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120 Part II: Metrology
5. OUT-OF-CALIBRATION EFFECTS
Describe the effects that out-of-calibration
instruments can have on product acceptance
and the actions to take in response to this
situation. (Application)
Body of Knowledge II.F.5
Part II.F.5
The effects of using out-of-calibration equipment are the same as the type I and
type II errors (also known as producer’s and consumer’s risks) discussed in
Chapters 18 and 19 of this book. In essence, the effects of out-of-calibration equipment
cause stakeholders to believe that 1) the equipment is calibrated and functioning
properly when it is not, or 2) the equipment appears to fail calibration
when it is, in fact, functioning correctly.
Using out–of-calibration equipment in production or service delivery operations
can cause a number of difficulties for manufacturers and service providers.
In the best-case situation, once discovered, out-of-calibration equipment functions
correctly, and exceptions reporting must document the out-of-calibration incident,
a corrective action plan must be developed or initiated, and product or service
quality must be systematically verified—all of which is wasteful, potentially compromises
customer confidence and goodwill, and costs the company time and
money. In the worst-case situation, once discovered, out-of-calibration equipment
does not function correctly, and containment of product or service delivery must be
initiated, material control and segregation procedures must be employed, a comprehensive
evaluation of product/service performance must be conducted, material
review board action is required, a root-cause analysis is required, warranty or
recall may become necessary, and a company may be exposed to legal or regulatory
action.
At a minimum, procedures for dealing with an out-of-calibration event or discovery
require the following:
1. Identification of the out-of-calibration condition (as described above
in terms of type I or type II errors)
2. Determination of the magnitude of the condition (that is, how far out
of calibration was the equipment?)
3. Assessment of when the out-of-calibration condition occurred
4. Quantification of the amount of product/service delivery produced
or delivered during the out-of-calibration condition
5. Evaluation of product or service delivery status (that is, has any product
been produced or service been provided to customers during the
out-of-calibration condition?)
6. Identification of who is authorized to manage the containment efforts