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Three elements of process validation
The measurement process confirmation is divided into the following parts:

1. General

As a part of the measurement management system, the measurement process should be planned, confirmed, implemented, recorded and controlled. The influence quantity that affects the measurement process should be identified and considered.

The complete specification of each measurement process should include all relevant equipment identification, measurement procedures, measurement software, use conditions, operator's ability and other factors that affect the reliability of measurement results. The measurement process control shall be carried out according to documented procedures.

2. Design of measurement process

Measurement requirements shall be determined according to the requirements of customers, organizations and laws and regulations. The measurement process designed to meet these requirements shall be documented and its effectiveness shall be confirmed, and the customer's consent shall be obtained if necessary.

For each measurement process, relevant process elements and controls should be determined. The selection of elements and control limits should be commensurate with the risks caused by non-compliance with the specified requirements. These process elements and controls should include the influence of operators, equipment, environmental conditions, influence quantities and application methods.

The design of measurement process should be able to prevent wrong measurement results, and ensure that existing problems can be found quickly and corrective measures can be taken in time.

The performance characteristics required for the intended use of the measurement process shall be determined and quantified.

3. Realization of measurement process

The measurement process should be realized under the designed controlled conditions to meet the measurement requirements.

The controlled conditions shall include:

(1) Use the confirmed equipment;

(2) Application of validated measurement procedures;

(3) The required information resources can be obtained;

(4) Maintain the required environmental conditions;

(5) Use competent personnel;

(6) When and how to report the results;

(7) Monitoring according to regulations.

4. Record of measurement process

The measurement function shall keep records to prove that the measurement process meets the requirements.