In manufacturing, we do many processes . The product is a result of these processes. Every process adds some feature to the product. Some processes like cutting ,machining ,bending etc are processes leading to some physical attributes and we can see the result by making some measurements . But there are certain processes ,which add certain features but results are not measurable. That takes us to the concept of special process .
What is considered a
special process?
Special Processes are those individual
processes whose results on the product cannot be completely verified by
measurements or objective checks, and where discrepancies can affect in service
performance of the parts.
In
this case ,baking is a special process . You may get reasonably good report
even if process parameters are not met. Even in this case, insulation was hard,
could be even filed off . The requirement of pressure was not met and result was such a big loss. A power station got out of service for a few months causing
loss of generation, loss of man-hours and production from industry and
agriculture.
What is special process validation?
Regulatory
and quality system requirements state that every process that cannot be
verified by subsequent monitoring or measurement shall be validated. If
you can't confirm the output with a direct test or measurement of the product –
then you have a “special process” and must validate.
Is welding special process?
Welding
is considered as a 'Special Process', which means that its quality
cannot be readily verified and its successful application requires specialist
management, personnel and procedures above and beyond those that are considered
for general quality systems such as ISO 9001.
Yes. Properties like adhesion, corrosion resistance and light-fastness can't be
verified unless the painted item is destructively tested. By
definition, it's a special process.
Is soldering a special
process?
Soldering
is definitely a special process just like welding and brazing. You
can't verify the integrity(strength) without destroying a solder joint.
In my professional journey , I have faced many problems in special processes and understood how important it is to accept special process dependence on parameters only. I have experts failing because of over confidence.
So for me the Mantra is , special process means process parameter control.
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