APQP, FMEA, and Poka-Yoke in Manufacturing

Posted on Mar 24, 2025 in Business Administration and Innovation Management

Advanced Product Quality Planning (APQP)

APQP defines and establishes the steps needed to ensure product quality and customer satisfaction. The goal is to facilitate communication between all involved parties.

1. Program Planning and Definition

The objective of this stage is to identify customer needs and expectations for subsequent tackling of project planning and quality plan definition.

  • Inputs:
    • Customer requirements
    • Market research
    • Functional analysis of the product
  • Outputs:
    • Design objectives
    • Product specifications
    • Preliminary lists of materials
    • Preliminary process characteristics

2. Product Design and Development

Design details and characteristics are developed to their final form during this stage.

  • Inputs:
    • Design objectives
    • Product specifications
    • Preliminary lists of materials
    • Preliminary process characteristics
  • Outputs:
    • Product design
    • Product FMEA
    • DFMEA (Design Failure Mode and Effects Analysis)
    • Control and verification tooling requirements
    • Requirements for new potential equipment, tools, and installations

3. Process Design and Development

This stage analyzes the main factors involved in developing a production system and the relative control plans required to achieve quality products.

  • Inputs:
    • Product design
    • Product FMEA
    • DFMEA
    • Control and verification tooling requirements
    • Requirements for new potential equipment, tools, and installations
  • Outputs:
    • Process FMEA
    • Skateboard manufacture
    • Control plan
    • Product and process validation tests

4. Product and Process Validation

During this stage, the main aspects of the production process validation are analyzed by taking a series of samples.

  • Inputs:
    • Process FMEA
    • Skateboard manufacture
    • Control plan
    • Product and process validation tests
  • Outputs:
    • Product and process validation
    • Validation of the measurement system
    • Production control plan
    • Production launch

5. Feedback, Validation, and Corrective Action

Quality planning does not end with process and installation validation. This product production stage is where production outputs have to be evaluated. *In our case, we are not able to establish a production system of the skateboard in a company, so we are not able to obtain feedback of the production system.*

Planning (entire), Product Design and Development (from the beginning to 3/4), Process Design and Development (almost a part), Product and Process Validation (a little bit more than half), Production (a small part from the beginning to the end), Planning in parallel above (Feedback, the entire part below).

Failure Mode and Effects Analysis (FMEA)

FMEA is a methodology to achieve quality, which attempts to identify and prevent failures in processes or products. There is a tool to investigate the weak points (product, process, service) that quantifies and evaluates the risk of failure.

Process: Failure mode -> Cause -> Effect

Quantitative Analysis:

  • Occurrence: Probability of a cause occurring and leading to a failure mode.
  • Severity: Measurement of the effect of failure.
  • Detection: Probability of the failure mode being detected with the controls in place.

Types:

  • Design: Related to the definition.
  • Process: Process elements.
  • Means: Related to their definition and maintenance.

Steps of Diagram:

  1. Subject of study and team training.
  2. Information gathering.
  3. Definition of functions.
  4. Qualitative analysis.
  5. Quantitative analysis.
  6. Definition and implementation of actions.

Poka-Yoke

Poka-Yoke aims to eliminate product defects by either preventing or correcting them as soon as they arise.

3 Components of Zero Defects:

  1. Source Inspection: Verify the factors behind errors, not the resulting effects.
  2. 100% Inspection: Use a low-cost Poka-Yoke device to automatically inspect for errors or inadequate operating conditions.
  3. Immediate Action: All operations are immediately stopped when an error occurs.

3 Techniques in the Field of Quality:

  • Evaluation Inspections: Separate the defective parts from good ones.
  • Information Inspections: Investigate the cause.
  • Source Inspections: A defect is a result generally caused by a simple error. Zero Defects is possible.