Validation of production processes
According to the requirements of ISO 9001 (see clause 7.5.2 of the standard), the organization must confirm all production processes, the results of which can not be verified through sequential monitoring or measurement. These include all processes whose shortcomings become apparent only after the use of the product or after the provision of the service. Validation should demonstrate the ability of these processes to achieve the planned results.
Let's consider in more detail the specified processes. There are some processes and associated types of goods or services for which:
• results of measurements of the degree of conformity of goods or services can not be received immediately;
• measurements are not possible without damage to the product during its manufacture.
An example of a production of the first type can be casting of concrete blocks. The mechanical properties of concrete at the time of casting are unknown. Concrete is gaining full strength for several weeks, and samples taken at the time of casting blocks are tested only after 28 days. Therefore, in order to achieve the required strength of concrete, it is necessary: to carefully monitor the quantities of cement, crushed stone and water; follow the mixing and filling processes; Ensure the execution of all work on casting and processing blocks by trained people. Thus, careful control of the technological operations ensures that after receiving the results of the tests of the samples taken after 28 days, it will not be necessary to replace all the cast concrete.
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An example of the second situation is the welding process, where the methods of experimental verification of the strength of the weld metal do not give any information about the strength of the resulting compound. For full-scale tests of welds on the strength of welded products must be destroyed in order to cut out samples from them. Therefore, to guarantee the strength of welded seams, it is necessary that the welder has the necessary training and a license to manufacture this kind of work on this technology.
An example from the food industry: in the production of bakery products, parameters such as taste, texture and appearance can only be determined after the end of the manufacturing process, therefore, monitoring of materials, equipment and process parameters should be ensured.
At many service enterprises, the required services are provided immediately, which does not allow to immediately check the quality of services before they are received. A typical example of such enterprises can be travel agencies. Their services are sold long before they turn up.
Identification and traceability
According to the requirements of the standard (clause 7.5.3 of ISO 9001):
1) "the organization must identify the product by appropriate means at all stages of the life cycle";
2) "The organization must identify the product status with respect to monitoring and measurement requirements";
3) "If traceability is a requirement, then the organization must manage and fix the unique product identification."
Product Identification - establishing the identity of product characteristics with its essential characteristics (1.1). Identification means knowing which product or service is at the output of a particular process, even if the process is intermediate.
Examples of identification can be the registration of part numbers, work numbers, barcodes, surnames of performers, color codes, edits and numbers of the software being developed.
Traceability - the ability to trace the history, application and location of what is being considered (2.3).
Traceability for products may refer to:
• the origin of materials and components;
• Processing history;
• distribution and location of products after delivery.
Example from the service industry
In order to monitor the condition of the hotel, where the number of rooms is to be cleaned after the departure of the previous guests, there are two states for each number: ready and not ready & quot ;. The staff usually informs about the availability of telephone numbers on the reception desk.
The traceability for production will be shown using the example presented in .
In the US, due to a defect in the brake hose of the car, an accident occurred with serious consequences for the driver. The lawyers of the victim and his insurance company are suing the car manufacturer. In the conditions of Western legal practice, the car company must pay to the injured and its insurance companies both direct losses ($ 40,000-50,000) and lost profits (perhaps $ 100,000-300,000), with payments for moral damage often reaching several million dollars.
After receiving notification of the accident, the manufacturer starts an investigation. Suppose, as a result of the investigation, it turned out that the brake hoses from a poor-quality lot were installed on 200 cars. What should the managers do in this situation? Wait, when the next car with poor-quality brake hoses from this batch will get into an accident or prevent new accidents, installing quality brake hoses on the remaining 199 cars?
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It is to reduce losses that the car company conducts identification in order to ensure traceability. In particular, the firm conducts an investigation to identify the causes of marriage and those responsible for marriage; as well as the establishment of car owners who use a brakonos knot.
Having established the residence of car owners, the firm replaces defective units (in this case - brake hoses). It is clear that replacing defective nodes is a troublesome business and is not cheap. If necessary, the company provides the owner for the time while in his car eliminate the malfunction, another car of the same class. However, it is economically more profitable and expedient than waiting for the initiation of lawsuits.
When servicing vehicles, the status of each operation on the checklist is changed from "should be done" to " on done by punching the hole in the appropriate place after the operation is completed.
The reasons for the need for identification and traceability may be different. Here are some examples: in the production of clothing, materials in a batch of the same color must also be processed in batches in order to avoid a mismatch of shades; in courier service it is necessary to track the selection and delivery of items in order to withstand schedules and delivery obligations.
Internal traceability requirements must be established and documented. If there is a need for a recall of the delivered products, the availability of an effective identification system and ensuring traceability greatly facilitates the fulfillment of this task.
Although it is difficult to revoke the services provided in the event of a claim from the consumer, an effective identification and traceability system can facilitate the task of correcting poor-quality services and take measures to prevent the re-emergence of claims by retraining staff and reviewing the technology for performing service processes.
Methods of identification and ensuring traceability that are not fixed in industry and national standards, recognized by the most suitable for the enterprise, are described in working instructions and other internal documents of the organization.
In some industries, the presence of an identification and traceability system is prescribed by contracts or supervisory organizations. For example, manufacturers of finished products, such as assembly car factories, in the contracts for the supply of components, provide for the development of a supplier of an automated system for the identification and traceability of products.
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