ML18011A313
| ML18011A313 | |
| Person / Time | |
|---|---|
| Site: | 07100951 |
| Issue date: | 03/16/2017 |
| From: | Favre A Daher Nuclear Technologies GmbH |
| To: | Patricia Silva NRC/NMSS/DSFM/IOB |
| Tapp J | |
| Shared Package | |
| ML18011A311 | List: |
| References | |
| 0023-QAP-2017-001-Rev 1 | |
| Download: ML18011A313 (15) | |
Text
0023-QAP-2017-001-Rev1 Prepared Checked Released A. FAVRE F. HILBERT W. HAKER 1 / 15 Geistiges Eigentum der DAHER NUCLEAR TECHNOLOGIES GmbH - Vervielfltigung oder Weitergabe nur mit ausdrücklicher Zustimmung.
Property of DAHER NUCLEAR TECHNOLOGIES GmbH - Reproduction not permitted.
QUALITY ASSURANCE PROGRAM DESCRIPTION 10 CFR 71 Subpart H 0023-QAP-2017-001-Rev1
0023-QAP-2017-001-Rev 1 2 / 15 Geistiges Eigentum der DAHER NUCLEAR TECHNOLOGIES GmbH - Vervielfltigung oder Weitergabe nur mit ausdrücklicher Zustimmung.
Property of DAHER NUCLEAR TECHNOLOGIES GmbH - Reproduction not permitted.
Table of Contents 1
Introduction....................................................................................................................... 3 2
Revision record................................................................................................................. 4 3
Purpose and scope........................................................................................................... 5 4
Quality Assurance Criteria............................................................................................. 11 4.1 Organization............................................................................................................... 11 4.2 Quality Assurance Program........................................................................................ 11 4.3 Package Design Control............................................................................................. 11 4.4 Procurement Document Control.................................................................................. 13 4.5 Instructions, Procedures, and Drawings...................................................................... 13 4.6 Document Control....................................................................................................... 13 4.7 Control of Purchased Material, Equipment, and Services........................................... 13 4.8 Identification and Control of Materials, Parts, and Components.................................. 14 4.9 Control of Special Processes...................................................................................... 14 4.10 Internal Inspection...................................................................................................... 14 4.11 Test Control................................................................................................................ 14 4.12 Control of Measuring and Test Equipment.................................................................. 14 4.13 Handling, Storage, and Shipping Control.................................................................... 14 4.14 Inspection, Test, and Operating Status....................................................................... 14 4.15 Nonconforming Materials, Parts, or Components........................................................ 15 4.16 Corrective Action........................................................................................................ 15 4.17 Quality Assurance Records........................................................................................ 15 4.18 Audits......................................................................................................................... 15
0023-QAP-2017-001-Rev 1 3 / 15 Geistiges Eigentum der DAHER NUCLEAR TECHNOLOGIES GmbH - Vervielfltigung oder Weitergabe nur mit ausdrücklicher Zustimmung.
Property of DAHER NUCLEAR TECHNOLOGIES GmbH - Reproduction not permitted.
1 INTRODUCTION The objective of DAHER NUCLEAR TECHNOLOGIES GmbH (DNT), a company belonging to the DAHER Group isorganization of shipping, forwarding, warehouse, commission and packag-ing business, insurance brokering and any other transactions connected to this, in particular provision of services in the nuclear sector such as development of packaging and accessories.
DNT headquarters with offices, secured parking place for lorries and storage buildings for interim storage of non-fissile radioactive materials (e.g. contaminated packaging and radioactive waste),
as well as maintenance halls, is located within an industrial area at Hanau-Wolfgang.
Infrastructure like Plant security Radiation protection Fire brigade are either existing at DNT (radiation protection) or are available via a third-party contract (plant security and fire brigade of the Industriepark Wolfgang GmbH situated on an area close to DNT).
DNT has a staff of employees with a long experience in the field of logistics and transports of dangerous, especially radioactive goods.
0023-QAP-2017-001-Rev 1 4 / 15 Geistiges Eigentum der DAHER NUCLEAR TECHNOLOGIES GmbH - Vervielfltigung oder Weitergabe nur mit ausdrücklicher Zustimmung.
Property of DAHER NUCLEAR TECHNOLOGIES GmbH - Reproduction not permitted.
2 REVISION RECORD Rev. No.
Revised Pages 0
Creation 19.10.2011 1
New QM ID; Modification of the company Name; Modification of the references accord-ing to the QM-System
0023-QAP-2017-001-Rev 1 5 / 15 Geistiges Eigentum der DAHER NUCLEAR TECHNOLOGIES GmbH - Vervielfltigung oder Weitergabe nur mit ausdrücklicher Zustimmung.
Property of DAHER NUCLEAR TECHNOLOGIES GmbH - Reproduction not permitted.
3 PURPOSE AND SCOPE This Quality Assurance Program Description identifies how each of the regulations in Subpart H of 10 CFR Part 71 applies to the DNT quality management system and how the requirements are implemented by:
DAHER NCULEAR TECHNOLOGIES GmbH (DNT)
Rodenbacher Chaussee 6 D-63457 Hanau Germany The purpose of DNT quality management system is to assure a permanent and optimal quality of services. It describes the QM measures which were introduced and which must be permanently observed to fulfil the essential objective of avoiding errors and faults. The quality management manual is valid for all organization units and for all DNT staff members.
These requirements are applicable for purchase orders or contracts that invoke regulatory re-quirements or specifically require compliance to this program. Each contract will be reviewed to determine regulated activities and the appropriate measures to be implemented.
DNT has no packaging hardware production. Packaging products are not manufactured by DNT.
Packaging hardware suppliers are required to prove that they have a certified QM-System.
The requirements of Subpart H of 10 CFR Part 71 shall be complied with as applicable to the products or services provided. Additionally, the requirements for reporting of defects and non-compliance according 10 CFR Part 21 will be accepted.
Table 1 shows procedures that demonstrate implementation of a documented QA program.
Table 1. QA-Program Implementing Procedures Implementing Document Title Regulatory Position Description QM, Section 5, Management
§ 71.103 QUALITY AS-SURANCE ORGANIZA-TION 1
Responsibilities for the establishment and implementation of the quality assurance program are defined. The organizational structure, functional responsibilities, levels of authority and lines of communications for activities affecting quality are docu-mented. The organization chart provides an outline of the organizational structure.
0023-QAP-2017-001-Rev 1 6 / 15 Geistiges Eigentum der DAHER NUCLEAR TECHNOLOGIES GmbH - Vervielfltigung oder Weitergabe nur mit ausdrücklicher Zustimmung.
Property of DAHER NUCLEAR TECHNOLOGIES GmbH - Reproduction not permitted.
Implementing Document Title Regulatory Position Description QM, Section 6, Planning the Inte-grated Manage-ment System
§ 71.105 QUALITY AS-SURANCE PROGRAM 2
Describes how the quality assurance pro-gram is planned, implemented and main-tained. Identifies the activities and items to which it applies. The program provides control over activities affecting quality to an extent consistent with their importance.
The program includes monitoring activities against acceptance criteria in a manner sufficient to provide assurance that the ac-tivities affecting quality are performed sat-isfactorily.
QM, Section 8.2, Requirements to-wards products and services QM, Section 8.3, Developing prod-ucts and services Main Process Development of packaging
§ 71.107 PACKAGE DESIGN CON-TROL 3
Design inputs are specified and translated into design documents. Design interfaces are identified and controlled. Individuals other than those who designed the item or computer program verify design adequacy.
Design changes are governed by control measures commensurate with those ap-plied to the original design.
QM, Section 8.4, Controlling exteri-orly supplied pro-cesses, products and services QM, Section 8.5, Production and providing services Process Prepa-ration of the man-ufacturing Process Sur-veillance of the Manufacturing
§ 71.109 PROCURE-MENT DOCU-MENT CON-TROL 4
Applicable design bases and other re-quirements necessary to assure adequate quality are included or referenced in docu-ments for procurement of items and ser-vices. To the extent necessary, procure-ment documents require suppliers to have a quality assurance program consistent with the applicable requirements of the QM.
0023-QAP-2017-001-Rev 1 7 / 15 Geistiges Eigentum der DAHER NUCLEAR TECHNOLOGIES GmbH - Vervielfltigung oder Weitergabe nur mit ausdrücklicher Zustimmung.
Property of DAHER NUCLEAR TECHNOLOGIES GmbH - Reproduction not permitted.
Implementing Document Title Regulatory Position Description QM, Section 8.3, Developing prod-ucts and services Process Crea-tion of concepts AA-0147/xx-AK, Preparation of drawings Process Docu-ment Manage-ment Dept. De-sign and Technol-ogies
§ 71.111 INSTRUC-TIONS, PRO-
- CEDURES, AND DRAWINGS 5
Activities affecting quality and services are prescribed by and performed in accord-ance with documented instructions, proce-dures or drawings that include or refer-ence appropriate quantitative or qualitative acceptance criteria for determining that prescribed activities have been satisfacto-rily accomplished. The activity is described to a level of detail commensurate with the complexity of the activity and the need to assure consistent and acceptable results.
The need for and level of detail in written procedures or instructions are determined based upon complexity of the task, the sig-nificance of the item or activity, work envi-ronment and worker capability (education, training, experience).
QM Section 4.5.2 Document Man-agement Process Control of documents Process Control of Records
§ 71.115, CONTROL OF PURCHASED
- MATERIAL, EQUIPMENT, AND SER-VICES 7
The procurement of items and services are controlled to ensure conformance with specified requirements. Such control shall provide for the following as appropriate:
source evaluation and selection, evalua-tion of objective evidence of quality fur-nished by the Supplier, source inspection, audit, and examination of items or services upon delivery or completion.
QM, Section 8.5, Production and providing services
§ 71.117 IDENTIFICA-TION AND CONTROL OF MATERIALS, PARTS, AND COMPO-NENTS 8
Controls are established to assure that only correct and accepted items are used or installed. Identification is maintained on the items or in documents traceable to the items, or in a manner that assures that identification is established and main-tained.
QM Section 8.1 Operational plan-ning and control Special instructions (e.g. 0023-PA-2015-016)
§ 71.119 CONTROL OF SPECIAL PROCESSES 9
Special processes that control or verify quality, such as those used in welding, heat treating, and nondestructive examina-tion, are performed by qualified personnel using qualified procedures in accordance with specified requirements.
0023-QAP-2017-001-Rev 1 8 / 15 Geistiges Eigentum der DAHER NUCLEAR TECHNOLOGIES GmbH - Vervielfltigung oder Weitergabe nur mit ausdrücklicher Zustimmung.
Property of DAHER NUCLEAR TECHNOLOGIES GmbH - Reproduction not permitted.
Implementing Document Title Regulatory Position Description QM Section 8.5.2 Purchasing AA-0201/xx-TBS Incoming Inspec-tion AA-0105/xx-AK Preparation, Ex-amination and Tests of Approval Documents Special forms (e.g. FPP)
Special instruc-tions (e.g. 0023-HA-2015-001)
§ 71.121 INTERNAL IN-SPECTION 10 Inspections required to verify conformance of an item or activity to specified require-ments or continued acceptability of items in service are planned and executed.
Characteristics subject to inspection and inspection methods are specified. Inspec-tion results are documented. Qualified per-sons other than those who performed or directly supervised the work being in-spected perform inspections for ac-ceptance.
QM Section 8.1 Operational plan-ning and control Process Mate-rial Qualification Process Me-chanical and Thermal Calcula-tions Process Drop and Fire testing
§ 71.123 TEST CON-TROL 11 Tests required to collect data such as for design input, to verify conformance of an item or computer program to specified re-quirements, or to demonstrate satisfactory performance for service are planned and executed. Characteristics to be tested and test methods to be employed are speci-fied. Test results are documented and their conformance with test requirements and acceptance criteria are evaluated.
Process Moni-toring, Measuring and Testing Equipment
§ 71.125 CONTROL OF MEASURING AND TEST EQUIPMENT 12 Tools, gages, instruments, and other measuring and test equipment used for activities affecting quality are controlled, calibrated at specific periods, adjusted, and maintained to required accuracy lim-its.
QM, Section 8.5.4 Customers property
- HANDLING, STORAGE, AND SHIP-PING CON-TROL 13 Handling, storage, cleaning, packaging, shipping, and preservation of items are controlled to prevent damage or loss and to minimize deterioration. These activities are conducted in accordance with estab-lished work and inspection instructions, drawings, specifications, shipment instruc-tions, or other pertinent documents or pro-cedures specified for use in conducting the activity.
0023-QAP-2017-001-Rev 1 9 / 15 Geistiges Eigentum der DAHER NUCLEAR TECHNOLOGIES GmbH - Vervielfltigung oder Weitergabe nur mit ausdrücklicher Zustimmung.
Property of DAHER NUCLEAR TECHNOLOGIES GmbH - Reproduction not permitted.
Implementing Document Title Regulatory Position Description QM, Section 8.5.3 Identifica-tion and traceabil-ity Process Docu-ment Manage-ment Dept. De-sign and Technol-ogies Process Control of Records
§ 71.129 INSPECTION, TEST, AND OPERATING STATUS 14 The status of inspection and test activities are identified either on the items or in doc-uments traceable to the items where it is necessary to ensure that required inspec-tions and tests are performed and to en-sure that items that have not passed the required inspections and tests are not in-advertently installed, used, or operated.
Status is maintained through indicators, such as physical location and tags, mark-ings, shop travelers, stamps, inspection records, or other suitable means. The au-thority for application and removal of tags, markings, labels, and stamps are speci-fied. Status indicators shall also provide for indicating the operating status of sys-tems and components of the nuclear facil-ity, such as by tagging valves and switches, to prevent inadvertent operation.
QM, Section 10, Improvement AA-0104/xx-AK Preparation, Ex-amination and Checking of Devi-ation Reports
§ 71.131 NON-CON-FORMING MATERIALS, PARTS, OR COMPO-NENTS 15 Items that do not conform to specified re-quirements are controlled to prevent inad-vertent installation or use. Controls shall provide for identification, documentation, evaluation, segregation when practical, and disposition of nonconforming items, and for notification to affected organiza-tions.
QM, Section 10, Improvement Process Correc-tive Action AA-0104/xx-AK Preparation, Ex-amination and Checking of Devi-ation Reports
§ 71.133 CORRECTIVE ACTION 16 Conditions adverse to quality are identified promptly and corrected as soon as practi-cable. In the case of a significant condition adverse to quality, the cause of the condi-tion is determined and corrective action taken to preclude recurrence. The identifi-cation, cause, and corrective action for significant conditions adverse to quality are documented and reported to appropri-ate levels of management. Completion of corrective actions is verified.
QM, Section 4.5.2, Document Management Process Control of Records
§ 71.135 QUALITY AS-SURANCE RECORDS 17 The control of quality assurance records is established consistently with the schedule for accomplishing work activities. Quality assurance records shall furnish documen-tary evidence that items or activities meet specified quality requirements. Quality as-surance records are identified, generated, authenticated, and maintained, and their fi-nal disposition specified. Record control requirements and responsibilities for these activities are documented.
0023-QAP-2017-001-Rev 1 10 / 15 Geistiges Eigentum der DAHER NUCLEAR TECHNOLOGIES GmbH - Vervielfltigung oder Weitergabe nur mit ausdrücklicher Zustimmung.
Property of DAHER NUCLEAR TECHNOLOGIES GmbH - Reproduction not permitted.
Implementing Document Title Regulatory Position Description QM, Section 9, Evaluating perfor-mance Process Plan-ning Audits Process Execu-tion of Audits
§ 71.137 AUDITS 18 Audits are performed to verify compliance to quality assurance program require-ments, to verify that performance criteria are met, and to determine the effective-ness of the program. Personnel who do not have direct responsibility for perform-ing the activities being audited perform these audits in accordance with written procedures or checklists. Audit results are documented and reported to and reviewed by responsible management. Follow-up action is taken where indicated.
0023-QAP-2017-001-Rev 1 11 / 15 Geistiges Eigentum der DAHER NUCLEAR TECHNOLOGIES GmbH - Vervielfltigung oder Weitergabe nur mit ausdrücklicher Zustimmung.
Property of DAHER NUCLEAR TECHNOLOGIES GmbH - Reproduction not permitted.
4 QUALITY ASSURANCE CRITERIA 4.1 Organization The DNT Management is responsible for the development and realization, as well as for continu-ous improvement of the efficiency of the quality management system.
Responsibilities and authorities are presented in the DNT organization chart and result from the corresponding job descriptions, according to the following pattern:
Position Title Subordinations Superseding relations Deputy relations Objectives Special authorizations and duties Tasks and duties The Managing Directors have entrusted the planning, introduction, maintenance and permanent improvement of the QM system to the head of the Quality Assurance Department.
It is the duty of head of the QA Department to implement the Companys quality management system in the organization and to make sure that it is understood and followed at all levels. For this, head of the QA Department has the full support of the Managing Directors.
4.2 Quality Assurance Program DNT keeps up a process oriented QM system based on DIN EN ISO 9001. It contains all QM requirements that must be observed by all organization units and by all DNT staff members.
Documentation related to the QM system has a step shaped structure, the highest step being the QM manual and the others consisting of procedures, guidelines and work instructions. The ISO 9001 Standard program is a framework that is used to implement the DNT QM system quality program.
In general, the regulations in 10 CFR 71, Subpart H, are included within a Quality Assurance Program complying with ISO 9001. Requirements from German standard KTA 1401 and from IAEA TS-G-1.4 The Management System for the Safe Transport of Radioactive Material sup-plement the ISO 9001 requirements to provide additional detail required by 10 CFR 71, Subpart H.
4.3 Package Design Control Generally, customers initiate the development of new products. The technical and economical requirements towards the product are assessed and taken into account during development and design. The head of Design/Technology department coordinates development projects. He works out a development plan which appoints the members of the development team, defines their tasks, the development steps and the schedule.
The processes used during the development of a new packaging concept are presented in Figure 1 and Figure 2.
0023-QAP-2017-001-Rev1 0023-QAP-2017-001-Rev0 - Quality Assurance 10_CFR_71_bearb WHA 12 / 15 Geistiges Eigentum der DAHER NUCLEAR TECHNOLOGIES GmbH - Vervielfltigung oder Weitergabe nur mit ausdrücklicher Zustimmung.
Property of DAHER NUCLEAR TECHNOLOGIES GmbH - Reproduction not permitted.
Figure 1. Process Development of packagings Figure 2. Process Development Offer release Development Preparation of the manufacturing Surveillance of the manufacturing Certificate of Approval process Validation Maintenance Project Management Nulcear calculations Mechanical and thermal calculations Material qualification Creation of concept Preparation of the manufacturing surveillance of the manufacturing Drop and fire testing Redaction of the Safety Analysis Report
0023-QAP-2017-001-Rev 1 0023-QAP-2017-001-Rev0 - Quality Assurance 10_CFR_71_bearb WHA 13 / 15 Geistiges Eigentum der DAHER NUCLEAR TECHNOLOGIES GmbH - Vervielfltigung oder Weitergabe nur mit ausdrücklicher Zustimmung.
Property of DAHER NUCLEAR TECHNOLOGIES GmbH - Reproduction not permitted.
Control steps are planned within the course of the single development projects, in order to make sure that the defined quality requirements are actually achieved. When doing so, preliminary re-quirements which might have been expressed by exterior inspection instances, customers, etc.,
will be taken into account.
The degree to which the development objective has been achieved is checked internally through DNT by means of the conditions in the system requirement specifications or in similar documents, and, depending on project conditions, also submitted to external controls (authorities, experts, customers).
Assurance that the product can fulfill the requirements inherent to the use to which it is foreseen will be, as a rule, verified through cold handling.
Changes of the design and development parameters will take place whenever customer require-ments or requirements imposed by the authorities change during the course of development, or if it should become apparent, when checking development, that the defined objectives cannot be achieved.
Changes of quality related documents (e.g. system requirement specifications, safety reports) will be carried out through the corresponding responsible instance and will only be valid when carrying the corresponding control/release remark.
4.4 Procurement Document Control All suppliers of safety related products and services are supervised by means of adequate quality assurance measures. These include:
a first evaluation of the quality capabilities of possible suppliers an evaluation of samples periodic evaluations of suppliers Hardware suppliers will as a rule are required to prove that they have a certified QM system.
Purchasing documents for the different fields of business are very different as far as their contents and form are concerned. Corresponding details are regulated in the corresponding procedures.
4.5 Instructions, Procedures, and Drawings Production drawings will be worked out, based on design drawings, insofar as no definitive pro-duction drawings were worked out with the safety report. These production drawings may be worked out by DNT, insofar as they have sufficient knowledge and experience concerning pro-duction processes and possibilities. If experience concerning production processes and possibil-ities is not sufficient, the manufacturer of the packaging may be entrusted with the working out of the production documents.
4.6 Document Control This quality management element describes the decisions made to assure a correct flow of infor-mation. It is thus assured that the correct and valid versions of all required documents are avail-able at all places within the company and to the customers and suppliers.
Generally, every organization unit (department, group) will prepare the documents necessary for its activity, being thus responsible for these documents. In case of documents that cover more than one organization unit, a responsible organization unit is appointed.
4.7 Control of Purchased Material, Equipment, and Services DNT does not produce packagings by themselves. This is assured by manufacturers selected by DNT, who are in the list of qualified suppliers or who were entered into this list before the order was placed.
0023-QAP-2017-001-Rev 1 14 / 15 Geistiges Eigentum der DAHER NUCLEAR TECHNOLOGIES GmbH - Vervielfltigung oder Weitergabe nur mit ausdrücklicher Zustimmung.
Property of DAHER NUCLEAR TECHNOLOGIES GmbH - Reproduction not permitted.
The manufacturers specification, drawings and the instructions mentioned in the manufacturers specification are part of the acquisition documents.
4.8 Identification and Control of Materials, Parts, and Components The inspection status of hardware and documents is identified by means of stamps, labels, ac-companying cards, control reports, signatures or other adequate means indicating that require-ments are fulfilled or not, based on the quality controls which were carried out. The verification of the inspection status is maintained throughout the service performance process.
4.9 Control of Special Processes Special processes that control or verify quality, such as those used in welding, heat treating, and nondestructive examination, are performed by qualified personnel using qualified procedures in accordance with specified requirements.
4.10 Internal Inspection The manufacturer will work out the preliminary checking documents, based on the manufacturers specification and the drawings of the packaging:
List of materials, Fabrication and control follow-up plan (in part also named construction control follow-up plan, according to the manufacturers choice),
Welding plan, If applicable, completion drawings (e.g. forging drawings).
The supervision of fabrication through DNT is settled in the preliminary checking documents. The checking steps are carried out under the responsibility of the person responsible for acceptance appointed by DNT. Implementation of the supervising steps is documented in the preliminary checking documents and, insofar as necessary, in the corresponding records.
4.11 Test Control Testing programs are set up for the development projects, for which technical safety characteris-tics must be verified by means of practical tests. This may be due to technical causes (nonexistent or not sufficiently validated analytic procedures) or to economic reasons (the costs for application of analytic processes are higher than verifications by empirical tests).
4.12 Control of Measuring and Test Equipment All monitoring/measuring devices used to evaluate safety relevant quality characteristics (e.g. for radiation protection), are kept locally by the corresponding instances in a file, and are subject to permanent monitoring, manage with the CALVIN software.
Those responsible for the corresponding monitoring/measuring devices will make sure that in-spections/calibrations are carried out in due time. When a monitoring/measuring device appears to be nonconforming, it will be identified by means of a blocking sticker and the blocking will be recorded in the file.
4.13 Handling, Storage, and Shipping Control Proceedings are taken to avoid damages of packages during handling, storage and transport.
4.14 Inspection, Test, and Operating Status Recordings concerning quality are gathered and assembled by the corresponding project man-ager or, if no such person has been appointed, by the instance responsible for documentation in the concerned case.
The documents are examined according to documentation criteria for
0023-QAP-2017-001-Rev 1 15 / 15 Geistiges Eigentum der DAHER NUCLEAR TECHNOLOGIES GmbH - Vervielfltigung oder Weitergabe nur mit ausdrücklicher Zustimmung.
Property of DAHER NUCLEAR TECHNOLOGIES GmbH - Reproduction not permitted.
Completeness Unambiguous allocation Legibility Traceability Actualization 4.15 Nonconforming Materials, Parts, or Components If a product (e.g. packaging, study or preliminary drafts for this) does not fulfil quality requirements, it is marked and/or segregated to make sure it will not be used by mistake. The corresponding processes have been defined in such a way that identification, documentation, evaluation and measures for further treatment are given in advance.
Corrective actions will be carried out at once by the responsible instances, since they are known, in order to allow for the continuation or finishing of the service performance process.
4.16 Corrective Action The QM system can only be effective if identified faults are permanently eliminated (avoiding of repetition of faults, etc.) and the system is continuously adapted to internal/external changes (op-timization).
Corrective action will be carried out, especially in order to effectively eliminate systematic faults.
The reasons for triggering corrective action are the evaluation of quality data, of audits and the evaluation of single nonconformities.
Each corrective action will be followed by a check whether the detected error can also occur in other areas. Measures are taken to prevent the occurrence oft the error in other areas.
4.17 Quality Assurance Records This quality management element describes the decisions made to assure a correct flow of infor-mation. It is thus assured that the correct and valid versions of all required documents are avail-able at all places within the company and to the customers and suppliers.
4.18 Audits Planning of internal audits will be oriented according to the necessity of periodical controls of the effectiveness of the QM system. It shall be foreseen that all processes and all organization units involved in the QM system will be audited once during the validity of a certificate (3 years). The intensity of the audits will depend on the safety relevance of the concerned processes.