Radiation Physics Division Quality Management System Guide RPD-G-07

NONCONFORMANCE

Version: 2.11 Page 1 of 4 Approval: JMA Effective Date: 11/15/2021

Purpose

The purpose of this Guide is to outline the steps to be taken when any aspect of 

the testing or calibration work, including the results of the work, is found to be 

out of conformance with RPD procedures or the agreed requirements of the client.

Scope

The Guide applies to all calibration activities. The nonconformance of the 

test/calibration may be due to shipping damage, operator error, equipment 

malfunction or any other parameter that jeopardizes the integrity of the work. It 

may also be due any previously undiscovered change in the measurement facility, 

system or method, procedures, processes, or controlled parameters that results in 

changes in currently disseminated calibration or measurement values.

Definitions

Item – an all-inclusive term used in place of any of the following: assembly, 

component, equipment, material, module, part, structure, system, unit, software or 

results.

Nonconformance – any deviation from standard practice or operation that renders 

the quality of a calibration/test unacceptable.

Equipment

N/A

Health & Safety Precautions

N/A

Procedure

General

Nonconforming work may be identified through a variety of activities such as 

internal or external audits, management reviews, the calibration or testing process, 

feedback from clients or staff member observations.

Complaints received by clients may result in the identification of nonconforming 

calibration and/or testing work. The RPD-G-04 explains complaints within the 

division.

The calibration personnel involved shall:
Radiation Physics Division Quality Management System Guide RPD-G-07

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Version: 2.11 Page 2 of 4 Approval: JMA Effective Date: 11/15/2021

1. Identify whether the work is truly non-conforming (e.g., not simply due to 

improper electrical connections).

2. Evaluate the significance of the nonconforming work and determine the root 

cause by following the Corrective Actions (RPD-G-08) guide and completing 

the form found in the Appendix of RPD-G-08. This form is found as a Word 

document at: https://www.nist.gov/pml/radiation-physics/quality-systemservices/radiation-physics-division-quality-system-guide-forms. RPD-G-08

quality forms are not required for nonconforming work associated with theses 

cases: the inspection of a client calibration item and the calibration item is 

operating in a manner inconsistent with design.

NOTE: Other calibration personnel, the Group Leader and/or the Quality 

Manager may be requested to assist in this step.

Inspection of client calibration item

1. Client calibration items shall be inspected by calibration personnel according 

to criteria specific to the Procedure used.

2. Items that fail inspection should be addressed in a timely manner.

3. Client shall be notified of inspection failure.

4. Calibration personnel may rectify the failure upon receipt of a written request 

to do so by the client.

5. If the failure cannot be rectified, the item shall be returned to the client.

6. All actions shall be documented.

7. No RPD quality forms are required.

Results outside the scope of desired calibration/test efforts 

1. Make note of nonconforming work on data sheets corresponding to the 

results. Place data sheets in calibration file.

2. Notify client to ascertain if he/she wishes to recalibrate or accept the 

nonconforming work.

3. If applicable, inquire if client would like to send replacement items.

4. If the client wishes to accept the nonconforming work, the acceptance must 

be in writing. The acceptance note shall be placed in the client’s file. Make 

note of nonconformance issue in calibration report, if applicable.

5. If a need for revision of procedures is determined proceed to Corrective 

Actions (RPD-G-08).

Calibration item is operating in a manner inconsistent with design

1. Notify client immediately of problem.
Radiation Physics Division Quality Management System Guide RPD-G-07

NONCONFORMANCE

Version: 2.11 Page 3 of 4 Approval: JMA Effective Date: 11/15/2021

2. At the client’s written request, the calibration personnel may repair the item. 

All repairs shall be noted in the client’s calibration file. Upon repair, repeat 

the calibration.

3. If not repaired, the item shall be returned to the client.

4. No RPD quality forms are required.

Malfunction of calibration equipment or software

1. Stop all calibration work.

2. Notify the Group Leader when repairs will involve new equipment or repair 

services provided by an outside vendor.

3. If a delay in work is expected, notify all clients affected.

4. Proceed to Corrective Actions (RPD-G-08).

Application of incorrect conditions

1. Make note of incorrect conditions (i.e., wrong technique, incorrect time or 

distance, etc.) on data sheets corresponding to nonconforming results. Place 

data sheets in calibration file.

2. Repeat calibration if applicable.

3. If item has been sent to client, request client to return item for recalibration or 

to send replacement items if applicable.

4. If a need for revision of procedures is determined, proceed to Corrective 

Actions (RPD-G-08).

Acceptance Criteria

N/A

References

N/A
Radiation Physics Division Quality Management System Guide RPD-G-07

NONCONFORMANCE

Version: 2.11 Page 4 of 4 Approval: JMA Effective Date: 11/15/2021

Documentation

Calibration data documents

Filing and Retention

1. Calibration data documents are filed in the calibration files. All incidents 

of nonconforming work are documented in the Division’s quarterly quality 

report.