CONSCERT publications :
.................................................
CCG 115/rev. 2 - Guidelines for use of EN ISO 9002
Quality systems in the industry for production of prestressing steel
ISO 9002 guidelines for use in the steel manufacturing industry
Traceability (EN ISO 9002)

Quality systems – Model for quality assurance in production, installation and servicing (ISO 9002: July 1994)

Contents  
0 Introduction 4.9 Process control
1 Scope 4.10 Inspection and testing
2 Normative reference 4.11 Control of inspection, measuring and test equipment
3 Definitions 4.12 Inspection and test status
4 Quality system requirements 4.13 Control of nonconforming product
4.1 Management responsibility 4.14 Corrective and preventive action
4.2 Quality system 4.15 Handling, storage, packaging, preservation and delivery
4.3 Contract review 4.16 Control of quality records
4.4 Design control 4.17 Internal quality audits
4.5 Document and data control 4.18 Training
4.6 Purchasing 4.19 Servicing
4.7 Control of customer-supplied product 4.20 Statistical techniques
4.8 Product identification and traceability Bibliography

Quality systems Model for quality assurance in production, installation and servicing

0 Introduction

This International Standard is one of three International Standards dealing with quality system requirements that can be used for external quality assurance purposes. The quality assurance models, set out in the three International Standards listed below, represent three distinct forms of quality system requirements suitable for the purpose of a supplier demonstrating its capability, and for the assessment of the capability of a supplier by external parties.

a) ISO 9001, Quality systems – Model for quality assurance in design, development, production, installation and servicing

– for use when conformance to specified requirements is to be assured by the supplier during design, development, production, installation and servicing.

b) ISO 9002, Quality systems – Model for quality assurance in production, installation and servicing

– for use when conformance to specified requirements is to be assured by the supplier during production, installation and servicing.

c) ISO 9003, Quality systems – Model for quality assurance in final inspection and test
– for use when conformance to specified requirements is to be assured by the supplier solely at final inspection and test.


It is emphasized that the quality system requirements specified in this International Standard, ISO 9001 and ISO 9003 are complementary (not alternative) to the technical (product) specified requirements. They specify requirements which determine what elements quality systems have to encompass, but it is not the purpose of these International Standards to enforce uniformity of quality systems. They are generic and independent of any specific industry or economic sector. The design and implementation of a quality system will be influenced by the varying needs of an organization, its particular objectives, the products and services supplied, and the processes and specific practices employed.

It is intended that these International Standards will be adopted in their present form, but on occasions they may need to be tailored by adding or deleting certain quality system requirements for specific contractual situations. ISO 9000-1 provides guidance on such tailoring as well as on selection of the appropriate quality assurance model, viz. ISO 9001, ISO 9002 or ISO 9003.

Introduction to the guidelines:

These guidelines represent the application of EN ISO 9002 in the manufacture of prestressing steel. They have been produced by CONSCERT WG 8 "QA for prestressing steels". The text of the standard is printed in bold.

1 Scope

This International Standard specifies quality system requirements for use where a supplier's capability to supply conforming product to an established design needs to be demonstrated.

The requirements specified are aimed primarily at achieving customer satisfaction by preventing nonconformity at all stages from production through to servicing.

This International Standard is applicable in situations when

a) the specified requirements for product are stated in terms of an established design or specification, and

b) confidence in product conformance can be attained by adequate demonstration of a supplier's capabilities in production, installation and servicing.

NOTE 1: For informative references, see annex A.

Guidelines:

The main objective of these quidelines is to help provide a common interpretation of EN ISO 9002 by the auditors of certification bodies. As outlined in the clauses of EN 45011 which relate to certification personnel the auditors selected by the certification body should be competent for their functions and in the areas they are assigned to audit. Qualifications, training and experience shall be verified and the respective records should be kept up to date.These guidelines have been drawn up on the basis of EN ISO 9002 (1994) and actual practice and experience of a group of auditors, of members of certification bodies and manufacturers representatives.

These guidelines shall serve as the basis of individual checklists for each competent certification or inspection body. When part of this work is subcontracted, the bodies involved with the work must meet the applicable requirements.

This guideline is related specifically to prestressing steels and covers the scope of prEN 10138 (prEN-status at time) and is in accordance with prEN 10138-5 (1994) "Attestation of conformity by certification." The above standard is in accordance with the European Council Directive of 21.Dec. 1988 on the approximation of laws, regulations and administrative provisions of the Member States relating to Construction products (doc. 89/106/EC, called Construction Product Directive (abbrev. CPD).

The specific scope of the present document is the compliance of steel products with prEN 10138 by certification.

2 Normative reference

The following standard contains provisions which, through reference in this text, constitute provisions of this International Standard. At the time of publication, the edition indicated was valid. All standards are subject to revision, and parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent edition of the standard indicated below. Members of IEC and ISO maintain registers of currently valid International Standards.

ISO 8402 :1994

Quality management and quality assurance – Vocabulary

prEN 10138-1 Prestressing steels - General requirements

prEN 10138-2 Prestressing steels - Wire

prEN 10138-3 Prestressing steels - Strand

prEN 10138-4 Prestressing steels - Hot rolled and processed bars

prEN 10138-5 Prestressing steels - Attestation of conformity by certification

EN 45011 General criteria for certification bodies operating product certification

3 Definitions

For the purposes of this International Standard, the definitions given in ISO 8402 and the following definitions apply.

Additional definitions for this guideline extract from prEN 10138-5:

Certification

Assessment and regular surveillance by a certification body of the quality system and compliance of the products with the European Standard using sampling and testing of the product supported by statistical analysis.

Certification body

Impartial body, governmental or non-governmental, possessing the necessary competence and authority to carry out conformity certification according to given rules of procedures and management.

Technical file

A document setting out manufacturing processes and methods in outline.

Product family

Group of related products as defined in prEN 10138-5, table 1.

Provisional certification

Certification for manufacture which is granted by the certification body for a product family and a limited period of time after the initial assessment.

Full certification

Certification for manufacture which is granted by certification body for a product familiy after the satisfactory completion of the provisional certification.

 

3.1 Product

Result of activities or processes.

NOTE 2: A product may include service, hardware, processed materials, software or a combination thereof.

NOTE 3: A product can be tangible (e.g. assemblies or processed materials) or intangible (e.g. knowledge or concepts), or a combination thereof.

NOTE 4: For the purposes of this International Standard, the term product applies to the intended "product" offering only and not to unintended "by-products" affecting the environment. This differs from the definition given in ISO 8402.

3.2 Tender

Offer made by a supplier in response to an invitation to satisfy a contract award to provide product.

3.3 Contract

Agreed requirements between a supplier and customer transmitted by any means.

4 Quality system requirements

4.1 Management responsibility

4.1.1 Quality policy

The supplier's management with executive responsibility shall define and document its policy for quality, including objectives for quality and its commitment to quality. The quality policy shall be relevant to the supplier's organizational goals and the expectations and needs of its customers. The supplier shall ensure that this policy is understood, implemented and maintained at all levels of the organization.

4.1.2 Organization

4.1.2.1 Responsibility and authority

The responsibility, authority and the interrelation of personnel who manage, perform and verify work affecting quality shall be defined and documented, particularly for personnel who need the organizational freedom and authority to:

a) initiate action to prevent the occurrence of any nonconformities relating to the product, process and quality system;

b) identify and record any problems relating to the product, process and quality system;

c) initiate, recommend or provide solutions through designated channels;

d) verify the implementation of solutions;

e) control further processing, delivery or installation of non-conforming product until the deficiency or unsatisfactory condition has been corrected.

4.1.2.2 Resources

The supplier shall identify resource requirements and provide adequate resources, including the assignment of trained personnel (see 4.18), for management, performance of work and verification activities including internal quality audits.

4.1.2.3 Management representative

The supplier's management with executive responsibility shall appoint a member of the supplier's own management who, irrespective of other responsibilities, shall have defined authority for

a) ensuring that a quality system is established, implemented and maintained in accordance with this International Standard, and

b) reporting on the performance of the quality system to the supplier's management for review and as a basis for improvement of the quality system.

NOTE 5: The responsibility of a management representative may also include liaison with external parties on matters relating to the supplier's quality system.

4.1.3 Management review

The supplier's management with executive responsibility shall review the quality system at defined intervals sufficient to ensure its continuing suitability and effectiveness in satisfying the requirements of this International Standard and the supplier's stated quality policy and objectives (see 4.1.1). Records of such reviews shall be maintained (see 4.16).

4.2 Quality system

4.2.1 General

The supplier shall establish, document and maintain a quality system as a means of ensuring that product conforms to specified requirements. The supplier shall prepare a quality manual covering the requirements of this International Standard. The quality manual shall include or make reference to the quality system procedures and outline the structure of the documentation used in the quality system.

NOTE 6 Guidance on quality manuals is given in ISO 10013.

Guidelines:

The organizational structure of the suppliers management need only be as comprehensive as necessary to meet the quality objectives for the production of prestressing steel.

For contractual, mandatory and assessment purposes, demonstration of the implementation of identified elements in the system includes factory production control, for ref. see prEN 10138-5.

The extent of the details in the manual will depend on the content of the associated working documents such as standing instructions, operating procedures and description of methods and responsibilities.

4.2.2 Quality System procedures

The supplier shall

a) prepare documented procedures consistent with the requirements of this International Standard and the supplier's stated quality policy, and

b) effectively implement the quality system and its documented procedures.

For the purposes of this International Standard, the range and detail of the procedures that form part of the quality system shall be dependent upon the complexity of the work, the methods used, and the skills and training needed by personnel involved in carrying out the activity.

NOTE 7: Documented procedures may make reference to work instructions that define how an activity is performed.

4.2.3 Ouality planning

The supplier shall define and document how the requirements for quality will be met. Quality planning shall be consistent with all other requirements of a supplier's quality system and shall be documented in a format to suit the supplier's method of operation. The supplier shall give consideration to the following activities, as appropriate, in meeting the specified requirements for products, projects or contracts:

a) the preparation of quality plans;

b) the identification and acquisition of any controls, processes, equipment (including inspection and test equipment), fixtures, resources and skills that may be needed to achieve the required quality;

c) ensuring the compatibility of the production process, installation, servicing, inspection and test procedures and the applicable documentation;

d) the updating, as necessary, of quality control, inspection and testing techniques, including the development of new instrumentation;

e) the identification of any measurement requirement involving capability that exceeds the known state of the art, in sufficient time for the needed capability to be developed;

f) the identification of suitable verification at appropriate stages in the realization of product;

g) the clarification of standards of acceptability for all features and requirements, including those which contain a subjective element;

h) the identification and preparation of quality records (see 4.16).

NOTE 8: The quality plans referred to [see 4.2.3 a)] may be in the form of a reference to the appropriate documented procedures that form an integral part of the supplier's quality system.

4.3 Contract review

4.3.1 General

The supplier shall establish and maintain documented procedures for contract review and for the coordination of these activities.

Guidelines:

Contracts shall be filed by product family as described in prEN 10138 and /or other standards or separate agreements. Contracts under the prEN 10138 shall be reviewed according the respective product families.

The name of the person responsible for vetting the contract or customer's order shall be recorded.

Only written contracts shall be accepted.

4.3.2 Review

Before submission of a tender, or the acceptance of a contract or order (statement of requirement), the tender, contract or order shall be reviewed by the supplier to ensure that:

a) the requirements are adequately defined and documented; where no written statement of requirement is available for an order received by verbal means, the supplier shall ensure that the order requirements are agreed before their acceptance;

b) any differences between the contract or order requirements and those in the tender are resolved;

c) the supplier has the capability to meet the contract or order requirements.

4.3.3 Amendment to a contract

The supplier shall identify how an amendment to a contract is made and correctly transferred to the functions concerned within the supplier's organization.

4.3.4 Records

Records of contract reviews shall be maintained (see 4.16).

NOTE 9: Channels for communication and interfaces with the customers organization in these contract matters should be established.

Guideline:

Records should be accessible and retrievable.

4.4 Design control

The scope of this International Standard does not include quality-system requirements for design control. This subclause is included to align the clause numbering with ISO 9001.

4.5 Document and data control

4.5.1 General

The supplier shall establish and maintain documented procedures to control all documents and data that relate to the requirements of this International Standard including, to the extent applicable, documents of external origin such as standards and customer drawings.

NOTE 10: Documents and data can be in the form of any type of media, such as hard copy or electronic media.

4.5.2 Document and data approval and issue

The documents and data shall be reviewed and approved for adequacy by authorized personnel prior to issue. A master list or equivalent document control procedure identifying the current revision status of documents shall be established and be readily available to preclude the use of invalid and/or obsolete documents.

This control shall ensure that:

a) the pertinent issues of appropriate documents are available at all locations where operations essential to the effective functioning of the quality system are performed;

b) invalid and/or obsolete documents are promptly removed from all points of issue or use, or otherwise assured against unintended use;

c) any obsolete documents retained for legal and/or knowledgepreservation purposes are suitably identified.

4.5.3 Document and data changes

Changes to documents and data shall be reviewed and approved by the same functions/organizations that performed the original review and approval, unless specifically designated otherwise. The designated functions/organizations shall have access to pertinent background information upon which to base their review and approval.

Where practicable, the nature of the change shall be identified in the document or the appropriate attachments.

4.6 Purchasing

4.6.1 General

The supplier shall establish and maintain documented procedures to ensure that purchased product (see 3.1) conforms to specified requirements.

Guideline:

Requirement for steel see prEN 10138-1, par.4 and 6.1

 

4.6.2 Evaluation of subcontractors

The supplier shall:

a) evaluate and select subcontractors on the basis of their ability to meet subcontract requirements including the quality system and any specific quality assurance requirements;

b) define the type and extent of control exercised by the supplier over subcontractors. This shall be dependent upon the type of product, the impact of subcontracted product on the quality of final product and, where applicable, on the quality audit reports and/or quality records of the previously demonstrated capability and performance of subcontractors;

c) establish and maintain quality records of acceptable subcontractors (see 4.16).

4.6.3 Purchasing data

Purchasing documents shall contain data clearly describing the product ordered, including where applicable:

a) the type, class, grade or other precise identification;

b) the title or other positive identification, and applicable issues of specifications, drawings, process requirements, inspection instructions and other relevant technical data, including requirements for approval or qualification of product, procedures, process equipment and personnel;

c) the title, number and issue of the quality system standard to be applied

The supplier shall review and approve purchasing documents for adequacy of the specified requirements prior to release.

4.6.4 Verification of purchased product

4.6.4.1 Supplier verification at subcontractor's premises

Where the supplier proposes to verify purchased product at the subcontractor's premises, the supplier shall specify verification arrangements and the method of product release in the purchasing documents.

4.6.4.2 Customer verification of subcontracted product

Where specified in the contract, the supplier's customer or the customer's representative shall be afforded the right to verify at the subcontractor's premises and the supplier's premises that subcontracted product conforms to specified requirements. Such verification shall not be used by the supplier as evidence of effective control of quality by the subcontractor.

Verification by the customer shall not absolve the supplier of the responsibility to provide acceptable product, nor shall it preclude subsequent rejection by the customer.

4.7 Control of Customer -supplied product

The supplier shall establish and maintain documented procedures for the control of verification, storage and maintenance of customer-supplied product provided for incorporation into the supplies or for related activities. Any such product that is lost, damaged or is otherwise unsuitable for use shall be recorded and reported to the customer (see 4.16).

Verification by the supplier does not absolve the customer of the responsibility to provide acceptable product.

4.8 Product identification and traceability

Where appropriate, the supplier shall establish and maintain documented procedures for identifying the product by suitable means from receipt and during all stages of production, delivery and installation.

Where and to the extent that traceability is a specified requirement, the supplier shall establish and maintain documented procedures for unique identification of individual product or batches. This identification shall be recorded (see 4.16).

Guidelines:

Every unit of production according to prEN 10 138 shall retain a means of identification to ensure traceability back to individual heats of wire rod.

Means of identification may be for example:

- a label with the necessary reference numbers e.g. works order number, coil number, data, client,

or other information which enables identification of the product

- printing directly on the product

Prestressing wire in coils is produced from wire rod separated according to different heats.

Wires cut to length and presented in bundles should ideally be from the same heat. If, however, two heats are present within the same bundle then there should be separation such that heat traceability is possible.

Three-wire and seven-wire strands can be made of wires from different heats. For purposes of attestation and traceability, then the heat which comprises the largest number of wires in the strand shall be identified.

This identification should enable traceability of other wires present within the strands from other heats. Bundles of bars should consist of only one heat.

Full identification is needed from the wire rod throughout all steps of production until the delivery of the prestressing steel. The user has to bear in mind, that traceability is interrupted, when the production unit loses its means of identification.

Traceability back to the different stages of production enables traceability to documented test results which in turn ensures the deduction and, where appropriate, application of effective corrective actions in cases of non-conformance.

4.9 Process control

The supplier shall identify and plan the production, installation and servicing processes which directly affect quality and shall ensure that these processes are carried out under controlled conditions. Controlled conditions shall include the following:

a) documented procedures defining the manner of production, installation and servicing, where the absence of such procedures could adversely affect quality;

b) use of suitable production, installation and servicing equipment, and a suitable working environment;

c) compliance with reference standards/codes, quality plans and/or documented procedures;

d) monitoring and control of suitable process parameters and product characteristics;

e) the approval of processes and equipment, as appropriate;

f) criteria for workmanship, which shall be stipulated in the clearest practical manner (e.g. written standards, representative samples or illustrations);

g) suitable maintenance of equipment to ensure continuing process capability.

Where the results of processes cannot be fully verified by subsequent inspection and testing of the product and where, for example, processing deficiencies may become apparent only after the product is in use, the processes shall be carried out by qualified operators and/or shall require continuous monitoring and control of process parameters to ensure that the specified requirements are met.

The requirements for any qualification of process operations, including associated equipment and personnel (see 4 .18), shall be specified.

NOTE 11: Such processes requiring pre-qualification of their process capability are frequently referred to as special processes.

Records shall be maintained for qualified processes, equipment and personnel, as appropriate (see 4.16).

Guidelines:

According to the philosophy of quality assurance, process control is of predominant importance and as such should be well planned and documented.

Procedures and instructions for process control should be sufficiently detailed to enable the product requirements to be consistently achieved.

prEN 10138-5 gives further information about process control.

In addition to procedures and instructions for process control general information should be used as for instance:

- literature

- training of the personnel

- statistical records of process parameters and test results, e.g.

Process control for pre-stressing steels may include the following stages in production:

Reheating and hot rolling where applicable,

pickling and surface treatment,

cold reduction by drawing or rolling,

stranding, stabilizing, storage, packaging and transport.

Main process parameters to be covered by procedures and instructions, depending on the type of product, are:

 

WIRE STRAND BAR

Steel brand x x x

Billet size x

Wire rod diameter x x

Steps of cold reduction x x

Geometry of the dies x x

Drawing speed x x

Pickling program x x

Rolling temperature x

Rolling speed x

Cooling system x x x

Surface treatment x x x

Stretching process x

Stabilizing control x x

Stranding speed x

Cutting out of welds x x

 

Process parameters covered by suppliers working under a quality system according EN/ISO 9002 must not be controlled by the steel producer.

Welds are not allowed in wires. Welds in wires for strands are allowed only when made in the wire rod before drawing. All welds made in later production steps of drawing have to be removed from the product.

 

For this special process procedures are needed for:

- making welds

- maintenance of the welding equipment

- training of welders and

- regular control of the weld

4.10 Inspection and testing

4.10.1 General

The supplier shall establish and maintain documented procedures for inspection and testing activities in order to verify that the specified requirements for the product are met. The required inspection and testing, and the records to be established, shall be detailed in the quality plan or documented procedures.

Guidelines:

prEN 10138-5 is valid. See also "Quality System" par. 3.4 as well as 4 concerning "Certification Procedure".

Testing of prestressing steel comprises normal testing and special testing. Special properties are tested periodically according to prEN 10138-5. Therefore clause 4.10 refers mainly to testing of standard properties as described in prEN 10138-1, Annex A.

4.10.2 Receiving inspection and testing

4.10.2.1 The supplier shall ensure that incoming product is not used or processed (except in the circumstances described in 4.10.2.3) until it has been inspected or otherwise verified as conforming to specified requirements. Verification of conformance to the specified requirements shall be in accordance with the quality plan and/or documented procedures.

Guideline:

See prEN 10138-1, par. 6.1

The incoming product is mainly wire rod. In case of wire rod supplied by a certified (accord. EN ISO 9002) producer, the check of data delivered from the rod mill is sufficient.

In the case of a non certified but accepted producer of wire rod, the following inspections (see table below) are carried out on the incoming product:

  Prestressing steel production Bar production
Steel brand    
Chemical analyses 1)    
Diameter and ovality    
Tensile strength    
Striction    
Billet size    
Structure    

1) Control of the data given on the certificate, otherwise by chemical analysis.

4.10.2.2 In determining the amount and nature of receiving inspection, consideration shall be given to the amount of control exercised at the subcontractor's premises and the recorded evidence of conformance provided.

4.10.2.3 Where incoming product is released for urgent production purposes prior to verification, it shall be positively identified and recorded (see 4.16) in order to permit immediate recall and replacement in the event of nonconformity to specified requirements.

4.10.3 In-process inspection and testing

The supplier shall:

a) inspect and test the product as required by the quality plan and/or documented procedures;

b) hold product until the required inspection and tests have been completed or necessary reports have been received and verified, except when product is released under positive-recall procedures (see 4.10.2.3). Release under positive-recall procedures shall not preclude the activities outlined in 4.10.3a).

4.10.4 Final inspection and testing

The supplier shall carry out all final inspection and testing in accordance with the quality plan and/or documented procedures to complete the evidence of conformance of the finished product to the specified requirements.

The quality plan and/or documented procedures for final inspection and testing shall 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 specified requirements.

No product shall be dispatched until all the activities specified in the quality plan and/or documented procedures have been satisfactorily completed and the associated data and documentation are available and authorized.

4.10.5 Inspection and test records

The supplier shall establish and maintain records which provide evidence that the product has been inspected and/or tested. These records shall show clearly whether the product has passed or failed the inspections and/or tests according to defined acceptance criteria. Where the product fails to pass any inspection and/or test, the procedures for control of nonconforming product shall apply (see 4.13).

Records shall identify the inspection authority responsible for the release of product (see 4.16).

4.11 Control of inspection, measuring and test equipment

4.11.1 General

The supplier shall establish and maintain documented procedures to control, calibrate and maintain inspection, measuring and test equipment (including test software) used by the supplier to demonstrate the conformance of product to the specified requirements. Inspection, measuring and test equipment shall be used in a manner which ensures that the measurement uncertainty is known and is consistent with the required measurement capability.

Where test software or comparative references such as test hardware are used as suitable forms of inspection, they shall be checked to prove that they are capable of verifying the acceptability of product, prior to release for use during production, installation or servicing, and shall be rechecked at prescribed intervals. The supplier shall establish the extent and frequency of such checks and shall maintain records as evidence of control (see 4.16).

Where the availability of technical data pertaining to the inspection, measuring and test equipment is a specified requirement, such data shall be made available, when required by the customer or customer's representative, for verification that the inspection, measuring and test equipment is functionally adequate.

NOTE 12: For the purposes of this International Standard, the term "measuring equipment" includes measurement devices.

Guidelines:

This requirement relates to all equipment which is mentioned in the quality system of prestressing steel to ensure conformity.

In practical terms the following items related to the type of product should be present:

- master list or lists of relevent equipment

- programme for calibration, validation or specific measuring and testing equipment and maintenance

- identification of equipment including records of initial testing, calibration status and maintenance

- calibration procedures for specific equipments used for all tests according to prEN 10138

- records and actions taken as a result of finding equipment out of calibration

However, consideration should be given to other types of instrumentation used for process and production control if they are important for the final product quality e.g.

- timing devices and pressure control devices

- flow regulation equipment and equipment for stabilization and controlled cooling.

- specific equipment of testing related to the type of product (e.g. deflected tensile test, corrosion test)

Comment:

Where temperature control is by infra-red camera and calibration of the camera utilises the "black box" principle, then the resulting calibration values may not be sufficiantly fined.

4.11.2 Control procedure

The supplier shall:

a) determine the measurements to be made and the accuracy required, and select the appropriate inspection, measuring and test equipment that is capable of the necessary accuracy and precision;

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 and test equipment (see 4.16);

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 calibrations, inspections, measurements and tests being carried out;

h) ensure that the handling, preservation and storage of inspection, measuring and test equipment is 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.

NOTE 13: The metrological confirmation system for measuring equipment given in ISO 10012 may be used for guidance.

Guidelines:

Paragraphs a) through i) are all applicable in a prestressing steel manufacturing situation. Attention should be given to par. a) through c) which are related to the product requirements in prEN 10138-2 to 4. Paragraph h) requires trained personnel to obtain the accuracy and fitness for use needed. Paragraph f), g) and i) are related to the problem of the accuracy of hardware and software for creating the required processing or testing conditions (which should not be taken for granted) and should be validated. One typical example is the software for process control within a mechanical test. In cases where accredited calibration services are not available, the use of internal calibration procedures incorporating traceable calibration standards are mandatory.

4.12 Inspection and test status

The inspection and test status of product shall be identified by suitable means, which indicate the conformance or nonconformance of product with regard to inspection and tests performed. The identification of inspection and test status shall be maintained, as defined in the quality plan and/or documented procedures, throughout production, installation and servicing of the product to ensure that only product that has passed the required inspections and tests [or released under an authorized concession (see 4.13.2)] is dispatched, used or installed.

Guideline:

The identification and testing of production units is covered in prEN 10138-5 (8.2 and 10).

4.13 Control of nonconforming product

4.13.1 General

The supplier shall establish and maintain documented procedures to ensure that product that does not conform to specified requirements is prevented from unintended use or installation. This control shall provide for identification, documentation, evaluation, segregation (when practical), disposition of nonconforming product, and for notification to the functions concerned.

4.13.2 Review and disposition of nonconforming product

The responsibility for review and authority for the disposition of nonconforming product shall be defined.

Nonconforming product shall be reviewed in accordance with documented procedures. It may be

a) reworked to meet the specified requirements,

b) accepted with or without repair by concession,

c) regraded for alternative applications, or

d) rejected or scrapped.

Where required by the contract, the proposed use or repair of product [see 4.13.2 b)] which does not conform to specified requirements shall be reported for concession to the customer or customer's representative. The description of the nonconformity that has been accepted, and of repairs, shall be recorded to denote the actual condition (see 4.16).

Repaired and/or reworked product shall be reinspected in accordance with the quality plan and/or documented procedures.

Guidelines:

Documented procedures should be produced and applied in practice such that inadvertant use of non-

conforming products is prevented. Identification of non-conforming products must be ensured by e.g. separate storage, marking or other acceptable means.

4.14 Corrective and preventive action

4.14.1 General

The supplier shall establish and maintain documented procedures for implementing corrective and preventive action.

Any corrective or 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 risks encountered.

The supplier shall implement and record any changes to the documented procedures resulting from corrective and preventive action.

4.14.2 Corrective action

The procedures for corrective action shall include:

a) the effective handling of customer complaints and reports of product nonconformities;

b) investigation of the cause of nonconformities relating to product, process and quality system, and recording the results of the investigation (see 4.16);

c) determination of the corrective action needed to eliminate the cause of nonconformities;

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

4.14.3 Preventive action

The procedures for preventive action shall include:

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, analyse and eliminate potential causes of nonconformities;

b) determination of the 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 (see 4.1.3).

4.15 Handling, storage, packaging, preservation and delivery

4.15.1 General

The supplier shall establish and maintain documented procedures for handling, storage, packaging, preservation and delivery of product.

Guidelines:

See the specific product standards

prEN 10138-2 par. 6

prEN 10138-3 par. 7

prEN 10138-4 par. 6 according to the type of steel

prEN 10138-1 par. 9.3

4.15.2 Handling

The supplier shall provide methods of handling product that prevent damage or deterioration.

4.15.3 Storage

The supplier shall use designated storage areas or stock rooms to prevent damage or deterioration of product, pending use or delivery. Appropriate methods for authorizing receipt to and dispatch from such areas shall be stipulated.

In order to detect deterioration, the condition of product in stock shall be assessed at appropriate intervals.

4.15.4 Packaging

The supplier shall control packing, packaging and marking processes (including materials used) to the extent necessary to ensure conformance to specified requirements.

Guidelines:

Packing, storage and delivery time shall be recorded, and verified after completion execution.

Precautions are required depending on the type of product and destination of delivery (e.g. transportation in marine environment).

4.15.5 Preservation

The supplier shall apply appropriate methods for preservation and segregation of product when the product is under the supplier's control.

4.15.6 Delivery

The supplier shall arrange for the protection of the quality of product after final inspection and test. Where contractually specified, this protection shall be extended to include delivery to destination.

Guidelines:

Packing, storage and delivery time shall be related, and verified after completion.

Precautions are required depending on the type of product and destination of delivery (e.g. transportation in marine environment).

4.16 Control of quality records

The supplier shall establish and maintain documented procedures for identification, collection, indexing, access, filing, storage, maintenance and disposition of quality records.

Quality records shall be maintained to demonstrate conformance to specified requirements and the effective operation of the quality system. Pertinent quality records from the subcontractor shall be an element of these data.

All quality records shall be legible and shall be stored and retained in such a way that they are readily retrievable in facilities that provide a suitable environment to prevent damage or deterioration and to prevent loss. Retention times of quality records shall be established and recorded. Where agreed contractually, quality records shall be made available for evaluation by the customer or the customer's representative for an agreed period.

NOTE 14: Records may be in the form of any type of media, such as hard copy or electronic media.

Guidelines:

Quality records should be readily available and enable separation into product families (see prEN 10138-5, par. 3.3, table 1, 4.4 through 4.6).

Initial assessments as well as provisional and full certification shall be documented (handling of documents and statistics): Documents of factory production control, results of testing and statistical notations shall be recorded at the location of testing as well as in the files of the product families.

Retention times for quality records may vary according to the element of the quality system that they represent. Procedures should ensure, however, that they are retained for at least as long as legislation requires or for an agreed period, whichever lasts longer. Retention times should account for product liability requirements.

4.17 Internal quality audits

The supplier shall establish and maintain documented procedures for planning and implementing internal quality audits to verify whether quality activities and related results comply with planned arrangements and to determine the effectiveness of the quality system.

Internal quality audits shall be scheduled on the basis of the status and importance of the activity to be audited and shall be carried out by personnel independent of those having direct responsibility for the activity being audited.

The results of the audits shall be recorded (see 4.16) and brought to the attention of the personnel having responsibility in the area audited. The management personnel responsible for the area shall take timely corrective action on deficiencies found during the audit.

Follow-up audit activities shall verify and record the implementation and effectiveness of the corrective action taken (see 4.16).

NOTE 15: The results of internal quality audits form an integral part of the input to management review activities (see 4.1.3).

NOTE 16: Guidance on quality system audits is given in ISO 10011.

4.18 Training

The supplier shall establish and maintain documented procedures for identifying training needs and provide for the training of all personnel performing activities affecting quality. Personnel performing specific assigned tasks shall be qualified on the basis of appropriate education, training and/or experience, as required. Appropriate records of training shall be maintained (see 4.16).

4.19 Servicing

Where servicing is a specified requirement, the supplier shall establish and maintain documented procedures for performing, verifying and reporting that the servicing meets the specified requirements.

4.20 Statistical techniques

4.20.1 Identification of need

The supplier shall identify the need for statistical techniques required for establishing, controlling and verifying process capability and product characteristics.

Guidelines:

Documents should be filed according to product families (see prEN 10138, par. 3.3, tab. 1).

In addition to the importance of recording data about the operation of the quality management system, attention is given here to the relevant paragraphs of the product standard prEN 10138 specifically prEN 10138-5/ par. 5.4 and 8.4. In these paragraphs "Evaluation of test results" and "Assessment of the characteristic values" of the strength of steels are specified.

4.20.2 Procedures

The supplier shall establish and maintain documented procedures to implement and control the application of the statistical techniques identified in 4.20.1.

Bibliography : List of related documents:

EN 45011 General Criteria for certification bodies operating product certification

ISO 9002 (1994) Quality Systems- Model for quality assurance in production, installation and servicing

pr EN 10138-1 (1994) Prestressing steels - Part 1: General requirements

pr EN 10138-5 (Jan.1994) Prestressing steels - Part 5: Attestation of conformity by certification

documents of CONSCERT and other organisations:

CCG 48 (WG 1/ doc. 1) EN 29002 Guidelines for use by the steel manufacturing industry (specific for reinforcing steel)

EAC Guidelines on the application of the EN45011 (Dec. 1994)

 

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