SAE AS 13004:2017 pdf free download – Process Failure Mode and Effects Analysis (PFMEA) and Control Plans

SAE AS 13004:2017 pdf free download – Process Failure Mode and Effects Analysis (PFMEA) and Control Plans.
• Identification and results of actions taken to reduce or eliminate risk
The FMEA assists in the identification of CIs as well as Key Characteristics, helps prioritize action plans for mitigating risk, and serves as a repository for lessons learned. These may include: System FMEA. Interlace FMEA, Design Failure Mode and Effects Analysis (DFMEA). and Process Failure Mode and Effects Analysis (PFMEA).
INSPECTION PLAWEST PLAN: A detailed description of inspection and test activities (e.g., tolerances, methods, gauges) for features or attributes to be performed during specific manufacturing operations.
KEY CHARACTERISTIC (KC): An attribute or feature whose variation has a significant effect on product fit, form, function, performance, service life, or producibility, that requires specific actions for the purpose of controlling variation (refer to
AS9100).
This definition is further explained as follows:
• Product or system KCs are those selected geometrical, material properties. functional, and/or cosmetic features; which are measurable, and whose variation control is necessary for fulfilling customer requirements and enhancing customer satisfaction.
• Process KCs are those selected measurable characteristics of a process whose control is essential to manage variation of product or system KCs.
• Substitute KCs may be identified when a customer defined KC is not readily measurable, within the productioft”maintenance setting, and other characteristics may need to be controlled to ensure conformance.
NOTE: Design output can include identification of Cis that require specific actions to ensure they are adequately managed. Some CIs shall be further classified as KCs because their variation needs to be controlled.
ORGANIZATION: Person or group of people that has its own functions with responsibilities, authorities and relationships to achieve its objectives (refer to ISO 9000).
PREVENTION CONTROL: Prevention control descses how a cause and/or failure mode Is prevented or how the rate of occurrence is reduced. It is used as input to the occurrence ranking when integrated as part of the process.
PROCESS: A combination of people, material, machines. tools, environment, and methods that produce a product or service
PROCESS CHARACTERISTICS: Process variables that have a cause and effect relationship with design characteristics. Process characteristics can only be measured at the time they occur.
PROCESS FLOW DIAGRAM (PFD): A representation of the sequential steps of the process which includes all operations from receipt of the material through to storage, packaging. and shment.
• Design Risk Analysis (e.g., DFMEA)
• Existing PFMEA on similar products and processes
• Product KCs (including customer defined KCs)
• Process KCs (potential or as defined in the design records)
• Control Plan from similar processes
4.7.2 Outputs from the development of a PFMEA shall Include:
• PFMEA with action plans to mitigate risks where necessary
• Product and process KCs identified through the PFMEA
4.7,3 The organization shall use the PFMEA methodology to identity additional product KCs and/or relevant process KCs, in addition to those defined in the design records.
4.7.4 The PFMEA shall include all operations Identified in the PFD. Details of steps within each operation shall be considered and included based on the potential risk (see Appendix C. Figure C3 and C4).
4.7.5 The PFMEA severity, occurrence and detection rankings shall be reviewed and actns considered for reprioritization when changes are made to the process or product, when rate of failure occurrence is not reflective of actual frequency, nonconformance has occurred that was not previously listed or when new controls are implemented or existing controls modified.
4.7.6 PFMEA Template and Ranking Criteria
4.7.6.1 The organization shall use the PFMEA template defined within this standard, or one with equivalent content (see Appendix F). Any deviation to this shall be approved by the customer.
4.7.6.2 The organization shall use the severity, occurrence, and detection ranking cnteria defined within this standard (see Appendix E). Use of alternative ranking criteria is acceptable with prior customer approval.
4.7.7 Identification of Potential Failure Modes
4.7.7.1 The PFMEA shall identify potential failure mode(s). Any potential manner in which the product could fail to meet requirements or fail to deliver the intended function shall be considered as a potential failure mode.
NOTE: Experiences based on similar products can be a valuable input. To aid failure mode identification, the team should also refer to previous product history, similar product history, lessons learned, customer feedback, etc.