Core Tools (PPAP / FMEA / MSA / SPC / APQP / Control Plan)

These tools are primarily used in automotive industry but can be applied universally to identify defects at an early stage, sometimes much before actual start of production or service, and to qualify processes before bulk processing and to mitigate risks effectively.

FMEA:
Failure mode and effects analysis (FMEA), also sometimes referred as FMECA (Failure mode, effect and criticality analisys) is a prevention based early warning system used widely in Six Sigma, IATF 16949, TS 16949, Reliability Engineering, Product Development and Operations management. FMEA is a team activity which identifies potential failure modes based on past experience with similar products or processes or based on common failure to prevent such failures in advance and saving potential losses, cost and time.

MSA:

Measurement System Analysis (MSA) is a collection of many statistical analysis methods of evaluating variability in the measurement process. Some popular methods of MSA include Gauge R&R analysis, bias Study, Linearity study, measurement uncertainty etc.

MSA is also widely used in IATF 16949, TS 16949, Six Sigma and quality improvement projects.

Just as processes that produce a product may vary, the process of obtaining measurements and data may have variation and produce defects. A Measurement Systems Analysis (MSA) evaluates the test method, measuring instruments, and the entire process of obtaining measurements to ensure that variability of measurement system is within acceptable limits and to evaluate its impact on process acceptance indicators.

SPC:

SPC (Statistical Process Control) is also a collection of statistical methods used to control a process within desired limits and to identify patterns of normal (random or chance cause) variation and special (assignable cause) variation in order to identify opportunities for intervention in the process and to take correct decision on process and product acceptance.

Refer section on Six Sigma / SPC for details.

PPAP:

Production Part Approval Process (PPAP) is mechanism of qualifying a process for production during various stages e.g. Prototype development, Pre-launch and routine / bulk production.

In IATF 16949, TS 16949 system, a supplier obtains PPAP approval from customer based on fulfillment of process qualification requirements set by customer or as per PPAP manual where no specific requirements are set by customer.

PPAP in TS 16949 has 5 levels and 19 requirements, each level having slightly different submission requirements. The 19 requirements include Part Submission Warrant (PSW), FMEA, Control Plan, Appearance approval reports, Dimensional reprots etc.

APQP:
Advanced Product Quality Planning (APQP) is a product development methodology followed in IATF 16949, TS 16949. The purpose of APQP is "to produce a product quality plan which will support development of a product or service that will satisfy the customer."

APQP covers all stages of Development, Production and Corrective action or Feedback in 5 phases:

1. * Plan and define program
2. * Product design and development verification
3. * Process design and development verification
4. * Product and process validation and production feedback
5. * Launch assessment and corrective action.

 

Major elements of APQP include:

• * Understanding the needs of the customer
• * Proactive feedback and corrective action
• * Designing within the process capabilities
• * Analyzing and mitigating failure modes
• * Verification and validation
• * Design reviews
• * Control special / critical characteristics.

Control Plan:
Another standard method of IATF 16949, TS 16949 but extensively used in all industries with same or similar requirements. Control plan defines the controls exercised by the organization on various processes during different stages.

Generally prepared in 3 stages i) Prototype development ii) Pre-launch and iii) Production, control plan is seamlessly linked with process flow diagram (PFD) and FMEA and identifies controls at each stage of PFD and for each failure mode of FMEA

Both part specific and product family based control plans are used and provide guidance for process and product acceptance to concerned decision makers which may include machine operator, quality personnel or customer.

APQP / PPAP / MSA / FMEA / SPC / CONTROL PLAN Qualicon Offers
Consultancy	Training	Audit	Software
Consultancy for Core Tools i.e. SPC, MSA, FMEA, PPAP, APQP, Control Plans Consultancy For IATF 16949 Certification PPAP Documentation Consultancy Consultancy for Vendor Approval	IATF 16949 Awareness Training IATF 16949 Internal Auditor Training Core Tools Training :       SPC Training      FMEA Training       PPAP Training       APQP Training     Control Plan Training    MSA Training	Second party audits Third party audits Supply chain compliance audits Facility Evaluations Factory Assessments Run@rate audits	SPC: X-R Control Charts X-s Control Charts I-MR Control Charts Short Run Control Charts P Chart C Chart U Chart Short run standardized control chart EWMA Control Chart Process Capability Analysis (both Bilateral and Unilateral Tolerances)   MSA: Attribute R&R Variable R&R Within Part Variation R&R Cp-R&R Conversion Bias Calculator Linearity Calculator Six Sigma Calculator DOE Analysis Calibration: Calibration Analyst