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Risk Management Implementation for ISO 9001:2015
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Risk Management Implementation for ISO 9001:2015
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  Post Number #49  
Old 28th November 2017, 10:05 AM
SpinDr99

 
 
Total Posts: 62
Re: Risk Management Implementation for ISO 9001:2015

Jen,

We're a small machine job shop. Very streamlined on our procedures and transitioning to 2015 from 2008. You talked about documented procedures for process controls. We have none of these and no work instructions. Instead, we work strictly off our work order/production traveler and the drawing for the job. Do you think this will this satisfy the auditor?

The work order/traveler determines when the product goes to the lather or milling areas and the CNC program runs in each area. First Article and in-process inspections are performed to monitor processes and whether we are meeting customer requirements. There is a big emphasis on aiming for the nominal dimension and not just staying within tolerance. Communication between QC (at First Article Inspection) and the operators is excellent so operators know what adjustments to the CNC program is required to achieve nominal dimensions. Do you think we still need to have documented procedures to maintain process control?

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  Post Number #50  
Old 28th November 2017, 10:12 AM
SpinDr99

 
 
Total Posts: 62
Re: Risk Management Implementation for ISO 9001:2015

My point exactly Jim. My question was answered. Thanks!
  Post Number #51  
Old 28th November 2017, 10:30 AM
Crusader's Avatar
Crusader

 
 
Total Posts: 838
Read This! Re: Risk Management Implementation for ISO 9001:2015

Quote:
In Reply to Parent Post by Crusader View Post

Thanks for chiming in above! We wrote new/revised old procedures and included the RBT in all except a couple. But since we just implemented it within the last 2 - 3 months, I wonder how we will do in the Stage 1....we'll all find out very soon (Monday 17th). I wasn't even sure how to audit it since it is so new. Everything written is what we do since it's newly written in text and not tribal knowledge. It's like everyone says, we've all been doing it but not realizing it and it was never outlined/written down until now.

HA! I am quoting myself! Now that a few months have flown by and I have had a chance to see how the system works....NOT. FYI - Putting the RBT in procedures is a waste. No one looks at procedures. In addition, I also have all of those RBT's in a Register thingy in excel. Double effort here. Which has proved to fail because if I want to update a risk, I have to update the darn-tootin' procedure too. UGH.
I am going to revise the procedures to eliminate the RBT. Maybe I will add a reference to the Register-thingy in the procedures instead? Maybe not? I will end up just having an external register-thingy in Excel. Which can be printed and posted in each department.

Now, for the chore of revising 18 procedures....

comments, suggestions......
  Post Number #52  
Old 28th November 2017, 10:31 AM
Crusader's Avatar
Crusader

 
 
Total Posts: 838
Re: Risk Management Implementation for ISO 9001:2015

Quote:
In Reply to Parent Post by SpinDr99 View Post

Jen,

We're a small machine job shop. Very streamlined on our procedures and transitioning to 2015 from 2008. You talked about documented procedures for process controls. We have none of these and no work instructions. Instead, we work strictly off our work order/production traveler and the drawing for the job. Do you think this will this satisfy the auditor?

The work order/traveler determines when the product goes to the lather or milling areas and the CNC program runs in each area. First Article and in-process inspections are performed to monitor processes and whether we are meeting customer requirements. There is a big emphasis on aiming for the nominal dimension and not just staying within tolerance. Communication between QC (at First Article Inspection) and the operators is excellent so operators know what adjustments to the CNC program is required to achieve nominal dimensions. Do you think we still need to have documented procedures to maintain process control?
Holy cow! Yes, it will work-passed, certified, and registered to ISO 9001:2015. You just described where I work! Wait, who are you? Do you work here? LOL! Let me help...just PM me offline here for anything more specific.
  Post Number #53  
Old 28th November 2017, 11:01 AM
Crusader's Avatar
Crusader

 
 
Total Posts: 838
Re: Risk Management Implementation for ISO 9001:2015

Quote:
In Reply to Parent Post by howste View Post

If you are logged in to ASQ, here's a direct link to the article: Standards Outlook: Prove It
THIS.^^
This is what I will head for when revising procedures and removing specific RBT callouts, etc. The article "Prove It" is so simple. Thanks for posting the link!
Thanks to Crusader for your informative Post and/or Attachment!
  Post Number #54  
Old 28th November 2017, 11:44 AM
Marc's Avatar
Marc

 
 
Total Posts: 26,591
Re: Risk Management Implementation for ISO 9001:2015

The article essentially says: "You're already doing it, you just haven't recognized it as such." More people should recognize that fact.

"Risk Based Thinking" isn't new, any more than the "Process Approach" was when the 2000 version came out and people made a big deal about it. Same for, as the author points out, "Continual Improvement". John J. Guzik wrote:
Quote:
If you were around for the release of ISO 9001:2000, you may remember the introduction of what was at that time a new topic called continual improvement. This caused many people to go off and create continual improvement programs as new tools in their QMSs.

Eventually, people saw how continual improvement could be demonstrated through areas listed in subclause 8.5.1: quality policy, quality objectives, audit results, analysis of data, corrective action, preventive action and management review.
In the many implementations of standards I did over the years, particularly with ISO 9001, the majority of it was going through the standard(s) and showing them that "You're already doing that. You comply with <ISO 9001 clause X> here in your system. Now, be ready to explain it to the auditor."

The key to implementations was teaching someone in a company what the standard was really asking/requiring, and as I have said before the most common "you don't do that" was internal audits. Typically my client companies were already doing everything (or very close to) the standard required.
Thank You to Marc for your informative Post and/or Attachment!
  Post Number #55  
Old 6th August 2018, 04:24 PM
Jethead

 
 
Total Posts: 1
Re: Risk Management Implementation for ISO 9001:2015

Was wondering how other organizations document the risk and the actions taken to meet the ISO 9001-2015 Section 6.1.2. We use a SWOT for our overall business model and use a custom FMEA template for the major processes. Auditor indicated that a number of companies place the Risk item and the evaluation for effectiveness on their Turtle diagram. Any examples would be great
  Post Number #56  
Old 6th August 2018, 08:37 PM
AndyN's Avatar
AndyN

 
 
Total Posts: 9,029
Let Me Help You Re: Risk Management Implementation for ISO 9001:2015

Quote:
In Reply to Parent Post by Jethead View Post

Was wondering how other organizations document the risk and the actions taken to meet the ISO 9001-2015 Section 6.1.2. We use a SWOT for our overall business model and use a custom FMEA template for the major processes. Auditor indicated that a number of companies place the Risk item and the evaluation for effectiveness on their Turtle diagram. Any examples would be great
I've had much success with using management review for nearly all of the section 4 requirements. I wouldn't listen to any CB auditor who mentions risk and turtles in the same breath. That's not what ISO 9001:2015 is looking for you to do. Plus they are brining mission creep from other schemes which think the answer to everything is a turtle. SWOT is good. FMEA is OK, but it takes a lot of work and input - and did you then create a control plan to manage the RPNs?
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