DTA The Dynamic Testing Agency - NAFEMS · PDF fileDTA The Dynamic Testing Agency QUALITY ASSURANCE ... may be incorporated in specific quality assurance systems. The Dynamic Testing

DTA

The Dynamic Testing Agency

QUALITY ASSURANCEPRIMER

Version 1 - March 1993

DTA 1993; Version 1 22 March 1993ii

PRIMER 5: ISSUE HISTORY (Quality Assurance Primer)

Status Date Comments

Working Group Issue I January 1991 Initial Draft.

Working Group Issue 2 February 1991 Modified followingcomments from WGBmembers.

Working Group Issue 3 May 1992 Modified followingcomments from NAMAS,

Working Group Issue 4 September 1992 Format and minor textualchanges made by DTASecretary.

Draft 1 December 1992 Textually identical to WG 4.Reformatted and submittedfor Peer Group comments.

Draft 2 March 1993 Modified following PeerGroup Review comments.

Version 1 March 1993 Released for issue tomembers.

DTA 1993; Version 1 22 March 1993iii

DTA PRIMERS PRIMER 5 COPYRIGHT

© Crown copyright 1993. Published with the permission of the Controller of Her Majesty'sStationery Office.

ISBN 1 899630 03 1

Published by the Dynamic Testing Agency.

Except as permitted under current legislation, no part of this work may be photocopied, stored in aretrieval system, published, adapted, recorded or reproduced in any form or by any means, withoutthe prior permission of the Dynamic Testing Agency. Enquiries should be addressed to the DTASecretariat, FSML, College of Aeronautics, Cranfield University, Cranfield, Bedford, MK43 OAL.

Every effort has been made to ensure that the information given herein is accurate and appropriateto the topic being covered. No responsibility is accepted by the DTA, or any companies orindividuals mentioned, for direct or consequential damages claimed to result from use of the materialfor any particular application. No legal responsibility is accepted for any errors, omissions ormisleading statements in the information caused by negligence or otherwise.

Quality Assurance Primer

DTA 1993; Version 1 22 March 1993iv

PREFACE

Dynamic testing, in conjunction with the measurement and interpretation of data, is an increasinglyindispensable aid to the design and development of cost competitive, safe and reliable engineeringstructures and components. The multi-discipline nature of dynamic testing covers a wide ranging,often complex, number of fields in which the knowledge and experience of the tester are paramountto success. Recognising the complexity of the subject, and the problems that relatively inexperiencedpersonnel can encounter, a need was identified for best practice standards in dynamic testing whichmay be incorporated in specific quality assurance systems.

The Dynamic Testing Agency (DTA) comprises industrial companies, research organisations anduniversities who are involved directly with dynamic testing and analysis and who share the concernsexpressed above. Its brief is to develop best practice guidelines in the field of engineering testing,measurement and data analysis relating to structural and machine dynamics.

To achieve the stated aims, the DTA has established specialist Working Groups to consider a numberof technical disciplines covering:

InstrumentationData acquisition and signal processing Modal testing and validationNon-Linearity in dynamic testingMaterials testingShock and vibration testingLaboratory simulation testingCondition monitoringStructural integrity assessment

The DTA has embarked on the production of a series of primers and a handbook covering the variousdisciplines listed above. The primers are intended to give an appreciation of the various facets to beregarded when considering dynamic testing, measurement and analysis, and are of interest both toproject managers and technical managers. The handbook is aimed at the practitioners of thetechnology and explores each specialist area in greater detail, giving guidance on best practiceprocedures to be followed when undertaking dynamic testing.


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ACKNOWLEDGEMENTS

This primer was prepared under the auspices of DTA Working Group B, comprising: N. Manning(GEC Alsthom, Chairman), N. Harwood (NEL, Secretary), A. Abell (BEQE), J. Batte (MIRA),R. Bootle (BAe), M. Brayfield (GKN Technology), J. Johnson (GEC Alsthom), S. Jones (Rover),R. Neish (DRA - Dunfermline), P. Reeve (Schlumberger), S. Rogers (Nuclear Electric), S. Styles(Hawtal Whiting), M. Youngman (LMS).


DTA 1993; Version 1 22 March 1993vi

CONTENTS

1. INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

2. MANAGEMENT RESPONSIBILITY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

3. QUALITY SYSTEM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

3.1 Quality Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

3.2 Quality Assurance Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

3.2.1 Customer Enquiries and Preparation of Proposals . . . . . . . . . . . . . . . . . . 73.2.2 Customers' Orders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73.2.3 Project Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83.2.4 Control of Project Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83.2.5 Purchasing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83.2.6 Goods Receiving . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93.2.7 Goods Forwarding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93.2.8 Test Procedures and Test Programmes . . . . . . . . . . . . . . . . . . . . . . . . . . 93.2.9 Quality Plans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103.2.10 Test Non-Conformances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103.2.11 Drawings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103.2.12 Security of Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113.2.13 Control of Test Facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113.2.14 Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113.2.15 Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

3.3 Work Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

4. AUDITS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

5. CONTROL OF TEST OBJECTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

6. CALIBRATION AND CONTROL OF INSTRUMENTATION . . . . . . . . . . . . . . . . . 17


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7. MAINTENANCE OF TEST EQUIPMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

8. REPRODUCIBILITY OF TEST PARAMETERS . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

9. TEST REPORTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

10. ACCREDITATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

BIBLIOGRAPHY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27


DTA 1993; Version 1 22 March 19931

1. INTRODUCTION

The rapid development of the technique of quality and reliability control in recent years has becomean important feature of modern industry. It is now universally accepted that a Company needs todefine its Quality Policy by commitment from the highest level of Management.

Quality Assurance is primarily concerned with ensuring that an organisation consistently deliversproducts and services that meet the exact requirements of its customers. A critical aspect of doingthis is the specification and control of the equipment, materials and methods it employs in itsactivities, and so these are normally precisely documented as Quality Assurance Procedures. Oftenit is felt by the workforce that the introduction of a procedure for working is a change for the sakeof change. Not so! Very often changes to practical working arrangements are not necessary, but thearrangements need to be documented and compliance with the relevant Standards ensured.

The aim of this Primer is to introduce Quality Assurance as it applies to testing in an industrialenvironment, and to set down the guidelines for the construction and establishment of an effectiveQuality Assurance System, for compliance with the appropriate parts of BS5750/IS09000. TestLaboratories intending to obtain NAMAS accreditation, have, in addition to satisfy the requirementsof NAMAS documents M10 and M11.



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2. MANAGEMENT RESPONSIBILITY AND ORGANISATION

The Company's Management need to define and document its policy and objectives for Quality. Thisis a commitment which must be made by the highest level of Management, ie Managing Director orTechnical Manager. The Management should state and publish the policy throughout theorganisation and this policy should be seen to be supported by Management, who should take allnecessary steps to ensure that the policy is understood, implemented and maintained. The policyshould be reviewed as necessary to ensure continuing suitability and effectiveness. When preparingthe policy it is necessary to consider Company requirement, Customer requirements and objectivessuch as safety and reliability, performance, fitness for use, and also the costs associated with Qualityelements.

To achieve the policy objectives there obviously needs to he a structured system of organisationalresponsibility. The Quality System within a Company is usually controlled by a Quality AssuranceManager who would be directly responsible to the Managing Director or Technical Manager. It isthe role of a Quality Assurance Manager to establish, monitor, develop and maintain an effectiveQuality System within the Company. In the execution of these tasks he should be vested with theauthority to initiate action to prevent the occurrence of product non-conformity, identify and recordany product quality problems, initiate and recommend solutions as required, and verify theimplementation of solutions.

The structured organisation system extends down through the workforce and all employees areresponsible for ensuring that the work under their control is executed in a way that meets thespecified requirements.

For example, in a multi-disciplined research organisation, the structure might consist of the followingelements:

"Section Heads" are responsible for ensuring that adequate resources for their expertise are availableand that the personnel assigned to tasks have the necessary qualifications, experience and training.

"Project Officers", appointed by the "Section Head" to control a specific project or projects, have theresponsibility for ensuring that the work under their control, including that of any subcontractors, iscarried out to a suitably high scientific standard and in compliance with any defined Qualityrequirements. Where more than one Section is involved in a project, the "Project Officer" isresponsible for adequate communication across interfaces.

The "Engineer Responsible", is appointed by the "Project Officer" to assist him in his duties. Thisperson may be one who deals with specific tasks at Technician or Workshop level.



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3. QUALITY SYSTEM

Quality Systems are usually arranged in a three-tier system comprising a Quality Manual, QualityAssurance Procedures and finally Work Procedures or Work Instructions.

3.1 Quality Manual

This is the top level document which should be prepared by the Quality Assurance Manager andauthorised by the Managing Director or Technical Manager.

The Manual outlines the Quality System within the Company, cross-referencing where necessary toQuality Assurance Procedures, and would of necessity include the Management's Quality PolicyStatement. The Manual needs to be sufficiently detailed to be used by the Customer for auditingpurposes and to give him confidence that a system exists, that it is operating, and that it is suitablefor the purpose.

The Manual should contain the key elements of the System, as defined, for example in BS 5750:1987. These comprise, with brief explanations:-

Management Responsibility and Organisation - which has previously been discussed, together witha diagram of the organisational structure.

Principles of the Quality System - which we are currently considering.

Contract Review - which defines the procedure for ensuring that Customer requirements areadequately defined and reviewed and that the Company has the capability to meet the contractualrequirements.

Design or Project Control - which includes planning, activity assignment, technical interfaces anddesign input, output, changes and verification.

Document Control - provision of procedures for the approval and issue of documents, andmodifications and revisions thereto, and the control of incoming documentation.

Purchasing - establishment of a system which ensures that the purchased product conforms tospecified requirements, assessment of suppliers and sub-contractors, and verification of thepurchased product.

Identification and Traceability - applicable to materials, test samples and products, where necessarywith unique identification and the ensurance of the traceability from receipt until despatch.



Process Control - the provision of documented Work Procedures or Instructions for manufacture,special processes and experimental projects.

Inspection and Testing - covers receipt, in-process and final inspection and/or testing activities andthe establishment and maintenance of records.

Inspection, measuring and test equipment - the division of equipment into categories, the uniqueidentification, calibration and recall procedures in compliance with BS 5781: 1979.

Inspection and Test Status - the control of identification and verification of status of products anditems during all stages of manufacture and test.

Control of non-conforming product - the procedure used to ensure that non-conforming products arenot inadvertently used or installed, and review procedures.

Corrective Action - establishment of documentation for, investigating the cause of non-conformancy,analysis of compliants, preventative actions and corrective actions.

Handling, storage, packing and delivery - the establishment and maintenance of procedures anddocumentation for handling, storage, packing and delivery.

Quality Records - the establishment and maintenance of records a) by the Quality AssuranceManager to demonstrate effective operation of the Quality System, and b) by the controller of theproject for work under his direct control.

Internal Quality Audits - planned arrangements to determine the effectiveness of the Quality System,initiation of time-limited corrective actions for deficiencies found by Audit, and the confirmation oftheir timely closure.

Training - the procedure for identifying training needs and the provision of required training.

Care has to be taken in the selection of the appropriate part of BS5750 to avoid the system of controlbeing unnecessarily rigorous. For example, in a 'testing only' situation, the design requirements ofPart 1 would not be necessary. Each case should be considered on its own merits, but the followingguidelines are of value:

Part 1 applies to companies which design and manufacture a product or offer design services to theirCustomers;

Part 2 is applicable when a product is being made or a service provided to Customer instructions;

Part 3 is used when a service is provided to material or data supplied by the Customer.



3.2 Quality Assurance Procedures

These are second level documents which should be prepared by the Quality Assurance Manager andauthorised by the Managing Director or Technical Manager.

Quality Assurance Procedures deal with the overall requirements for compliance with the QualityManual and the Quality Policy Statement, and not with particular processes or operations. They doneed, however, to be reasonably detailed, as they instruct the reader how to conduct his project asregards systems, documentation and authorisation. Issue, updating and maintenance of theprocedures is the responsibility of the Quality Assurance Manager who should ensure that the correctissues of the documents are available at the required locations.

A summary follows of the main elements considered necessary in a testing environment combinationof some topics into a single Procedure can be done where reasonable and practical.

3.2.1 Customer Enquiries and Preparation of Proposals

A system needs to be set up which defines the control of an enquiry and preparation of a proposalor tender. This should include typically:

a) the decision as to who should prepare the proposal and what form it should take, ieformal, informal or, indeed, verbal with established Customers,

b) consideration of suitable sub-contractors,

c) definition of the Customer's requirements, the Company's requirements and any requirementsto cover quality, reliability and safety,

d) a statement of the Contract conditions and the policy concerning availability and access ofrecords to Customer,

e) a suitable and agreed security classification for the work,

f) an explanation of the process for preparing, authorising and issuing a proposal or tender,

a) the mechanism for dealing with variations or changing requirements.

3.2.2 Customers' Orders

This document defines the process whereby the Customer’s Order is processed, including:preparation of any internal documentation for control of the project, approval and acceptance ofContract conditions and acknowledgement of the Order.



It might be found useful at the initiation stage of a Project and for overall control of the project tocreate a document such as a Project or Contract Sheet. Such a document should contain the title,objectives and brief programme of the work; the name of the Customer and the technical contact; theCompany's Project or Working number; definitions of the type of contract; any security classificationand the Quality Assurance requirements. Provision can be made on the lower part of the sheet forindicating the Customer's Order number and the value of the order, and for signature by the personcontrolling the project and those authorising the content, conditions and spend. This documentshould be prepared before work is commenced and will serve to provide guidelines until thecompletion thereof.

3.2.3 Project Control

The purpose of this Procedure is to define the responsibilities of the person controlling the projectas regards Project Control, Interface Control, Quality Assurance and Product Safety.

The actions required of this person should be set out in detail as regards maintenance of projectdocumentation, the issuing of work instructions, the issuing of variation, hold and releaseinstructions, and communication with the Customer and the Quality Assurance Manager.

3.2.4 Control of Project Documentation

Ideally, a Project File or files should contain documents or copies of documents raised or receivedat all stages throughout the project, viz enquiry review, tender preparation, order review andacknowledgement, test specification/procedure preparation, test performance and reporting.

The Procedure should define that all documents and files should be clearly marked to ensure that theyare traceable to the project. Although it is sufficient for the project files to be marked with merelythe title and reference number, the contents where possible should have in addition a sequencenumber, date and name of the originator. The purpose of this control sheet is to say why thedocuments are being sent, give their issue status and to request an acknowledgement of receipt. Thisprocedure should also detail the control of test records - UV records, computer disks and tapes, andstate their storage conditions and retention period.

3.2.5 Purchasing

It is necessary to establish and document a format system for obtaining goods from a supplier. Thechain starts with the person requiring the quality-related goods, materials or services, who shoulddefine in writing on say a Purchasing Requisition, the following:-

- the proposed Supplier, bearing in mind their capability to meet Contract and QualityRequirements,



S a detailed description of what is being ordered,

S the agreed price and delivery,

S and any specific requirements such as source inspection or the need for provision of testcertificates.

This requisition should then be signed and processed through the Company's authorisation chain.This process having been completed, the Company's Purchasing Department are able to place aformal order on the Supplier.

3.2.6 Goods Receiving

A system has to be established and maintained whereby there is assurance that any incoming goodsor materials are not used or processed until they have been inspected or otherwise verified as'conforming to the specified requirements. It should normally be the responsibility of the GoodsReceiving Department to accept deliveries, carry out a visual inspection, advise the requester ofarrival and issue Goods Receipt Notes against the formal purchase order. Detailed examination orinspection should be made by the requester or someone technically competent, who should sign theGoods Receipt Note for receipt and inspection. The procedure for dealing with non-conforminggoods should be defined and this should be achieved by the Goods Receiving Department inconjunction with the requester and Quality Assurance Manager. Any comments on nonconformanceshould be entered on the Goods Receipt Note and on a copy of the formal order and where necessaryquarantine arranged by the Goods Receiving Department. Test objects, although not subject to aformal purchase order, should on arrival, be subject to a similar acceptance system. More detail onthe control of test objects is given in Section 5.

3.2.7 Goods Forwarding

A method needs to be devised and documented for Goods Forwarding using a system of AdviceNotes. The Goods Receiving Department normally takes care of the forwarding procedure, ensuringthat consignments are traceable, that they are despatched in the preferred manner, that the receipt ofgoods is acknowledged, and that copies of the Advice Note are issued as appropriate.

3.2.8 Test Procedures and Test Programmes

A test procedure should cover all main tests, subsidiary tests, function tests and inspectionprocedures required by the Customer’s Technical Specification or those agreed with the Customer.It may even embody Company Process Specifications or requirements.

A test programme is a more detailed document which gives itemised actions during the chronologicalevents. It can on occasion contain provision for signature by operator, Customer and Witness.



Both documents should be prepared taking regard to scope, form and content, be reviewed and besubject to the Company's approval system before issue. In many cases the approval system willextend through to Customer and possibly a witnessing authority. These type of documents need tobe uniquely identified and carry an issue status. After issue it becomes the responsibility of theperson controlling the work to ensure that the correct issue of the document is available at therequired locations that and all obsolete issues are removed.

3.2.9 Quality Plans

The main objective of a Quality Plan is to identify any special or unusual requirements and to set outchecks and milestones which will be needed to ensure acceptable quality in a contract. It can coverrequirements which are not encompassed by Quality Assurance Procedures and Work Proceduresand it must be provided if the Customer requires it. here need not be a mandatory form for theQuality Plan, it being sufficient that it sets out the requirements and necessary actions. A QualityPlan should be subject to a similar authorisation procedure as for Test Procedures, and the documentneeds to be uniquely identified and to have an issue status.

3.2.10 Test Non-Conformances

In some cases, conformance may not be a feature of the testing. If it is a feature, the followingguidelines apply:-

The person controlling the project is responsible for the documentation, control and resolution oftesting non-conformances and deviations from test specification requirements.

Testing non-conformances occur when the equipment or material under test fails to fulfil the contentof the test specification, and these must be recorded, reported to the Customer and the witnessauthority, and a resolution obtained in writing.

For deviations from test specifications, the controller of the project should negotiate the deviationwith the Customer, reach agreement and arrange to have the necessary documents approved, updatedin status and issued.

3.2.11 Drawings

A method should be established for preparing, approving, issuing, revising and storing engineeringdrawings. A drawing will be prepared by the draughtsman according to the Company style orCustomer requirements, be reviewed, approved and then issued. A clear, understandable and areasonably simple sequential numbering system should be devised and a suitable storage system fororiginals organised that enables easy retrieval of the required drawing. When a drawing is revised,the issue status should be updated and copies of pertinent issues made available at the requiredlocations, and obsolete drawings promptly removed.



3.2.12 Security of Data

All documents relating to a project, viz the contents of the Project File, should be securely stored bythe person controlling the project. Access to computers holding software programs should beprotected by the use of passwords to restrict access to authorised users only. The policy regardingthe access of documents and their retention period should be as defined at the contracting stage.

3.2.13 Control of Test Facilities

Definition is required as to the security system within the Company and how it affects the testfacilities. Test facilities should be controlled and used according to the appropriate instructions orWork Procedures, and only authorised and suitably trained persons allowed to carry out the specifictasks, such as experimentation, operation of equipment and in-house calibration. Good housekeepingshould be encouraged throughout the test area, which should be conducive to effective working.

3.2.14 Training

A training structure for the Company's employees must be documented. This should include recordsfor each individual, of professional qualifications, formal training and work experience. Inductiontraining should be provided and recorded and ongoing training needs, including those in matters ofquality, identified and actioned. No trainees should be allowed to accept responsibility for specifictasks until they have received suitable training.

3.2.15 Software

Procedures need to be set up which control the software content of projects. These should define andaddress:-

a) responsibilities and interface control,

b) requirement specifications and the planning of software projects,

c) coding of software and coding walkthroughs,

d) software reviews, appraisals, and the testing of software,

e) corrective actions,

f) configuration management,

g) the registration of software which includes defining the responsibilities of a librarian.



There are other subjects on which procedures are required, including the control of test objects;calibration and control of instrumentation; maintenance of test equipment and test reporting,which are addressed separately later in the chapter.

3.3 Work Procedures

These are third tier documents which would be prepared by the person controlling the project orby a person with suitable expertise, and authorised by the Quality Assurance Manager. Updatingof Work Procedures would usually be by initiation from the originator and issue by the QualityAssurance Manager. Work Procedures deal in detail with operation of specific equipment whichmay in some cases include or reference the manufacturer's instructions, and the instructions forconducting specific tasks and calibrations.



4. AUDITS

Quality Audits fall into two categories, external and internal. External audits are those conductedat the Company's premises by a Customer or external body to ensure compliance with a particularStandard. Internal audits are conducted by the Company's own Quality Department and are primarilyused to verify that the Quality System has been implemented and maintained. They are also used toevaluate the efficiency and effectiveness of procedures and to use the information obtained insubsequent system reviews and audits. BS7229: Pt. 1: 1991 (ISO 10011-1) provides guidelines forestablishing, planning, carrying out, and documenting audits of Quality Systems.

This section deals only with internal audits and sets out suggested guidelines.

a) Frequency - this would be determined by the Quality Assurance Manager or the QualityDepartment according to their assessment of previous audits, non-conformance reports andCustomer's requirements. A programme should be prepared which ensures that all activitiesare audited periodically and that areas where there are any suspected weaknesses receive moreattention.

b) Preparation - before an audit there would be discussion between the Quality Department and theperson in charge of the department to be audited to establish, a date for the audit, the functionsand activities to be audited, and a nominee to assist the auditors. The Quality Department willprepare audit questionnaires to ensure that Management objectives, assignments, methods andcontrols are effective; that deficiencies and irregularities are revealed, potential danger spotsuncovered, and that corrective action procedures are effective.

c) Conduct of Audit - typically an audit team would consist of the Quality Assurance Managerand/or a representative from the Quality Department and from the department to be audited,the person in charge and/or the nominee. The audit team must proceed in accordance with thequestionnaires prepared earlier, and in the event of a non-conformance coming to light, theauditors issue a Corrective Action Notice and have the authority to stop further work untilcorrective action has been taken.

d) Audit Review and Report - at the conclusion of the audit, the auditors must report theirfindings to the person in charge of the department which has been audited. The QualityDepartment issue a report which summarises the findings and details Corrective ActionNotices which have been issued against non-conformances. A copy of this report should besent to senior Management.



e) Corrective Action Notices - when a Corrective Action Notice has been served, the recipientmust investigate the problem and take appropriate action within the agreed timescale specifiedon the document. When the appropriate action has been taken, the Notice is completed andreturned to the Quality Department, who after they are satisfied that the action has had thedesired result, arrange for it to be signed off.



5. CONTROL OF TEST OBJECTS

"Test Objects" covers all equipment, materials and substances supplied for process or test. It isessential that test objects are inspected upon receipt, identified, controlled during the processing ortest programme, and inspected after test, prior to despatch.

As regards inspection, the handling, inspection and segregation of test objects is the responsibilityof the person controlling the project. Inspection must be carried out to ensure that the test objectsare in conformance with Customer's specification and not damaged in any way. Any non-conformance noted at this stage should be recorded in the Project File and reported in writing to theCustomer.

Identification of test objects can be done by labelling, etching, painting, stamping, etc, but must bedone in such a way that it will not damage the test object, does not have to be removed or defacedduring the test programme, does not impede testing and does not alter the function of the object aftertest.

The test objects must remain identified and controlled during the test programme and any significantnotes on their ongoing condition recorded in the Project File. Final, or after test inspection is againthe responsibility of the person controlling the project, who should record any findings in the ProjectFile.

It can be helpful, for ease of retrieval of information, to include a separate summary page in theProject File for each test object. This sheet can include the unique identification of the testobject; receipt details such as the Advice Note number, the date of arrival and the signature of thepersons accepting receipt and carrying out inspection; notes on the on-receipt inspection; brieftesting history; notes on post-test inspection; and despatch details.



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6. CALIBRATION AND CONTROL OF INSTRUMENTATION

BS 5781: Part 1: 1979 specifies requirements for selecting, using, calibrating, controlling andmaintaining measurement standards and measuring equipment. The main elements to beconsidered when setting up such a system are outlined below:

a) Basic requirements - it is necessary that an instrument or instrument system has anaccuracy which is suitable for the task it is to perform, that the level of accuracy can bedemonstrated or sensibly inferred, and that where calibration is involved, it is traceable toNational or other acceptable Standards.

b) Categories - for convenience, instruments can be divided into the following categories--those that require regular calibration; those which need to be calibrated not regularly, but asrequired; robust items which perform satisfactorily provided they are intact and visuallyundamaged; stored instruments not readily available for use; and instruments which areused for indication only.

c) Identification - instruments which require regular calibration must carry a uniqueidentification and a label giving the calibration status. Those which are to be calibratedbefore use must carry unique identification and bear the date when the last calibration wascarried out. Stored instruments, not readily available for use should be marked that theyare not to be used for accurate measurements, and instruments used for indication onlyshould carry a label to that effect.

d) Recall Procedure - all instruments which need to be calibrated should be identified to theQuality Department by their owner. The information supplied should include thedescription of the instrument the maker, the type, its unique identification (which can bethe Manufacturer's serial number), the calibration category, the date the next calibration isdue, and the recall period. From this information, the Quality Department will compile arecall system. At periods of say one month, the Quality Department will consult the recallsystem and issue a recall notice to the owners of any instruments that are ready forcalibration. The department which owns the instruments must arrange for calibrationbefore the deadline and, after this has been completed, sign the recall notice accordinglyand return it to the Quality Department who will update their recall system. If theinstrument cannot be calibrated before the deadline, this must be reported to the QualityDepartment who will issue notification to all concerned that the instrument is out ofcalibration. Any instrument whose calibration is invalid for any reason must be withdrawnfrom use until the problem has been corrected. However, in certain circumstances, such aswhen the instrument is employed on a long term test which cannot be interrupted,provision should be made for extension of the calibration deadline, as long as the evidenceof previous calibration indicates that this is a reasonable action.



e) Calibrations - calibrations must be capable of being shown to be traceable to international,national or other acceptable Standards.

The frequency of calibration, having once been established, may be shortened if the resultsof preceding calibrations indicate that it is necessary to ensure the continued accuracy, orlengthened if they indicate that it will not affect confidence in the accuracy of theequipment.

In smaller organisations, calibrations are usually sub-contracted to an instrumentmanufacturer or Calibration Service test house. It is necessary to ensure that the sub-contractor is competent and that instruments returned from calibration carry a calibrationstatus label supported by a valid calibration certificate.

In larger organisations, in-house calibration is often employed. If this is done, the workshould be carried out to an approved Work Procedure and again the instrument labelledwith the calibration status supported by a valid calibration certificate.

f) Labelling and Sealing - labels giving the calibration status of an instrument should indicateby whom the calibration was performed, the date it was carried out and the date the nextcalibration is due. Access to adjusting devices on instruments which are set duringcalibration must be sealed or safeguarded against interference. Seals should be designed sothat tampering destroys them.



7. MAINTENANCE OF TEST EQUIPMENT

All equipment used in testing needs to be regularly maintained and should be easily identifiable bya Company reference number or the Manufacturer's serial number. Instrumentation has beendiscussed in the previous section, and we are now considering test rig components and generalhardware.

All test equipment should be included in an inventory which gives the identifying number of thecomponent, sub-assembly or equipment; a brief description; the Manufacturer; a maintenanceinterval and a maintenance category. This inventory or accompanying log sheets should be used torecord the inspections, any comments and corrective actions.

Categories can be established to suit the type of equipment involved and the following is a suggestionwhich may be useful:

i) Generally maintenance free unless mechanical damage has occurred, eg pipework, couplings,electrical wiring and connectors. For this category a visual inspection will suffice, payingattention to mechanical wear and leakage.

ii) Fasteners, bolted joints and fixing mechanisms where loss of tightness could cause problems.For this category a check on tightness should, be accompanied by a visual inspection, payingparticular attention to any mechanical damage or displacement from the normal workingposition.

iii) Hand operated ball valves and gate valves, etc where sticking or leakage through infrequentoperation could cause problems. Such equipment should be subject to a visual inspection toexamine for mechanical damage, leaks or signs of seizure, and hand operation through onecomplete cycle.

iv) Hydraulic accumulators, relief valves, etc which may need resetting to specified workingconditions. Visual inspection should be accompanied by operations necessary to establish thereset.

v) Pumps, motors, oil filters, etc which require specialist servicing as well as periodic visualinspection. Such equipment should be maintained in accordance with the Manufacturer'sservicing and maintenance instructions. If sufficient detail to enable in-house servicing is notincluded in the Manufacturer's handbook, the equipment should be despatched to a recognisedservicing agency to be repaired or serviced as required.

vi) The Company's general plant and site equipment such as cranes, lifting tackle and pressurevessels should be subject to periodic inspection by the Company's insurers.



For all the suggested categories above it is necessary to conform with Statutory Health and SafetyRegulations and any other legal requirements, where applicable. For certain items there is legislationrelevant to maintenance and operation, eg hydraulic accumulators.



8. REPRODUCIBILITY OF TEST PARAMETERS

Experimental work must lead, as far as is possible, to results which satisfy the Customer's needs andmeet the input requirements as specified by the Test Procedure. To achieve reproducibility ofparameters it is essential that the same work instructions, procedures or specifications are used duringtesting of say a batch of components. Failure to do this will lead to test results which perhapsunknowingly give little confidence. It is desirable that, prior to a series of tests, parameters are setand then maintained throughout the test series - which indeed may occupy some considerable timeand may not even be continuous. During testing, experimental arrangements and any enforcedchanges should be recorded in detail. Parameters which are necessary for the definition ofexperimental arrangements and those which are necessary for the production of experimental results,should be identified, measured and recorded. Conclusions drawn from experimental results musttake full account of statistical variations in the measurements.

During testing, measurements must be made with instruments or systems of known accuracy.Instrumentation, and the calibration thereof, has previously been discussed, but this is a convenientpoint for a reminder that when calibrating or using a measuring system, the cumulative effect oferrors from each link of the chain must be taken into account.

Qualitatively, reproducibility of results can be viewed as the closeness of agreement obtained withthe same method of test on identical materials, but under different conditions, ie operators, apparatusand Company. Quantitatively, reproducibility of results can be viewed as the closeness of agreementobtained using standardised test methods on identical materials.



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9. TEST REPORTING

Reporting of test results can take many forms verbal, memorandum, letter, test certificates, interimwritten results statements without comment or conclusion (records of test), interim semiformalprogress reports or working papers, and formal reports. In this section we shall deal with the lattertwo types.

The working paper or interim semi-formal progress report is a means of recording and reportinginformation on non-standard processes, operations and tests. Such a document may not be subjectedto the scrutiny given to a formal report and it is a device to make the results speedily available. Itis however, a document for transmission to the Customer and a report-writing style should beencouraged where applicable. The document, when issued, should bear a unique identification,security classification and shall have passed through the Company's review and authorisationprocedures.

Formal reports are usually issued at the end of a test series or project. The report should clearly,accurately, unambiguously and objectively present the results and all relevant information. It shouldcontain a reason for the project, description of the objects or material tested, a method of test oranalysis, results or data, conclusions, recommendations and as many illustrations or enclosures asare considered necessary to the clear interpretation of the report. In some instances, the contents ofa report will be controlled by Customer’s requirements or by a Specification or Standard. In a littlemore detail, there follows a suggested minimum content for a formal test report but in some casesit may be necessary to make additions due to imposed conditions.

a) Name and address of the test house;

b) Unique identification of the report;

c) Name and address of the Customer and any relevant order details and references;

d) Description and identification of the test objects and a statement to the effect that the testreport relates only to the objects tested;

e) Date of receipt of test objects, dates of performance of tests and date of issue of report;

f) Identification of the test specification, method and procedure, a description of samplingprocedures where necessary, and disclosure of any non-standard test method or procedureused;

g) Any deviations from or exceptions to the test specification and any other informationrelevant to a specific test;



h) Measurements, examinations and derived results, supported by tables, sketches, graphs andphotographs as appropriate, and the identification of any failures.

i) Statement of any measurement uncertainty - possibly by inclusion of a copy of the relevanttest certificates.

j) Signature of an authorised member of the test house accepting responsibility for the reporton the Company's behalf

Before issue, the formal report should have passed through the Company's approval system andshould contain a security classification and a distribution list in line with the Customer's andCompany's requirements.

Reports transmitted without full authorisation should be marked as preliminary and in the eventof re-issue being necessary, the document should be updated in status and re-authorised.



10. ACCREDITATION

Once a Quality System has been established and is in operation, approval to specific standards (vizBS 6460, BS 5750, EN29000, EN45001, ISO Guide 25) can be sought from NAMAS, BritishStandards, CAA and Lloyds' Register, etc. Of particular interest to Testing Laboratories is NAMASAccreditation. NAMAS is the National Measurement Accreditation Service, a service of theNational Physical Laboratory.

NAMAS was formed in 1985 by the amalgamation of the activities of the British Calibration Service(BCS) and the National Testing Laboratory Accreditation Scheme (NATLAS). NAMAS assesses,accredits and monitors calibration and testing laboratories. Application for NAMAS accreditationis open to any UK laboratory performing objective calibrations or tests. To meet NAMASrequirements, the organisation applying for accreditation needs to satisfy the requirements of theNAMAS Accreditation Standard (M10) and NAMAS Regulations (Ml l) which incorporate therequirements of EN45001 and ISO Guide 25.

The aims of NAMAS are to:-

- provide a national unified laboratory accreditation service which establishes widespreadrecognition of the competence of accredited calibration and testing laboratories;

- improve the authority and standard of calibration and testing within the UK and therebyenhance the quality and reputation of British goods in markets at home and overseas;

- eliminate multiple assessment of calibration and testing laboratories;

- negotiate agreements on mutual recognition with other national schemes and thereby obtaininternational acceptance of the competence of accredited laboratories;

- provide publicity for accredited laboratories and a service to their users through the publicationof a NAMAS Directory of Accredited Laboratories.



BIBLIOGRAPHY

1. BS 5750: Part 1: 1987 (IS09001, EN29001) "Specification for design/development production,installation and servicing".

2. BS 5750: Part 2: 1987 (IS09002, EN29002) "Specification for Production and Installation".

3. BS 5750: Part 3: 1987 (IS09003, EN29003) "Specification for final inspection and test".

4. BS 5781: Part 1: 1979 "Specification for system requirements"

5. BS 6460: Part 1: 1983 "Specification of the general requirements for the technical competenceof testing laboratories".

6. BS 5882: 1990 "Specification for a total quality assurance programme for nuclearinstallations".

7. AQAP 1 (1986) "NATO requirements for an industrial quality control system".

8. EN 45000 Series:

EN 45001 (BS 7501: 1989) "General Criteria for the Operation of Testing Laboratories". EN45002 (BS 7502: 1989) "General Criteria for the Assessment of Testing Laboratories".EN 45003 (BS 7503: 1989) "General Criteria for Laboratory Accreditation Bodies".EN 45011 (13S 7511: 1989) "General Criteria for Certification Bodies Operating ProductCertification".EN 45012 (BS 7512: 1989) "General Criteria for Certification Bodies Operating QualitySystem Certification".EN 45013 (BS 7513: 1989) "General Criteria for Certification Bodies Operating Certificationof Personnel".EN 45014 (BS 7514: 1989) "General Criteria for Suppliers' Declaration of Conformity".

9. EN 29000 series - These European Standards were accepted by Comit6 European deNormalisation (CEN) in 1987. CEN members are the national standards organizations ofAustria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Netherlands,Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.

10. ISO Guide 25: 1990 - General requirements for the competence of calibration and testinglaboratories.

11. BS7229: Part 1: 1991 (IS010011-1) "Auditing".

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