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Risk Management Implementation for ISO 9001:2015
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Risk Management Implementation for ISO 9001:2015
Risk Management Implementation for ISO 9001:2015
Risk Management Implementation for ISO 9001:2015
Risk Management Implementation for ISO 9001:2015
Risk Management Implementation for ISO 9001:2015
Risk Management Implementation for ISO 9001:2015
Risk Management Implementation for ISO 9001:2015
Risk Management Implementation for ISO 9001:2015
Risk Management Implementation for ISO 9001:2015
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iso 9001 - quality management systems, iso 9001:2015, organizational knowledge, risk management and analysis
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  Post Number #9  
Old 20th May 2015, 09:37 AM
hogheavenfarm's Avatar
hogheavenfarm

 
 
Total Posts: 541
Re: Risk Management Implementation for ISO 9001:2015

4.4.2 - Process approach
“The organization shall:
d) determine the risks to conformity of goods and services and customer satisfaction if unintended outputs are delivered or process interaction is ineffective;”


This clause seems conditional. Note that the determination is required IF unintended outputs are delivered OR process interaction is ineffective. Sort of like a corrective action here, not any advance planning.

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  Post Number #10  
Old 20th May 2015, 11:45 AM
Paul Simpson's Avatar
Paul Simpson

 
 
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Re: Risk Management Implementation for ISO 9001:2015

Quote:
In Reply to Parent Post by hogheavenfarm View Post

4.4.2 - Process approach
“The organization shall:
d) determine the risks to conformity of goods and services and customer satisfaction if unintended outputs are delivered or process interaction is ineffective;”


This clause seems conditional. Note that the determination is required IF unintended outputs are delivered OR process interaction is ineffective. Sort of like a corrective action here, not any advance planning.
Like others I can't find the clause reference mentioned and the text you've quoted is not that included in my copy of the DIS.

So I'm not sure of the value in responding to text that doesn't exist in a draft standard that is soon to be superseded by another (final) draft standard!
Thanks to Paul Simpson for your informative Post and/or Attachment!
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  Post Number #11  
Old 20th May 2015, 12:17 PM
hogheavenfarm's Avatar
hogheavenfarm

 
 
Total Posts: 541
Re: Risk Management Implementation for ISO 9001:2015

My comment was strictly on the grammar used in the OP, not on the validity of the quoted section. I did find in my ever-growing expansion of 2015 related files, a spreadsheet entitled "ISO 9001:2015 vs. 2008 Matrix" that exact quote which appears to have been from a consultants site on the net. The creation date was 11/21/13, so it could very well be material that is no longer being considered.
Thanks to hogheavenfarm for your informative Post and/or Attachment!
  Post Number #12  
Old 20th May 2015, 12:30 PM
SystemsQualityGuy

 
 
Total Posts: 6
Re: Risk Management Implementation for ISO 9001:2015

I copied it from another thread. It apparently originated from an article The Many Uncertainties of Risk as Currently Stated in ISO 9001: 2015 in Quality Digest by James Lamprecht, August 2013.
  Post Number #13  
Old 20th May 2015, 06:44 PM
Jen Kirley's Avatar
Jen Kirley

 
 
Total Posts: 6,021
Re: Risk Management Implementation for ISO 9001:2015

Quote:
In Reply to Parent Post by Big Jim View Post

I agree that the concept of involving risk is not nearly as daunting as some seem to fear. Most companies have always practiced some level of risk mitigation anyway. The ultimate risk mitigation is to no bid a project that a company is not comfortable with.

I do question your thought that there is a requirement for a procedure for process controls. From the last paragraph of 4.4 in the DIS:

"The organization shall maintain documented information to the extent necessary to support the operation of processes and retain documented information to the extent necessary to have confidence that the processes are being carried out as planned."

Documented information is defined in Section 3 of the DIS.

Documented information controls are detailed in 7.5 of the DIS.

In my search of all of this I cannot find where any written procedures are required. Every place that documented information is mentioned appear to require keeping what we now know as records. It appears that documented information may include what we now know as procedures, but at the organizations discretion.

As I see it, 4.4 certainly does not require a written procedure.
These are really good points. I have reviewed the following lines in section A.6 to help clarify my position: 1662 through 1672. Particularly 1668 and 1669, where
Quote:
1668 Where ISO 9001:2008 would have referred to documented procedures (e.g. to define, control or
1669 support a process) this is now expressed as a requirement to maintain documented information.
Documented information is defined in 3.11.

"Documented information" as associated with operational controls is mentioned in 4.4 with the caveat "to the extent necessary..." in 7.5.1, with the qualifier "...determined by the organization as being necessary..." also in section 8.5.1 without these caveats or qualifiers.

I agree there seems to be a lot of loopholes and weasel words regarding controlled documents, but not in 8.5.1.
Thanks to Jen Kirley for your informative Post and/or Attachment!
  Post Number #14  
Old 21st May 2015, 02:08 AM
Big Jim

 
 
Total Posts: 2,803
Re: Risk Management Implementation for ISO 9001:2015

Quote:
In Reply to Parent Post by Jennifer Kirley View Post

These are really good points. I have reviewed the following lines in section A.6 to help clarify my position: 1662 through 1672. Particularly 1668 and 1669, where Documented information is defined in 3.11.

"Documented information" as associated with operational controls is mentioned in 4.4 with the caveat "to the extent necessary..." in 7.5.1, with the qualifier "...determined by the organization as being necessary..." also in section 8.5.1 without these caveats or qualifiers.

I agree there seems to be a lot of loopholes and weasel words regarding controlled documents, but not in 8.5.1.
8.5.1 in the DIS:

a) the availability of documented information that defines the characteristics of the products and services;

b) the availability of documented information that defines the activities to be performed and the results to be achieved;

This looks like what you would include in a traveler and/or the traveler package. That would be routing, work instructions, drawings, specifications, and the like.

I don't see a requirement for a written procedure here.
Thank You to Big Jim for your informative Post and/or Attachment!
  Post Number #15  
Old 21st May 2015, 07:53 AM
Jen Kirley's Avatar
Jen Kirley

 
 
Total Posts: 6,021
Re: Risk Management Implementation for ISO 9001:2015

Good points Jim.

Discussions like this one are so important.

Last edited by Jen Kirley; 21st May 2015 at 10:17 PM. Reason: Adding a note
Thanks to Jen Kirley for your informative Post and/or Attachment!
  Post Number #16  
Old 23rd May 2015, 12:24 AM
somashekar's Avatar
somashekar

 
 
Total Posts: 5,251
Re: Risk Management Implementation for ISO 9001:2015

Change and Risk based thinking ....
A good article in "Qualitydigest" to garnish some understanding further what RISK can be.

READ HERE
Author: William A. Levinson
Thank You to somashekar for your informative Post and/or Attachment!
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