Connecting AS9100 D Clause 4.2 to 9.3.2 b - Interested parties and relevant issues

QE1993

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#1
All,

I am having a hard time connecting the interested parties and relevant issues which we are required to be determined in clause 4.2. to clause 9.3.2. b (disucssing changes in external and internal issues that are relevant to the QMS in mgmnt review).

We have determined our relevant parties and their issues in our quality manual. These issues we listed in our QM for 4.2 are very broad. We say things like "needs of the interested parties will be reviewed at management meetings such as employee morale, customers, suppliers' satisfaction and overall business profitability." Those, in my opinion are just categories of needs/issues, not specific issues themselves.

So, when it comes to discussing any changes in external and internal issues (per 9.3.2. b) in management review meetings, we can't rely on what we have for clause 4.2 - because those actual categories will never change. So, during our management review meetings we just end up coming up with completely new issues rather than discussing what the changes to these issues have been (which, I think is a little different because we don't really reference back to what the original issues were).

I have a gut feeling we are missing the intent of 9.3.2.b and also maybe clause 4.2. Are those two supposed to be connected? If so, the fact that we need to discuss changes implies that these issues and relevant parties need to be on some kind of record which can be updated on a rolling basis, rather than written in concrete in the quality manual.

My questions are:

1. Did the standard intend for 4.2. to be written in stone in something like a quality manual. We rarely update our QM.
2. If these interested parties and issues are meant to be reviewed and changed on a rolling basis, where would you recommend recording them?
3. In 9.3.2.b I'm struggling between the distinction between discussing the changes to internal/external issues rather than just discussing what the issues are and what we are going to do about them. Any insight?

Thanks!
 
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Sidney Vianna

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#2
1. Did the standard intend for 4.2. to be written in stone in something like a quality manual. We rarely update our QM.
It does NOT have to be in the manual. The manual should provide for the FRAMEWORK to exist.

2. If these interested parties and issues are meant to be reviewed and changed on a rolling basis, where would you recommend recording them?
The section of the standard that you are struggling with should be your BIGGEST HINT: record this in the management review minutes of meeting, or whatever record you keep for that purpose.

3. In 9.3.2.b I'm struggling between the distinction between discussing the changes to internal/external issues rather than just discussing what the issues are and what we are going to do about them. Any insight?
As AN EXAMPLE, customer tells you that from February 2nd, 2020 on, you will be required to DROP SHIP parts at addresses they will provide you, instead of shipping all parts to their plants. They state "...Seller shall adhere to the requirements contained within Boeing Document D6-83720 -"Drop Ship Requirements for Boeing Suppliers". ... They are CHANGING part of the contractual requirements for parts shipment. Do you have any idea of what Boeing D6-83270 requires? When are you going to review the document? What are the implications of that change for your Accounts Receivable, Packaging and Shipping functions? RELEVANT requirements and expectations have to be identified and acted upon ASAP, based on a risk based approach. Remember that old cliche: If you fail to plan, you are planning to fail.
 

QE1993

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#3
Thank you.

I am still struggling with making this connection.

We need to know our internal and external interested parties and their issues to determine the scope of our organization (per 4.1 and 4.3). Since our QM IS our framework, it seems like the most practical place to include our scope (including our relevant issues and interested parties), so it really confuses me when 9.3.2.b is asking us to talk about the changes to these internal/external issues (I'm assuming 9.3.2.b is referring to the same issues that are being brought up in clause 4). Does that mean the scope of our organization is expected to change since it is clearly anticipated that there will be changes in these internal/external issues?
 

Sidney Vianna

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#4
In the example I offered in my previous post, because of your customer mandate, NEW INTERESTED PARTIES are being added to your organization. The companies where you are going to start drop shipping parts to, obviously have an interest that the goods/parts they are receiving are in conformity with what they ordered (from your customer), are received properly protected, identified and free from damage during transportation. So, that will have an impact onto your quality system, yes.

Business conditions change all the time. One more cliche': the only constant in life is change. Your customer requirements and expectations change, technology changes, suppliers change, regulations change, employees expectations and rights change, etc...When the world of photography went digital, KODAK, as a mega corporation ceased to exist. The world changes, forcing business to change their processes, forcing the quality systems to either adapt or lead the organization into oblivion. The AS9100 standard is just trying to highlight the imperative that the aerospace supply chain has to deal with: a changing world.

The alternative is being Olivetti, a great manufacturer of typewriters. :naughty:

Good luck.
 

Tagin

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#5
>> (I'm assuming 9.3.2.b is referring to the same issues that are being brought up in clause 4)

Speaking from a ISO 9001 perspective (it sounds like the clauses align)...I don't think 9.3.2b is at all synonymous with the issues as clause 4.

I look at the goal of COTO and interested parties in clause 4 as an exercise used to inform how you will plan and structure your QMS. (In 9001 0.3.2 PDCA diagram, COTO and interested parties are inputs to the Planning of the QMS.) These interested parties and the framework of how you are going to meet their needs/expectations in your QMS structure should change infrequently. For us, it is an annual exercise (or if the nature of the business (i.e., what kind of company we are) suddenly changes significantly), and we retain the results in a simple worksheet. The results of that annual exercise determine if any changes in the scope statement are needed/desired. That in turn, would trigger other changes.

On the other hand, for 9.3.2b, as Sidney points out, external market changes occur often - new regulations are passed, tariffs get instituted, competitors merge, etc. Internal issues might be significant personnel role changes, company finances impacting purchases, some facility is temporarily down while electrician work is being done, etc.

Management review is part of performance evaluation: how are we doing?, what's going on internally/externally that we need to take into account that can affect performance?

COTO/interested parties is more like: who do we need to consider when we are building this QMS? what categories of things will they want/need? where does our org fit into the larger ecosystem?
 
#6
Hmm. I've always read it as 9.3.2b being related much more to 4.1 than 4.2. In 4.1, you define the external and internal issues and in 9.3.2.b you talk about how they changed. And for 4.2, there is a "monitor and review" requirement so I wouldn't think it should be "written in stone." We put ours in a form and review it annually as part of our Management Review.
 

Big Jim

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#7
There is no connection between 4.2 and 9.3.2b. Interested parties and changes to interested parties IS NOT part of 9.3.2b. That's why you can't make the connection.

9.3.2b is actually a carryover from ISO 9001:2008 / AS9100C. The wording in the old standard was "changes that could effect the quality management system". Internal and external changes were not in the actual wording before, but I believe that it always included both. That is the word "changes" wasn't limited to internal changes as most seemed to interpret it. Perhaps that is part of what TC-176 had on their mind when they expanded the wording to include internal and external. I have run across those who did talk about internal and external changes in management review under the old standard.

It is easy enough to find internal issues. They may include acquiring additional equipment, adding personnel, rearranging the shop floor, installing a new MRP system, and an infinite number of other examples.

Some topics could be both internal and external, or external issues may trigger internal issues so sometimes they are connected in that manner.

Determining external issues requires getting your mind outside of the organization itself. Examples may include new competition, new technology, new market opportunities, local, regional, and even global economy, tariffs, and an infinite number of other factors.

It should be noted that generally speaking different members of the group participating in management review may have better insight to some of these many changes than others. For example, the engineering team may have better insight about technology trends, sales managment may have better insights about competitors and markets, and top management may have better insights about global issues.

Isn't that one of the reasons for having management review? To bring the best and brightest of the company together and mine the knowledge each member has that is above and beyond what most of the others have? Thus raising the overall knowledge of the entire group?

What I'm trying to say is that no one person needs to have all the answers, or even all the questions. That's why management is a team.

Anyway, quit trying to bring 4.2 into how you address 9.3.2b. It isn't there.
 

Sidney Vianna

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#8
There is no connection between 4.2 and 9.3.2b. Interested parties and changes to interested parties IS NOT part of 9.3.2b. That's why you can't make the connection.
I differ with your take, as I see a clear connection. In 4.2 we read "... The organization shall monitor and review information about these interested parties and their relevant requirements...." The word MONITOR signifies that the organization must continually assess the relevant interested parties and their pertinent requirements. Because they are dynamic and continually evolving, it is imperative for the organization to identify changes and the impact on it's QMS.

Maybe in the 1980's an on-time delivery performance of 85% was acceptable for many customers. Nowadays, with JIT, inventory optimization strategies, etc., that level of performance would be, for the most part, unacceptable for many customers.
 

Big Jim

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#9
I absolutely agree that 4.2 requires monitoring and reviewing information about the interested parties. Where I disagree is that there is nothing in 9.3.2b about monitoring and reviewing interested parties. 9.3.2b is not the venue for that.
 

Sidney Vianna

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#10
In 9.3.2.b), you are expected to assess changes emanating from internal and external sources, a.k.a interested parties. That's monitoring.

ISO/TS 9002:2016 clearly makes the connection where it reads (in 4.2) "...Monitoring and reviewing can be done by using the organization's processes....snip....and (at a more strategic level) during management review...."

In 9.3.2, ISO/TS 9002:2016 provides the following guidance: "... Management review can also be extended to cover other requirements in ISO 9001 for monitoring and reviewing information (such as in ISO 9001:2015, 4.1 and 4.2)...."
 
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