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BS EN 9103:2023 – TC

$217.84

Tracked Changes. Aerospace series. Quality management systems. Variation management of key characteristics

Published By Publication Date Number of Pages
BSI 2023 84
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1.1 General This document is primarily intended to apply to new parts and products intended to be produced in an on-going production phase but can also be applied to parts currently in production (e.g., manufacturing, maintenance). This document is applicable to all production processes that influence the variation of KCs, as well as maintenance and service processes in which KCs are identified. It applies to organizations for assemblies and all levels of parts within an assembly, down to the basic materials including castings and forgings, and to organizations that are responsible for producing the design characteristics of the product. The variation control process begins with product definition, typically stated in the design documentation (e.g., digital model, engineering drawing, specification) which identifies KCs, and leads to a variation management process for those KCs. This process may also be used for producer-identified KCs (e.g., process KCs, additional/substitute product KCs). Producers and their subcontractors are responsible for flow down of the standard requirements to those external providers, who produce design characteristics and provide production and service provisions, to ensure that KCs conform to the customer’s requirements. 1.2 Purpose This document is designed to drive the improvement of manufacturing and maintenance processes through adequate planning and effective management of KC variation. This focus is intended to improve uniformity (less variation or minimum variation of product KCs) and acceptance probability of the end-product. NOTE Control of a product or process KC per this document does not constitute, nor imply acceptance of the resulting product. If variation management, under this document, is to be part of an acceptance decision, the requirements need to be specified in the applicable product acceptance plan or contract. 1.3 Convention The following conventions are used in this document: – “shall” indicates a requirement; – “should” indicates a recommendation; – “may” indicates a permission; and – “can” indicates a possibility or a capability.

PDF Catalog

PDF Pages PDF Title
48 undefined
56 1 Scope
1.1 General
1.2 Purpose
1.3 Convention
57 2 Normative references
58 3 Terms and definitions
61 4 General requirements
4.1 Flow down of product key characteristics
62 4.2 Preparation of control plan inputs and outputs
63 4.3 Conditions for performing statistical process control
4.4 Application of switching rules
4.5 Restrictions of statistical process control
64 4.6 Personnel competence and training
4.7 Key characteristic variation management and control documentation
65 5 Process model for variation management of key characteristics
5.1 General
67 5.2 Stage 1: conduct product performance and key characteristics review
5.2.1 Reviewing customer provided design documentation to identify product key characteristics
5.2.2 Determining process key characteristics
5.2.3 Identifying substitute product key characteristics
68 5.2.4 Releasing and maintaining identified key characteristics
5.2.5 Outputs of stage 1
5.3 Stage 2: define the plan to ensure a capable process
5.3.1 Preparing the control plan
69 5.3.2 Developing the manufacturing or maintenance process flow diagram
5.3.3 Developing a manufacturing or maintenance process risk analysis
70 5.3.4 Establishing the manufacturing or maintenance process
5.3.5 Updating the control plan
5.3.6 Outputs of stage 2
5.4 Stage 3: operate the process on trial basis to generate data
5.4.1 Developing the data collection plan
71 5.4.2 Producing trial parts
5.4.3 Conducting a measurement system analysis study
72 5.4.4 Collecting data to monitor process performance
5.4.5 Plotting collected data or summary statistics on control chart
73 5.4.6 Updating the control plan
5.4.7 Outputs of stage 3
5.5 Stage 4: analyse data for action
5.5.1 Reviewing the control chart to monitor process performance
74 5.5.2 Periodically analysing the data to ensure on-going process capability
5.5.3 Pursuing investigation into out-of-control conditions or sources of variation
5.5.4 Updating the control plan
5.5.5 Outputs of stage 4
5.6 Stage 5: take action from process performance study
5.6.1 Applying the control plan’s reaction plan to deal with an unstable process
75 5.6.2 Performing measurement system analysis to deal with incapable process
5.6.3 Implementing the plan to achieve containment
5.6.4 Updating the control plan
76 5.6.5 Outputs of stage 5
5.7 Stage 6: continue to monitor the process
5.7.1 Conducting verification of process performance on a regular basis
5.7.2 Continually reviewing quality and/or workmanship indicators
5.7.3 Outputs of stage 6
77 5.8 Stage 7: manage process change
5.8.1 Documenting changes
5.8.2 Implementing changes, as required
5.8.3 Outputs of stage 7
5.9 Maintaining documentation to demonstrate compliance
6 Control plan content requirements
6.1 Purpose
6.2 General control plan principles and elements
79 6.3 Variation management
80 Annex A (informative)Acronym log
81 Annex B (normative)Reaction plan guidance (use/application and content)
BS EN 9103:2023 - TC
$217.84