H
hofrob
Hi could anyone provide me an example of a Process Interaction Chart as "required" by ISO 13485 2003?
Regards, Robert
Regards, Robert
There are numerous examples already attached in posts. You can find them by using the search towards the top of the page. You can also scroll down the page that your post appears on and find similar threads that may contain what you are looking for. The requirement for ISO 13485 is the same as ISO 9001.hofrob said:
M
mkaganov
ISO 9001:2000 - A Process Interaction Matrix
A Case Study
By Mark Kaganov
This article was originally published by Quality Progress in October 2004, p 194
Abstract
This article presents a case study of development and implementation of a process interaction matrix to address one of the requirements of ISO 9001:2000 standard [1]. Going beyond a simple case study model, this tool may also be used for quality management systems (QMS) compliant with ISO 13485:2003 standard [2]. This article will be of interest to companies developing or improving their QMS for such standards.
Introduction
One of the new requirements of ISO 9001:2000, specified in the paragraph 4.2.2 c), requires a company to develop a quality manual that, among other attributes, shall contain “a description of the interaction between the processes of the quality management system.” Through my experience, as a professional auditor, with dozens of companies around the world, I found that very few businesses had developed practical approaches to address this requirement. Attempts to document process interactions range from busy and hard to read flow charts to establishing cross-reference tables in the quality manual. I observed one of the best tools to address process interaction requirement at Quality Works, a small on-line publishing company. ...
For the entire paper visit quality-works website
Patricia Ravanello
Quite Involved in Discussions
Hello mkaganov,
I have to wholeheartedly agree with your comment that "few companies have developed a practical approach to addressing this requirement".
However, while the referenced Model (from Quality Works) provides an interesting cross-reference of the how the Standard interfaces with the Business Operating System, it does not answer the question of how the processes in the system interact with each other, and most certainly sheds no light on their sequence. It does not meet the requirement. I would not recommend it as the solution to the question posed.
Patricia Ravanello
I have to wholeheartedly agree with your comment that "few companies have developed a practical approach to addressing this requirement".
However, while the referenced Model (from Quality Works) provides an interesting cross-reference of the how the Standard interfaces with the Business Operating System, it does not answer the question of how the processes in the system interact with each other, and most certainly sheds no light on their sequence. It does not meet the requirement. I would not recommend it as the solution to the question posed.
Patricia Ravanello
M
mkaganov
Patricia,
I am lost! Where did you see a “cross-reference of the how the Standard interfaces with the Business Operating System” on our Process Interaction Matrix? The table at http://**********/article-process-interaction.htm shows ONLY processes that a company uses. While you stated that “… it does not answer the question of how the processes in the system interact with each other” symbols “<” and “>” show these interactions per the legend on the bottom of the chart. While you also noted that it “… certainly sheds no light on their [processes] sequence”, the arrow next to the product realization processes defines exactly that sequence. Take another look at it – it is a cool tool and hundreds of companies are using it.
Regards,
Mark Kaganov
I am lost! Where did you see a “cross-reference of the how the Standard interfaces with the Business Operating System” on our Process Interaction Matrix? The table at http://**********/article-process-interaction.htm shows ONLY processes that a company uses. While you stated that “… it does not answer the question of how the processes in the system interact with each other” symbols “<” and “>” show these interactions per the legend on the bottom of the chart. While you also noted that it “… certainly sheds no light on their [processes] sequence”, the arrow next to the product realization processes defines exactly that sequence. Take another look at it – it is a cool tool and hundreds of companies are using it.
Regards,
Mark Kaganov
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Patricia Ravanello
Quite Involved in Discussions
Hello Mark,
I owe you a partial apology. The PDF version posted is not very clear, even if enlarged, and I mistakedly assumed that the processes listed down the left-hand column represented the elements and sub-element of the standard (hence, my comment regarding the "interface of the standard with your system processes). I see now, that the same processes are listed both down and across the matrix.
So let me restate my commnets...the matrix referenced still falls short of the requirement to identify/define the "Management System Processes" (not every sub-process in the organization), and to demonstrate their sequence (not just Product Realization) and interaction.
As an example...if I go to your 'Purchasing Process" in the left column, it appears to have no interface with the "Corrective Action Process" or the "Management Review Process"....I could go on with several similar "lacking interfaces"...I think you get my point.
I believe the point of this exercise is to capture the dynamics of the "Business/Management/Quality Operating System", thereby demonstrating an organization's understanding and vision of the "System"...and not necessarily to try to capture and interrelate all the nuances of every process and sub-process.
As you mentioned, most companies have failed to identify a practical approach to this, because they are trying to capture too much information in one model, and end up with a document that fails to really provide any value to anyone.
The model provided still does not address the requirement, as I understand it.
Patricia
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M
mkaganov
Patricia,
P: I owe you a partial apology.
M: Accepted, if you send me your root cause analysis
P: "...the matrix referenced still falls short of the requirement to identify/define the "Management System Processes" (not every sub-process in the organization), and to demonstrate their sequence (not just Product Realization) and interaction."
M: This matrix was not intended to be a complete list of processes for every compnay. This is an example for a given compnay and specific set of process.
P: ...if I go to your 'Purchasing Process" in the left column, it appears to have no interface with the "Corrective Action Process"
M: Look at the "Purchasing" in the horizontal line on the top - here are all your interfaces with CAPA, MR, etc.
P: The model provided still does not address the requirement, as I understand it.
M: Training, trainig and training... Visit our ********and give me a call. I think I can help you.
Regards,
Mark
P: I owe you a partial apology.
M: Accepted, if you send me your root cause analysis
P: "...the matrix referenced still falls short of the requirement to identify/define the "Management System Processes" (not every sub-process in the organization), and to demonstrate their sequence (not just Product Realization) and interaction."
M: This matrix was not intended to be a complete list of processes for every compnay. This is an example for a given compnay and specific set of process.
P: ...if I go to your 'Purchasing Process" in the left column, it appears to have no interface with the "Corrective Action Process"
M: Look at the "Purchasing" in the horizontal line on the top - here are all your interfaces with CAPA, MR, etc.
P: The model provided still does not address the requirement, as I understand it.
M: Training, trainig and training... Visit our ********and give me a call. I think I can help you.
Regards,
Mark
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While I appreciate your offer to help on a personal level, this forum is really more geared towards helping people here in the forum rather than referring people to your web site and/or business. Your participation here is appreciated, but self promotion is a touchy subject here.
Two quickie reference searches:
Process Interaction
A 'Grandfather' thread: Process Mapping - Process Flow and Interactions of Processes
Process Interaction
A 'Grandfather' thread: Process Mapping - Process Flow and Interactions of Processes
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R
RLGALLAGHER
Another company....same argument....... Does the FDA "require" that the organizational chart have the actual given names of the staff/manangement?
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