IATF16949:2016 {10.2.4} Error-proofing - Explained

IATF16949:2016 {10.2.4} Error-proofing

The organization shall have a documented process to determine the use of appropriate error-proofing methodologies. 

Details of the method used shall be documented in the process risk analysis (such as PFMEA) and test frequencies shall be documented in the control plan.

The process shall include the testing of error-proofing devices for failure or simulated failure. 

Records shall be maintained. Challenge parts, when used, shall be identified, controlled, verified, and calibrated where

feasible. Error-proofing device failures shall have a reaction plan.

HOW TO MAKE PROCEDURE FOR ERROR-PROOFING

Use cross-functional teams (CFT) approach to mistake proofing.

Selection of process for mistake proofing.

During the third phase of advanced product quality planning (APQP), the CFT shall identify the processes, where, due to avoidable human errors, the rating of “occurrence” and/or “detection” have increased thereby increasing the risk priority number (RPN) for the process. 

Poka-yoke techniques of mistake proofing are applied to these processes in order to lower the ratings of occurrence and/or detection.

Analysis of customer complaints also reveals activities which are in need of mistake proofing, in order to achieve a zero defect level of working. 

CFT will undertake application of poka-yoke techniques to these processes.

The selected mistake proofing technique should qualify the following criteria:

Inexpensive Based upon common sense, preferably of the operator or the first line employee

It MUST eliminate occurrence/detection of the problem at the source itself

Occurrence Oriented poke-yoke should follow the procedure as below- First classify the source of occurrence as follows:

Required action is NOT performed or is performed incorrectly.

Undesired action is exercised.

Information essential for performing the action is misinterpreted.

Mistake occurs due to complexity.

Use of 100 percent prevention devices such as fouling pins; contoured locators or templates; proximity or photo-electric sensors; limit- or micro-switches; warning lights or buzzers; or pressure transducers.

Design to modify to ensure that in assembly the parts shall not join if aligned wrongly. The machine will not run if operators’ hands or feet are not outside, or if the job and tooling are not in right position. 

These techniques should be integral part of the process. The devices are placed sufficiently close to where the mistakes occur, providing fast feedback to the operator, of mistakes occurring.

 Detection Oriented poka-yoke should use one of the following techniques for ensuring 100 percent detection of the mistake:

It should be autonomous inspection occurring without intervention.

It should be 100 percent inspection which occurs without intervention.

It should determine before-the-fact whether the conditions for 100 percent quality exist or not.

It should make the error visible to the operator.

Consider supply of exactly made kits of components to the assembler, so that any balance part will signal error in assembly.

Consider use of electronic sensors to activate warning lights or buzzers.

Use color coded parts or graphics.

Make use of contact devices (e.g., fixtures, limit switches, probes or non-contact devices such as LEDs and pressure transducers).

 Effectiveness of the applied poka-yoke technique should be judged after observing the performance, for a period on minimum one month.

If there is any abnormity in PokaYoke Working Condtion / Beak down situation, you can bypass the pokayoke after approval from Quality Head. In this case, Special care to be taken for processes.