BAE Systems
April 12th, 2021
Electronic Systems Inc.  
SUMMARY
The purpose of the PPAP Submission Guide is to assist the supplier to complete the various aspects of the Enhanced First Article (PPAP).
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12 Apr 2021
Updated to align with AS9145 and associated BAE documents. Updated to reflect associated command media
Table of Contents 1.0 Purpose 5 2.0 Scope - When is PPAP Submission Required? 5 3.0 Reference Documents 5 4.0 Terms and Definitions 6 Key Control Characteristic (KCC) 8 5.0 Requirements for PPAP Submission: 9 6.0 PPAP Submission Clausing: 10 7.0 Submission Method 10 7.1 Submission Status 10 7.2 Ongoing Requirements 11 7.3 Changes 11 7.4 Partial Submissions 11 7.5 Post Submission Activites 13 8.0 Instructions for completing a PPAP Submission 14 8.1 Design Records and Ballooned Drawings 14 8.1.1 Key Characteristics 15 8.1.2 Completing the balloon drawing 15 8.2 Approved Engineering Change Documentation 16 8.3 Customer Engineering Approvals 16 8.4 Manufacturing Feasibility Assessment 16 8.5 Design Failure Mode and Effects Analysis (DFMEA) 17 8.5.1 10 Steps to Conducting a DFMEA 17 8.5.2 Completing the DFMEA 19 8.5.3 Severity (DFMEA) 21 8.5.4 Occurrence (DFMEA) 21 8.5.5 Detection (DFMEA) 22 8.6 Process Flow Diagrams 23 8.7 Process Failure Mode Effects Analysis (PFMEA) 25 8.7.1 Severity (PFMEA) 31 8.7.2 Occurrence (PFMEA) 32 8.7.3 Detection (PFMEA) 33 8.8 Control Plan 34 8.8.1 Completing the Control Plan 35 8.9 Measurement System Analysis (MSA) 36 8.10 Packaging 38 8.11 FAI (First Article Submission) 39 8.11.1 When is a Full FAI Required? 39 8.11.2 When is a Partial FAI Required? 39 8.11.3 Submission of the FAI Report 40 8.12 Material and Performance Test Results 43 8.13 Initial Process Study (Cpk, Ppk) 44 8.14 Qualified Laboratory Documentation 45 8.14.1 Internal Labs located at Supplier 45 8.14.2 External Labs located offsite from the Supplier 45 8.15 Sample Parts 45 8.16 Checking Aids 45 8.17 Customer Specific Requirements 46
Purpose
The purpose of the PPAP Submission Guide is to assist the supplier to complete the various aspects of the Enhanced First Article (PPAP) as part of a process in accordance with AS9145.
The purpose of the Production Part Approval Process (PPAP) is:
1. To provide the evidence that all engineering, design record and specification requirements are properly understood and fulfilled by the manufacturing organization.
2. To demonstrate that the established manufacturing process has the potential to produce consistently conforming product which meets all requirements during an actual production run at the quoted production rate.
Scope - When is PPAP Submission Required?
BAE Systems may require a PPAP submission per purchase order requirements, when any of the following occur:
New parts, process or suppliers
1. New part or product
2. New process or technology
3. New supplier
2. New, additional or modified tools
3. Refurbishment of current tools
4. Production or equipment transfer to a different location
5. Change of sub supplier or material source
6. New source of raw material
7. Change in production process or method
8. Product when tooling has been inactive for 12 months or greater.
9. Major environmental impact affecting fit, form or function of the product.
Reference Documents
SAE International AS9145™ – Requirements for Advanced Product Quality Planning and Production Part Approval Process
SAE International AS9103 – Variation Management of Key Characteristics
SAE AS13003 Measurement Systems Analysis Requirements for the Aero Engine Supply Chain
SAE AS9102 Aerospace First Article Inspection Requirement
SAE AS13004 Process Failure Modes and Effects Analysis (PFMEA) and Control Plans
MIL-HDBK-896 Department of Defense Handbook – Manufacturing Management Program Guide
AIAG FMEA Manual
AIAG APQP Manual
AIAG PPAP Manual
AIAG SPC Manual
AIAG MSA Manual
AIAG SPC Manual
AIAG MSA Manual
IEEE 1490:2011 Adoption of the Project Management Institute (PMI(R)) Standard; A Guide to the Project Management Body of Knowledge
B25279: Supplier Requirements for FAI Reports
BAE Systems Supplier Variation Request (SVR)
J1739 JAN2009 PFMEA, DFMEA
Bill of Material (BOM):
Total list of all components and materials contained in the design record of a product required to manufacture the product.
Containment:
Recognition, identification and where possible, the segregation of the entire population affected by the condition of nonconformance. Containment includes raw material, stock inventory, kits, work-in-process, product in sell-off, finished goods inventory, goods in transit, and goods at BAE Systems.
Control Plan:
A written description of the systems for controlling production parts, materials and processes. Control plans identify the important characteristics and engineering specifications of the product and how they are controlled to assure quality of the product. The control plan should be linked to the process flow diagram and the process failures modes and effects analysis.
Critical Item (CI):
Those items (e.g., functions, parts, characteristics, processes) having significant effect on the product realization and use of the product; including safety, performance, form, fit, function, producibility, service life, etc.; that require specific actions to ensure they are adequately managed. Examples include: safety CIs, fracture CIs, mission CIs, Key Characteristics (KCs), and maintenance tasks critical for safety (reference AS9103 standard). These Critical Items are candidates to become KC’s (Key Characteristics and KCC’s (Key Control Characteristics.).
Hardware Engineering shares the drawings with BAE Systems Supplier Quality Engineer for determining information needed from suppliers. This communication should include a technical discussion of the Key Characteristics & risks to ensure understanding.
When Key Characteristics are not identified on the drawing the BAE Systems Supplier Quality Engineer can work with the supplier to identify the Quality Characteristics used to help the supplier know the process is performing as intended.
Correction:
Customer:
The recipient of the supplier’s or organizations products or service.
Deliverables:
Design Records:
Design Risk Analysis:
Analytical techniques (e.g., Design Failure Modes and Effects Analysis – DFMEA) 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. [Reference SAE J1739 FMEA Standard].
Design Validation
The assurance that a product, service, or system fulfills the needs of the customer and other identified stakeholders. It often involves acceptance with external customers (defined in IEEE 1490:2011). Relevant types of validation include: – Confirmation through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled. Testing and/or analysis to ensure the product design conforms to defined user needs and/or requirements. Design validation follows successful design verification and may involve preproduction product (e.g., development, prototype) [Reference SAE AS9145 Aerospace Series – Requirements for Advanced Product Quality Planning (APQP) and Production Part Approval Process (PPAP)].
Design Verification
Testing to assure that all design outputs meet the requirements of the design inputs with objective evidence that the specified product requirements have been fulfilled. Testing and/or analysis to ensure that all design outputs satisfy requirements may include activities such as: design review, performing alternate calculations, understanding tests and demonstrations, and review of design stage documents before release [Reference SAE AS9145 Aerospace Series – Requirements for Advanced Product Quality Planning (APQP) and Production Part Approval Process (PPAP)].
Failure Mode and Effects Analysis (FMEA):
An organized methodology used to assure that potential design and manufacturing risks are mitigated through mistake proofing and design/process enhancements. Potential risks are ranked and prioritized for improvement. [Reference SAE J1739 FMEA Standard].
PFMEA: Process FMEA
DFMEA: Design FMEA
Key Characteristic (KC)
An attribute or feature whose variation has a significant influence on product fit, performance, service life, or producibility; that requires specific action for the purpose of controlling variation (reference AS9103, AS9145, SAE J1739 standards).
KCs for a part, subassembly, or system are those selected geometrical, material properties, functional, and/or cosmetic features; which are measurable, whose variation control is necessary in meeting customer requirements and enhancing customer satisfaction.
Key Control Characteristic (KCC)
Measurable characteristics of a process whose control is essential to manage variation of part, subsystem, or system KCs.
Key Control Characteristic (sometimes called Special Process Characteristic or process KC) is a parameter that requires special care. Key Control Characteristics are monitored during manufacturing/assembly. The purpose of the KCC is to ensure the process is monitored to maintain validated settings and identify variation anomalies requiring attention. Monitoring process characteristics is preferred over measuring the correlated product characteristics. (SAE J1739)
Measurement Systems Analysis (MSA)
A study of the effects of selected elements (repeatability and reproducibility) of a measurement process on accuracy, precision, and uncertainty of measurement. [Reference SAE AS13003 Measurement Systems Analysis Requirements].
Nonconformance:
The failure or potential failure of a characteristic to conform to the requirements specified in a contract, purchase order, drawing, specification or other approved product description. Potential/suspect non-conformances include improper handling, storage, transport, and exposure to out-of-tolerance environmental, test or process conditions.
Nonconforming Material:
Any item, part, or product containing one or more nonconformance
Preliminary Capacity Assessment:
An assessment performed early in the process planning and development phase to determine resources (e.g., people, equipment, facilities) necessary to produce product at the customer demand rate.
Preventive Action:
Action to eliminate the cause of a potential nonconformity or other undesirable condition. If a nonconformance has not occurred, but an action is taken to proactively reduce the risk of a nonconformance, the action is preventive. [Reference SAE J1739 FMEA Standard].
Process Capability:
Process Validation:
Confirmation through physical demonstration that a process consistently produces a result or product fulfilling its predetermined specifications, including key product or process characteristics which are stable and capable at the desired level. [Reference SAE J1739 FMEA Standard].
Production Process Verification (PPV):
A review of the manufacturing process (e.g., equipment, operator training, manufacturing documentation, control plan, associated measurement tools) by a multi-disciplinary team to verify that the production processes are appropriately defined, documented, and ready for production.
Repair:
A procedure that reduces but does not eliminate a nonconformance and is approved by the Customer when required by contract.
Rework:
A procedure applied to a nonconformance that will completely eliminate the nonconformance, and result in a characteristic that conforms completely to the drawing, specification or contractual requirement.
SCAR:
Scrap:
Nonconforming material that is not usable for its intended purpose that cannot be economically reworked.
Supplier:
The entity or party that supplies product or services to a customer in accordance with contract requirements.
Requirements for PPAP Submission:
BAE Systems PPAP requirements are based on AS9145 and AIAG "Production Part Approval Process" standard. The following elements are required (unless otherwise specified by the BAE Systems Supplier Quality Engineer):
1. Design Records (If Applicable)
2. DFMEA (If applicable)
3. Process Flow Diagram
8. Packaging, Preservation, and Labeling Approvals
9. FAI: First Article Inspection
10. Customer Specific Requirements
11. PPAP Approval Form
NOTE:
BAE Systems provides suggested templates of all forms for the PPAP submittal, however Supplier generated forms meeting the requirements of SAE INTERNATIONAL AS9145™ or AIAG may also be utilized.
Completion and submission of PPAP records conveys no additional data rights to BAE Systems than that defined in the respective Procurement Agreement.
PPAP Submission Clausing:
There are two forms of PPAP submission Clausing:.
099 Clause – This Clause requires the supplier to engage in the review and creation of the PPAP deliverable in Phase one and Phase II of the product introduction cycle. It encompasses the Design Records, and DFMEA Deliverables (Elements 1 and 2).
199 Clause – This clause is intended to cover all the 5 phases of the product introduction cycle. All of the 11 PPAP Elements listed above may be selected for submission. In addition to the PPAP deliverables, there may be a Process Control Audit that is conducted subsequent to the submission of the PPAP package.
Submission Method
PPAPs ARE NOT TO BE SENT VIA REGULAR, UNSECURE EMAIL!!!
PPAPs are considered Technical Data and therefore must be controlled in accordance with contractual requirements specified in the special provisions of the Purchase Order / Subcontract or incorporated Terms and Conditions.  Such requirements may include ITAR, Export Control, and Proprietary Information Agreements.  Unclassified technical data shall be submitted through BAE Systems approved methods including but not necessarily limited to Secure File Transfer System (SFTS), Exostar, or physical mail. 
Classified technical data shall be specially handled as specified in the Purchase Order or Subcontract. 
Contact your BAE Systems procurement representative to confirm the approved transmittal method. 
Submission Status
The PPAP approval process will be carried out by BAE Systems. The PPAP submission will be reviewed and dispositioned one of the following ways:
APPROVED:
A formal acceptance of the submission which has met all of the criteria set by BAE Systems
REJECTED:
The submission is not acceptable and does not meet the criteria set by BAE Systems
INTERIM:
An interim approval can be given if it is deemed by BAE Systems that product is useable. The interim status is a temporary approval for a specified time-frame which is determined by BAE Systems. The interim approval shall contain and expiration date and notes which elements require modification. The supplier must implement the required corrective actions and re-submit PPAP for full approval during this time frame. If a re-submission does not occur within the required time-frame the PPAP will be rejected.
Ongoing Requirements
BAE Systems reserves the right to request any information you have provided in any data or document in any element of approval, at any time, including after the approval has been granted. The PF, CP, and PFMEA are “living” documents and should be updated as risks are mitigated, new risks are identified, or additional controls are put in place.
Changes
In order to minimize risks associated with changes, BAE Systems will require PPAP revisions and submittal ahead of such changes. These changes can originate at the supplier (new risks identified and mitigated, equipment or facility moves, etc.) or at BAE Systems (Engineering Changes). Changes are normal and part of the continuous improvement process. Some triggers for change are:
· Customer Requirement (New/additional)
· A lapse in Production
If a change is identified, the supplier will need to contact the assigned BAE Systems Supplier Quality Engineer & Supply Chain Lead to request a PPAP Approval Form indicating the requirements for approval of the change. The BAE Supplier Quality Engineer & Supply Chain Lead will assess the nature of the change relative to the APQP documents and the balance of the PPAP elements. This risk review will also include the complexity and criticality of the part or assembly. Once completed the supplier will be presented with the requirements indicated for interim or full approval.
BAE Systems to be able to receive material after the change. If a change is discovered without proper PPAP approval, BAE Systems may render the previous PPAP as invalid and therefore, new material receipts may not be able to be processed.
Partial Submissions
Partial submissions are allowed provided the assigned BAE Systems SQE has reviewed the circumstances and indicates which elements will be submitted on the PPAP Approval form. Any substitutions from the standard submission should be noted on the form. The following are examples where the SQE may adjust the expectations;
· Phase I
· If the supplier does not have design authority or the part is currently being produced, the design records may not be required.
· There should be an assessment of the sourcing plan relative to the following;
· Technology
· Logistics
· Productivity
· Capability
· Quality
· Cost
· These assessments should be carried forward into the APQP Phase III where they can be integrated into the PFMEA and Control Plan as appropriate.
· A parts list may be used in place of a BOM provided the SQE agrees.
· An unreleased drawing can be used as part of interim approval but a released drawing must be in place before full PPAP approval is granted.
· Phase II
· If the supplier does not have design authority or the part is currently being produced, the DFMEA may not be required.
· A CDR (Critical Design Review) may be used instead provided the SQE agrees.
· Key points from DFMEA’s created by BAE may be carried forward for consideration when the Control Plan and PFMEA is being created.
· A revised DFMEA may be required if the Design Change or Reliability triggers noted in Section 5.4 are in play.
· Phase III
· In cases of Corrective Action, a partial PPAP submission that includes the APQP documentation affected (Process Flow, Control Plan, PFMEA) and a new Approval Sheet, can be allowed.
· Phase IV
· A partial Submission that includes the Capability Study and associated MSA may be required if the value add process affecting a key characteristic is changed.
· Phase V
· The SQE shall use his/her discretion to determine which metrics will be tracked and how they will be reported back to the supplier.
· Partial PPAP Submission
· A partial submission may be required when any of the triggers in Section 5.4 of this document are in place.
Post Submission Activities
· Control Plan Audits
If required, Control Plan audits will be scheduled to verify execution against the APQP documents and to ensure the documents are updated, when appropriate, as related to Changes and Corrective Actions. Audits can be conducted either virtually or onsite. In either case, the auditor will work collaboratively with the supplier to verify adherence to the documentation.
· Pre-work
The BAE Systems Supplier Quality Engineer will require to obtain the most current versions of the following documents;
· Purchase Order
· Shop Traveler
· PFMEA
The documents will be assessed to see if they are in alignment with each other relative to part, drawing revision, and sequence of operations.
· GEMBA Walk
If required, a walk of the process will be conducted onsite with the supplier using the Control Plan as the guiding document. The review must start at Receiving Inspection and continue through Shipping. The following items will be verified;
· Each Process Operation Name and Number identified.
· All machines, devices, and jigs listed.
· The balloon number on the drawing corresponds with the product characteristic listed on the plan.
· Process and Product characteristics are clearly identified.
· All special or Key characteristics are listed.
· The requirement is defined.
· The measurement technique with frequency and sample size is listed.
· The measurement system for Key characteristics is approved.
· There is a reaction plan for each operation.
· Quality System Assessment
The suppliers Quality System will be assessed for the following areas;
· PPAP Overview
· Notification of Changes
· Supplier must notify of any changes to their process, special processes, or materials prior to any changes.
· Any changes in drawing revision will require a partial PPAP submission.
· Reference Section 7.3 Changes of this document for a list of triggers that require the review of the PPAP submission to determine if customer notification and a re-submission is needed.
Instructions for completing a PPAP Submission
The Part Submission Warrant (PSW) must be filled out and signed by the supplier.
Figure 1: BAE Systems PPAP Submission Form
The part number must match the Purchase Order issued by BAE Systems.
The correct Hardware and Drawing revision level and submission level must be entered.
Any fields that do not apply to your submission should be filled in with “N/A” (Not Applicable).
It is important that the PPAP approval Form is filled out correctly and contains accurate and legible information.
Design Records and Ballooned Drawings
The purpose of designed records and ballooned drawings is to document and provide a copy of the formal drawing and to provide any additional engineering records for reference.
Figure 2: Ballooned Drawing Example
A ballooned drawing shows the parts or assemblies in a part drawing with numbered “balloons” that point to individual requirements of the part. The numbers on the ballooned drawing correlate with the numbers found on the Dimensional Data Sheet. A ballooned drawing must be submitted as part of the PPAP for every submission when dimensional results are required.
Key Characteristics
The purpose of selecting product Key Characteristics is to communicate the risk to manufacturing, assembly and/or other interfacing design disciplines. It is essential that manufacturing engineering is engaged during the technical discussion to understand the impact to manufacturing and assembly when selecting product design.
KCs are required for both BAE Systems and Supplier designed products. If there are no KCs on the drawing the BAE Systems Supplier Quality Engineer will work with the supplier to identify potential KCs.
BAE Systems Supplier Quality Engineer reviews Supplier Manufacturing and Assembly Documentation to confirm they identify, document, and control potential product and process KCs. Supplier Quality Engineer will ensure suppliers that are design responsible provide Product Producibility and Launch Engineer with their product and process KCs per Supplier PPAP for review and approval.
Key Product Design Characteristic (KC)
A key product (Design) characteristic (KC) is a feature of a product that requires special care because incorrect nominal values/tolerances and corresponding manufacturing/assembly variation may have significant influence on product safety, performance, fit, and service life. [Reference SAE J1739 FMEA Standard]. 
Special Process Characteristic (KCC)
A Special Process Characteristic (KCC) is a parameter that requires special care which identifies where variation must be controlled to ensure process performance remains stable. The purpose of the KCC is to ensure the process is monitored to maintain validated settings and identify variation anomalies requiring attention. These characteristics are measured while the process is running; e.g. machine settings, temperature, pressure, current, fluid level, speed, etc. Process characteristics may be standard or special as shown on a control plan. [Reference SAE J1739 FMEA Standard]. 
Completing the balloon drawing
All part requirements on the BAE Systems or Supplier drawing must be ballooned and numbered for reference and measurement. These may include:
1. Dimensions and tolerance of parts
2. Electrical requirements (performance data, functional tests, etc.)
3. Visual features (color, texture, etc.)
4. Chemical characteristics (cure time, etc.)
5. Physical and mechanical properties (tensile strength, plating thickness, heat treat hardness, etc.)
6. Any other specified requirement that you have the capability to measure or that is described in the drawing notes or reference specifications.
When dimensions are specified at multiple location on the drawing, the data for each location should be numbered separately.
Approved Engineering Change Documentation
When a supplier identifies a drawing or specification issue/error and recommends a change to the BAE Systems drawing. A Supplier Variation Request (SVR) shall be submitted to BAE Systems to review and approve the requested the change. The SVR should be made prior to fabrication or as early in the fabrication process as possible.
Please note the following:
1. Material not in compliance with drawing(s) or specification(s) shall NOT be shipped without prior BAE Systems Approval.
2. The supplier must receive an approved and closed SVR as authorization to ship product.
1. If the SVR disposition requires a drawing change then upon release of the ECO, a PO revision change will be issued to reflect the new part revision Product should not ship until ECO is completed and the SVR closed.
3. The supplier shall not perform any repair activity before getting BAE Systems approval via a documented repair procedure approved on the SVR by BAE Systems.
A copy of the Supplier Variation Request form and submission instructions can be found on the BAE Systems Supplier Quality Assurance Portal.
Customer Engineering Approvals
The supplier submission is to include BAE Systems Engineering Approval documentation when requested. This will primarily requested if the supplier has design authority of the parts/products.
Manufacturing Feasibility Assessment
If required by BAE Systems, the supplier will participate in an MFA (Manufacturing Feasibility Assessment).
The MFA review will consider the manufacturability of the design of the component or assembly. This will take into consideration availability of material and the supplier’s capability to meet the design requirements. The supplier will provide feedback on the overall manufacturability of the product.
Design Failure Mode and Effects Analysis (DFMEA)
A Design Failure Mode and Effects Analysis (DFMEA) shows evidence that potential failure modes and their associated risks have been addressed in order to eliminate or minimize their effects through product design changed and improvements.
The DFMEA is only required when the supplier has design authority of the product. The DFMEA must address all Critical Items (CI) and identify Key Characteristics (KCs).
Severity, Occurrence and Detection ratings are used when performing FMEA activities. These rating scales must be compliant with the [Reference SAE J1739 FMEA Standard] or AIAG guidelines for FMEA.
Any potential failure mode not mitigated in the DFMEA should be included in the PFMEA.
· The following items should be considered while performing the DFMEA;
· Analysis
· Inspection
· Simulation
· Testing
· Step 1 | Review the design
· Use a drawing or schematic of the design/product to identify each component and interface.
· Help assure all team members are familiar with the product and its design.
· Identify each of the main components of the design and determine the function or functions of those components and interfaces between them.
· Use a drawing or schematic for the review.
· Balloon the drawing/schematic (Add Reference Numbers to each component and interface.)
· Document the function(s) of each component and interface.
· Step 2 | Brainstorm potential failure modes
·  
· Before you begin the brainstorming session, review documentation for clues about potential failure modes.
· Use Non-conformities, Scars, Rework and Scrap reports, as inputs for the brainstorming activity.
· Consider potential failure modes for each component and interface.
· A potential failure mode represents any manner in which the product component could fail to perform its intended function or functions.
· Remember that many components will have more than one failure mode.
· Example: Four Reasons Behind Hydraulic System Failure
· Hydraulic Fluid Contamination
 
· The effect is related directly to the ability of that specific component to perform its intended function.
· An effect is the impact a failure could make should it occur.
· Some failures will have an effect on customers; others on the environment, and some on the process or product itself.
· The effect should be stated in terms of product performance. If the effects are defined in general terms, it will be difficult to identify and mitigate the true potential risks.
· Steps 4, 5, and 6 | Assign Rankings
· NOTE: The latest SAE J1739 rating scales must be used. See sections 8.5.3-8.5.5.
· Step 4 | Assign Severity rankings
·  This is based on a relative scale ranging from 1 to 10.
· A “10” means the effect has a dangerously high severity leading to a hazard without warning.
 
· Step 5 | Assign Occurrence rankings
· This is based on how frequently the failure is likely to occur on a scale from 1 to 10.
 
· Step 6 | Assign Detection rankings
·  This is based on the chances the failure will be detected prior to the customer finding it.
·  Consider the design or product-related controls already in place for each failure mode and then assign a detection ranking for each control.
· The detection ranking is an evaluation of the ability of the design controls to prevent or detect the mechanism of failure.
· A detection ranking of “1” means the chance of detecting a failure is almost certain. Conversely, a “10” means the detection of a failure or mechanism of failure is absolutely uncertain.
· Step 7 | Calculate the RPN
· RPN = Severity x Occurrence x Detection.
· The RPN (Risk Priority Number) The RPN gives a relative risk ranking.
· The higher the RPN, the higher the potential risk.
 
· Step 8 | Develop the Action Plan
· Taking action to reduce the RPN.
· The RPN can be reduced by lowering any of the three rankings (severity, occurrence, or detection) individually or in combination with one another.
· Reducing Severity usually requires a design change.
· Reducing Occurrence is accomplished by removing or controlling the potential causes or mechanisms of failure.
· Reducing Detection Ranking is accomplished by adding or improving prevention or detection controls.
· Step 9 | Take action
· Implement the improvements identified by your DFMEA team.
· The Action Plan outlines what steps are needed to implement the solution, who will do them, and when they will be completed.
 
 
· Re-evaluate each of the potential failures once improvements have been made and determine their impact on the RPNs.
· To recalculate the RPN, reassess the severity, occurrence, and detection rankings for the failure modes after the action plan has been completed.
Completing the DFMEA
The DFMEA [Reference SAE J1739 FMEA Standard] supports the design process by reducing the risk of failures. The DFMEA shall be initiated before the design concept is finalized. Each item / function needs to be addressed. Any potential failure mode of the item / function should be defined as completely as possible. Recommended actions should be recorded.
Prevention is the preferred method to address the design failure mode. If prevention is not possible, then highlight detection controls. The DFMEA is not a standalone document and should also be linked to the PFMEA and Control Plans.
BAE Systems has developed a DFMEA form which can be utilized by suppliers. The form uses embedded ratings which will automatically produce the initial Risk Priority Number (RPN). This form answers the questions of How Bad, How Often, and How Well.
Severity (DFMEA)
An assessment of how serious the Failure Effect (due to the Failure Mode) is to the customer:
Occurrence (DFMEA)
An assessment of the likelihood that a particular cause will happen and result in the Failure Mode:
Detection (DFMEA)
An assessment of the likelihood that the current controls will detect the cause of the Failure Mode or the Failure Mode itself, should it occur, thus PREVENTING the Failure Effect from reaching your customer.
Process Flow Diagrams
The purpose of Process Flow Diagrams is to document and clarify all the steps required in the manufacturing of a part. The primary process steps must be linked to both the PFMEA and the Control Plan so that all process steps are addressed for risk and control. Process flows must include the entire manufacturing process, receiving through shipping, including operation sequence numbers. Inputs and outputs for each process step should be listed. The inputs and outputs are extremely useful when creating the PFMEA and Control plan. The SAE J1739 PFD template is recommended as it has direct linkage to the PFMEA template.
Figure 3: SAE J1739 PFD template to PFMEA linkage.
Figure 4: SAE J1739 PFD template example.
Figure 5: Example of a Block PFD with inputs and outputs.
The Process Flow Diagram must also include key steps in the process and all offline activities (such as measurement, inspection and handling). The flow of the nonconforming material such as scrap parts, non-conforming parts and rework parts should also be included the supplier is not authorized to perform a repair on a part. [Reference SAE J1739 FMEA Standard or SAE AS13004 Process Failure Modes and Effects Analysis (PFMEA) and Control Plans].
NOTE: Suppliers may utilize their own Process Flow Diagram format.
Process Failure Mode Effects Analysis (PFMEA)
A PFMEA project is the entire set of PFMEAs that need to be performed during the process development timeframe to support the quality objectives of the manufacturing/assembly processes and how they relate to the safety, reliability and performance objectives of the product design [reference SAE J1739 FMEA Standard].
The scope should define the process operations required to manufacture and assemble the hardware, electrical, or software for which the team is responsible. The partitioning of the overall project into individual PFMEAs depends on who is responsible for the manufacturing, assembly, or aftermarket operations. The general rule is whomever has process responsibility has ownership for the corresponding PFMEAs. Companies responsible for manufacturing individual components will have responsibility for completing the manufacturing PFMEAs. The PFMEA is a cross functional activity and should not be conducted in isolation.
(Consider using the updated PFMEA format from SAE J1739 FMEA Standard that documents Product Key Characteristics and Process Key Control Characteristics in two columns in place of the classification column)
Potential Failure Mode:
Potential failure modes are the manner in which the manufacturing and assembly process could potentially fail to meet the defined outputs of the operation step, called “requirements” in the SAE J1739 PFMEA template. It is a description of a product defect as a result of the process failure (product non-conformance) within a specific operation. Potential failure modes can be in-process related when the process function and requirement are specific to process outcomes or a potential product defect when the function and requirement is related to a product outcome.
There are several categories of potential failure modes, including:
• Does not meet function
• Intermittent function (i.e., operation output randomly in and out of specification)
• Unintended function (i.e., operator safety)
For legacy parts, NC and SCAR history must be reviewed to include past known failures.
Potential Effects of Failure:
Effects are consequences or results of each potential failure mode and must be listed in the PFMEA. The effects, for each potential failure mode, can be the effect at the operation, subsequent operations, customer operations, as well as the end customer (operator of the vehicle). If known, the effects of a potential failure mode can include what the customer might notice or experience such as the impact safety or non-compliance to regulations (as applicable). The intent is to forecast the potential effect(s) of failure consistent with the team’s level of knowledge. Examples for the windshield wiper PFMEA are shown in Figure 39.
Potential Causes of Failure:
Causes of failure modes need to be listed in actionable terms (I see a lot of “operator error” causes instead of actionable causes like “operator selects wrong drill or operator release torque tool trigger prior to achieving torque”). There could be multiple causes to a failure mode. SAE J1739 gives good guidance on using the 6M typical cause categories which may help with discussion leading to specific causes for a given potential failure mode. Each cause needs listed separately in order to identify specific prevention/detection controls.
· Machine/equipment (machine capability, initial setup adjustment, machine wear over time, inadequate gating/venting, inadequate or no lubrication, tool wear over time, tool breakage, tool-to-tool differences, fixture tolerance, fixture adjustment, fixture wear over time, chip on locator, worn locator, weld current too high or low, weld pressure, heat treat temperature too high or low, conveyor speed too fast or too slow, equipment maintenance including repair, replacement, reassembly, and adjustment, inspection gauging failures including inaccuracies, and ineffectiveness, etc.)
· Methods/systems (sequence, procedures, layout, off-line rework/repair, off-line inspection, material flow, process control programming, scrap containment, etc.)
· Material/components (part missing, part mislocated, incoming raw material, purchased parts, previous operations)
· Manpower/operator (manual over torque, manual under torque, operator skill, ergonomic factors, time, missing or inadequate visual aids, lack of concentration, etc.)
· Measurements (gauge wear out, gauge out of calibration, etc.)
· Mother Nature (environment) (e.g., plant temperature, lighting, humidity, dust, noise, etc.)
NOTE: The above examples represent categories. Specific details need to be added to complete the cause description. Only specific errors or malfunctions (e.g., part installed upside down) should be listed; ambiguous phrases (e.g., operator error, machine malfunction) should not be used. The PFMEA team has direct or indirect responsibility towards mitigating the causal risk. Three core risk management tools may be applied to reduce risk. These are: (1) error proof the process or change the design, (2) add a preventative control, (3) add a detective control. Documenting very specific causes makes the analysis more concise and useful.
Current Prevention and Detection Controls:
A prevention control describes how a cause, failure mode or effect is prevented based on the current or planned actions, but may not be applicable for every cause and/or failure mode. Prevention process controls are based on the application of standards, specifications, process rules, process guides, lessons learned, process norms or best practices, etc., as a means to prevent the occurrence of the cause. Product and process error proofing features and devices and automated process controls are examples of prevention controls.
Detection controls describe how the operation failure mode and/or cause is detected based on automated or manual methods that are currently planned or in place, before the manufacturing or assembly process is released for production. The detection control assumes a failure has occurred and describes how a cause and/or failure mode is detected during the production process. The process control may occur at the subject operation or at subsequent operations and are used as an input to the detection ranking. When not known or not applicable, the detection controls field can be left blank and should be rated according to the detection rating criteria (i.e., detection 10).
A detection control may not be applicable for every cause and/or failure mode. When listing detection controls, it is important to be detailed enough for subsequent reviewer to confirm how well that the process control will, in fact, detect the failure mode and/or cause should it occur. Details should include the type of automated or mechanical equipment/tooling, operator inspection, and when the detection will occur (in-station or subsequent operation).
Assess Severity of Effect, Likelihood of Occurrence, and Ability to Detect. The latest SAE J1739 rating scales must be used. See sections 8.7.1 – 8.7.3.
When calculating the Risk Priority Number (RPN) for the PFMEA the following rating mechanism should be utilized to assess Severity, Occurrence, and Detection: (Severity x Occurrence x Detection = RPN)
High RPNs must be evaluated for recommended actions. There is no threshold for RPN values. Start with the top few and work down the list to improve as many RPNs as possible.
Figure 6: BAE Systems PFMEA Template
The PFMEA worksheet is a tool used to identify and show potential process risks associated with the manufacture of each part. It also highlights the controls at each stage of the manufacturing process; this detail should read across to the Control Plan.
[Reference SAE J1739 FMEA Standard or AS13004 PFMEA and Control Plan Standard].
Any know non-conformances should be considered when completing the PFMEA or Control Plan.
The PFMEA identifies the process Key Control Characteristic (KCC), when applicable, that contribute to the process controls strategy. Key Control Characteristics influence the conformance of a Special Product Characteristic.
When assigning Severity make sure to prioritize the assignment in to following order of importance;
1. Impact to the End User ( When Known)
2. Impact to Ship to Plant (When Known)
3. Impact to your plant
Often times the Impact to the submitting plant is the main or only focus. Doing this overlooks the possibility of undesirable impact to the customer or lend user. Two separate columns for severity ratings can be used; one for Internal (impact to plant) and one for External (impact to ship to plant / end user). Following this method would then require two separate RPN columns, one for Internal (impact to plant) and one for External (impact to ship to plant / end user). BAE Systems would then be looking for recommended actions to reduce the high external RPNs.
Severity (PFMEA)
An assessment of how serious the Failure Effect (due to the Failure Mode) is to the customer:
Occurrence (PFMEA)
An assessment of the likelihood that a particular cause will happen and result in the Failure Mode:
Detection (PFMEA)
An assessment of the likelihood that the current controls will detect the cause of the Failure Mode or the Failure Mode itself, PREVENTING the Failure Effect from reaching your customer. The customer in this case could be the next operation, subsequent operations, or the end user:
Table 6: SAE J1739 Appendix C – PFMEA
Control Plan
A Process Control Plan (PCP) [reference SAE J1739 FMEA Standard] provides written descriptions of the systems used for controlling parts and processes. It can be component or process specific, or family where multiple parts are produced using the same processing line. The control plan describes the actions that are required at each phase and detailed operation of the process including receiving, processing, material handling, and periodic requirements to assure that all process outputs will be in control. The control plan provides the process monitoring and control methods that will be used to control product or process characteristics. Typical PCP types include Prototype, Pre-Launch and Production.
The Process Control Plan should place emphasis on pro-active controls at the point of manufacture. Good manufacturing practice should consider: the control of the process inputs to obtain the desired product outputs; employ prevention rather than detection (e.g., use of error-proofing instead of operator dependent work or inspection); and verification of output at the earliest possible operation/step within the process.
The Control Plan provides a structure for receiving information from the Process Flow Diagram (PFD) and PFMEA. It also provides the format for capturing the detail on control methods and reaction plans. The Control Plan has 4 major sections of information:
1) Product / Process Information,
3) Methods, and
4) Reaction Plan
A Control Plan defines the operation, processes, materials, equipment, methodologies and CIs for controlling variations in key product or process characteristics integral to the manufacturing process. Its purpose is to communicate the supplier’s decisions during the entire manufacturing process from material purchase through to final shipping. Specifically the control plan should address the following:
1. Methods of production
3. Identification of KC
5. Materials and their physical and chemical characteristics
6. Types of process equipment at each operation
7. Types of test equipment used to measure each characteristic
8. Specifications, sampling strategy, control and reaction methods used.
9. Periodic conformance testing and product verification
All processes must have a control plan that defines all methods used for process control and complies with BAE Systems specified requirements. The control plan must clearly state each step in the process; the specification and all KC characteristics must be addressed for product and process. The Process Flow Diagram, PFMEA and Control Plan must be aligned. Each major process step in the process flow diagram should correlate with PFMEA steps and there should be documented control plan actions for each of the steps.
Completing the Control Plan
This is a process whereby the Supplier documents all materials and processes involved in the manufacturing process from start to finish. The process flow diagram, ballooned drawing, and PFMEA all provide inputs to the Control Plan. All KCs identified as Process, First-Piece or Safety Related by the supplier or BAE Systems must be listed on the Control Plan.
Links form the Process Flow Diagram to the Control Plan
Links from the PFMEA to the Control Plan
A control plan should address all testing requirements, inspection and measurements that are required to verify product quality and conformity. The control plan must not be excessively dependent on visual inspection and should always target prevention techniques wherever possible.
The control plan provides the process monitoring and control methods that will be used to control all product and process characteristics but most importantly the product KCs and process KCCs.
All items on Form 3 of the FAI should be accounted for on the Control Plan.
The control plan should be developed in stages, from Prototype to Pre-Production and then into Production. The control plan is a “living” document and should be updated to reflect any changes to the manufacturing process and its controls throughout product lifecycle. BAE Systems may conduct a Control Plan Audit to verify the execution of the process matches latest revision of the Control Plan.
BAE Systems has developed a Control Plan format which is available for suppliers to utilize if required.
Figure 7: Example of Control Plan document
Measurement System Analysis (MSA)
Measurement System Analysis (MSA) is a mathematical method of determining how much variation within the measurement process contributes to overall process variability. MSA is used to ensure the right measurement equipment is used to qualify production parts or processes.
MSA’s are conducted on the measurement systems that measure Key Product and Process Characteristics, specifically those which use Statistical Process Control (SPC) to ensure control and conformance.
SPC cannot be implemented until the measurement system is determined to be acceptable.
BAE Systems requires an MSA study to be conducted on all measurement equipment that is used to accept or fail the product. This generally covers all measurement tools identified in the control plan.
A Gauge Repeatability and Reproducibility (GR&R) study is used to ensure that measurements taken in the manufacturing process and reasonably consistent regardless of how many times they are performed or how had performed them. It is important to select a sample size that encompasses the full range of parts.
The result of an MSA is an error percentage. The following are generally accepted guidelines for determining if an MSA is acceptable:
BAE Systems recommends the following acceptance levels to be used:
1. % R&R 10% or less is considered to be an acceptable measurement system; for KCs % R&R shall be 10% or less.
2. Marginal gauges (between 10% and 30%) may be acceptable depending upon the application. May need an action plan to address and improve the method of measurement.
3. Gauges with R&R at 30% or more cannot be used. Actions to reduce the measurement variation are needed to lower the variation to an acceptable level.
Statistical software, IE: Mini-tab, SPC Excel or equivalent may be utilized to conduct the measurement study. BAE Systems has also developed at GR&R worksheet for the suppliers to utilize. Instructions on how to complete the GR&R are included in the worksheet.
Figure 8: Example of GR&R worksheet
Packaging
A packaging, preservation, and labeling plan shall at a minimum define:
1. Packaging process & pictures
· The forms Revision and supplier name should also be included.
· Must identify if the material is HAZMAT.
· Supplier must submit images for the part in packaging position, the container with label shown (label content (part number, SN, barcodes, etc.), label material, and label location(s)), and dunnage.
2. Internal packaging material (including identification if it is ESD safe)
· Supplier must provide a list of packaging materials including, description, manufacturer, and lead time.
3. Packaging reusability (as applicable)
4. Labeling requirement, including label  content (part number, SN, barcodes, etc), label material, and label location(s)
5. Qty. per box, (as applicable) boxes per pallet, and per layer
6. Box size & weight for the part, container, pallet and unit load. Supplier shall provide the staking rules for the pallet and unit load.
FAI (First Article Submission)
The primary purpose of FAI is to validate that product realization processes are capable of producing parts and assemblies that meet engineering and design requirements.
An FAI will:
· Provide confidence that the product realization processes are capable of producing conforming product.
· Demonstrate that the manufacturers and processors of the product have an understanding of the associated requirements.
· Provide objective evidence of process capability.
· Reduce potential risks associated with production startup and/or process changes.
· Provide assurance of product conformance at the start of production and after changes outlined in this standard.
An FAI is intended to:
· Reduce future escapes, risks, and total costs.
· Help ensure safety of flight.
· Improve quality, delivery, and customer satisfaction.
· Reduce costs and production delays associated with product non-conformances.
· Identify product realization processes that are not capable of producing conforming product, and initiate and/or validate corrective actions.
When is a Full FAI Required?
A full PPV/FAI is required upon:
· New production part introduction
· New supplier or location of manufacture
· Lapse in production for more than 24 months, unless otherwise specified within procurement documentation
· When required by BAE Systems:
· NOTE: QA codes are listed on all BAE Systems purchase orders and are listed within the BAE Systems web site
When is a Partial FAI Required?
· A partial FAIR is submitted for affected characteristics, when any of the following CHANGE(S) occur:
· Design characteristics affecting form, fit or function of the part (revision level change).
· If no change to form, fit, or function, only Form 1 is required to identify clerical changes.
· Source(s) supply for product or service.
· Manufacturing source
· Special Process source
· Inspection method(s): When the difference between the two methods reduces the accuracy of inspection results.
· Location of manufacture, tooling, material or raw materials, or Special Processing suppliers that can potentially affect Form, fit, or function.
· Numerical control program or translation to another media that can potentially affect form, fit or function. Including changes to ATP, ATE, and associated Software programs affecting product.
· A natural or man-made event, which may adversely affect the manufacturing process.
· A lapse in production as defined on the Purchase Order requires a full FAI/FAIR.
Submission of the FAI Report
The Purchase Order, Parts, List and/or Bill of Material (BOM), and Drawing are all essential documents used to identify the FAI Report.
The FAI Report shall be submitted electronically using Net Inspect.
0. Form 1 Part Number Accountability
· Establishes the level of inspection FULL/PARTIAL
· Detail or Assembly
· Field 15 – Field 18
Form 1 Example:
· Record specifications used to achieve design characteristics:
· Supplier approval verification.
· Document identification number(s).
· Functional test report(s).
· Record inspection results for the design characteristics
· Document any applicable non-conformances.
The Dimensional Inspection and Test Results are to be documented via submission of an FAI report. The measurements, inspection, and test results shall be recorded on Form 3 of the report. All Certificates of Compliance shall be recorded on Form 2. All items in on Forms 2 and 3 shall be referenced to the balloon drawing that is supplied with the FAI submission.
The parts used for dimensional data must be from production intent tooling / process and randomly sampled (if possible) from a run at production rate. The dimensional report must address all of the following:
1. All dimensions
2. All applicable notes on the drawing
3. Any dimensions contained on referenced drawings
NOTE: The parts measured to obtain the dimensional results must be the same parts submitted for PPAP approval and shall be retained by the supplier when requested by BAE Systems.
All dimensional requirements on the ballooned drawing must be listed on the dimensional data sheet. All sections of the dimensional data sheet must be filled out completely. The measurement method must be documented for every line item.
When a specific feature on the drawing has multiple requirements I.E. GD&T symbols the data must be recorded on individual line items with the dimensional data sheet.
Example: This call out would require 3 lines of separate data on the dimensional report.
1. Hole diameter (25+/-0.2)
2. True Position (0.05 MMC on datum A,B,C)
3. Cylindricity (0.1)
Figure 9: Dimensional Drawing Example
Dimensional Data and all requirements should be documented via the standard BAE Systems FAI process per BAE Systems Supplier Requirements for First Article Inspections Reports, B25279 or AS9102.
Form 3 Example:
NOTE: Any concerns identified in the Dimensional Data should be brought to the attention of BAE Systems before submitting your PPAP.
Material and Performance Test Results
The purpose of this item is to ensure that the material is verified for its properties and acceptable performance is demonstrated.
Material test results should be provided in the form of a material composition report also called a Certificate of Analysis (C of A) from an accredited lab that confirms the material content meets a known standard, IE: Chemical and Physical Analysis Report.
It is the Supplier’s responsibility to confirm the composition of material not only at PPAP submission stage but also ongoing during the life of the product / project. This step should be placed into the FMEA process and the Control Plan.
A Certificate of Compliance (C of C) is acceptable during production shipping but is not acceptable during PPAP submission as the C of C will not give actual test results.
Performance Test Results should be acceptable, and meet the agreed upon specifications to be measured. Performance results may include data confirming any referenced specifications in the part drawing or specific testing required by BAE Systems.
BAE Systems will communicate specific material, performance and testing requirements either in the part drawing, reference specifications or by a specific request prior to PPAP approval. It is the responsibility of the supplier to confirm the data and format of this requirement with the appropriate BAE Systems representative.
Test Data should not be submitted with the PPAP unless the purchase order calls contains a material clause such as 111, 134, 135 or 168. The prior list is not meant to be all inclusive as all clauses should be reviewed and requirements identified as part of your contract review.
Initial Process Study (Cpk, Ppk)
The purpose of initial process studies (Cp, Cpk, Pp, Ppk) is to determine if the production process is likely to manufacture product that will meet BAE Systems requirements. Initial process studies (capability) are highly recommended for all KCs.
If there are no KCs on the drawing the BAE Systems Supplier Quality Engineer will work with the supplier to identify the Quality Characteristics that are tracked as indicators of the process. These Quality Characteristics could be either Product related KC’s or Process related KCC’s.
There are two primary indexes used in determining process capability.
Cpk predicts future capability and should be used when developing new parts or revising specifications on a part. Cpk should also be used when materials, processes, manufacturing location, or equipment have changed or Material suppliers have changed.
Ppk indicates past performance. Use Ppk when you are a new supplier to BAE Systems but have already been manufacturing the part which BAE Systems will purchase.
The capability study is to be performed on samples taken from an actual production run at the quoted production rates. The minimum acceptance capability for all KCs is 1.33 and 1.67 for all safety related KC’s. In some cases, it may be impossible or prohibitively expensive to meet the stability and capability requirements. These exceptions shall be documented by the producer and may require customer approval. An alternative control method (such as 100% gauging) may be required.
The supplier can submit the Capability data on the format of their choice, and Mini-tab, SPC Excel or equivalent may be utilized.
Qualified Laboratory Documentation
The purpose of Qualified Laboratory Documentation is to ensure that the testing for PPAP has been done by a qualified lab. If your organization is performing testing or measurement internally or externally at an outside facility, then proof of Scope and accreditation is required.
Internal Labs located at Supplier
All suppliers that have testing or measurement performed on site must provide the following in this section of the PPAP submission:
A. Record / Scope that identifies the testing to be done and it must include:
B. List of your personnel’s competency and training to perform the testing.
C. List of all test equipment used in process and offline.
D. List of methods and standards used to calibrate the equipment.
External Labs located offsite from the Supplier
If you are sending out for measurement and testing, you must ensure that you use an accredited lab and can provide proof of accreditation. BAE Systems prefers external labs be accredited to known standards such as ISO 17025, ISO 10012:2004, or ANSI/NCSL Z540-1-1994.
1. Provide a copy of the lab company’s Third Party accreditation.
2. Results must be on company letterhead and include the following:
1. The name of the lab
2. Date of testing
Sample Parts
When sample parts are determined to be included they should be the actual samples measured in the dimensional analysis (FAI submission). Sample parts are to be delivered with or before the PPAP submission.
The PPAP samples may reside at the supplier as retained samples or could be delivered as a separate shipment. In either case they should be labeled identifying them as PPAP Samples.
Segregation of the sample parts is needed to avoid the PPAP sample parts being inadvertently misplaced or mixed up with production parts.
Checking Aids
The purpose of this item is to provide evidence that the checking aids used to verify product exist and have been properly validated.
There are many different types of checking aids. Examples of checking aids include but are not limited to certified check fixtures, un-certified check fixtures, templates, custom gauges and test equipment.
BAE Systems requires all checking aids to be verified as repeatable through an MSA study. The MSA can be either attribute or variable depending on the type of checking aid in use.
Customer Specific Requirements
This item is to address BAE Systems specific requirements during PPAP submission.
BAE Systems will advise during the PPAP process on specific requirements as there may vary depending on the scope of the project / product being supplied. This item is also utilized to flow down requirements of BAE Systems customers to ensure these elements are captured during PPAP submission.
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