IATF16949 {8.5.1.1} Control Plan
The organization shall develop control plans (in accordance with Annex A)at the system, subsystem, component, and/or material level for the relevant manufacturing site and all product supplied, including those for processes producing bulk materials as well as parts. Family control plans are acceptable for bulk material and similar parts using a common manufacturing process.
The organization shall have a control plan for pre-launch and production that shows linkage and incorporates information from the design risk analysis (if provided by the customer),process flow diagram, and manufacturing process risk analysis outputs( such as FMEA).
The organization shall, if required by the customer, provide measurement and conformity data collected during
execution of either the pre-launch or production control plans. The organization shall include in the control plan:
a) controls used for the manufacturing process control, including verification of job set-ups;
b) first-off/last-off part validation, as applicable;
c) methods for monitoring of control exercised over special characteristics (see Annex A)defined by both the customer and the organization;
d) the customer-required information, if any;
e) specified reaction plan (see Annex A); when nonconforming product is detected, the process becomes statistically unstable or not statistically capable.The organization shall review control plans, and update as required, for any of the following:
f) the organization determines it has shipped nonconforming product to the customer;
g) when any change occurs affecting product, manufacturing process, measurement, logistics, supply sources, production volume changes, or risk analysis (FMEA) (see Annex A);
h) after a customer complaint and implementation of the associated corrective action, when applicable;
i) at a set frequency based on a risk analysis.
If required by the customer, the organization shall obtain customer approval after review or revision of the
control plan
Explanation - Control Plan can be made by referring following Procedure
PROCEDURE OF CONTROL PLAN
Collect the Control Plan Blank Format
Write the Component Part no/latest change level, customer Eng. Approval date, Component Part no., part revision status, CFT team detail, key contact, type of control plan, Control plan origin date, revision no., last and next review date.
As control plan is live document it should be review at define frequency (1 Year). Control plan will be revised in case of customer complaint received if required
Control plan can be also revised in the following cases.
-ECN/PCN
-Supplier change
-process change
Write down the Process Steps/Operation No as mentioned in the Process Flow Diagram (PFD) of respective product.
Write down the name of the Process Name/Operation Description with its no.as mention in the Process Flow Diagram (PFD) of respective product.
Identify &Mention the Machine/Device/Jig/tool used to complete the operation
Write down the Process and Product Characteristics separately. Process Characteristics can be obtained from PFD whereas Product characterizes can be taken from Product Drawing.
e.g.
Process Characteristic - Tempering Temp 360°± 10°
Product Characteristics - Thickness 1.75 ± 0.05
Write the Classification of Product or Process in terms of "Critical" or "Special" Characteristics if any, with specific symbols assigned to them.
Identify & Mention the Product/Process specification/Tolerances
Identify & Mention the Evaluation/ Measurement techniques to measure the process & product characteristics
Identify & Mention the sample size of measurement
Identify and Mention the Control method
If it is [Safety/ Regulatory] Follow Any One of the Following Control method
1.Prevention Poke Yoke
2.Detection Poke Yoke
3. Online SPC (Control Chart)
4.100% Gauge Check (If Applicable)
5. 100% Inspection for Visual Defects
If it is Significant/Critical. (Affecting Primary Function) Follow Any one of the Control Method
1.Prevention/ Detection Poke Yoke
2. Online SPC (Control Chart)
3.Product & Process Inspection Reports & Gauge Report (If Applicable)
4.CMM Inspection Report
5. 100% Inspection for Visual Defects
For General Characteristic
1. Start Up Check Sheet
2.First off Inspection
3.Inprocess Inspection
4.Final Inspection Report
5.Gauge Report. (If Applicable) ,
6.100 % Inspection for Visual defects.
Identify and Mention Error Proofing/Poka Yoke system to prevent the potential defect like
[1. Operation Missing
2. Sub Part missing
3. Model mix - up
4. Fitment problem
5. Dimension variation
6. Possibility of wrong loading
7. Functional problem.
Also defined Testing Frequency of Error Proofing Device / Poka Yoke.
Initiate Reaction Plan to avoid producing Non Conforming Products. Also define reaction plan for Error Proofing Device / Poka Yoke.
Mention the Corrective Action Plan
Mention the revision history for changes of the Control Plan with date of revision and describe of the revision, when the document is revised for any reason. Take the signs of the CFT member present for the review.
Audit the document. If OK, sign the document for approval. File the " MASTER COPY' of Control Plan, Ensure Master List is updated for latest revision
Release the Control Plan and handover a Controlled Copy to
QA and Production
Review:
QA Head Reviews Control Plan based on annual plan for review
Plan, Review and updating will be done on following basis:
• Customer /In –house complaints.
• Process Change
• ECN/PCN
Revised Date will be updated in Control Plan.
Coherence
QA Head will prepare the Coherence annual plan
Coherence will be studied between Drawing, PFD, PFMEA, Control Plan, Incoming and in process, Final Inspection stage and recording sheet.