Certification Processes for NDT Operatives, Equipment & Facilities Used for Inspecting Rail Vehicles

Transcription

1 Page 1 of 37 Certification Processes for NDT Operatives, Equipment & Facilities Used for Inspecting Rail Vehicles Signatures removed from electronic version Submitted by... G A Clayton Nominated Responsible Manager Approved by... C P Boocock Chairman, Traction and Rolling Stock Subject Committee Authorised by... J R Mitchell Controller, Safety Standards, Railtrack PLC Synopsis This standard specifies the requirements for the Certification of Operatives and Facilities used to undertake non-destructive testing of safety critical components fitted to railway vehicles operating on Railtrack s controlled infrastructure. This document is the property of Railtrack PLC. It shall not be reproduced in whole or in part without the written permission of the Controller, Safety Standards. Published by Safety & Standards Directorate Railtrack PLC Floor 2, Fitzroy House 355 Euston Rd London NW1 3AG Copyright 1995 Railtrack PLC R A I L T R A C K 1

2 Page 2 of 37 Withdrawn Document This page is intentionally blank. 2 R A I L T R A C K

3 Page 3 of 37 Contents Section Description Page Part A Issue record 2 Responsibilities and distribution 2 Implementation 2 Health and safety responsibilities 2 Supply 2 Part B 1 Purpose 3 2 Scope 3 3 Definitions 3 4 Requirements 3 Appendices A Guidelines for the Preparation of NDT Procedures 9 B Guidelines for the Essential Elements of a Management System for Facilities Undertaking NDT Inspections 14 References 35 R A I L T R A C K 3

4 Page 4 of 37 Withdrawn Document Issue record Part A This standard will be updated when necessary by distribution of a complete replacement. Amended or additional parts of revised pages will be marked by a vertical black line in the adjacent margin. Issue Date Comments 1 May 94 Original document superseded MT/311 2 Dec. 95 Supersedes Issue 1 Now includes section covering approval of NDT Procedures. Responsibilities and distribution Train operators shall ensure that the provisions of this standard are communicated to all persons and organisations with responsibilities for NDT inspections of safety critical components of rail vehicles which operate on Railtrack controlled infrastructure. Implementation The requirements of this are mandatory and replace those of Issue 1 as from 6 April Existing NDT certificates shall continue to be recognised subject to the following conditions: BR Ultrasonic Axle testing Operator Certificates, subject to normal controls, shall remain valid until such time that EN 473 certification becomes available, thereafter operators shall be required to hold certificates that are fully compliant with this standard. BR Certificates of Approval NDT Facilities, subject to normal conditions, until expiry, thereafter approval of NDT facilities shall be fully compliant with this standard. Health and safety responsibilities Supply In authorising this Standard, Railtrack PLC makes no warranties, express or implied, that compliance with all or any s is sufficient on its own to ensure safe systems of work or operation. Each user is reminded of its own responsibilities to ensure health and safety at work and its individual duties under health and safety legislation. Controlled and uncontrolled copies of this standard must be obtained from The Catalogue Secretary, Safety & Standards Directorate, Railtrack PLC, Floor 2, Fitzroy House, 355 Euston Road, London, NW1 3AG. 4 R A I L T R A C K

5 Page 5 of 37 Part B 1 Purpose This standard specifies the requirements for the Certification of Operatives and Facilities used to undertake non-destructive testing of safety critical components on rail vehicles. Particular requirements for the non-destructive testing of axles are specified. 2 Scope This document applies to Certification Bodies and all organisations which undertake the non-destructive testing of safety critical components of rail vehicles operating on Railtrack controlled infrastructure. 3 Definitions Certification Body A qualified Body (see GM/RT2450) accredited by a nationally recognised Body with authority to issue Certificates. Non Destructive Testing Method of testing materials for fitness for purpose without causing them any damage. Facility (In this standard only) Any depot, workshop or mobile apparatus which undertakes nondestructive testing of axles fitted to railway vehicles. Safety Critical Component A component or vehicle part on which the safe operation of the vehicle depends. 4 Requirements 4.1 Certification Bodies Certificates shall only be issued by organisations accredited against the requirements of EN45013 or (as appropriate) by a nationally recognised body. Note: The nationally recognised body in the UK is the United Kingdom Accreditation Service (UKAS) Certification Bodies shall have accredited procedures to issue certificates in one or more of the following areas:- (a) Certificate of Competence - Operatives, in one or more of the following areas:- - Eddy current testing (ET) - Penetrant testing (PT) - Magnetic testing (MT) - Ultrasonic testing, general (UT) - Ultrasonic testing of railway axles (UAT) - Radiographic testing (RT) R A I L T R A C K 5

6 Page 6 of 37 Withdrawn Document (b) - Approval of facilities (see Section 3) used for non-destructive testing of railway axles. Note: The recognised Certification Body in the UK is PCN, a subsidiary of the British Institute of Non-Destructive Testing. PCN may be contacted at the following address: PCN, 1 Spencer Parade, Northampton, NN1 5AA Certificates of Competence - Operatives, shall only be issued to applicants who have met the qualification requirements of EN The Certification Body shall audit the training and examination programmes of all establishments who issue certificates on its behalf Certificates of Approval - NDT Facilities shall only be issued for facilities which meet the requirements of Section Certification of Operatives Operatives shall undergo a course of training covering the specific methods required and successfully pass an examination in accordance with EN473 at an Examination Centre approved by a Certification Body For training programmes covering non-destructive testing of railway axles the following minimum requirements shall be included:- Calibration procedures Axle familiarisation *Classical trajectories *Trace pattern prediction Axle scanning techniques The training programme covering both practical and theory for Level 1 applicants shall be a minimum of 80 hours. *Note: These elements are not required for personnel exclusively operating semi-automated procedures which do not require the Operative to interpret the results of the test. The training programme may be of reduced duration. The Certificate of Competence - Railway Axles issued to such personnel shall clearly indicate the limited scope Within 3 months of gaining a Certificate of Competence in railway axles new certificate holders shall be reassessed to ensure that they are correctly interpreting the techniques and documentation. Level 1 certificate holders shall be reassessed by personnel certificated to Level 2 or 3 and Level 2 certificate holders by personnel certificated to Level 3. 6 R A I L T R A C K

7 Page 7 of 37 Note: For the definition of the competence Levels 1, 2 or 3 please refer to EN To maintain the validity of the Certificate of Competence - Railway Axles the operative shall meet the following minimum work experience requirements:- a) Ultrasonic Testing of Wheelsets (40 hours minimum in each) - Operative reassessed every 2 years (4 week period* ) b) Ultrasonic Testing of Wheelsets (20 hours minimum in each) - Operative reassessed each year (4 week period* ) c) Ultrasonic Testing of Wheelsets (10 hours minimum in each) using semi-automated techniques (4 week period* ) where the operative is not required to interpret the results - Operative reassessed every 2 years. *Note: The 4 week period excludes periods of sickness, courses or legal holidays of less than 1 month The employer shall maintain auditable records to demonstrate that its operatives are maintaining their competence in accordance with these requirements Re-assessment, for the purpose of implementation of this standard, shall be a practical on site evaluation of an operators ability to carry out axle testing to the required standard. Level 1 certificate holders shall be reassessed by personnel certificated to Level 2 or 3. Level 2 certificate holders shall be reassessed by personnel certificated to Level Approval of NDT Procedures NDT procedures shall be obtained from suppliers qualified in accordance with GM/RT NDT procedures shall be prepared by personnel who are qualified to at least Level 2 as defined in EN NDT procedures shall be produced to meet the specification of the customer The customer shall define the components to be tested and any limitations on the methods to be adopted, the areas to be examined and the desired defect level which should be detected by the procedure. R A I L T R A C K 7

8 Page 8 of 37 Withdrawn Document NDT procedures shall include at least the following:- a) Scope; b) Definitions; c) References; d) Health and Safety; e) Personnel; f) Equipment; g) Equipment control calibration; h) Surface preparation; i) Method; j) Acceptance criteria; k) Reporting; l) Post test cleaning. Appendix A gives guidelines on the preferred format and content of NDT procedures Validation and Approval of NDT procedures shall be in accordance with auditable procedures. Note: It is recommended that the process used to validate and approve NDT procedures for safety critical components, follow the guidelines in ENIQ Report No.1, European Methodology for Qualification of Non-Destructive Tests Validation and approval of NDT procedures shall be performed by personnel qualified to Level 3 as defined in EN473. The person approving the procedure shall not be the author or producer of the procedure The validation process shall check that the defect sizes specified can be detected in the areas specified using the processes in the documented procedure. The validation assessment may be the sum of the two following processes:- a) Performance Demonstration or practical assessment conducted on representative test pieces; b) Technical justification which involves assembling all the evidence on the effectiveness of the test, including previous experience of its application, laboratory studies, mathematical modelling and physical reasoning. 8 R A I L T R A C K

9 Page 9 of 37 The appropriate mix of these sources of evidence must be judged for each particular test method. Where an NDT procedure uses an earlier procedure as its basis, the validation may be restricted to solely technical justification. The evidence used shall be formally documented and retained for future scrutiny. The Performance Demonstration shall be undertaken using the equipment, facilities and methods defined in the procedure. For new axle designs the validation shall be undertaken on a full size representative test piece. Where the axle is a new design with no previous established NDT procedures, the representative test piece used in the Performance Demonstration shall be a complete wheelset with all its components that may affect the ultrasonic trace patterns. 4.4 Approval of Facilities undertaking NDT Inspections of Railway Axles All locations and mobile NDT facilities that carry out testing of railway axles shall hold a current Certificate of Approval - NDT Facilities Facilities undertaking the non-destructive testing of axles shall only use Operatives certificated in accordance with this standard A Certificate of Approval - NDT Facilities shall only be granted after a satisfactory assessment by a Body accredited by a nationally recognised Body in accordance with the requirements of EN45012 or EN Where a depot or facility which undertake NDT examinations of railway axles is not qualified in accordance with GM/RT2450, then it shall be required to provide evidence of a satisfactory special audit of its NDT facilities by an accredited organisation. When a depot or facility which undertakes NDT examination of railway axles has its general management system assessed (as per the requirements of GM/RT2450) by an accredited organisation, the assessment shall specifically include a special process audit to cover the NDT facilities. Where a depot or facility that carries out NDT of railway axles have an existing quality management system approval awarded by an accredited organisation but the scope of the approval does not specifically cover NDT, they shall be required to provide evidence of an additional special process audit of these facilities by a qualified and accredited organisation. R A I L T R A C K 9

10 Page 10 of 37 Withdrawn Document To obtain a Certificate of Approval - NDT Facilities, the applicant organisation shall demonstrate its capability for testing railway axles. The management system facilities and equipment used shall be generally in accordance with the guidelines outlined in the informative Appendix B To maintain the Certificate of Approval - NDT Facilities, the facility shall demonstrate its on-going compliance by further assessment at periods not exceeding 2 years The performance characteristics of ultrasonic flaw detection equipment used by the facility shall be assessed in accordance with the general requirements of BS4331, Electrical Supply Industry Standard 98-9 (ESI 98-9) and the appropriate specification for the equipment where this exists The facility shall have a documented system for recording the qualification and certification of personnel authorised to undertake nondestructive testing of safety critical components of rail vehicles. The system should ensure the timely renewal of certificates of competence. 4.5 Validity of Certificates The validity of certificates shall generally be in accordance with EN473 except in the case of operatives testing railway axles. In this case the certificate holder shall be reassessed at the following minimum periods:- (a) (b) (c) Every 2 years for operatives undertaking a minimum of 40 hours axle testing in each 4 week period (see 4.2.4a). Yearly for operatives undertaking a minimum of 20 hours axle testing in each 4 week period (see 4 2.4b). Every 2 years for operatives undertaking a minimum of 10 hours axle testing using semi-automated techniques where the Operative is not required to interpret the results of the tests (see 4.2.4c). Level 1 operatives shall be reassessed by an operative certificated to Level 2 or 3 and Level 2 operatives by personnel certificated to Level Certificates shall be renewed every 5 years in accordance with EN R A I L T R A C K

11 Page 11 of 37 Appendix A (This Appendix is for information only) Guidelines for the Preparation of NDT Procedures The following example shows, in normal text, the preferred format and content of a general NDT procedure suitable for all methods. Additional information has been added, in italic script, to illustrate the use of this format for ultrasonic axle test procedures. The following abbreviations are used in the text:- BR British Railways HA High Angle CB Calibration Block IQI Image Quality Indicator ESI Electrical Supply Industry BS British Standard PCN Personnel Certification for Non-Destructive Testing 1 Scope A description of the test method and precise definition of the application. The following procedure shall be used for the manual ultrasonic inspection of Class 123 driving axles/wheelsets at initial assembly and main works overhaul. A separate procedure shall be used for in service inspection. 2 Definitions A list of definitions for terms, words and symbols that are used in the procedure and not defined in sources listed under references. Far end scan 0 compression wave scan along the axis of the axle, carried out from both (either) ends. Near end scan Low angle (5-25 ) compression wave scan of the axle wheelseat or disc brake seat from the axle end. High Angle scan Shear wave scan of the wheelseat or disc brake seat from the body of the axle. Slant Range The projected distance to an ultrasonic reflector measured along the axis of the ultrasonic beam. R A I L T R A C K 11

12 Page 12 of 37 Withdrawn Document Appendix A continued Stand off distance The horizontal distance between the HA probe index and the wheel or disc brake boss. 3 References A list of all documents and drawings that are relevant to the preparation and/or application of the procedure. BS 5892 pt.1 BS 4331 pts 1 to 3 BS 3683 BS 3683 pt 4 GM/RT 2005 X & Co Drgs. No ESI 98-9 ESI Railway Rolling Stock Materials Specification for axles for traction and trailing stock. Methods for assessing the performance characteristics of ultrasonic flaw detection equipment. Glossary of terms used in non destructive testing. Ultrasonic flaw detection. Certification of NDT operatives, equipment & facilities used for inspecting rail vehicles. Class 123 driving axle assembly. Ultrasonic flaw detectors. Calibration and routine performance checks of ultrasonic NDT equipment. 4 Health & Safety A statement indicating the responsibility of users to observe and comply with national and international Health & Safety, COSHH requirements. Persons using this procedure shall be responsible for observing national and local Health and safety regulations, including:- Health and safety at work act. Use of hard hats, ear defenders, safety shoes etc. Familiarity with the location of first aid and fire assembly points. Compliance with company safety training and certification requirements. 5 Personnel Shall state the required minimum operator qualifications necessary for persons implementing the procedure. Where level 1 operators are permitted there shall also be a proviso stating that a level 2 supervisor shall be available on site at all times. Operators implementing this procedure shall hold, as a minimum, PCN level 1 certification in the relevant sector and method. Level 1 operators shall be under the supervision of a qualified level 2 person. 6 Equipment A comprehensive list of equipment required to implement the procedure. Ultrasonic flaw detector BR 2000, or other approved instrument Calibration block CB 88M 12 R A I L T R A C K

13 Page 13 of 37 Appendix A continued Probes BR ref L Double crystal 2,5 MHz BR ref L HE double crystal 2.5 MHz Tools for surface preparation Smooth cross cut file or powered abrasive (36 grit) disc. Couplant Lithium grease or similar. 7 Equipment Control Checks Shall define the need for periodic, documented, equipment calibrations prior to implementation of the procedure. Prior to use with this procedure equipment shall be subject to the control checks defined by BS 4331 pts.1 & 3, ESI 98/9. They shall include but not be limited to:- Annual electronic/electrical calibration of flaw detectors. Dimensional calibration of all reference/calibration blocks. Daily checks for satisfactory probe resolution, index point and angle. Daily control checks on the combined sensitivity of probes and flaw detector. 8 Surface Preparation Shall define any test surface preparation that must be carried out prior to implementation of the procedure, and shall also define any protection measures necessary to prevent damage to or contamination of the equipment being tested. Prior to the application of this procedure the front cover and axle box end caps shall be removed and the axle ends visually examined to determine that they are suitable for testing (3,2μm Ra). Where they are found to be unsuitable, the axle ends shall be dressed to the required standard with a smooth file or abrasive disc. Where high angle scans are to be carried out on painted axles/wheelsets, an area of paint shall be removed from the axle body to permit direct contact of the probe with the axle material. Vehicles shall not be moved with the axle end caps removed. Procedures shall be in place to enforce this requirement. 9 Method A detailed description of the test method defining equipment settings, calibrations and all operations necessary to determine that the product is compliant with the relevant quality specification. The method section of the procedure shall detail, as a minimum, the following information. Equipment. Calibrations/Control checks. Sensitivity settings. R A I L T R A C K 13

14 Page 14 of 37 Withdrawn Document Appendix A continued Radiographic source X or Gamma (type) Position of IQI s (radiography) A description, diagrams and calculations for all scans/exposures to be used (Ultrasonic, Radiographic and Eddy Current). The precise location and extent of the test area with respect to datum s defined on the component. Typical trace patterns (Ultrasonic axle and Eddy Current test procedures). A table identifying the source of each ultrasonic signal with dimensions (Ultrasonic axle test procedures and Eddy Current procedures). Acceptance levels. Method to be used for indicating the inspection status of the component. Action to be taken by the operator in the event of the component failing inspection. 10 Acceptance Criteria Shall give precise details of the acceptance criteria in both units of measurement defined by the specification and those generated by the test method. If these units of measurement are not the same then this section shall reference the method used for translation, i.e. validation test piece, calculations etc. Signals in excess of 20% screen height (1.5mm) occurring in the critical area when testing with the near end scan shall be cause for rejection of the axle/wheelset. 11 Reporting Shall define the minimum information required in the test report. Test reports shall, as a minimum, contain the following information:- Date. Location that the test was carried out. Name of the company, organisation or person who carried out the test and their qualification. Description of the axle and its serial number. Test procedure number. Written description of any deviations from the test procedure. Details and location of any spurious signals/reject indications detected. Result of the test Pass/Fail. Signature of the operator (and supervisor in the case of Level 1 operators). 12 Post Test Cleaning A description of any cleaning or protection measures to be carried out on satisfactory components before they are released for use. 14 R A I L T R A C K

15 Page 15 of 37 Appendix A continued All axles that have passed ultrasonic inspection shall be cleaned with solvent and wipers to remove any testing debris before they are allowed back into service. Where axles have had paint removed to facilitate high angle scanning, they shall be locally re-painted in accordance with an approved repair paint procedure. R A I L T R A C K 15

16 Page 16 of 37 Withdrawn Document Appendix B (This Appendix is for information only) Guidelines for the Essential Elements of a Management System for Facilities Undertaking NDT Inspections The following text, which has been provided by the British Institute of Non-Destructive Testing, gives guidelines for the essential elements of a Management System for Facilities undertaking NDT inspections. The text is extracted directly from their documentation using the original clause numbers, etc. The main headings are consistent with those in BS-EN-ISO 9000 and interpretations to cover facilities which undertake NDT inspections are given as Notes plus, where appropriate, sections in italic script. The following abbreviations are used in the text:- NDE Non-Destructive Examinations NDT Non-Destructive Testing The clause references in the text refer only to the clause numbers in this Appendix. 4.1 Management Responsibility Quality 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 organisational 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 organisation Organisation Responsibility and authority The responsibility, authority and interrelation of personnel who manage, perform and verify work affecting quality shall be defined and documented, particularly for personnel who need the organisational freedom and authority to: a) initiate action to prevent the occurrence of any non-conformities relating to the product, process and quality system; b) identify and record any problems relating to the product, process and quality system; 16 R A I L T R A C K

17 Page 17 of 37 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. A nominated person holding appropriate level 3 certification should be responsible for the overall technical quality of inspections undertaken by the organisation. Where no full time level 3 certificated inspector is employed, the Organisation must be able to demonstrate equivalent technical control through the documented use of external level 3 services for which adequate procedures exists. An appropriate number of persons should be appointed to give adequate supervision of all the Organisation s activities, offices and (where applicable) site operations. The NDE Organisation should define its organisation and document the responsibilities and terms of reference of all staff, together with the required NDE personnel certification of technical personnel. A nominated person should be responsible for ensuring compliance with statutory and customer specific requirements on all matters concerned with Health and Safety, including the Ionising Radiations Regulations (reference 2) where applicable. As part of his duties the nominated person should ensure: (i) (ii) that written procedures specifying safe working practices and actions to be taken in the event of an accident to personnel or equipment are available and complied with by all personnel. that, where applicable, all personnel working on site are aware of, and comply with local safety rules and regulations 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. R A I L T R A C K 17

18 Page 18 of 37 Withdrawn Document The Organisation should assign trained and appropriately qualified personnel to a list of approved signatories for verification activities, which should include, as a minimum, checking and approving inspection reports, random re-inspection, and monitoring of the overall service provided. The Organisation should document and implement a system of monitoring (see definitions), by witnessing inspections, reviewing results or by re-inspecting, the performance of NDE personnel to establish and demonstrate reliability and integrity. Such monitoring should (i) be conducted in accordance with a documented procedure; (ii) be conducted for each authorised inspection employee at a maximum of a yearly interval; (iii) include all NDE methods which the inspection employee is authorised to apply; (iv) be carried out be senior personnel who currently hold and have held a minimum of Level 2 (as defined in EN473) certification in the relevant NDE sector and method for at least two years. Personnel assigned responsibility for monitoring should be independent of those having direct responsibility for the activity being monitored (see clause 4.17) 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. The use of external quality assistance is not precluded, provided such assistance operates through the supplier s own management representative. 18 R A I L T R A C K

19 Page 19 of 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). Record of such reviews shall be maintained (see 4.16). A management review meeting should be conducted at least annually to an agenda which should include, as a minimum. (i) (ii) (iii) (iv) (v) (vi) (vii) Results of internal and external audits, including re-inspections; Product and system non-conformance, corrective and preventive actions; Changes in the Organisation; Changes in the nature of the work carried out; Customer complaints; Approved supplier and sub-contractor listings; Effectiveness of calibration systems. Minutes of the management review meeting, which record agreed actions, to whom they are assigned and a date for completion, should be maintained. Management reviews conducted by third parties are prohibited. The Management Representative should monitor and expedite the completion of corrective actions agreed at the Management Review. 4.2 Quality System 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 Quality system procedures The supplier shall a) prepare documented procedures consistent with the requirements R A I L T R A C K 19

20 Page 20 of 37 Withdrawn Document 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. Quality procedures and work instructions should be authorised by the management representative, but may be prepared by authorised personnel having received appropriate documented training Quality 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 realisation of product; g) the clarification of standards of acceptability for all features and requirements, including those which contain a subjective element; 20 R A I L T R A C K

21 Page 21 of 37 h) the identification and preparation of quality records (see 4.16). NOTE 8 The quality plans referred to (see 4.2.3a) 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 General The supplier shall establish and maintain documented procedures for contract review and for the co-ordination of these activities 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 requirements 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. The Organisation should establish a procedure for conducting a sufficiently extensive and timely review of the specified requirements of each service enquiry to ensure that: (i) (ii) (iii) orders received by verbal means should be translated into written instructions by the supplier, who should confirm that these reflect the requirements of the client. Evidence of confirmation should be retained as a contractual record. the customer s requirements are adequately recorded at the tender or enquiry stage and reviewed upon contract placement (should the tender be successful, any requirements differing from those in the tender are to be identified and resolved). the required NDE technology, inspection equipment, procedures and personnel with appropriate certification exist within the Organisation or can be acquired and/or developed to time scale consistent with contractual requirements. R A I L T R A C K 21

22 Page 22 of 37 Withdrawn Document 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 organisation Records Records of contract reviews shall be maintained (see 4.16). NOTE 9 Channels for communication and interfaces with the customer s organisation in these contract matters should be established. 4.4 Design control The scope of this International Standard does not include quality system requirements for design control. This sub-clause is included to align the clause numbering with ISO Document and data 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 Document and data approval and issue The documents and data shall be reviewed and approved for adequacy by authorised 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. The 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 preservation purposes are suitably identified. 22 R A I L T R A C K

23 Page 23 of Document and data changes Changes to documents and data shall be reviewed and approved by the same functions/organisations that performed the original review and approval, unless specifically designated otherwise, The designated functions/organisations 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 General The supplier shall establish and maintain documented procedures to ensure that purchased product conforms to specified requirements Evaluation of subcontractors The supplier shall: a) evaluate and select subcontractors on the basis of 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 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 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) 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 issue of specifications, drawings, process requirements, inspection instructions and other relevant technical data, including requirements for approval or qualification product, procedures, process equipment and personnel; c) the title, number and issue of the quality system to be applied. The supplier shall review and approve purchasing documents for adequacy of the specified requirements prior to release. R A I L T R A C K 23

24 Page 24 of 37 Withdrawn Document Verification of purchased product 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 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 the 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. Sub-contractors should be interpreted as encompassing both suppliers of materials, goods and services which affect the quality of NDE carried out and organisations to which the performance of NDE is sub-contracted in its entirety. The Organisation should not sub-contract any part of NDE to be carried out under a contract requiring compliance with this specification without the consent of the client. Any such sub-contract should invoke the requirements of this specification. The Organisation should maintain a list of approved sub-contractors. The basis for approval and the scope of approved supply should be identified. 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. 24 R A I L T R A C K

25 Page 25 of 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 or individual product or batches. This identification shall be recorded (see 4.16). 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 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 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. R A I L T R A C K 25

26 Page 26 of 37 Withdrawn Document Records shall be maintained for qualified processes, equipment and personnel, as appropriate (see 4.16). The Organisation should ensure that personnel are properly authorised to carry out NDE for the Organisation and that only appropriately qualified staff are authorised to work to specific NDE Instructions and Procedures. All inspection and testing should be carried out in accordance with approved NDE procedures which should be readily available to the NDE technicians. All procedures should be approved by a level 3 as defined in EN Inspection and testing 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. The term product is interpreted as encompassing (i) (ii) (iii) inspection equipment; inspection consumables; material and/or items to be inspected. These should be considered at each stage of the process Receiving inspection and testing The supplier shall ensure that incoming product is not used or processed (except in the circumstances described in ) 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 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. 26 R A I L T R A C K

27 Page 27 of 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 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 ). Release under positive-recall procedures shall not preclude the activities outlined in a) 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 despatched 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 authorised 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). R A I L T R A C K 27

28 Page 28 of 37 Withdrawn Document 4.11 Control of inspection, measuring and test equipment 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 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 releaser 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 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 recognised standards. Where no such standards exist, the basis used for shall be documented; 28 R A I L T R A C K

29 Page 29 of 37 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 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 test results when inspection, measuring or test equipment is found to be out of calibration; g) ensure that the environment conditions are suitable for the calibrations, inspections, measurements and tests being carried out. h) ensure that the handling, 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 may be used for guidance. A documented procedure should cover calibration and maintenance, as well as pre-use and in-service checks to ensure continuing satisfactory function. The Organisation should define and document the traceability of equipment calibration, which should be in accordance with an appropriate national, international or regional standard if applicable. Any item of equipment which gives suspect results, or has been shown by calibration or otherwise to be defective should be immediately identified as defective and withdrawn from service. All NDE carried out with such equipment since it was last known to be operating correctly/properly calibrated should be reviewed for validity and repeated if necessary. All equipment calibration requirements should be met before the equipment is returned to service. Records of calibration, servicing and maintenance should be maintained Inspection and test status The inspection and test status of products shall be identified by suitable means, which indicate the conformance or nonconformance of product R A I L T R A C K 29