Process Approach : Query by Steve Pring
Hey Steve !
For Process Approach you dont have to sweat a lot. Just remember that as a process owner your own the responsibility for complete care of the process to make it profit oriented. This is the basic. Other steps to meet the requirements of Clause 4.1 of the standard are as follows;
1. First of all sit down coolly and call the heads of the processes and brainstorm on what are the processes we are managing to deliver or meet the requirements of our customers. These processes shall fall under three separate heads ::;;
(A) Management Processes : These could be Quality Policy, Quality Planning, Management Review, Internal Auditing etc.
(B) Customer Oriented Processes : Under this category those process will fall where customer has something to give and something to get back after some value addition. In this category, processes like Marketing, Order Acceptance, New Product Development, Contract Review, Customer Complaints, Quality etc..
(C) Product Realisation Processes : Here all those processes (Manufacturing Processes will be dealth one by one with a view that an accountability is generated with each of them and these meet the requirements in 100% manner. In fact this segment could be combined with (B) above.
(D) Support Processes : These are the processes which provide all the support to Management, Customer Oriented Processes and Product Realisation Processes. These are HRD, Safety, EMS, Purchase, etc
So in this you list all the processes.
Next draw a matrix of establishing the Process interaction for all the above processes. While doing so, please do take care to mention these vertically top to bottom on the left hand side of the xl sheet and repeat in the same sequence on the top of xl sheet horizontally. Now having done this, establish the interaction. This document will serve as a Ready-Recknor when each process will be dealth separately in the TURTLE Sheet.
Draw TURTLE for each of the processes and fill in the columns. This turtle has boxes for the following :
(a) Supplier input, Supplier, Parameter, Acceptance Criteria
(b) Flow chart for the activities that take place within the process
(c) Customer to the Process
(d) Customer Requirement, Parameter and Acceptance Criteria. Here the next process will be the customer Process.
(e) Control Points, saying How Much
(f) Interacting processes and their acceptance criteria. If there is only one process interacting, this line could be ignored.
(g) Parameter for Continual Improvement
(h) Responsibility : WHO with Competence Criteria
(g) With What : Here mention The machines and other support service equipment that will be used in this process
(g) Feedback : Type of feedback and to whom the feedback to be provided.
I will send a copy of Turtle separately to you. It is self explanatory document.
When handling the Quality Planning clause 5.4.2, please read the standard where it says, Quality plans including those of 4.1. From the turtles we shall pick up those processes only where Acceptance criteria is not being met.
In this way one by one all the processes will be handled and monitored by individual process owners. If all the processes are singing well, you will appreciate that your QMS will singe equally better.
Should you need more information, please feel free to ask. Now cheer up
HS Anand
MD
Quality Growth Professionals
Mohali (Pb) - India
[email protected]
Hey Steve !
For Process Approach you dont have to sweat a lot. Just remember that as a process owner your own the responsibility for complete care of the process to make it profit oriented. This is the basic. Other steps to meet the requirements of Clause 4.1 of the standard are as follows;
1. First of all sit down coolly and call the heads of the processes and brainstorm on what are the processes we are managing to deliver or meet the requirements of our customers. These processes shall fall under three separate heads ::;;
(A) Management Processes : These could be Quality Policy, Quality Planning, Management Review, Internal Auditing etc.
(B) Customer Oriented Processes : Under this category those process will fall where customer has something to give and something to get back after some value addition. In this category, processes like Marketing, Order Acceptance, New Product Development, Contract Review, Customer Complaints, Quality etc..
(C) Product Realisation Processes : Here all those processes (Manufacturing Processes will be dealth one by one with a view that an accountability is generated with each of them and these meet the requirements in 100% manner. In fact this segment could be combined with (B) above.
(D) Support Processes : These are the processes which provide all the support to Management, Customer Oriented Processes and Product Realisation Processes. These are HRD, Safety, EMS, Purchase, etc
So in this you list all the processes.
Next draw a matrix of establishing the Process interaction for all the above processes. While doing so, please do take care to mention these vertically top to bottom on the left hand side of the xl sheet and repeat in the same sequence on the top of xl sheet horizontally. Now having done this, establish the interaction. This document will serve as a Ready-Recknor when each process will be dealth separately in the TURTLE Sheet.
Draw TURTLE for each of the processes and fill in the columns. This turtle has boxes for the following :
(a) Supplier input, Supplier, Parameter, Acceptance Criteria
(b) Flow chart for the activities that take place within the process
(c) Customer to the Process
(d) Customer Requirement, Parameter and Acceptance Criteria. Here the next process will be the customer Process.
(e) Control Points, saying How Much
(f) Interacting processes and their acceptance criteria. If there is only one process interacting, this line could be ignored.
(g) Parameter for Continual Improvement
(h) Responsibility : WHO with Competence Criteria
(g) With What : Here mention The machines and other support service equipment that will be used in this process
(g) Feedback : Type of feedback and to whom the feedback to be provided.
I will send a copy of Turtle separately to you. It is self explanatory document.
When handling the Quality Planning clause 5.4.2, please read the standard where it says, Quality plans including those of 4.1. From the turtles we shall pick up those processes only where Acceptance criteria is not being met.
In this way one by one all the processes will be handled and monitored by individual process owners. If all the processes are singing well, you will appreciate that your QMS will singe equally better.
Should you need more information, please feel free to ask. Now cheer up
HS Anand
MD
Quality Growth Professionals
Mohali (Pb) - India
[email protected]
. I'm sure that folks here will be happy to have a look at your QM, and we'll look forward to your contributions in the forums.
, and good luck with your manual, system et all...
This is an sample process map for Design/Development Activities. It reflects requirements of ISO 9001:2000 & ISO 13485:2003. Hope it's helpful...