Article aimed at showing entrepreneurs simple ways to implement a Quality Management System under the ISO 9.001 version 2.000 standard, on this occasion we present the topic that the standard titles as production and service provision and that in addition to touching on what is related to control that must be had in the process of making the product, specifies the treatment that should be given to the products after they are made while they remain in the hands of the organization until they reach the customer's hands; as well as the care that must be given to those components that are owned by the client and supplied to us to facilitate or achieve the development of our products.
Production and service provision
Part I
Control of production and service provision
The ISO 9.001 standard states the following:
“The organization (our company) must plan and carry out production and service provision under controlled conditions. Controlled conditions should include, where applicable "
a) " the availability of information that describes the characteristics of the product ", This information is provided to us through the design and development process that we discussed in a previous article.
b) “ the availability of work instructions, when necessary ”, If these work instructions have not been prepared during the design and development process, it is prudent to analyze the competence of those people who are directly related to the quality of the product (for example, operators) and prepare them if necessary; Sometimes, it is assumed that the staff has the necessary skills and it is only detected that this is not the case when non-conformities occur or when a certain activity takes longer than planned; To avoid this type of inconvenience, it is best to communicate with the operators who will work at each stage of the production of the product and, if necessary, prepare these instructions and verify that the operator has them in view and uses them.
c) " the use of appropriate equipment ", The identification of the appropriate equipment, machines and tools to produce the product or provide the service is carried out in the design and development stage, now the question is to control that the recommended equipment and tools are used.
d) “ the availability and use of monitoring and measurement devices ”, Generally there are equipment, devices and tools (gauges, tape measures, etc.) that allow us to maintain control in the production of the product, especially in relation to the dimensions of said products, it is necessary that these equipment be available in a timely manner.
e) " the implementation of monitoring and measurement, and"
Although the previous item talked about the availability of the devices, now the question is to implement their use properly, for this it is necessary to verify that it is used correctly and that there are adequate conditions for it.
f) “ the implementation of release, delivery and post-delivery activities ”.
In the design and development phase, criteria were discussed for the release of the product, here it is about implementing the activities that are required for that release, such as the review, verification of compliance with the requirements, etc.
Part ii
Validation of production processes and service provision
“The organization must validate those production and service provision processes where the resulting products cannot be verified by subsequent monitoring or measurement activities. This includes any process in which deficiencies become apparent only after the product is being used or the service has been provided ”.
Here we talk about those products such as matches, candles, explosives, etc. where it is difficult to test its operation after elaboration without affecting its useful life; In these cases, it is where the control of the production process must be more demanding, especially in the part related to monitoring and measurement activities.
"Validation must demonstrate the ability of these processes to achieve planned results."
"The organization must establish the provisions for these processes, including, where applicable":
a) " the criteria defined for the review and approval of the processes ", The criteria for the review and approval of the processes must be defined.
b) " approval of equipment and qualification of personnel ",
We must identify and approve the equipment required to control these processes as well as the required qualification of the personnel who will handle the equipment.
c) “ the use of specific methods and procedures ”, We must also identify the specific methods and procedures to be used to control compliance with product requirements.
d) " registration requirements, and"
Identify the records that must be made to demonstrate with objective evidence compliance with the requirements.
e) “ revalidation ”.
Finally, if necessary, these control processes must be revalidated.
Part iii
Identification and traceability
Let's initially see what the ISO 9,000 standard defines as traceability:
"Definition of traceability: Ability to follow the history, application or location of everything that is under consideration."
Notes:
1) " When considering a product, traceability may be related to":
- The origin of the materials and the parts. The history of processing. The distribution and location of the product after delivery.
"Where appropriate, the organization should identify the product by appropriate means, throughout the realization of the product."
There are products in which it is required to maintain strict control during their production (this is very common in the military, electronics, chemical, software, explosives, etc. industries). For this, the concept of traceability is used. For example, in most countries the weapons that go on the market are tracked.
"The organization must identify the status of the product with respect to the monitoring and measurement requirements."
"When traceability is a requirement, the organization must control and record the unique identification of the product."
Generally, the products are assigned a unique code (serial number) that allows their identification in any place where they are even after going on the market (in the case of televisions, computer parts, car engines, etc.)
"Note: In some industries, configuration management is a means of maintaining identification and traceability."
Part iv
Customer property
Sometimes the client provides us with part of the supplies or elements to manufacture our product, for example if we produce bicycles, it is possible that the client provides the rims and tires for the product, in these cases the standard requires the following:
“The organization (our company) must take care of the goods that are property of the client while they are under the control of the organization or are being used by it. The organization must identify, verify, protect and safeguard the goods that are property of the client supplied for their use or incorporation into the product. Any property that is owned by the client that is lost, deteriorated or that in any other way is considered inappropriate for its use must be registered and communicated to the client ”.
Note. Customer property may include intellectual property.
As we can see, the standard is very clear about what our organization must do with respect to the goods that are owned by the client; If we apply a logical process, we will do the following:
- Receive the good Verify its condition (if defects are found, communicate it to the client) Make an adequate record of the goods received Identify them properly Protect and safeguard them properly (care in handling and storage) In case any of these elements is lost or deteriorated it must be communicated to the customer.
Many times the elements that the client provides us are plans, manuals or they provide us with some confidential information to which we must give the appropriate treatment to protect intellectual property rights, etc.
Part v
Preservation of the product
“The organization must preserve the conformity of the product during the internal process and delivery to the intended destination. This preservation must include identification, handling, packaging, storage and protection. Preservation must also apply to the constituent parts of the product ”.
Controlling and guaranteeing the quality of the product is not only at the time of its manufacture, but also compliance with the requirements must be guaranteed in the subsequent phases until the product reaches the hands of the direct client of our organization (remember that the direct client is the one who buys the product from us); However, in order to guarantee adequate treatment until the product reaches the end user, sufficient information must be provided in order to give it reliable handling during transport and storage, it is for this reason that normally in the packaging of products appear messages such as "fragile" "this side up" "treat with care" etc. that facilitate proper treatment.
In any case, according to the characteristics of the product and the type of material in which it is made, this will be the type and conditions of the packaging.
Instructions for identification, handling, packaging, storage and protection must be clearly established and documented; This treatment should also be given to the complementary parts of the product such as user manuals, accessories and others.
"Finally, I ask the reader friend that if you find this article interesting, give it to an entrepreneur or a colleague and thus we will contribute to disseminating the culture for quality in our countries."
