trends for both product and process before nonconformities actually occur?

d) Does the procedure or quality plan ensure the objectivity of the

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inspection and test results, including situations where in-process inspection is carried out by production personnel?

AUDIT CHECKLIST

NO ELEMENT 4.10 INSPECTION AND TESTING FINDINGS

4. FINAL INSPECTION AND TESTINGa) Does the quality plan and/or documented procedures for final

inspection and testing require that all specified inspection and tests including those specified either on receipt of product or in-process; have been carried out and that the results meet the specified requirements?

b) Does all dispatched product undergone all the verification activities specified in the quality plan and/or documented procedures and had been satisfactorily completed?

c) Who has the inspection authority and responsibility for product release? Does all associated data and documentation used are available and authorized?

d) Does all repaired and/or reworked products re-inspected or retested? By whom?

NOElement 4.11 CONTROL OF INSPECTION, MEASURING

AND TEST EQUIPMENTFINDINGS

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Does all inspection, measuring, and test equipment that can affect the specified characteristics of a product or process suitably controlled, calibrated and maintained? Is the process contained in a documented procedure?

Is there a control being exercised over gauges, instruments, sensors, special test equipment and related test software? And also, manufacturing jigs, fixtures, such as test hardware, comparative references and process instrumentation that can affect the specified characteristics of a product or process suitably controlled.

Does statistical methods being used in achieving and demonstrating fulfillment of requirement that “Inspection, measuring and test equipment shall be used in a manner which ensures that measurement uncertainty is known and is consistent with the required measurement capability"?

Does test software or comparative references such as test hardware being used as suitable forms of inspection are checked to prove that they are capable of verifying the acceptability of product, prior to release for use during production, installation or servicing?

Does the test software or comparative references being rechecked at prescribed intervals including the extent and frequency of such checks with supporting records as evidence of control?

Does the control Procedure?a) Does the control procedure determine the measurement to be

made and the accuracy required, and select the appropriate

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inspection, measuring and test equipment that is capable of the necessary accuracy and precision?

AUDIT CHECKLIST

NOELEMENT 4.11 CONTROL OF INSPECTION MEASURING

AND TEST EQUIPMENTFINDINGS

b) Identify all inspection, measuring and test equipment that can affect product quality and calibrate and adjust them at prescribed intervals or prior to use against certified equipment having a known valid relationship to internationally or nationally recognized standards? Where no such standards exist the basis used for calibration shall be documented.

c) Define the process employed for the calibration of inspection, measuring and test equipment including details of equipment type, unique identification, location, frequency of checks, check method, acceptance criteria, and the action to be taken when results are unsatisfactory.

d) Identify inspection, measuring and test equipment with a suitable indicator or approved identification record to show the calibration status.

e) Maintain calibration records for inspection, measuring or test equipment

f) Assess and document the validity of previous inspection and test results when inspection measuring or test equipment is found to be out of calibration.

g) Ensure that the environmental conditions are suitable for the calibration, inspections, measurements and tests being carried out.

h) Ensure that the handling, preservation and storage of inspection measuring and test equipment in such that the accuracy and fitness for use are maintained.

i) Safeguard inspection, measuring and test facilities, including both test hardware and test software, from adjustments which would invalidate the calibration setting.

NO Element 4.12 INSPECTION AND TEST STATUS FINDINGS

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Does the inspection and test status of product identified by suitable means, which indicate the conformance or nonconformance of product with regards to the inspection and tests performed?

Does the identification of inspection and test status maintained and defined in the quality plan and/or documented procedures, throughout production, installation and servicing?

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AUDIT CHECKLIST

NOELEMENT 4.13 CONTROL OF NONCONFORMING

PRODUCTFINDINGS

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Does the documented procedure define and ensure that product that does not conform to specified requirements is prevented from unintended use or installation? What are the actions taken to prevent the unintended use or installation of nonconforming product?

Does the control procedure provide adequate identification, documentation, evaluation, segregation and disposition of nonconforming product and for notification of the functions concerned?

Does the nonconforming product being reviewed by designated persons to determine whether it can be accepted with or without repair by concession, repaired, reworked, regraded or scrapped?

Does the persons carrying out the review are competent to evaluate the effect of the decision on interchangeability, further processing, performance, demonstrability, safety and aesthetics?

Who is responsible and authorized for the disposition of nonconforming product? Does the decision to accept the use of nonconforming product documented, together with the reason for doing so, in authorized waivers, with appropriate precautions?

Does the repaired and/or reworked product re-inspected in accordance with the quality plan and/or documented procedures?

Does the established procedures meet the following purposes?- to determine which product units are involved in the

nonconforming, for example what production time interval,. Or production machines or product lots are involved

- to mark the nonconforming product units to make sure that they can be distinguished from conforming product units

- to document the existence of the nonconformity and for example which product units, production machines or product lots are involved

- to evaluate the nature of the nonconformity

- to consider the alternatives for the disposition of the nonconforming product, to decide what disposition shall be made and to record this disposition.

- Physically to control the movements, storage ands subsequent processing of the nonconforming product consistent with the disposition decision

- To notify other functions that may be affected by the

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nonconformity, including where appropriate the purchaser

AUDIT CHECKLIST

NOELEMENT 4.14 CORRECTIVE AND PREVENTIVE

ACTIONFINDINGS

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Does the corrective and preventive action taken to eliminate the causes of actual or potential nonconformities shall be to a degree appropriate to the magnitude of problems and commensurate with the risk encountered?

Does the procedure and implementation of corrective action include:a) the effective handling of customer complaints and reports of

product nonconformitiesb) investigation of the cause of nonconformities relating to

product process and quality system and recording the results of investigation

c) determination of the corrective action needed to eliminate the cause of nonconformity

d) application of controls to ensure that corrective action is taken and that is effective

Does the procedure and implementation of preventive action includes:a) the use of appropriate sources of information such as processes

and work operations which affect product quality, concessions, audit results, quality records, service reports and customer complaints to detect, analyze and eliminate potential cause of nonconformity

b) determination of steps needed to deal with any problems requiring preventive action

c) initiation of preventive action and application of controls to ensure that it is effective

d) ensuring that relevant information on actions taken is submitted for management review

Does the causes of detected(or potential) nonconformities promptly identified so that corrective action may be taken and recurrence (or occurrence) may be prevented?

Does the procedure identifies the responsibility for taking corrective action and how this action will be carried out and the verification of the effectiveness?

NOElement 4.15 HANDLING, STORAGE,

PACKAGING,PRESERVATION & DELIVERYFINDINGS

1. HANDLINGa) Does handling of product done in an adequate methods to

prevent damage or deterioration. Does the system defined is a documented procedure covering the incoming, in-process and final product considering also the method of delivery and the time of being put into use

b) Does the methods for handling of product provides a correct

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selection and use of suitable transportation units (such as pallets, containers, conveyors, vessels, tanks, pipelines and vehicles) so that damage, deterioration or contamination ( due to vibration , shock, abrasion, corrosion, temperature variation

AUDIT CHECKLIST

NOELEMENT 4.15 HANDLING, STORAGE, PACKAGING,

PRESERVATION AND DELIVERYFINDINGS

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Radiation or any other conditions occuring during handling and storage) may be prevented

c) does the maintenance of handling equipment being considered

STORAGEa) Are designated storage areas identified? Does the designated

storage areas or stockrooms adequate to prevent damage or deterioration of product?

b) Is there an appropriate method for authorizing receipt to and dispatch form such areas?

c) Does the storage facilities, suitable and considering not only physical securing but also environmental conditions (e.g. temperature and humidity)?

d) Is there as appropriate and periodic check/assessment of items in storage to detect possible deterioration, loss or damage?

e) Does the method for marking and labeling gives legible and durable information in accordance with the specification?

f) Does the existing system contains administrative procedure for expiry dates, and stock rotation and lot segregation? How is this implemented?

g) Does the storage and packaging requirements consider the tiering, layering or stacking of product as part of the design parameters?

PACKAGINGa) Does the packaging procedure, materials, packaging and

labeling designs provide appropriate protection against damage, deterioration or contamination during storage, transportation or any later period until the suppliers responsibility ceases?

b) Does the various forms of storage and the types of transportation that can be encountered being considered?

c) Does the packaging provides a clear description of the contents or ingredients where regulations or contract specify?

d) Does the existing system provides a provisions for checking the effectiveness of the packaging.

PRESERVATIONa) does the documented procedure specify appropriate methods

for preservation and segregation of product?

DELIVERYa) Does the existing system includes provisions for protection of

the quality of product after final inspection and test and extended during all phases of delivery to destination?

b) Does the system contains procedure to ensure that deteriorated product is not shipped and put into use and those product with

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limited shelf-life or requiring special protection during transport or storage identified?

c) Is there a delivery lead time in consideration to various types of delivery and variations in environmental conditions that may be encountered to meet the delivery time?

AUDIT CHECKLIST

NO ELEMENT 4.16 CONTROL OF QUALITY RECORDS FINDINGS

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Is there a documented procedures for identification, collection, indexing, access filing, storage, maintenance and disposition of quality records?

Does the quality records is capable of providing evidence that the quality system is satisfactorily implemented, if not does the quality records indicate what correction was made?

Does all quality records legible, stored and retained in such a way that they are readily retrievable in facilities that provide suitable environment to prevent damage or deterioration, unauthorized access, loss, and alteration?

What is the retention period of the quality records?

NO Element 4.17 INTERNAL QUALITY RECORDS FINDINGS

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Who is responsible for planning and implementing an sudit?

Does the person(auditor) carrying-out the audit is independent of the area being audited?

Does periodic internal audits performed, on what frequency, on what basis or purpose?

Does the results of the audit recorded and brought to the attention of the personnel having responsibility in the area audited?

Does corrective and preventive action adequately taken by responsible personnel to correct the deficiencies found during the audit? Does target dates established?

Does proper verification implemented during follow-up audit to check the implementation and effectiveness of the corrective action taken?

Does the results of internal quality audits form an integral part of the input to management review activities?

Does the audit carried out by qualified/certified auditor? What is their qualification for selection?

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AUDIT CHECKLIST

NO ELEMENT 4.18 TRAINING FINDINGS

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Does the existing system /procedures provides provisions for identifying training needs and provide training for all personnel performing activities affecting quality?

Does all personnel performing specific assigned tasks qualified on the basis of appropriate education, training and/or experience?

Is there a system for maintaining proficiency of personnel by conducting periodic evaluation such as :

- Evaluation of the General education experience and proficiency of personnel for the activities to be performed.

- Identification of the individual training needs against those required for satisfactory performance.

- Planning, organizing and carrying out of appropriate training, either in-house or by an outside body.

- Recording of training and achievement so that records can be updated gaps in training can readily be identified and filled.

Is there a particular attention given to qualifications, selection and training of newly recruited personnel and personnel transferred to new assignments?

Is there a training given to provide executive management with an understanding of the quality system together with the tools and techniques needed for full executive management participation in the operation of the system?

Does the executive management aware of the criteria available to evaluate the effectiveness of the system?

Does process Supervisors and operating and technical personnel trained in the procedure and skills required to perform their tasks such as:- The proper operation of instruments, tools and machinery they

have to use?- Reading and understanding the documentation provided?- The relationship of their duties to quality?- And safety in the workplace?Note: As appropriate, personnel should be certified in their skills such as welding, training in basic statistical techniques?

Does the personnel aware of the advantages of proper job performance at all levels, and of the effects of poor job performance on other people, customer satisfaction, operating cost and the economic well-being of the organization?

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9. Does the need for quality emphasized through an awareness programme that which include introduction and elementary programmes for new personnel, provision for personnel to initiate preventive and corrective actions and other procedures? Does appropriate records of training maintained?

AUDIT CHECKLIST

NO ELEMENT 4.20 STATISTICAL TECHNIQUES FINDINGS

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Does the need for statistical techniques required for establishing, controlling and verifying process capability and product characteristics identified? What are those?

Example of statistical methods application:

a.) market analysisb.) product designc.) dependability specification, longevity and durability prediction d.) studies of process control and process capabilitye.) determination of quality levels in sampling plansf.) data analysis, performance assessment and nonconformity

analysisg.) process improvementh.) safety evaluation and risk analysis

Is there a procedure to implement and control the application of the statistical technique identified?Such as;a) designs of experiment and factorial analysisb) analysis of variance and regression analysisc) test of significanced) quality control charts and cusum techniquese) statistical sampling

Is there an adequate and maintained records of statistical techniques application?