Conformity assessment involves processes that demonstrate a product, service, or system meets standards requirements. It provides benefits like added consumer confidence, competitive advantages for companies, and ensuring health and safety regulations are followed. The main forms of conformity assessment are testing, certification by an independent body, and inspection to check a product meets criteria on a regular basis. Validation is the collection and evaluation of data to ensure manufacturing processes can consistently produce a product meeting specifications and attributes, as defined by regulatory bodies like the FDA and WHO. It is a quantitative approach to proving quality, functionality, and performance of a product's production process.
Basic Civil Engineering first year Notes- Chapter 4 Building.pptx
What is Conformity Assessment?
1. What is conformity assessment?
Conformity assessment involves a set of processes that show your product, service or
system meets the requirements of a standard.
Undergoing the conformity assessment process has a number of benefits:
It provides consumers and other stakeholders with added confidence.
It gives your company a competitive edge.
It helps regulators ensure that health, safety or environmental conditions
are met.
The main forms of conformity assessment are testing, certification, and inspection.
Certification: Certification is the written assurance (a certificate) by an
independent body that the product, service or system in question meets
specific requirements. Certification is also known as third party conformity
assessment.
Testing: Testing is the determination of one or more of an object or
product’s characteristics and is usually performed by a laboratory.
Inspection:Inspectiondescribesthe regular checking of a productto make
sure it meets specified criteria.
In addition, ISO has a committee, CASCO, that develops standards and addresses
issues related to conformity assessment.
What is Validation?
According to FDA, validation is method to establish documented evidence which
provides a high degree of assurance that specific process will consistently produce a
product meeting its predetermined specification and quality attributes.
According to WHO, Validation is the collection and evaluation of data, beginning at
the process development stage and continuing through the production phase, which
ensure that the manufacturing processes – including equipment,buildings,personnel
and materials - are capable of achieving the intended results on a consistent and
continuous basis.
It is a quantitative approach needed to prove quality, functionality and performance
of product manufacturing process. It is very broad term.
It will apply to individual parts of fish processing equipment and also to the fish
processing as a whole.
Some testing procedure of validity of a product: reliability test, production test,
acceptance test, dependability test.