Part of the scope of our QMS covers processes needed in the hospitality business specifically food and beverage services. We purchase merchandised items and we sell. We also buy raw materials, we create recipe, we cook foods and we sell.

I reported the following as an observation – potential nonconformity.

"Suggest establishing and maintaining records of the following:
1. Design and development input
2. Design and development review
3. Design verification actions
4. Design validation actions
5. Design changes and results

If records not appropriately maintained could result in nonconformity being identified at the external audit."

They (management and R&D group head) said R&D group doesn’t “design”. They even told me that R&D people are not scientist and better not to state in the documentation those records because they will be audited if those things will reflect in the documentation.

Based from limited information above, do you think we can say that clause 7.3 Design and development is not applicable to our QMS? Our QMR wants me this to justify if it should be included in the permissible exclusion or not.

Should an organization that creates recipe and cook food from available ingredients apply to clause 7.3? Or can we declare it as permissible exclusion considering that we are technically just cooking foods?

For our recipes, the driver is not our customers’ preference but based on cost and availability of ingredients.

Thank you

we create recipe, we cook foods and we sell.

Fine - then just throw away all the recipes, dissolve the R&D group (because they clearly don't DO anything) and use other people's recipes. Then you can exclude design. :sarcasm:

Look, if you're creating recipes, and using those recipes to create foods that you sell, then you're considered to be doing 'design' per ISO 9001. No, it's not the same as designing rockets, but it's still taking a bunch of inputs and creating a recipe. Then using that recipe to cook the food from (ie, applying the design).

But instead of simply listing a whole bunch of (relatively incomprehensible) requirements directly from the Standard to management, and then threatening them (might get us a nonconformity), you'd be providing real value if you took the time to think about what those clauses actually mean in your organisation and translate them into terms and language that your management can understand. Don't use the Standard-speak to hit them over the head and probably just confuse them - help them! Make it clear! Do some work on it!

In the early stage they design recipe. At present, they use the same recipes they made before. They already researched almost all Filipino dishes. Sometimes they come up with a new recipe or promo dishes, but it’s seldom. However, since they depend on the available raw materials the probability that they may adjust the ingredients as to its quantity or use alternative if one if the original one is not available, is high.

if they will only have some adjust, the best thing you should do is provide some limits to it, in order that the reciepe is not considered "design".
say "salt - 1/2 to 1 table spoon"

like jane said, as soon as the group provide "new ingriedients" or created a new menu, then the scope falls to the D&D.

and again, when the team makes that new menu, provide limits, so any small adjustment is not considered as a "design" but of existing process.

:bigwave::notme:

Thank you Jane and Kabayang SpongeMouse for your insights. Of course, i really want to follow your advices as a consultant and expert in this filed.

Personally, i really believe that what we do is considered as design and development. However, the President of the company and the R&D consultant don't want the processes to be under design and development. Our QMR even believe that R&D group's processes fall under design and development. Fact is it was never declared as permissible exclusion even before they had their first ISO 9001 certification a long time ago. When the President has disagreed on establishing and maintaining records required by 7.3, the direction has changed and it's not alligned with ISO 9001.

now, since we have to complete the documentation i am planning to make 2 documents.

1. exclusion of 7.3 Design and development and i am thinking of disputing that we don't do design as "justification".
2. make a document that conforms to 7.3

my concern in #2 is that even if documentation will be made, i doubt that it will be implimented the way it should be because they want to implement what the President and R&D consultant wants.

i was dismayed because it seems that there is a lack of commitment to the standard. they do wanted other departments seriously follow the standards but R&D processes are untouchable.

They perhaps fear that the dreaded D&D will be difficult. It doesn't have to be. After all, you're not designing nuclear power stations or BOeing jets/parts!!

Unless it's more complex than I'm guessing, I doubt you need more than a short procedure (if necessary) but some reasonable records. And it's all just sheer common sense, as per usual: who wouldn't want to control their recipes, make sure they'd been reviewed suitably, met their requirements etc etc??

But ultimately it's down to the registrar/certifier: if you (company) and they agree on exclusion, and they are OK with the agreed scope exclusion, then it could be excluded.

Dear Folks,

Please critic. I would appreciate to hear from you.


Design and Development Planning

<Company XYZ> currently doesn’t design new recipes and uses only the recipes made previously. However R&D develops a system on plan and control of future design and development of recipes headed by the President and in support by the R&D group, F&B Operations Managers, and Central Purchasing and Warehousing Group.

During the design and development planning, the organization shall determine the design and development stages, review, verification & validation that are appropriate to each design and development stage, including responsibilities and authorities for design and development. Refer to Procedure on Preparing of Operations Plan for Onboard Services and Procedure on Developing of New Product Design.

President manages interfaces between different groups involved in the design and development to ensure effective communication and clear assignment of responsibilities.

Inputs

Inputs relating to recipes requirements shall be determined and records maintained. These inputs shall include financial, health and safety considerations, and applicable statutory and regulatory requirements.

These inputs shall be reviewed for adequacy. Requirements shall be complete, unambiguous and not in conflict with each other. Refer to Procedure on Preparing of Operations Plan for Onboard Services and Procedure on Developing of New Product Design.

Design and Development Output

Design and Development output shall be provided in a form that enables verification against design and development input and shall be approved prior to release.

Output shall meet the input requirements for design and development, provide appropriate information for purchasing, production and for service provision, with reference on product acceptance criteria and specify the characteristics of the product that are essential for its safe and proper use.

Design and Development Review

Design and development review shall be performed in accordance with planned arrangements to evaluate the ability of the results of design and development to meet requirements and to identify any problems and propose necessary actions.

Participants in such reviews shall include representatives from F&B Operations, Central Purchasing and Warehousing Group, and R&D and other functions (if any) concerned with the design and development stage(s) being reviewed.

Design and Development Verifications

Design and development verification shall be performed in accordance with planned arrangements to ensure that the design and development outputs have met the design and development input requirements.

Design and Development Validation

Design and development validation shall be performed in accordance with planned arrangements to ensure that resulting product is capable of meeting the requirements for the specified application or intended use, where known. Wherever practicable, validation shall be completed prior to the delivery or implementation of the product.

Control of Design and Development Changes

Control of Design and development changes shall be identified and records maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes includes evaluation effect of the changes of ingredients and product already delivered.

All records as a result of Design and Development review, verification, validation, changes and any necessary actions shall be maintained. Refer to Procedure on Developing of New Product Design.

Bump up for your comments, please.:(

Is this a procedure or what?

If a procedure, it isn't. As an 'or what' - I have no idea who would read this - I can't. Too long, too hard. You're just copying words out of the Standard - don't.

It could/should be in simple, short plain English, in a form that someone could read in 5 minutes or so, and say 'well, that all sounds like good common sense'. As written, it sounds bigger than Ben Hur and twice as complicated. I doubt it actually is or need be.

Is this a procedure or what?

If a procedure, it isn't. As an 'or what' - I have no idea who would read this - I can't. Too long, too hard. You're just copying words out of the Standard - don't.

It could/should be in simple, short plain English, in a form that someone could read in 5 minutes or so, and say 'well, that all sounds like good common sense'. As written, it sounds bigger than Ben Hur and twice as complicated. I doubt it actually is or need be.

It’s a policy statement to be included in the quality manual. Here is the revised/simplified policy statement for your comments.

<Company XYZ> performs design and development of food/meal choices for passengers on board the vessel. This is done thru the R&D group in coordination with the different groups such as F&B Operations, Purchasing and Warehousing and Finance.


In creating food choices and recipes, <Company XYZ> considers cost component and availability of raw materials and supplies, customer acceptance, if applicable, market condition and financial contribution to the organization.

Developed recipes and menus are created in the existing system (RecipeSys), reviewed, approved for accuracy and completeness and communicated to all concerned to ensure proper implementation. Applicable validation procedures and reference materials such copy of recipe and visuals (posters, inserts) are provided to vessel. Any changes are likewise communicated to all concerned thru memorandums from the Office of the President. Records of the results the different processes are properly maintained. Refer to Procedure XXXX.

I agree with what JaneB and the rest have advised.

I would like to add the following recommendation to what they advise. If you have a good working relationship with your registrar, ask them now before the audit. I have always had a good working relationship with my registrars, and was always able to obtain interpretations between audits.

Note: Your registrar is not allowed to consult. That is, they cannot make recommendations on HOW to address an issue. They can, however, provide feedback on whether a particular course of action would meet the intent of the standard.

Several covers are ISO 9001 auditors. Hopefully they will weigh in on this.

dQApprentice

:applause:

Now that's the sort of stuff Imeant ! Forget the ISO gobbledegook - just have plain English, making sense to the people in/around YOUR organisation. Good stuff! Well done.

PS you might consider changing wording like "financial contribution to the organization' to perhaps just 'cost' or 'financial issues' or something similar.

dQApprentice

:applause:

Now that's the sort of stuff Imeant ! Forget the ISO gobbledegook - just have plain English, making sense to the people in/around YOUR organisation. Good stuff! Well done.

PS you might consider changing wording like "financial contribution to the organization' to perhaps just 'cost' or 'financial issues' or something similar.

Hi Ms. Jane,

Thank you for your guidance, very practical suggestions, and above all for being honest (if people will not take the comments constructively, may sounds rude but the truth is it's not and the result would be very rewarding). yes, i'll consider your wording suggestion.

Thank you for your help. Very much :)

Dear Folks,

Please critic. I would appreciate to hear from you.


Design and Development Planning

<Company XYZ> currently doesn’t design new recipes and uses only the recipes made previously. However R&D develops a system on plan and control of future design and development of recipes headed by the President and in support by the R&D group, F&B Operations Managers, and Central Purchasing and Warehousing Group.

During the design and development planning, the organization shall determine the design and development stages, review, verification & .......... (DELETED DUE TO SPACE hehehehe:rolleyes:)

............................implementation. The review of design and development changes includes evaluation effect of the changes of ingredients and product already delivered.

All records as a result of Design and Development review, verification, validation, changes and any necessary actions shall be maintained. Refer to Procedure on Developing of New Product Design.


aaaaaaargh!:bonk: man i thought i was reading a novel hehehe! (peace kabayan, labs you!):o:bigwave:

as mentioned by the peeps, make it short.


and again........... K.I.S.S.:cool: