IATF 16949 Clause 6.1.1 - My first Major NCR (Management Review)

Warcraft

Starting to get Involved
#1
Well,
last week had transition audit to IATF 16949 from ISO/TS.
Got first major nonconformity in matter of seconds (on management review).

NCR goes for 6.1.1, since we didn't have risk assessments for all of our processes.
Now, I have 20 days to provide a plan how we are going to resolve this and would kindly require help on how to do it.

FMEA would be hard to use to go trough all processes.
If using SWOT, than I have a problem that not all process owners know the system, so means I would have to do it :lmao:

Anyone has some xls sheets with ideas how to resolve this NCR on long run?

Thank You all.
 
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K. Lawrence

Quality Engineer
#2
How many processes did you identify? My intent for my company was to have process turtles for all processes (21 as of now) and then ensure that the FMEA's are updated. For processes that are not part of the FMEA system, then we'll do a "mini" SWOT. We've done one SWOT for the overall company so the other processes should be easier (I'm hoping).
 

K. Lawrence

Quality Engineer
#4
It's a lot of work but I'd go with FMEA's for technical processes and SWOT for administrative type processes. Keep in mind that the FMEA and SWOT do not have to be perfect and they can be updated at any time. For the SWOT, I did a simple four square table (2x2) in Word.
 
#5
I would not put everything in a PFMEA as some have suggested. I would keep it pretty simple and use turtle diagrams for your key core processes. You add a box on the turtle for Internal risks, How you a mitigating those risks and a box for External Risks and how you are mitigating those risks. Remember there are many ways to document a process. It can be done with a turtle, procedures, work instructions, Process flows, etc. it may even be an electronic process or software program. Keep it simple! Don't over complicate your processes so your team cannot function within those processes.
 

Warcraft

Starting to get Involved
#6
Anyone willing to share documents that are availabile?
PM me pls. if possible with some docs.
I really don't want to invent hot water again so help with examples is big help.
 

Scanton

Wearer of many hats
#7
I personally believe that turtle diagrams are the best way to go, they will take a bit of work and thought to complete however they are a simple framework to work with and easy to understand. If you are mapping a large system, then break it down into the smaller identifiable processes and if they are sequential, use the outputs from one turtle diagram for the inputs for the next.

For example the outputs from your Enquiry process would make up some of the inputs to your planning process. If it is a standalone process like auditing which can have inputs from many of the other processes then just include a reference to the other turtle diagrams and your manual as one of the inputs.

The internet is awash with tutorials for turtle diagrams, so if you are not familiar with them that would be a good place to start. The basic template I have provided has already passes an IATF audit (once completed). These templates are common knowledge so no copyright infringements have been made.

Good luck.
 

Attachments

#8
Well,
last week had transition audit to IATF 16949 from ISO TS.
Got first major nonconformity in mater of seconds ( on management review).

NCR goes for 6.1.1, since we didn't have risk assessments for all of our processes.
Can you provide the exact wording of the NC? There's NOTHING in 6.1.1 which states you have to do risk assessments, period. Before you rush off and start fixing something, do we know what's broken?
 

Warcraft

Starting to get Involved
#9
Can you provide the exact wording of the NC? There's NOTHING in 6.1.1 which states you have to do risk assessments, period. Before you rush off and start fixing something, do we know what's broken?
6.1.1 When planning for the QM sistem, the organisation shell consider the issues reffered to in 4.1 and 4.2 and determine the risks and opportunities that needs to be addressed to: a, b, c, d.....

IATF 16949 standard just directs to ISO 9001: 2015, and if You open it on 6.1.1 will see above quote.

So yeah, to finish this NC i need risk and opportunities assessment for every process that I have.
 
#10
6.1.1 When planning for the QM sistem, the organisation shell consider the issues reffered to in 4.1 and 4.2 and determine the risks and opportunities that needs to be addressed to: a, b, c, d.....

IATF 16949 standard just directs to ISO 9001: 2015, and if You open it on 6.1.1 will see above quote.

So yeah, to finish this NC i need risk and opportunities assessment for every process that I have.
I don't agree. I don't think you fully understand the linkage from the "Context" to the "Planning" requirements. You most certainly Do Not have to do risk assessments for all processes, according to the standard (it's simply not stated) and, hence, if your auditor left you with that NC or understanding, they are similarly incorrect.

Let me help you out: If, in understanding the internal and external issues which can affect the QMS (4.1) you determine that there's a risk in not finding sufficient skilled workers (a common theme here in the USA), your organization may chose to create a program to train their own skilled workforce. Now, looking at 6.1, the planning should address the QMS to create that training programme, since it's unlikely that your current training procedure is sufficient... Someone needs to decide to work on it, how long it will take, who else it will involve, know when it's working etc. That's how it's supposed to work.
 
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