Radiation Physics Division Quality Management System Guide RPD-G-09

PREVENTIVE ACTION

Version: 2.11 Page 1 of 4 Approval: JMA Effective Date: December 5, 2019

Purpose

The purpose of this Guide is to present a pro-active approach to identify service 

improvement opportunities. The RPD Preventive Form documents the preventive action

and risk assessment plan.

Scope

This Guide applies to any technical or quality management systems that relate to 

the calibration/testing services of the Radiation Physics Division.

Definitions

Equipment

N/A

Health & Safety Precautions

N/A

Protocol

Opportunities for needed improvement and potential sources of nonconformance may be 

identified in several ways. These include, but are not limited to, observations in other 

laboratories, suggestions made by visiting scientists, ideas based on the experience of 

NIST personnel, and necessary upgrades of equipment or computer programs. Risk will 

be assessed to prevent or reduce undesired impacts and potential failures in NIST 

measurement service activities. Actions taken to address risks and opportunities shall be 

proportional to the potential impact on the validity of laboratory results.

Initiation of preventive action

The initiator of the preventive action should discuss the action plan thoroughly 

with his/her Group Leader and other staff members, when appropriate, to 

determine feasibility of the plan. 

When it is decided to put the plan into action, a Preventive Action Form will be 

completed and signed by the preparer and the Group Leader (Appendix RPD-G09. A). The Preventive Action Form will then be delivered to the Quality 

Manager who shall sign acknowledging receipt. The Quality Manager will place 

the original in the Preventive Action folder and return a copy of the signed 

document to the preparer and Group Leader.
Radiation Physics Division Quality Management System Guide RPD-G-09

PREVENTIVE ACTION

Version: 2.11 Page 2 of 4 Approval: JMA Effective Date: December 5, 2019

Implementation

When the Preventive Action Form is completed, the preparer will devise an 

implementation program. This will include testing before and after the

installation of the action to ensure consistency. The program need not be written 

down formally, but all results from the program shall be documented. The 

implementers of the program shall decide what constitutes acceptance.

Monitoring Results

Once the implementation is accepted, the results of the preventive action shall be 

monitored for a length of time appropriate to the action to ensure that the action is 

indeed an improvement to the overall system. The Group Leader (or someone 

he/she delegates) shall decide how long the monitoring shall take place. There is 

no formal documentation of the monitoring unless actual test results are produced 

but notes in the logbook are recommended for tracking purposes.

Acceptance Criteria

The action plan is accepted when it passes all implementation tests and proves to 

be consistent through routine monitoring for a designated time. Once the action 

plan has been implemented into full service, the preparer of the plan will request 

the signature of the Division Chief and record the date on the original Preventive 

Action Form. All changes to the technical procedures that result from a preventive 

action and risk assessment shall be documented in the sub-level quality

documents.

If the action plan is rejected, for whatever reason, a separate sheet(s) shall be 

prepared indicating the implementation and/or monitoring test results and the 

reason for rejecting the plan. This will be attached to the original Preventive 

Action Form. 

If the action plan is modified, no further indications need to be made on the 

Preventive Action Form unless a complete change of action is indicated. In that 

instance, a new Preventive Action Form will be prepared and the first rejected.

 

References

N/A

Documentation

Preventive Action Form

Logbook and electronic records

All changes to the technical procedures that result from a preventive action and 

risk assessment shall be documented in the sub-level quality documents.
Radiation Physics Division Quality Management System Guide RPD-G-09

PREVENTIVE ACTION

Version: 2.11 Page 3 of 4 Approval: JMA Effective Date: December 5, 2019

Filing and Retention

The completed Preventive Action Form will be placed in the Preventive Action folder. 

The RPD Quality Manger shall include a description of each new preventive form in the 

NIST quarterly report. 
Radiation Physics Division Quality Management System Guide RPD-G-09

PREVENTIVE ACTION

Version: 2.11 Page 4 of 4 Approval: JMA Effective Date: December 5, 2019

Appendix RPD-G-09. A

PREVENTIVE ACTION FORM

REASON FOR PREVENTIVE ACTION

________________________________________________________________________

________________________________________________________________________

________________________________________________________________________

________________________________________________________________________

PREVENTIVE ACTION TAKEN

___ New protocol

___ Revised protocol

___ Modify equipment (explain below or on separate sheet of paper)

___ Addition or replacement of equipment

Equipment ________________________________________________

Vendor ________________________________________________

___ Other (explain below or on separate sheet of paper) 

__________________________________________________________________

__________________________________________________________________

__________________________________________________________________

Preparer ______________________________________ Date _____________

Group Leader _________________________________ Date _____________

Quality Manager _______________________________ Date _____________

Division Chief ________________________________ Date _____________

Date preventive action implemented into full service ____________________________