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Documentation Required by IATF 16949 (Automotive QMS)

bkirch

Involved In Discussions
#11
For IATF 16949 section 8.5.1.5 it is stated that the organization shall have a documented total productive maintenance system. Then it give a list of items that should be included in that system.

My question is does this mean we are required to have a procedure that explains our Total Productive Maintenance System or do we just need to have documented records that shows each of the system requirements are being addressed?
 
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hjoul

#12
Tx AthenaMZ.

I was not planning to create something huge, just wandering how experts interpreted these requirements.

What I usually do is checking how an organisation works and see wether this complies with the standard.

I have seen the presentation, as a consultant / trainer I was just looking for answers that I might use for my courses.

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H

hjoul

#13
@bkirch.

You should have a system, a way of working, that adresses the requirements.

A procedure is not the way to go in my opinion.

If you use excel files to organize your TPM you could use a turtle and/or flowchart adressing the requirements to demonstrate how they correlate and that you control them...


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Sebastian

Trusted Information Resource
#14
ISO/TS 16949 required documented procedures.
There was required process approach too.

Problem was, some procedures were created against process approach, e.g. by focusing on presenting personnel responsibilities, further promotion of departmentalisation, non-chronological description of activities, which did not support effective realisation of process.

So to prevent it, now IATF 16949 requires documented processes where by using of e.g. flow charts, procedures chronologically presenting activities, we have to convince ourselves (and third party auditor as well), that we understand, everything we do is a part of process.
 

joekirk

Involved In Discussions
#15
Below is a list of formal documented processes and implied processes required within IATF16949:2016
4.4.1.2 – Product safety
6.1.2.2 – Preventive Action **
7.1.5.2.1 – Calibration/verification records
7.2.1 – Competence – supplemental
7.2.3 – Internal auditor competency
7.3.2 – Employee motivation and empowerment
7.5.3.2.1 – Record retention (policy)
7.5.3.2.2 – Engineering specification
8.3.1.1 – Design and Development Process
8.3.3.3 – Special characteristics **
8.4.1.2 – Supplier selection process
8.4.2.1 – Type and extent of control – supplemental (Outsourced processes)
8.4.2.2 – Statutory and regulatory requirements
8.4.2.4 – Supplier monitoring
8.5.1.5 – Total productive maintenance *
8.5.6.1 – Control of changes – supplemental
8.5.6.1.1 – Temporary change of process controls
8.7.1.4 – Control of reworked product
8.7.1.5 – Control of repaired product
8.7.1.7 – Nonconforming product disposition
9.2.2.1 – Internal audits
10.2.3 – Problem solving
10.2.4 – Error proofing
10.3.1 – Continual improvement - supplemental

Many of the above can be combined. Companies should have a list of this processes and include them with documentation sent to their registrar prior to your audit. These would be the items covering clause 7.5.1.1 b)
 

Sebastian

Trusted Information Resource
#16
According to statistics from my software "Mad 33 1/3 Party Auditor" , we are required to have 18 documented processes, previously know as so called "documented procedures":
4.4.1.2
7.1.5.2.1
7.2.1
7.2.3
7.3.2
7.5.3.2.2
8.3.6.1
8.4.1.2
8.4.2.1
8.4.2.4
8.5.6.1
8.7.1.4
8.7.1.5
8.7.1.7
9.2.2.1
10.2.3
10.2.4
10.3.1

Then further 16 undocumented processes are required:
6.1.2.2
6.1.2.3
8.3.1
8.3.2.3
8.3.3.1
8.3.3.3
8.3.4.4
8.4.2.3.1
8.4.2.4.1
8.5.2.1
8.5.5.1
8.5.6.1.1
8.6.4
9.1.1.1
9.1.1.2
10.2.5

It should be all and there are some duplicated processes. By duplicated I mean, more than one section requiring establishing of the same process.
Of course establishing of some manufacturing processes is highly appreciated. :tg:
 
S

smaynhardt

#17
IATF 16949 comparison matrix

Can any one help me with a matrix that compares TS16949 clause to the new IATF clauses in an excel document I need a comparison matrix between the two. Thanks a million Sharon
 

qusys

Trusted Information Resource
#20
Hello,

I have been discussing the item about required documented process with several people, but consensus on the topic seems a though case.

What do you people understand in:

Shall have a documented process(es)
Shall document a/its process
Shall maintain a documented process

I counted 21 times documented process excluding documented system/policy.


Tx,
Documented process could be intended that it is managed by means of PDCA dynamics including a risk base thinking.
For example, using a context diagram with input/output and interrelated processes, establish process owners and scope of the process, indicators for effectiveness and efficiency as well as improvements activity , identify possible risks and threats for failure and action in case.
 
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