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EUROCOPTER INSTRUCTION
PROCESS CONTROL SYNTHESIS The rules governing the control of processes that are in development and in seriesproduction following a change are laid out in this document. It covers the processes implemented by Eurocopter, its sub-contractors or its partners (Saé, HAMC, etc.).
Reference language: French The reference language shall prevail in case of discrepancy or dispute Validity:
EC
Approvals / Certifications: ISO
DOA
POA
MOA
Military
EC ECD
Workgroup: D. LECURU - M.PIERANTONI - JM BERTHIER - C. JOUANNAUD - P. RICARD – J.P. GABERT
Effective date: 20/04/2001 Approvals: Technical Manager
Signed
P. RICARD
Document Executive Committee
Signed
C. AUBERT
"This document is the property of EUROCOPTER; it shall in no case 11 be duplicated and/or circulated without prior written approval from EUROCOPTER and its content shall not be disclosed to third parties". EUROCOPTER 04/2001
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SUMMARY
1. GENERAL PRINCIPLES 1.1 Object 1.2 Field of application 1.3 Terminology 1.3.1 Manufacturing process 1.3.2 Checking process 1.3.3 Special process 1.3.4 Process validation 1.3.5 Process qualification 1.3.6 Qualification of the process/manufacturer pair 1.3.7 Qualification of process changes
2. QUALIFICATION PROCEDURES 2.1 2.2
Process description Description of the procedure steps 2.2.1 Process requirements expression 2.2.2 Process selection 2.2.3 Process creation 2.2.4 Process validation 2.2.5 Qualification 2.2.5.1 Process qualification 2.2.5.2 Qualification of the process/manufacturer pair 2.2.5.2.1 Qualification conditions 2.2.5.3 Declaration of qualification 2.2.5.4 Process reliability enhancement 2.2.6 Monitoring qualification 2.2.7 The control of process changes
3. RESPONSIBILITIES APPENDIX 1: Example of a monitoring table for qualifications underway APPENDIX 2: Connections between the DPF-09-01 and EP-09-02
"This document is the property of EUROCOPTER; it shall in no case 11 be duplicated and/or circulated without prior written approval from EUROCOPTER and its content shall not be disclosed to third parties". EUROCOPTER 04/2001
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Page 3/ 13 SUMMARY TABLE Issue A
Date
Modified sections
20/04/2001
Reason for the change New document. Cancels and supersedes DPF-09-02
HIGHER ORDER DOCUMENTS EP 04-06
« Règles à suivre en fonction de la classe de sécurité des pièces et en particulier pour les Pièces Vitales » (Rules to respect according to the components safety classification and specifically for Vital Components)
EP 09-02
« Maîtrise des matériaux et des procédés » (Equipment and Process Control) ASSOCIATED DOCUMENTS
HS5011
« Liste des procédés spéciaux » (List of special processes)
DPF-09-01
« Validation des procédures de fabrication » (Validation of manufacturing procedures)
QAE 06-02
« Exigences Qualité pour les fabricants » (Manufacturer Quality requirements)
EI 16-01
« Archivage des documents relatifs à la Qualité » (Archiving Quality documents)
QAF 09-08
« Acquisition de la qualification des couples procédés/réalisateur à EC » (Granting of process/manufacturer pair qualification by EC)
"This document is the property of EUROCOPTER; it shall in no case 11 be duplicated and/or circulated without prior written approval from EUROCOPTER and its content shall not be disclosed to third parties". EUROCOPTER 04/2001
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1. 1.1
GENERAL PRINCIPLES Object This document lays out the rules governing process control throughout all the stages leading to their qualification and application. According to whether the process is new or not, these stages shall include all or some of the following steps:
1.2
•
definition of the characteristics that are to be achieved
•
performance of a feasibility study
•
creation (development, characterisation)
•
process validation
•
qualification of the process/manufacturer pair
•
reliability enhancement
Field of application This document governs the special procedures implemented during the manufacture and/or the inspections carried out, either internally, within EUROCOPTER, or at the sub-contractors’ or partners’ premises (Saé, HAMC, etc.) during the manufacture of helicopter components that are classified as being critical, important and secondary A in accordance with EI 04.06. With respect to applying these rules to secondary components or processes that are not special, these rules may be applied at the discretion of the services involved. Processes for which manufacturing documents already exist (or Quality documents in the case of non-destructive testing) are deemed to be valid.
1.3
Terminology 1.3.1 Manufacturing process The manner in which a product with the sought condition and characteristics is manufactured by implementing a set of predefined means and methods, in well-defined conditions. 1.3.2 Checking process The manner in which a product's sought condition and characteristics are inspected or assessed with the aim of guarantying compliance, by implementing a predefined set of means and methods, under well-defined conditions. 1.3.3 Special process A process for which inspection after the fact does not ensure an adequate guarantee that the product resulting from its implementation will comply with requirements.
"This document is the property of EUROCOPTER; it shall in no case 11 be duplicated and/or circulated without prior written approval from EUROCOPTER and its content shall not be disclosed to third parties". EUROCOPTER 04/2001
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Page 5/ 13 NOTE: Special processes notably include thermal processes, thermochemical and surface processes, bonding processes (brazing, welding, ...), non-destructive test processes, processes pertaining to non metallic materials. 1.3.4 Process validation The designer and manufacturer's provisional recognition of a process' suitability to be used to manufacturer helicopter components. It is embodied by an authorisation to put into operation, it is possible for said authorisations to be issued with restriction conditions. 1.3.5 Process qualification Final recognition of a process's suitability to produce components that may be installed on an aircraft in series-production in a reproducible and adequate manner. This stage may or may not include a reliability enhancement period. In any event, it is embodied by the associated definition, manufacturing and inspection documents. 1.3.6 Qualification of the process/manufacturer pair This is the manner in which EUROCOPTER recognises, following checking, that the manufacturer is in possession of the qualities required to apply a qualified process and abide by it within the allowed schedule. This check covers: •
the organisation (production, quality, ...),
•
performance of the industrial tool,
•
methods, procedures, and means used for the implementation of the process in question (including inspection),
•
the application of processes and result analyses,
•
the assessment of products' technical performance with respect to requirements,
•
means in terms of human resources,
•
the respect of regulations pertaining to the environment.
1.3.7 Qualification of process changes The manner in which EUROCOPTER recognises that process changes do not call the initial Technical Specifications into question.
2. 2.1
QUALIFICATION PROCEDURE Procedure description
The process qualification procedure includes the following steps:
"This document is the property of EUROCOPTER; it shall in no case 11 be duplicated and/or circulated without prior written approval from EUROCOPTER and its content shall not be disclosed to third parties". EUROCOPTER 04/2001
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STEPS
DOCUMENTS PRODUCED Technical Requirements Specification
MANAGER
1
Expression of requirement
Design department + LMP
2
Assessment – Feasibility LMP process selection document – Selection
3
Creation
LMP document (Process Technical Specification)
LMP
4
Process validation
LMP document (process validation)
LMP
5
Process qualification
Standardisation documents (IFMA, QAF, EI, …)
LMP
Design department + LMP
Synthesis Sheet 6
7
Process/manufacturer pair qualification
Monitoring
EC internal process: QAF 09.08 update
EC internal process: LMP
EC external process: Process/manufacturer pair qualification report
EC external process: External Supply Quality Department+ LMP
Monitoring report
EC internal process: The Quality Sector implementing the process. EC external process: External Supplies Quality Department
8
Change
Requalification programme
EC internal process: LMP
Update: - of the Synthesis Sheet – of the Process/Manufacturer pair Qualification report
EC external process External Provisions Quality + LMP
Observations A. Qualification of the manufacturer must be taken into consideration from the beginning (step 2) in order that the External Supplies Quality department may, if required, concurrently with process qualification, initiate manufacturer qualification B. The qualification procedure may include all or some of the steps mentioned hereover, in accordance with the particular situation in question. C. In order to ensure the control of contracts under way and to provide information concerning the various sections parties involved in the procedure, material entities of the LMP of the Industrial Competence Centres (CCI) are entrusted with implementing a managerial chart that they shall update twice yearly, describing the status of qualifications currently being "This document is the property of EUROCOPTER; it shall in no case 11 be duplicated and/or circulated without prior written approval from EUROCOPTER and its content shall not be disclosed to third parties". EUROCOPTER 04/2001
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Page 7/ 13 studied. The general consistency shall be ensured and summarised by the LMP quality entities An example is provided in Appendix 1. 2.2
Description of the procedure steps
2.2.1 Process requirements expression This step comprises specifying the requirements that the process must fulfil. These requirements describe the required technical and economic performance. Requirements are issued by the Design Office, working with the LMP, and are formalised in a Technical Requirements Specification (or equivalent document), which shall constitute the reference document for development. 2.2.2 Process selection The process shall be selected at the beginning of the DESIGN phase, in the sense that it is defined in DPF09.01 (refer to Appendix 2). The assessment of possible solutions (carried out in an industrial laboratory or pilot workshop), is carried out to check their feasibility and allow one of them to be selected, with the requester's approval, and specifically as a function of the following criteria: •
technology,
•
experience and know-how,
•
the means required for the implementation (human and equipment),
•
economics,
•
environment (hygiene and security file),
•
availability lead times.
•
manufacturer's ability and perpetuity.
A process selection LMP document synthesises the assessment works. 2.2.3 Process creation The aim of creation is to acquire complete knowledge and understanding of the process. At this stage, the LMP sets out all the works required for development to take place (drafting of a test programme ). The following points are, specifically taken into consideration in this programme: a) the functional definition classification of the type of components to be designed, b) the technical control. The aim of technical control is to obtain an acceptable process capability (reproducibility with a known confidence interval that is adequate and controlled). It demands that the parameters affecting the characteristics to be obtained, their interaction and the limits of the usage domain be known. c) controllability (direct or indirect), d) The Process Technical Specification, issued by the LMP, summarises the results of these works. 2.2.4 Process validation "This document is the property of EUROCOPTER; it shall in no case 11 be duplicated and/or circulated without prior written approval from EUROCOPTER and its content shall not be disclosed to third parties". EUROCOPTER 04/2001
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Page 8/ 13 An LMP validation document is drafted and incorporated into the drawing (either directly or through an HS contact) prior to the manufacture of the first prototype components. This document includes all the definition data, manufacturing data and inspection data required and adequate for the manufacture of components intended to be installed in prototype helicopters and on test benches (Polyvalent Rotor Bench, Back To Back, Iron Bird, etc.). 2.2.5 Qualification 2.2.5.1 Process qualification Responsibility for the qualification of new processes, whether they are to be implemented internally or externally, devolves on the LMP. Qualification is declared after adequate results are required for the steps described hereinafter: After process development is completed, its implementation conditions, verification conditions and application limits are formalised in an application document: • HS process or equivalent document, defining the expected performance and the manner in which this may be verified, • MP or IFMA, IFCN, defining the set of parameters required for the implementation and verification of the process, • IGC or EI, completing, if required, manufacturing documents, in order to specify the set of parameters which need to be controlled to guarantee product compliance, • or equivalent documents if the process is implemented outside EC. Process qualification is embodied by the signature and the circulation of application documents dealing with the process. Process qualification must be acquired before components intended for installation on test assemblies or sub-assemblies, certification, FAA tests, etc. may be manufactured. At this stage, the LMP drafts a Synthesis Sheet which bears mention of the references of all the documents that allowed the process to be validated, specifically: • the Technical Requirements Specification, • the Process Technical Specification, • the LMP provisional validation document, • justifications obtained (test operation, calculation and material documents, etc.), if any. The Quality sector, incorporated into the LMP, is responsible for archiving the Synthesis Sheet. 2.2.5.2 Qualification of the process/manufacturer pair Responsibility for process/manufacturer pair qualification devolves upon: •
the LMP internally
•
The External Supplies Quality department, which may call upon the LMP if required for processes that are implemented externally.
"This document is the property of EUROCOPTER; it shall in no case 11 be duplicated and/or circulated without prior written approval from EUROCOPTER and its content shall not be disclosed to third parties". EUROCOPTER 04/2001
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Page 9/ 13 2.2.5.2.1 Qualification conditions Following qualification of a process developed in an industrial laboratory or in a pilot workshop, the process/manufacturer pair must be qualified when this process is to be implemented on other sites. It is also necessary to qualify the process/manufacturer pair when EC sub-contracts the performance of a process that has already been qualified internally in EC. Qualification may be customised according to the process in question and the workshop in which it is to be implemented. This customisation is made with LMP approval. Qualification is a priori valid for any component resulting from the process/manufacturer pair. Under exceptional circumstances, restrictive qualification of a component or component type may be declared (as a function of component classification for example). Qualification of the process/manufacturer pair is acquired after positive results have been achieved for the 4 following steps: a) Assessment of the manufacturer's Quality System. This step does not apply to EC, ECD and other companies belonging to the Group. b) Specific process audit. This step may be implemented by EC, ECD and other companies belonging to the Group at their discretion. c) A demonstration of the workshop's suitability to fulfil, by applying the process, the requirements specified in terms of performance (HS process or equivalent documents). Proof is provided according to the process and the manufacturer, either: Ø by means of tests performed on test specimens and possibly on components These tests are laid out: v either in HS Processes, v or in qualification documents particular to each process type. v In the absence of such documents, the test programme is drafted by LMP. Ø by experience taking previous results into consideration (for example, comparison with qualification granted by other aeronautic order issuers). Some processes do not require testing: these are those for which « Not applicable » is marked under qualification documents d) Operator training is carried out according to the specific requirements provided in the process implementation documents and/or through qualification of an operator carrying out an activity subject to regulation (NDT, welding, …) 2.2.5.3 Process reliability enhancement Reliability enhancement involves checking that the first products that are produced via the implementation of the qualified process and means, comply in every way with the definition, in a reproducible manner. This check is carried out by means of specific checks, which may be destructive. Testing is described and set out in the specific qualification documents, or even HS processes. 2.2.5.4 Declaration of Process/Manufacturer pair Qualification: "This document is the property of EUROCOPTER; it shall in no case 11 be duplicated and/or circulated without prior written approval from EUROCOPTER and its content shall not be disclosed to third parties". EUROCOPTER 04/2001
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Page 10/ 13 Outside EC, qualification of the Process/Manufacturer pair is embodied by the issuing of a "Process/Manufacturer pair qualification report" (form F070 004). This report is issued and archived; by the External Supplies Quality department. The Process/Manufacturer pair qualification report authorises delivery of series-production components, with a standard test plan. For processes implemented within EC, it is not mandatory to draft and archive the Process/Manufacturer pair qualification report. 2.2.6
Monitoring qualification The aim of monitoring is to ensure that no deviations to the process occur. It is grounded on: • the « Series-production » inspection plan, as it is laid out in the manufacturing and/or test documents, • periodic monitoring which is mainly applied to the following parameters: Ø organisation, Ø operation modes, Ø human and industrial resources, Ø the components, ingredients and materials, Ø the environment (environment, temperature, hygrometry, etc.), Ø equipment storage and handling conditions, Ø changes in manufacturing conditions: methodology, means, procurement, site, etc. Ø the duration for which activity is interrupted Monitoring is carried out based on specific documents or monitoring process layout sheets, if they exist, for each process, drawn up following the creation of the process (the list of parameters to be monitored and the intervention frequency are included in the application documents). A Monitoring report is drawn up and identifies any corrective actions that it may be necessary to implement.
2.2.7 The control of process changes Qualification is called into question when the initial conditions under which the processes implemented change, as they are identified when process qualification is declared. This notably includes the following events: •
deterioration of quality, observed by the monitoring described hereover or via information feedback concerning any technical facts or events reported on the production line or on the flight line or by the Client,
•
process changes,
•
manufacturing condition changes,
•
changes in the implementation means,
This may lead to the re-performance of either all or some of the qualification steps. The change request should be forwarded to: •
LMP (for processes used within EC)
"This document is the property of EUROCOPTER; it shall in no case 11 be duplicated and/or circulated without prior written approval from EUROCOPTER and its content shall not be disclosed to third parties". EUROCOPTER 04/2001
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to the External Supplies Quality department (for processes used outside EC)
All change requests are analysed by the LMP, which then draws up the Requalification Programme that includes either all or some of the Development and Qualification steps. The Synthesis Sheet or the Process/Manufacturer pair qualification report is updated as a result of this . Similarly to initial qualification, the monitoring of all changes currently being processed is achieved through a managerial chart as defined in 2.1
"This document is the property of EUROCOPTER; it shall in no case 11 be duplicated and/or circulated without prior written approval from EUROCOPTER and its content shall not be disclosed to third parties". EUROCOPTER 04/2001
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APPENDIX 1: Example of a monitoring table for qualification underway 1 Processes
2 3 Manufacturer Requirements s Expression
4 Qualification Programme (reference doc.)
5 Result synthesis documents
6 7 LMP validation Application document de document (with associated (IFMA, HS, …) restrictions)
8 Synthesis Sheet
9 Process/manufactu rer qualification report
Management of information mentioned in the table 1. Information mentioned in the table shall be filled in and monitored by the LMP. 2. Information that is « greyed » in the table shall be circulated outside LMP to the services involved. 3. The monitoring table will incorporate both qualification of new processes and qualification of changes in pre-qualified processes
"This document is the property of EUROCOPTER; it shall in no case be duplicated and/or circulated 11 without prior written approval from EUROCOPTER and its content shall not be disclosed to third parties". EUROCOPTER 04/2001
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APPENDIX 2 – PROCESS CONTROL
Connections between the DPF 09-01 and EP 09-02
Preliminary design report Critical design report
DPF 09.01
INDUTRIA L GO MARK
Provisional First RIP Article Inspection
First Article RI Inspection
PRE-PROJECT DESIGN DRAWING / MAN. PROT DEVELOPMENT SERIES-PRODUCTION DRAWING
EP09.02 TECH. PRODUCTS REQUIREMENT EXPRESSION
SERIES-PRODUCTION PREPARATION SELECTION
SERIES-PRODUCTION
ASSESSMENT Creation DEVELOPMENT (on test samples, on components)
RELIABILITY ENHANCEMENT
(pre-series) CRUISE PRODUCTION VALIDATION PROCESS QUALIFICATION PAIR QUALIFICATION
BENCH MARK QA BENCH MARK QA 1 2
TECHNICAL REQUIREMENTS SPECIFICATION
LMP DOC
BENCH MARK QA 3 Qualif. programme Process specifications
LMP DOC
BENCH MARK QA 4 EVALUATION Technical shets (FT), Inspection sheets (IF), QA. etc. Synthesis Sheet
First Article Inspection, Report
"This document is the property of EUROCOPTER; it shall in no case be duplicated and/or circulated 11 without prior written approval from EUROCOPTER and its content shall not be disclosed to third parties". EUROCOPTER 04/2001
