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1.  Documented Procedures are No Longer Required.   - Documented procedures are helpful in regards to how to calibrate equipment and they may be useful to you.  However, you are no longer required to keep a physical manual on site.  There is going to be a lot more risk when equipment is not used properly or written procedures are not documented and followed.   There is an alternative to some of this with verifying the proper measurements via calibration, repeatability and reproducibility studies and proficiency testing. In addition, calibration data (records) will still be required (ISO9001 Clause 7.1.5.1 (b) are maintained to ensure their continuing fitness for their purpose.
The organization shall retain appropriate documented information as evidence for purpose of the monitoring and measurement resources.).


Image above is a normal distribution showing 50.1 % probability of of calling the measurement good, when it is not. The uncertainty of the measurement must be considered when evaluating risk.


2.   Preventative Action Clause No Longer Exists - Everything has been focused on risk-based thinking.  This requires the organization to start taking actions for the following:

Avoiding risk, both consumer and producer should be considered.   Measurement Uncertainty and the resolution of the Unit being tested should be considered when making statements of compliance. (ISO 9001 Clause 9.1.3 Analysis and Evaluation: The organization shall analyze and evaluate appropriate data and information arising from monitoring and measurement.
The results of analysis shall be used to evaluate;
a) conformity of products and services;
e) the effectiveness of actions taken to address risks and opportunities;

Also, see ISO 9001 Clause 10.2 Nonconformity and corrective action



Eliminating the source of risk - this is where SPC and good verification standards as shown above, may help.

Changing the likelihood or consequences of risk.

Making informed decision regarding elimination of risk versus managing the risk




3. Top Management is now held more responsible than before - The expectation is for Top Management to start risk-based thinking and may bear the responsibility for failures.    Remember that device that should have been calibrated and was not or its calibration interval was extended to save money? If there was no risk based evidence to support the decision, top management may be accountable. Use of Control Charts (SPC) is one of the tools to manage risk and calibration interval.   



Morehouse offers a SPC workshop that focuses on mitigating and managing risk in calibration.    Our full training schedule can be found here.



written by Henry Zumbrun with help from Dilip Shah
Dilip Shah teaches our SPC course
www.mhforce.com




Posted at, December 01, 2016 12:00:00