Au

Control Plan
First Edition: 1st March 2024 (AIAG)

The APQP and Control Plan Second

Edition was split into separate manuals

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 Control Plan
First Edition:
1st March 2024 (AIAG)

[Link] YouTube @anupamupadhyay5959

Manual Structure
The manual is laid out to support the effective
development and utilization of Control Plans.

Chapter 1: Control Plan Requirements and

Guidelines
Chapter 2: Control Plan Development
Chapter 3: Control Plan Phases (Prototype, Pre-
Launch, Production)
Chapter 4: Effective Use of Control Plans
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Chapter-4 Effective Use of
Control Plans

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4.1 Reverse PFMEA
• Reverse PFMEA is a document continuous important tool designed to find gaps
or weakness in the prevention and detection controls of a process.
• Reverse PFMEA can be applied reactively as well as proactively.
4.2 Using Software to Develop and Manage Control Plans
and Related Documents:
• Software to develop and manage FMEAs, Control Plans and related documents
are much more efficient and effective than “paper-based” or “linked individual
electronic file” systems.
• Software specially designed for this function is widely available, and the benefits
justify added expense of purchase or subscription.
• The scope of a software system typically includes FMEA and Control Plan, but
many include ability to develop and maintain linkage to related downstream
documents, such as work instruments and corrective actions.
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4.3 Layered Process Audits as Control Plan Verification:
• Layered Process Audits (LPAs) are verifications that the most
important standards and controls are in place, including the
organization’s Control Plan.
• LPAs verify work is done according to established standards, to
emphasize importance of those standards, and identify opportunities
for continuous improvement.
• “Layered” means different levels of [participants from working level to
top management. Different perspectives, fresh eyes, etc. Top
management participation reinforces importance and commitment.
• LPA is not a control but a verification of control and does not belong
in a Process Control Plan.

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4.4 Control Plans in Highly Automated Processes:
• The purpose of Control Plan is to minimize variation in a process.
Highly Automated process (e.g. Semiconductor fabrication) have the
same goal of minimized variation, but “traditional” Control Plans are
impractical in such an environment.
 Processes typically have self-adjusting parameters using automated
feed-forward and feed-back loops to keep the process on target.
Numerous sensors and controls are constantly monitoring and
measuring the process and charting the measurement.
 Self-adjusting parameters have “hard limits” applied by engineering.
If the parameters try to self –adjust beyond the established “hard
limit”, then the process goes offline for engineering to investigate.
 Control systems (FDC-Fault Detection and Classification, SPC, etc)
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4.4 Control Plans in Highly Automated Processes:
…..
 …monitor the results and are connected back to a
manufacturing execution system (MES). The controls will
self-inhibit the process, automatically log tools down, and
put the product on hold for disposition if the process
controls are flagged.
 Controls are defined (sample size, frequency, gage, tool,
control limit, reaction plan) within the automated system.
Therefore, trying to keep a redundant paper Control Plan in
sync with the automated “MES” system is not feasible.
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4.5 Using Family and Foundation FMEAs:
 Foundation FMEAs (also known as generic, baseline, template,
core, master, or best practice FMEAs) are FMEAs that contain
knowledge of the organization from prior developments which make
them useful as a starting point for new FMEAs. The foundation
FMEA is not program specific, therefore the generalization of the
requirements, functions, and measures is allowed.
 Family FMEAs are specialized foundation FMEAs. It is common to
develop products that generally contain common or consistent
product boundaries and related functions (a Product Family) or
processes which contain a series of operations that produce
multiple products or part numbers. In these cases, it is appropriate
to develop family FMEAs which cover the commonalities for those
Families.
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4.6 Control of Storage and Handling related Risk:
 Storage and handling related risks include failure modes such as
 Damage due to improper handling or logistics, or use of packaging
or conveyance methods that do not offer robust protection.
 Contamination or damage or due to inadequate cleanliness or
environmental controls, or cross contamination from storage or
handling process/methods/materials.
 Changes to properties or performance due to inadequate shelf-life
controls.
 Process elements related to received materials/components, in-
process product and finished product storage and handling are
sometimes not included in process flow charts, as these tend to
focus on “value-added” processing steps (actual part manufacturing
process)
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4.7 Abnormality Management in Relation to Control Plans:
 Control Plans assume supporting operations, resources and
conditions are in a “normal” state; however, several factors can
result in abnormal conditions the Control Plan is not setup to
mitigate.
 Such abnormal conditions may include:
 Absenteeism- assuring properly trained operator/inspector when
controls/inspections and reaction plans rely on responsible person’s
skill
 Line Stop and Re-Start mid-process –assuring completion of
process with no skipped or duplicated steps
 Equipment breakdown-assuring equipment functionality is fully
restored prior to resumption of process control via Control Plan; or
deciding alternate processing is required.
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4.7 Abnormality Management in Relation to Control
Plans:
……
 Process shut-down and restart after plant shutdowns
due to pandemic, part shortage, maintenance/retooling,
etc.-assuring all support operations, infrastructure and
facilities are fully restored to “normal”

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Appendix A
Control Plan Example

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Control Methods and Requirements illustrated:

1.”N/A” to be documented in non-applicable top fields rather

than leaving the fields blank.
2. Master part qualifications
3. Rework (how it appears/fits in CP and customer approval).
Repair requires its own CP.
4. Error proofing/red rabbit confirmation
5. Sample size/frequency: utilize lot inspection (quantity) rather
than time based

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Control Methods and Requirements illustrated:
………
6. Stand-alone example and an example of safe launch plan
included in CP (Chapter 2)
7. SPC is an acceptable control method
8. “Follow instructions….XXX” is recommended rather than
simply listing a number or referencing a document.
9. “Owner Responsible” is who initiates the reaction plan

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 Thank
You
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