ISO 9001:2000 Clause 7.1 Planning vs. Clause 7.5.1 Control

[Anton Ovsianko]

Clause 7.1 vs. Clause 7.5.1

Dear All,

I have been asked a question, which I could not answer properly. I mean I knew, what the answer should have sounded like, but could not put it into words.
The question was:
What is really the difference between Clause 7.1 Planning of realization processes and Clause 7.5.1 Control of production and service provision in the 9k2k?

One idea is that we should refer to 7.1 when designing new products and developing new technologies. While 7.5.1 deals rather with regular operation.

Another idea is that 7.1 concerns only project environment and can be omitted in the regular mass production environment.



Maybe my misunderstanding is based upon mere philology problems. I have about 5 Russian translations of the 9k2k text. The authorised one is by far not the best, as I discover.

Yours,

Anton

PS This is the third time I try to post this. I am technically unlucky these days

 

[sneekparty]

The differences....

Hi Anton,

I agree with Jim…If you ask me...the differences are that in 7.1 9k2k states that the (realisation) processes to make the product must be planned correctly and in 7.5.1 9k2k state that you must control the processes correctly...

The difference is that 7.1 states that you must ensure that the processes are planning in that way that the product is according to
requirements, qualitygoals, etc.

In 7.5.1 9k2k states that the process to make the product must be controled...(this is no different then 9k 1994)...and so there must be workinstructions. etc.

Hope this helps…
Cya,
Martin

 

[Anton Ovsianko]

OK, friends,

What do thay mean by planning then:
Planning is setting goals and working out sequenses of operations necessary to achieve these goals. That means that we can plan in form of a project (when we design the technology etc.) or in form of procedure (when we have beforehand planned all the operations necessary to achieve certain results). Should we refer to 7.1 in both cases? I mean, can we consider 7.1 implemented if we have determined all the operations necessary to produce the product (or provide a service to our client)?


As far as I understand, Jim suggests that 7.1 refers to all the business processes - not only those, concerning production or service provision. If so, this corresponds with the whole QMS, which implied defining processes necessary to assure quality. Then 7.1 refers to everything and nothing at the same time.


... and thanks a lot for the quick replies

Anton

 

[Anton Ovsianko]

Yes, Jim,

thanks for the reference!

We do not have to perform planning for generic products manufacture each time an item is let out from the conveyor, do we? The planning can in this case be performed in form of a procedure defining standard operations flow.

and one more idiotic question: how can the difference between planning and control according to 9k2k be put into words?



Anton

 

[anil2187]

Hi Anton,

On definition of Planning and Control:

Though ISO9001:2000 uses the word “Control” in titles as well as clauses , there is no formal definition for it in ISO9000:2000. However. ISO/TC176/SC 2 has published a guidance doc on terminology which can be downloaded free at (broken link removed)

This document defines control as follows :

Contrl: a) Power to give orders to restrain something
b) means of restraining or regulating
c) standard of comparison for checking the results of an action or measurement
(Note: it is different from the word ‘monitor”)

Plan (Verb) – arrange in advance (an action or proposed proceeding)
(noun) - formulation or organized method by which something is to be done.

(An interesting article on this came in February 2002 issue of Quality progress by JP Russell)

We need to link the above words to PDCA cycle to get the full understanding. And that is what Jim has said succinctly .

Coming to the difference between cl 7.1 Planning of product realization and 7.5.1 Control of production and service provision.

Pl ref fig 1 of ISO9001:2K Model of process based QMS.

• It can be seen from this figure that input to the product realization process is requirements(stated, implied and obligatory) and output is product (H/W,S/W ,Service or processed matl) As such product realization process covers all processes except those related to Management Responsibility , Resource Management & Measurement ,analysis and Improvement.
Now coming to 7.5.1 Control of production and service provision. It by and large covers all we learnt in 9001:94- cl 4.3,4.4,4.6,4.7,4.8,4.9,4.10,4.11 ,4.12 and 4.15) The requirements of 7.5.1 is as follows:

The organization shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable.

a) The availability of information that describes the characteristics of the product.
b) The availability of work instructions, as necessary,
c) The use of suitable equipment,
d) The availability and use of monitoring and measuring devices,
e) The implementation of monitoring and measurement, and
f) The implementation of release, delivery and post-delivery activities

7.1 Covers the Following:
The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the Quality Management System (see 4.1).
In planning product realization, the organization shall determine the following, as appropriate:

a) Quality objectives and requirements for the product;
b) The need to establish processes, documents, and provide resources specific to the product;
c) Required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance;
d) Records needed to provide evidence that the realization processes and resulting product meet requirements (see. 4.2.4).

The output of this planning shall be in a from suitable for the organization’s method of operations.


So we can say that 7.1 a,b,c&d are essentially the inputs required for 7.5.1 a,b,c,d,e,f

Anton asks another question :

“We do not have to perform planning for generic products manufacture each time an item is let out from the conveyor, do we? The planning can in this case be performed in form of a procedure defining standard operations flow”

Let us consider following aspects:

• Even though the product is same the Quality objective to be set under 7.1a need not be the same because objective with respect to QCDSM (Quality,cost,Delivery, Safety, Moorale) could be set entirely different considering the present market conditions, competitor performance, innovation in manufacturing technology and other breakthrough changes. That is the plan we make under 7.1a is not static. We need to revisit it as often as we can and as often we need to .
• As explained above 7.1b need to be revisited to evolve a new process based on new technological excellence elsewhere or by sheer benchmarking learnings (again it is not a must , but an option to re-visit all this in a closed loop form is essential- we change or we may not change the existing processes. But we need to review in the light of our new learning.

• Similary 7.1c and d may also need re-look.

ISO 9001:2000 envisages a totally dynamic systuation with multiple loops of learning.

The Changes required in 7.5.1(a,b,..f) may be triggered by Corrective action or preventive actions.(mostly CA) All the same both 7.1 and 7.5.1 are applicable except those clauses which are specifically excluded . But 7.1 may not be feasible to exclude when 7.5.1 becomes applicable as 7.5.1 gets its life from 7.1! Also PDCA cycle can not be effectively/efficiently rotated without the handshaking of 7.1 and 7.51 where it is not excluded.

Sorry for being unwontedly lengthy. Hope it elucidated the points raised.

Anilkumar

 

[gpainter]

7.5.1 is the movement of 7.1 to the floor for verification and use.

 

[Anton Ovsianko]

Dear all,

Thanks for the excellent detailed replies.
As I understand: we plan complying to 7.1;
we control the realization of the plans according to 7.5.1
What then do we control in 8.2.3 (Monitoring and measurement of the processes). Is it even closer down to the factory floor?

7.1 provides input for 7.5.1. 7.5.1 provides input for 8.2.3?

Anton

 

[ISO 9001 Guy]

Re: Clause 7.1 vs. Clause 7.5.1

I believe your question starts to ask into the difference between QA and QC. ISO 9001, by the way, is a standard for QA.

QA is a proactive management function, one concerned with meeting customer requirements. To that end, QA among other things determines which processes affect product/offering quality, determines where in these processes verifications are needed to assure quality at various stages of realization, determines what these verifications consist of, determines what measures of process effectiveness and efficiency are appropriate, etc. So, QA does all it can to assure the next order will be processed in such a way to meet customer requirements as efficiently as possible. QA makes it likely that requirements will be met by ensuring the proper resources are applied or supplied to the processes affecting quality. QA begins with promises made to customers in Sales, and ends with determining customer satisfaction after delivery. (Of course, it doesn't end there--QA then seeks to improve performance based upon performance results. So it never ends.)

QC, on the other hand, is an inspection function. QC involves determining if product in fact meets requirements. In a Venn diagram, QA is a big circle, while QC is a small circle within the big circle. QC performs the inspections and tests prescribed by QA, with the idea that if product meets all tests required of QA, product should meet customer requirements. This explanation apparently begins at the lower-level quality functions and ends at the system level.

To process each customer order (within QMS scope), ISO 9001 7.5.1 requires of realization processes both QA (a "plan" for processing an order) and for the first time in the standard, QC (7.5.1 e and 8.2.3/8.2.4 implementation/application of measurement per the plan). 7.5.1 is the planning required to process any given order. This level of planning extends to the specific activities required to deliver good product to a specific customer.

7.1, on the other hand, contains more general planning for performance of the realization processes themselves. It ensures that processing tasks and methods are defined (e.g., Travelers, work instructions) and resources specific to the product are provided (e.g., machines, personnel, inspection devices), and that as associated product acceptance criteria are defined (so "good" processing can be determined), etc. Verification/test activities should be built into any process where inputs are transformed into outputs (which is all of them). And process records. 7.1 is the planning required to adequately control any given realization process. This level of planning is directed at building quality into processes, ensuring provisions are in place to adequately control activities. This is more clearly QA, as is the following.

Still more general planning--system-level planning--is addressed in 5.4.2. This level of planning makes sure requirements in 4.1 are met. These are the general requirements that really drive home the importance of the process approach. Notice the requirements of 4.1 a) - f). Do you get the idea that the authors of the standard really wants users of the standard to manage processes? (There is a relevant word that is repeated in each of these requirements and elsewhere in 4.1 . . .)