After having written the article on processes related to the client where basically what it is about is to determine the requirements of the product, I proceed to treat the numeral that the standard titled as design and development and that should be sequentially given after the determination of these requirements.
Design and development concept
The ISO 9000 standard presents the following definition of what is Design and Development: "Set of processes that transform the requirements into specified characteristics or into the specification of a product, process or system".
The foregoing makes it clear that in order to carry out the design and development process for the case of a product, the requirements of that product that have already been obtained by applying the part of the standard related to "customer-related processes" are needed as input. and that the result is nothing more than a series of " specifications " that when elaborating the product would be reflected in its characteristics.
For example, if we work for a company that offers mining technology, the design process would imply determining the client's requirements, legal and regulatory, and based on the technology offered by our company, present a product proposal (in this case it would be an integrated technological package). for equipment, training, advice, etc.) that allows mining companies to carry out their work fully.
Design and development process
The standard proposes that this design and development process be carried out in four stages, which are:
- Design and development planning Design and development review Design and development verification and, Design and development validation
Let's see each of them in detail:
Stage I
Design and development planning
" The organization (our company) must plan and control the design and development of the product."
Let us remember that nowadays when speaking of "product" it also refers to the "services" offered by companies such as banks for example.
The question that should be asked would be: What does the planning stage include? The same rule answers us like this:
"During design and development planning the organization must determine:"
a) “ the stages of design and development ”, We have already said that the same standard raises four stages that we list (planning, review, verification, and validation).
b) “ the review, verification and validation, appropriate for each stage of design and development ”
But in turn, at each stage, a review, verification and validation must be carried out, which allows us to identify any flaw and correct it before moving on to the next stage of the process.
c) responsibilities and authorities for design and development.
Determining the responsibilities and authorities in this part of the system is very important since the decisions that must be made and the proposals that must be made involve various levels of the organization, sales, design, production, quality, purchasing, etc. which makes the progress of a design difficult if there are not previously established clear rules of the game and knowledge of all the people involved.
"The organization must manage the interfaces between the different groups involved in design and development to ensure effective communication and a clear allocation of responsibilities."
Since interdisciplinary and teamwork becomes really difficult in organizations, which generally comes up when an error has been made in the product development process, it is best to create an interdisciplinary and interdependent team with its respective coordinator to lead the process and make clear the responsibilities and authorities, but also that it allows the participation of the personnel involved in the process, including the operators, who have a lot to contribute to the design and development process.
"The planning results should be updated, as appropriate, as design and development progresses."
Input elements for design and development
“Input elements related to product requirements must be determined and records kept. These input elements must include:
a) functional and performance requirements, b) the applicable legal and regulatory requirements, c) information from similar previous designs, when applicable, and
d) any other essential requirement for design and development.
These elements should be reviewed for adequacy. The requirements must be complete, unambiguous and must not be contradictory.
Let us remember that part of this work was carried out in the part of the system corresponding to the "processes related to the client" where the client's requirements, the legal and regulatory requirements and those additional ones considered by the organization were determined, now this information must be complemented including those experiences of similar designs that the company has developed and that contribute to the new design, but it is also necessary to analyze and evaluate the designs of the competition to take the positive from them; This practice can be corroborated by observing the similarity in products manufactured by different companies and which compete with each other at the market level.
Design and development results
As we are already clear about what are the input elements for design and development and that can be classified as requirements of the product and the services associated with it, now we must touch on the output elements of design and development; We see that the norm states that:
"The results of the design and development must be provided in such a way that they allow verification against the input elements for the design and development, and must be approved before their release."
How these results are provided is important; it generally involves gathering documents of different types according to the type of product to be produced. These documents are plans, formats with technical specifications, drawings, photographs, prototypes, etc. I would make an important recommendation and that is to use a package of documents that is as simple as possible in a way that facilitates communication between the bodies and people involved.
In any case, the package of documents that is provided as an output element of the design and development must include the following components proposed by the standard:
"The results of design and development must":
a) meet the requirements of input elements for design and development, This is hardly logical, design that does not meet the required input elements is poorly done; This compliance will be verified in the subsequent stages of verification and review.
b) provide appropriate information for the purchase, production and provision of the service, Here we refer to the fact that the information provided must be so complete that it facilitates the purchase of materials, equipment or tools required for the elaboration of the product, but also that it includes what is required for the manufacture of the product, delivery times, mode of delivery etc. this information also serves as the basis for the subsequent stages of review, verification and validation.
c) contain or refer to the product acceptance criteria
Although it is true, some of the criteria (for example dimensions) are possibly included in a plan, it is convenient that to facilitate communication with those people or instances involved, for example operators or quality, take those that are considered relevant and include them in an additional format designed in a simple way.
Likewise, a simple format can be prepared in which the product acceptance criteria are included.
d) specify the characteristics of the product that are essential for safe and correct use.
There are dimensions or critical parts in a product that are important and that if nonconformities occur in them, its operation is automatically affected, affecting its safe and correct use; These characteristics must be made clear to them and must be seen by people directly related to the quality of the product. If this is done, it is possible for an operator to identify the nonconformities in a product and if he has the authority to do so, prevent it from going to the next phase of the production process.
Stage II
Design and development review
At the appropriate stages, systematic design and development reviews should be conducted as planned.
The same design is demanding with its dynamics the revisions that are necessary at the time; Since design itself is a dynamic process that requires proposing, review what is proposed to see that it is improved.
However, in the review process it is necessary:
a) assess the ability of design and development results to meet requirements
Here a comparison of the product design proposal made so far with the requirements for it is made, this comparison allows identifying improvements that can be made.
b) identify any problem and propose the necessary actions
The problems in the design are easy to identify to the extent that participation is given to all the entities involved in the process such as production, purchasing, warehouse, sales, quality, etc.
Participants in such reviews should include representatives of functions related to the design and development stage (s) being reviewed. Records of the results of the reviews and any necessary actions should be kept.
As we said previously, this review process occurs simultaneously with the design itself, since he or the designers constantly reflect, identify inconsistencies, consult with other agencies involved, receive their criticism and correct what has been done to improve the design and not only comply with customer requirements but also adapt to technology and current conditions in the company. However, it is necessary to be disciplined and record in the appropriate formats the product of these reviews, minutes of the meetings that are held to gradually improve this part of the design and development system.
Stage III
Design and development verification
Verification should be performed, as planned, to ensure that design and development results meet the requirements of the design and development input elements. Records should be kept of the verification results and of any action that is necessary.
Although a thorough design review has been carried out, verifying those parts that are considered critical and relevant, above all for the safe operation or use of the product, is not out of date, for this reason the system requires the verification stage of which records should also be kept regarding the results obtained and subsequent actions based on these results.
Stage IV
Design and development validation
Design and development validation should be performed as planned to ensure that the resulting product is capable of meeting the requirements for its specified application or intended use, when known. Wherever feasible, validation should be completed prior to product delivery or deployment. Records of the validation results and any necessary actions should be kept.
The most common system to validate the design is often elaborating a prototype that can be a scale model elaborated sometimes with different materials than the product that is going to be finally manufactured, on other occasions simulations are used for cost reasons, all This is valid insofar as the developed actions facilitate verifying that the product to be manufactured finally complies with the previously established requirements.
Another validation action may be to test the first product manufactured, so that the final adjustments required by the design can be made before continuing with the elaboration of the remaining products.
“ Control of design and development changes ”
“Design and development changes must be identified and records must be kept. Changes should be reviewed, verified and validated, as appropriate, and approved prior to implementation. The review of design and development changes should include evaluation of the effect of the changes on the constituent parts and on the product already delivered.
Records should be kept of the results of the change review and of any action that is necessary. ”
Controlling changes in design and development becomes essential because it is possible that a product or a part of it may end up being produced based on outdated documents (change in the dimensions of a part for example and that have not been disclosed to the operator on time) this generates great losses for the company especially when mass-produced articles and large volumes are produced. Likewise, it is required to define and make clear the responsibilities and authorities in the approval of said changes in such a way as to avoid what generally happens on a daily basis in production plants where the operator does not really know who should receive orders from his boss. immediately or the head of another area and in the end ends up appearing guilty of any mistake made in the development of the product.
Regarding the evaluation of the effects of changes in the product, it is essential to bear in mind that a change in the characteristics of one of the pieces may affect the operation of others, to which modifications may be required.
To conclude we see how the part of the quality management system that has to do with design and development is fundamental since it allows integrating in one package the aspirations of the client and other interested persons and those of the organization.
A real life example
With the aim of showing what the design process is in real life and its similarity with that carried out in organizations, I present the case of “HOME OF PEDRO Y MARIA”.
Pedro and Maria make up a beautiful and humble home from our countries, he dedicates himself to working in various trades in a company in his native town, while she, despite having finished university studies in the capital, has not managed to get a job so who is dedicated to household activities, one Monday Pedro (who will be the client) and Maria (who will act as the company offering the product "special anniversary dish") celebrate their second anniversary of marriage, so Maria plans to surprise her husband with a special dish taking advantage of a cooking recipe (preset design) that a friend had given him.
Before Pedro leaves for his workplace, Maria kisses her husband, promising upon arrival at night a rich nutritional surprise; Knowing the gastronomic gifts of his wife, he replies that he hoped that the dinner “would be delicious” (the only requirement specified by Pedro, who in this case acts as a client) and leaves happily for his work.
Maria took the recipe that her friend gave her and read the title that said “delicacy for anniversary” and saw its ingredients: (started the design planning process).
- Fresh fish (to prepare it fried) Rice (to combine with the coconut) Coconut Plantain Ripe (to prepare it in slices) Oil (to prepare the rice, fry the fish and the slices of ripe banana) Salt to taste
She immediately took the few pesos she had and left for the only store in town to buy the ingredients, keeping in mind the rich delicacy with which to surprise her husband on the anniversary.
When he starts shopping, he finds that there is no coconut in the store, so he decides to make the rice without the coconut, (he begins the review and first design changes) when he reaches the fish section and observes its price, he realizes the budget that is available does not allow him to buy and he barely has enough to buy cheese, so he decides to buy it, (another revision and change in the design) when he reaches the banana section, he only finds green banana, which is not Pedro's liking so he decides to replace it with ripe banana (another revision and change) and buying the remaining ingredients (oil and salt) he returns home to prepare dinner planning in his mind that to prepare the dish they usually dine daily (rice cheese and ripe banana) for the little income obtained by Pedro as a result of his work,You must have the utensils such as cauldron, kitchen knives, stove, matches etc. (which together with the list of ingredients purchased by María, become the output elements of the design and development).
From there and having verified that Maria has all the necessary elements to prepare the food, she proceeds to start the process.
Reflecting on this, we see how Maria did not take into account other instances (town store and budget), which commonly occurs in companies, which means that changes in design and development are necessary along the way. in real life in companies, the execution of the stages proposed by the standard is essential in order to obtain a quality design.
