1. Design Records
The organization shall have the design record of product or part. The organization shall have hard copy of drawing to identify measurements taken. Mostly organization requires Ballooned drawing. A Ballooned drawing shows the parts in a part print with numbered “balloons” that point to individual dimensions and requirements of the part. The numbers on the ballooned drawing must correlates with the numbers found on the dimensional data sheet.
2. Authorized engg. Change documents (If Any)
The supplier shall have any authorized engineering change documents for those changes not yet recorded in the design record but incorporated in the product, part or tooling.
3. Customer engg. Approval
This contain evidence of customer engg. Approval.
4. DFMEA (Design Failure Mode Effect Analysis)
DFMEA stands for Design Failure Mode Effect Analysis. DFMEA is only required when the part is designed by the supplier and must address all critical to quality characteristics. It is a live document and should be initiated in early stages of design. It supports the design process by reducing the risk of failure. Each item/function needs to be addressed. Any potential failure mode of the item/function should be defined as completely as possible. Recommended action should be recorded. Prevention is the preferred method to address the design failure mode. If prevention is not possible then highlight detection controls. Results of DFMEA can be used in PFMEA.
5. Process Flow Diagram
The purpose of process flow diagram is to document and clarify all the steps required in the manufacturing of a part. The primary process steps must match both the control plan and the PFMEA. Process flow must include the entire manufacturing process (receiving through shipping).
The PFD must also include all key steps in the process and all offline activities (such as measurement, inspection and handling). The flow of non-conforming material such as scrap parts, non-conforming parts and rework parts should be included. The PFD can be provided in any format used within organization.
6. PFMEA (Process Failure Mode Effect Analysis)
PFMEA stands for Process Failure Mode Effect Analysis. It is used to ensure that all potential failure modes and the effects they have on a process have been considered, addressed and/or eliminated. It is live document and should be initiated before or at the feasibility stage, prior to tooling for production. The PFMEA does not rely on product design changes to overcome limitation in the process. However, It does take into consideration a product’s design characteristics relative to the planned manufacturing or assembly process to assure that the resultant product meets customer needs and expectations.
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 associated with each process. Each process step/function should be identified with an action plan to address the process failure mode.
7. Control Plan
Control plan Defines all methods used for process control and complies with customer specific requirements. It list the product and process characteristics monitored during the manufacturing process, including measurement methods and necessary reaction plans for deviant conditions. While control plans generally do not improve product quality, they play the important role of sustaining product quality long after a manufacturing process is developed and launched. Without control plans, most processes will gradually drift into a state of disrepair due to employee turnover, knowledge loss, and short-term production priorities. All process must have control plan that defines all methods used for process control and complies with customer specific requirements. It must clearly state each step in process, the specification and critical to quality must be addressed for product and process.
8. MSA (Measurement System Analysis) studies
MSA stands for Measurement System Analysis. The purpose of this record is to verify that the gauge or measurement system is capable of accurately assessing the quality of the parts.The quality of measurement data is defined by the statistical properties of multiple measurements obtained from a measurement system operating under stable conditions. For instance, suppose that a measurement system, operating under stable conditions, is used to obtain several measurements of a certain characteristic. If the measurements are all “close” to the master value for the characteristic, then the quality of the data is said to be “high.” Similarly, if some, or all, of the measurements are “far away” from the master value, then the quality of the data is said to be “low.”
Common tools and techniques of measurement systems analysis include: calibration studies, fixed effect ANOVA, components of variance, attribute gage study, gage R&R, ANOVA gage R&R, destructive testing analysis and others. The tool selected is usually determined by characteristics of the measurement system itself.
9. Dimensional results
This record is used to verify that the parts meet all of the dimensional requirements called out on the Drawing and Control Plan. It is documented in Dimensional Data Sheet. The parts used for dimensional data must be from production tooling and randomly sampled from a run at production rate.
10. Records of material/performance test results
The organization should have records of material and/ or performance test results for test specified on the design records or control plan.
11. Initial process studies
The purpose of this record is to determine if the production process will produce product that meets the Customer's requirements. It contains all
Statistical Process Control charts (Cp, Cpk, Pp, Ppk)
affecting the most critical characteristics.
12. Qualified lab Documentation
Supplier should used an Accredited Laboratory or Testing Facility to perform all Material, Functional, and Performance testing called out on the Drawing and Control Plan.
13. AAR (Appearance approval report)
AAR stands for Appearance approval report. Submitted with PPAP and sample part/product for the customer to sign, verifying the part/product meet all aesthetic criteria if the part/product has appearance requirements on the design records.
14. Sample production part
The organization should provide sample part/product as specified by customer.
15. Master Sample
A sample signed off by customer and supplier, that usually is used to train operators on subjective inspections such as visual. The organization should retain a master sample for the same period as the production part approvals records, or i) until a new master sample is produced for the same customer part number for customer approval, or ii) where a master sample is required by the design record, control plan or inspection criteria, as a reference or standard.
16. Checking Aid
The supplier shall certify that all aspects of the checking aid agree with part dimensional requirements. This Document shows a picture of the tool and calibration records, including dimensional report of the tool. The purpose of checking aid document is to provide evidence that the checking aids used to verify product exists and have been properly validated.
17. Customer specific requirements
The organization shall have records of compliance to all applicable customer specific requirements.
18. PSW (Part Submission Warrant)
PSW stands for Part Submission Warrant. PSW is a form that summarizes the whole PPAP package. The purpose of PSW is to document the submission and the approval or rejection of purchased part/product prior to production.
