Hi Everyone!

I am trying to determine what part of our processes 7.1 Planning of Product Realization refers to. I think my company has two production realization processes. We:


design and manufacture product (prior to sales)
"configure" finished goods according to customer specifications (during sales)


We're sort of like Dell in some regards. We build the sub-components (ie. video cards, fans, mother boards, etc) and then we configure or assemble them together per the customer needs (ie., build the computer)

So, I'm pretty sure we would have two instances of planning - one for the design and mfg of the product and another for the specific customer requirements.

Question: Is this the case? Or, is ISO intending something else?
Thank you! :thanx:

Our Scope for product realization states:

"This procedure covers the Quality Planning and Implementation into Quality Documentation. Which shall include travelers, shipping instructions, inspection plans, engineering plans, and all other required quality planning to manufacture, assembly, design, service, or machine product per customer requirement."

I have worked with many companies who have asked this question. One of the easiest ways to look at this is that it is most likely the same process with different entry points. If you document the process from design to build, you will typically find that near or at the final design phase you could have an entry into the system for customer designed products.
I hope this helps.

Specific to Clause 7.1 Planning of Product Realization you will find that it is linked (not always stated directly) to the following clauses of the standard:

4.2.4 Control Of Records
5.4.1 Quality Objectives
6.1 Provision Of Resources
6.2 Human Resources
7.0 Product Realization, All Sub Clauses
8.2 Monitoring And Measurement

I am trying to determine what part of our processes 7.1 Planning of Product Realization refers to. I think my company has two production realization processes. We:


design and manufacture product (prior to sales)
"configure" finished goods according to customer specifications (during sales)

7.1 is the "big planning" clause that requires you to plan all the "other" activities covered by clauses 7.2 through to (the ridiculously placed) 7.6.

So it requires you to think about how (for example) sales (7.2) relates to design (7.3) purchasing (7.4), and production (7.5) and how they work together to satisfy customer requirements.

(Sorry, can't bring myself to add inspection and measuring equipment (7.6). :lol:

I forgot to post an example of a process map that shows 7.0 product realization. It also includes some of the other linkages to other ISO sections. It may help you understand the big picture.

(Sorry, can't bring myself to add inspection and measuring equipment (7.6). :lol:

Paul, I always assumed it was put in section 7 so it could be excluded if required. Is that true?:rolleyes:

I forgot to post an example of a process map that shows 7.0 product realization. It also includes some of the other linkages to other ISO sections. It may help you understand the big picture.

I had a problem attaching the file as a jpg so I had to convert it to a pdf. :bonk: I hope this diagram helps.

Paul, I always assumed it was put in section 7 so it could be excluded if required. Is that true?:rolleyes:

No idea, Colin.

I find the whole concept of exclusions a bit bizarre. I appreciate the need to say what your system covers and what it doesn't but to artificially limit exclusions to one set of clauses? :confused:

It's no wonder folk on the Cove spend a lot of time looking at "how" to exclude rather than how to describe what their organization does.

It's no wonder folk on the Cove spend a lot of time looking at "how" to exclude rather than how to describe what their organization does.

Right on Paul!

Which causes me to believe that too many organizations are more concerned with obtaining and keeping that piece of paper on the wall than to implement, maintain and improve a solid quality system.

Stijloor.

Specific to Clause 7.1 Planning of Product Realization you will find that it is linked (not always stated directly) to the following clauses of the standard:

4.2.4 Control Of Records
5.4.1 Quality Objectives
6.1 Provision Of Resources
6.2 Human Resources
7.0 Product Realization, All Sub Clauses
8.2 Monitoring And Measurement

These clauses are certainly related to, and supportive of, Product Realization. Thus, they are of course linked to it. But it drags the conversation further from the original question - "which process(es) are included in Product realization?"

I always disliked this term. There were so many good English terms already, but they had to invent one nobody used before. Perhaps it was a translation of a common European term?

In any case, it represents the concept of "realizing" a product from design concept to a finished product. It can address all the engineering, design and quality planning functions, or, some companies apply it to the whole core process chain, as Paul Simpson already described.

My advice would be to use your own terms - those terms your company is already familiar with.

These clauses are certainly related to, and supportive of, Product Realization. Thus, they are of course linked to it. But it drags the conversation further from the original question - "which process(es) are included in Product realization?"

I always disliked this term. There were so many good English terms already, but they had to invent one nobody used before. Perhaps it was a translation of a common European term?

Helmut,

"Realizing" was used to deemphasize "manufacturing." The intent was to make the standard more generic and applicable to all types of organizations. It took obviously some creative "word smithing", resulting in beautiful terms such as "Monitoring and Measuring" instead if good old "inspection."

Stijloor.

Helmut,

"Realizing" was used to deemphasize "manufacturing." The intent was to make the standard more generic and applicable to all types of organizations. It took obviously some creative "word smithing", resulting in beautiful terms such as "Monitoring and Measuring" instead if good old "inspection."

Stijloor.


Yeah, I understand. It was a compromise term. It just seems there could have been a better word. Unfortunately, now thousands of companies have a process entitled "Product Realization" instead of whatever they actually called it before.

How do I implement the clause 7 as We are a simple inspection services organization & our product is mostly inspection certificates.
What product realization means? How do we implement such things? :thanks:

How do I implement the clause 7 as We are a simple inspection services organization & our product is mostly inspection certificates.
What product realization means? How do we implement such things? :thanks:

Your product realization would look something like this.
1. Sales and marketing of your services
2. Receive requests for quotes
3. Job award
4. Verify quote
5. Receive product for inspection
6. Perform inspection
7. Prepare report/certificate
8. Ship to customer
9. Follow up activities (customer satisfaction, billing and etc.)
I hope this rough outline helps. Look up a few messages and you can see the process map I attached.:D

Hi Everyone

I_List of requirements (§7.1 Planning of Product Realization)

Requirement 1: The organism must plan the necessary processes of product realization
Requirement 2: The organism must develop the necessary processes of products realization

In this stage, the ISO 9001 don’t mention that the organism must identify the necessary processes of products realization. (Just plan and develop)
Why?
Because ISO 9001 indicates this in (§4.1: the organism must identify the necessary processes of QMS)
Necessary processes mean all processes which affect the MQS (always mention at your process map) and they can be classified in three categories:
1--process of realization: creating the value directly for customers, employees, and investors (i.e: process of production)
2--process of support: providing resources to permit the execution of the processes of realization, these processes don't create the value directly (i.e: processes of quality)
3--process of direction: create the vision of the enterprise, influencing the environment in which processes of level 1 and 2 are going to take place (i.e: processes of internal communication)
So if you have already satisfy the requirements of §4.1, you can take your processes of products realization and create your planning in order to respect requirements of §7.1. If not, try to do your process map first because it facilitate many problems of implementation.

Requirement 3: The organism must assure the consistency between the scheduling of the product realization and the other processes of the QMS.
Since: processes of the QMS = processes of realization + processes of support + processes of direction.
You can respect this requirement in showing the evidence of all interactions between process of realization, process of support, and process of direction

Requirement 4: The organism must determine objectives (and requirements) of products.
Requirement 5 : the organism must determine criteria of products acceptance
With these requirement you can follow §7-2


Requirement 6: The organism must put specifics processes for products.
Requirement 7: The organism must establish specifics documents for products.
Requirement 8: The organism must provide specifics resources for products.
You must satisfy these requirements just if you work by project or unit product.

Requirement 9: the organism must determine activities of control, validation……..
See §7.6 and §8

Requirement 10: appropriate documentation


II_Relation between 7-1 and others paragraphs
look at the file

I hope that it will help
Regards

Our Scope for product realization states:

"This procedure covers the Quality Planning and Implementation into Quality Documentation. Which shall include travelers, shipping instructions, inspection plans, engineering plans, and all other required quality planning to manufacture, assembly, design, service, or machine product per customer requirement."
I have just come aboard with my new employer and I am trying to get the message across of how the traveler/ work order is a valuable piece of evidence for product realization. Their argument is we have work instructions and procedures that provide this information. I tried to explain that objective evidence it needed to show where a product is located (e.g. planning), what process a part follows and the asscoiated guidelines/ docs that could be referenced. I have a two part question: 1) Are travelers required or can other documents take their place? 2) If no travelers are needing then should other docs contain sign-offs for operations perfromed (e.g assembly procedure or work instruction like acceptance test procedures)? Thank you and sorry for the long winded question.

I have a two part question:
1) Are travelers required or can other documents take their place?

No, travelers are not required, unless your organization considers it necessary to list the required operations and provide a document to record evidence of inspections, test, materials used, accept/reject numbers and the like.


2) If no travelers are needing then should other docs contain sign-offs for operations performed (e.g assembly procedure or work instruction like acceptance test procedures)?

Assuming that you are registered to ISO 9001, Clause 8.2.4 requires that "Evidence of conformity with the acceptance criteria shall be maintained. Records shall indicate the person authorizing release of product (see 4.2.4)." The evidence/records mentioned can be a traveler, but also an electronic document. Whatever works best for your company.

Hope this helps.

Stijloor.

How do I implement the clause 7 as We are a simple inspection services organization & our product is mostly inspection certificates.
What product realization means? How do we implement such things? :thanks:

I would say your product is the Inspection Service, itself. The certificate is only an output and record of the inspection performed.