Special understanding of the process

 GB/T19000 idt ISO9000: 2000 3.4.1 Note 3 This definition of a special process: the formation of the products are qualified or can not be economically difficult to verify the process, typically called
2, the definition of the object is to verify the results of the process, that is product, not process. words, difficult to verify that the product requirements, not the process characteristics to meet the process requirements are hard to verify. For example, we say to verify the object is coating thickness and adhesion, rather than what plating electroplating solution, how much power and time.

3, can be seen from the above discussion, determine whether a particular process is a special process, should be strictly in accordance with standards, to consider what the process output products, the specific requirements of the method used for authentication, this authentication method is economic, whether through the subsequent monitoring and measurement to implement such.

one, how to identify the specific process


1, meaning the special process


Therefore, any process in particular as special process, but standards should be strictly in accordance with the specific process under specific analysis.

Second, the process of how to confirm the special

1, be approved for special process equipment, personnel qualifications for special identification process, the use of specific methods and procedures, which is GB/T19001-2000 standard But I think only the equipment, personnel, process methods, the audit is not enough.
In fact, the equipment to achieve a certain precision, what culture of people with level, how advanced technology methods and so difficult to guarantee the outcome of the process will be able to meet the product requirements, the output of the special process meets the requirements must be validated.

; 2, the output of a special process to verify the need for
GB/T19001 -2001 Standard 8.2.4 clause states: characteristics of the product monitoring and measurement to verify that product requirements have been met. This monitoring and measurement should be in accordance with planned arrangements, the appropriate stages of product realization. objective evidence, it can not meet the standards requires authentication, then there is no standard called , the output of the product characteristics to meet the requirements need to be verified.
Standard said production operation, the product is difficult to verify for the normal. In other words, special products can not process output under normal production conditions, br>
3, how to process the output of special verify
normal production conditions, the special process output of products, validation.
If special arrangements for the process to run a special test to be a good solution to this problem, that is in normal production equipment, production personnel and production processes under the guidance of the test materials for determining processed, and then test products after processing to be verified. arrangements for such a test, the test chemicals may cause damage, but damage is only to test the product, rather than for delivery or sale products, due to the loss of product caused validation should be small. Through this experiment, the process can not only be running a special data, but also to verify whether the results of the special process output to meet specific product requirements, the actual production in the organization pilot production run is often used to simulate the test, process and experiment in their application.

4, can be seen from the above discussion, the confirmation process for special not only on the special process equipment, personnel, production process and so to confirm, but also the manner in which audit organizations, the results of the validation process runs, and to verify whether the results meet the specified requirements, that is, how to get the special process audit organization process elements, particularly the relevant process parameters.

Third, under what circumstances the process of re-confirmation
special Strictly speaking, the special The process elements of the process, that is, people, machines, materials, method, and other changes have to be re-confirmed on the particular process. Of course, the specific circumstances of each organization is different from the specific requirements of different specific processes, process elements for special results of the process is different, so in the field audit of the organization needs to identify the specific special process and can not be generalized. Generally speaking, when the special process equipment, material changes should be of special process parameters during the process of re- confirmed to ensure that the results of the process output to meet specific requirements.


example: the organization in general terms, electroplating process is judged to be a special process, because the coating thickness and adhesion can not be verified. But some organizations, a coating thickness measurement of coating thickness; a salt spray test according to estimated time of corrosion coating corrosion resistance; using specimens simultaneously with the workpiece, the friction of the specimens cut method testing method or the plating layer and substrate combination strength; and the use of other detection methods such as plating. of these organizations is concerned, the results of the electroplating process can be monitoring and measuring activities follow-up verification, the process is not a special process, no need to be controlled by a special process.