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Where to Start to Implement ISO 9001

Sidney Vianna

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Staff member
Admin
Re: Design to be included or excluded?

Sidney, I didn't read they designed the packaging - only that they design the label...hence my questions.

Saying they "We design the labelling as well as packaging of the bottles" could mean two things...only one of which is a preservation/packaging design responsibility.
Andy, in my opinion, even if they are responsible solely for the design of the label, due to potential regulatory requirements, such as the Fair Packaging and Labeling Act, they must be design responsible. Labeling of cosmetic products is important and proper design controls for the labels is a must. Liability concerns abound.
 
Elsmar Forum Sponsor
Re: Design to be included or excluded?

Andy, in my opinion, even if they are responsible solely for the design of the label, due to potential regulatory requirements, such as the Fair Packaging and Labeling Act, they must be design responsible. Labeling of cosmetic products is important and proper design controls for the labels is a must. Liability concerns abound.
Agreed, Sidney, they appear to be design responsible for the label, no doubt. I was questioning the 'packaging' design responsibility - plus their scope needs to be changed to reflect not simply labeling and packaging...
 
S

siewkingbee

Dear all thank you very much for the feedback.

I do know that i will need to control my process for designing of labels and packaging material. So of course i must have procedures for these.... yes I have.....my question is that is 7.3 applicable to me?

However, there are parties mentioning that 7.3 design and development is only applicable for designing the "product" that I am selling.
The "product" which is the skincare product......since i dont do the skincare formulation then designing is not applicable to me.....

But in actual fact what I want to argue is that now i am in the trading industry so my "product/services" is supply the packaging material and labelling. (and of course ensure correct quantity, correct product and etc as part of my "product/services")

So what do you think the "product" for me is still the skin care or what?
 
Your product is labels. You design them. Your service is packing/packaging the filled containers. You have two 'scopes' - designing labels, filling and packaging skin care products...
 
J

JaneB

Re: Where to Start to Implement ISO9001

Actually starting is simple:
1-Define all departments
2-For each department write down all the steps of the main proces and who is responsible at decision points. Find out how these decisions are registered.
3-Put up a drawing of how these departments are connected.
4-find out what secondary processes are in place: administration, HRM, etc. and do the same thing for these processes.
5-Find out where and what is going wrong during production and where this is being registered. Analyse this and have management decide what actions should follw.
6-check with ISO 9001.
Kees, I am afraid I disagree strongly with the order of these steps, especially 1, starting with departments! You seem to be saying 'each department has a main process'. This is contrary to the process approach that lies at the heart of the Standard.

Start with identifying PROCESSES! Never never, never start with 'departments'. That way lies madness and frustration. Not to mention contradicts the Standard.
 

harry

Super Moderator
Dear all thank you very much for the feedback.

I do know that i will need to control my process for designing of labels and packaging material. So of course i must have procedures for these.... yes I have.....my question is that is 7.3 applicable to me?.................
Welcome to the Cove. Both Andy and Sidney had given you good advice in previous posts but seems you have a problem grasping what they meant.

However, there are parties mentioning that 7.3 design and development is only applicable for designing the "product" that I am selling.
The "product" which is the skincare product......since i dont do the skincare formulation then designing is not applicable to me.....
While your product is 'skin care product', it includes the packaging (container - both inner plus outer) plus labeling which would need approval from the relevant authorities. You don't design the skin care product but is responsible (both design and seeking legal approval after design + plus any amendment if requested by the authorities) for the packaging and labeling.

But in actual fact what I want to argue is that now i am in the trading industry so my "product/services" is supply the packaging material and labelling. (and of course ensure correct quantity, correct product and etc as part of my "product/services")
Unless you are only selling the packaging and labeling material. Didn't Andy request you to clarify clearly what your exact involvement is in an earlier post?

So what do you think the "product" for me is still the skin care or what?
According to the ministry's requirement, the official owner (in this case your trading company) of the skin care product will need to apply for approval for the labels - indirectly, you are registered with them. There is no room to wriggle your way around by any sort of argument. However, if you are just selling packaging and labeling material, things are different.

Don't be afraid of the word 'design'. In practice, a checklist to remind and indicate that you had made various considerations and seek relevant approvals (input/output/verification/validation) is sufficient.
 
Last edited:

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
Re: Where to Start to Implement ISO9001

Kees, I am afraid I disagree strongly with the order of these steps, especially 1, starting with departments! You seem to be saying 'each department has a main process'. This is contrary to the process approach that lies at the heart of the Standard.

Start with identifying PROCESSES! Never never, never start with 'departments'. That way lies madness and frustration. Not to mention contradicts the Standard.
This is nothing more than a variation on a theme. Starting with departments and their immediate processes and then tying together the interaction of processes isn't a big deal, and each department does have processes which are 'main' to them. Purchasing, as an example, has a primary function with processes they are responsible for. It (they) interact(s) with other processes which other departments are responsible for, but purchasing isn't welding (for example) which typically has their own main process(es).

If one is doing an implementation identifying all processes isn't rocket science. You can do it department by department, or you can do it another way. I do not in any way see it as contrary to the process approach that lies at the heart of the Standard. As long as all processes and their interactions are identified, how you approach it isn't a big deal.

I am open to hearing how, for example, purchasing does not have a main process which they are responsible for. It may not be the 'main' process of the business as a whole, but it is specific to purchasing just as design engineering had a definite function and processes which are specific to them which they are responsible for. Their processes interact at places with processes of other departments, but that doesn't mean they don't have processes that they bear the main responsibility for.

Implementation can be done in many ways. I know some people are passionate about how they do their implementations, but they're all variations on the same theme and there simply is no single 'right' "one and only" way to go about implementation. As long as all processes, and their interactions, are identified, how you do it isn't important.

Going back 20 years I always started with individual departments. I would do the same today. We worked our way to inter-departmental process interactions. It never led to "madness and frustration", nor does it contradict the Standard. I am open to hearing *specifically* how it contradicts the standard.

In all the years I did implementations I never had a client which wasn't first audit successful, and many came through their registration audit with zero nonconformances (major or minor) and no observations. I might add many of my clients were quite large and complex such as Motorola and Borg-Warner. I always started with individual departments identifying their main processes and moved on to their interactions with other processes.

There is more than one way to reach the goal of identification of, and interaction of, all processes.
 

Jim Wynne

Staff member
Admin
Re: Where to Start to Implement ISO9001

Kees, I am afraid I disagree strongly with the order of these steps, especially 1, starting with departments! You seem to be saying 'each department has a main process'. This is contrary to the process approach that lies at the heart of the Standard.

Start with identifying PROCESSES! Never never, never start with 'departments'. That way lies madness and frustration. Not to mention contradicts the Standard.
If one is doing an implementation identifying all processes isn't rocket science. You can do it department by department, or you can do it another way. I do not in any way see it as contrary to the process approach that lies at the heart of the Standard. As long as all processes and their interactions are identified, how you approach it isn't a big deal.
Of these two points of view I tend to agree with Marc, but I also understand Jane's point regarding recognition of the process approach. The problem lies in the fact that there are no companies I have ever seen whose management systems were designed using the process approach. Companies divide responsibilities among departments, each with their own set of requirements and their own places in the management hierarchy.

The OP asks (as in the thread title) where to start to implement ISO 9001. Because in most cases the process approach doesn't exist in the early implementation stage, there is no place to start except in departments. The big challenge, after all, is to create (not identify) a contiguous flow of processes, and to eliminate the walls between departments to the extent that the walls inhibit process cohesion. I don't know how you can do this--starting from scratch--without understanding how the departments work and how their work affects the needs of other departments.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
Re: Where to Start to Implement ISO9001

<snip> Companies divide responsibilities among departments, each with their own set of requirements and their own places in the management hierarchy. <snip>
Which is logical because there are specializations within every company, even very small ones but to a lesser degree than in large companies. I can not think of a way to set up a company which does not have any defined departments with defined responsibilities and authorities. As in my example with purchasing - They are a specialized group. While their processes interact with processes of other departments, they do have processes which they are responsible for that other departments are not responsible for.

Secondly, there is no continuous flow of processes in any company in the sense of start here and end here where every function/department is in a single in-line flow. One can lay out the main flow but there are support processes hanging off of them (that is, the support processes are not in the linear flow). See: The Organization as a System, Subsystems, and Processes and the following few pages (such as An Extended System) as a simplified example.
 

Sidney Vianna

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Staff member
Admin
Re: Where to Start to Implement ISO9001

Of these two points of view I tend to agree with Marc, but I also understand Jane's point regarding recognition of the process approach. The problem lies in the fact that there are no companies I have ever seen whose management systems were designed using the process approach. Companies divide responsibilities among departments, each with their own set of requirements and their own places in the management hierarchy.

The OP asks (as in the thread title) where to start to implement ISO 9001. Because in most cases the process approach doesn't exist in the early implementation stage, there is no place to start except in departments. The big challenge, after all, is to create (not identify) a contiguous flow of processes, and to eliminate the walls between departments to the extent that the walls inhibit process cohesion. I don't know how you can do this--starting from scratch--without understanding how the departments work and how their work affects the needs of other departments.
I think you described brilliantly and succinctly in this post:
Here's the problem, imo: ISO 9000 and TS 16949 call for a process approach, but companies aren't set up that way, and the people in charge of the QMS have no power to change it. Manufacturing companies have departments, and there are walls between them. The intent of the process approach is to drill passages through those walls, if not break them down altogether. But executives like their walls, and managers like having their spheres of authority definitively circumscribed. "This is my bailiwick, and these are my people, and we'll do things my way." Enter the hapless management representative, an earnest type who has been granted responsibility and no authority, who is expected to erase those carefully drawn and jealously guarded lines and take the pork chop out of the hungry tiger's mouth. Good luck. Under those circumstances, is it any wonder that five people will give five different answers as to what a process is?
 
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