SAE AS 13004:2017 – Process Failure Mode and Effects Analysis (PFMEA) and Control Plans.
In this Aerospace Standard, the following verbal forms are used:
• shalr indicates a requirement;
• should” indicates a recommendation;
• ma indicates a permission;
• can” indicates a possibility or a capability.
Information marked as “NOTE:” is for guidance in understanding or clarifying the associated requirement.
Fo the purpose of this standard, terms and definitions stated in ISO 9000 and the following definitions apply. An acronym log for this document is detailed within Appendix [
ALTERNATIVE PROCESSES: Alternative piocesses are different approved processes used to achieve the same output (e.g., backup equipment, secondary source, alternative approved sequence).
CHARACTERISTICS MATRIX: An analytical technique for displaying the relationship between process parameters and manufacturing Stations.
CONTAINMENT PLAN: Action to control and mitigate the impact of a nonconformity and protect the customers operation (stop the problem from getting worse); includes correction, immediate corrective action, immediate communication, and verification that the nonconforming situation does not further degrade (refer to AS91O1).
CONTROL PLAN: A documented description linking manufacturing process steps to key inspection and control activities. The intent of a Control Plan Is to control the design characteristics and the process variables to ensure product quality.
CRITICAL ITEMS (CI): Those items (e.g., functions, paris, software, characteristics, processes) having significant effect on the provision and use of the products and services; including safety, performance, form. fit, function, producibility, service life. etc., that require specific actions to ensure they are adequately managed. Examples of critical items include safety critical items, fracture critical items, mission critical items, key characteristics, etc. (refer to AS91 00).
CUSTOMER: Person or organization that could or does receive a product or a service that is intended for or required by this person or organization (refer to ISO 9000).
Example: Consumer, client, end-user, retailer, receiver of product or service from an internal process, beneficiary, and purchaser.
DESIGN CHARACTERISTICS: Those cmensional. visual, functional, mechanical, and material features or properties, which describe and constitute the design of the article, as specified by drawing or Digital Product Definition requirements. These characteristics can be measured, inspected, tested. or verified to determine conformance to the design requirements. Dimensional features include in process locating features (e.g.. target-macfined or forged’cast dimensions on fo4’gings and castings, weld’braze joint preparation necessary for acceptance of finished joint). Material features or properties may include processing variables and sequences, which are specified by the drawing or Digital Product Definition (e.g.. heat treat temperature, fluorescent penetrant class, ultrasonic scans, and sequence of welding and heat treat). These provide assurance of intended characteristics that could not be otherwise defined (refer to AS91 02).
NOTE: For the purpose of this standard Design Characteristic is also known as Product Characteristic.
DESIGN RECORDS: The records of the engineering definition/specification, which fully define the product (system, part, component, or assembly), including physical or electronic/digital drawings, electronic/digital models, software, or other associated information. This Includes records of authorized engineering changes not yet incorporated into the released engineering definition/specification.
DESIGN RISK ANALYSIS: Analytical techniques used by the design responsible organization to identify, to the extent possible. potential failure modes related to product performance (i.e.. fit, form, and function), durability, manufacturability, and cost.
DETECTION CONTROL: Control to detect the cause of the failure mode or the actual failure mode after it has occurred. FAILURE MODE AND EFFECTS ANALYSIS (FMEA): A structured method for analyzing risk by ranking and documenting potential failure modes in a system, design, or process. The analysis includes:
• Identification of potential failures and their effects
• Ranking of factors (e.g., severity, frequency of occurrence, detectability of the potential failures)
• Identification and results of actions taken to reduce or eliminate risk
The FMEA assists in the identification of CI5 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, Interface FMEA, Design Failure Mode and Effects Analysis (DFMEA), and Process Failure Mode and Effects Analysis (PFMEA).
INSPECTION PLAN/TEST PLAN: A detailed description of inspection and test activities (e.g., tolerances, methods, gauges) tor features or atinbutes to be performed during specific manufacturing operations.
KEY CHARACTERISTIC (KC): An attnbute or feature whose vanahon has a significant effect on product fit, form, function, performance, service life, or producioility. that requires specific actions for the purpose of controlling variation (ref or to
AS9 100).
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 vanation of product or system KCs.
• Substitute KCs may be identified when a customer defined KC is not readily measurable, within the production/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 KC5 because their variation needs to be controlled.