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[Jürgen Eilers]

The IATF 16949, 1st edition, 2016-10-01 has become available. It can be useful to take a look at a description of the transition timeline, e.g. from IATF (http://www.iatfglobaloversight.org) or NFS (https://www.nsf.org – search for IATF 16949).

You will find FMEA (DFMEA, PFMEA) and Risk Analysis mentioned in the following sections:

Product safety (4.4.1.2)
Risk analysis (6.1.2.1)
Preventive action (6.1.2.2)
Contingency plans (6.1.2.3)
Plant, facility, and equipment planning (7.1.3.1)
Engineering specifications (7.5.3.2.2)
Design and development planning – supplemental (to ISO 9001:2015) (8.3.2.1)
Design and development outputs – supplemental (to ISO 9001:2015) (8.3.5.1)
Manufacturing process design output (8.3.5.2)
Control plan (8.5.1.1)
Temporary change of process controls (8.5.6.1.1)
Control of reworked product (8.7.1.4)
Control of repaired product (8.7.1.5)
Monitoring and measurement of manufacturing processes (9.1.1.1)
Identification of statistical tools (9.1.1.2)
Manufacturing process audit (9.2.2.3)
Management review inputs – supplemental (to ISO 9001:2015) (9.3.2.1)
Problem solving (10.2.3)
Error-proofing (10.2.4)
Continual improvement – supplemental (to ISO 9001:2015) (10.3.1)

[Fügen]

As i do not want to open a new topic concerning FMEA and IATF I would like to use this article to ask for some Lessons learned and best practice concerning the IATF requirement which is writtten down in 9.3.2.1 Input for the Management Review especially „identification of potential field failures identified through risk analysis (such as FMEA)“.

Is there any approach that has already been reviewd by auditors according to the new IATF?

I was hoping that maybe the Riskmatrix-Tool could be used… but unfortunately this is restricted to one file only and cannot evaluate a directory or a list fo directories.

Kind regards

O. Fügen

[Jürgen Eilers]

Collecting several structures into one temp FME could be done with the assistance of the IQ-Explorer. Search structures and special D&D into FFA will transfer all structures into on FME. Afterwards the statistic editor can be used. And also the summary function could be used to create the necessary management report. Take a look at the presentation from Chad Johnson “Quality of FMEA – Summary Function and more”; user meeting 2016.

Up to now file spanning statistics can only be done with IQ-CT Analysis. Unfortunately the available statistic views are different from the IQ statistics. Additional development would be necessary to integrate the risk matrix statistic.

If only an overview is necessary I would recommend using the IQ-Explorer and run a search request e.g. on failure causes where the risk matrix color is red. File based analysis can cover more than one FME.

We are discussing which management (approval) report functionality is necessary in the future. Any input is welcome. Reference to our tracking system is possible with V7-162. E.g. our next user meeting or this forum can be used to specify necessary functionality more precisely.

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