FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.4.9

Revision #: 02

Revised:

05/15/2019

Title: 

Control of Nonconforming Work Page 1 of 4

For the most current and official copy, check QMiS.

Sections in This Document

1. Purpose ....................................................................................................................................1

2. Scope .......................................................................................................................................1

3. Responsibility............................................................................................................................1

4. Background...............................................................................................................................2

5. References ...............................................................................................................................2

6. Procedure .................................................................................................................................2

7. Glossary/Definitions..................................................................................................................4

8. Records ....................................................................................................................................4

9. Supporting Documents .............................................................................................................4

10. Document History .....................................................................................................................4

11. Change History.........................................................................................................................4

12. Attachments..............................................................................................................................4

1. Purpose 

To provide guidelines when any aspect of testing, or the results of this work, 

do not conform with laboratory procedures or specified requirements.

2. Scope

This procedure applies to the Office of Regulatory Science (ORS) laboratories 

and laboratory work products. This procedure directly concerns the 

laboratory’s quality assurance program.

3. Responsibility 

The ORS laboratory designates the responsibilities and authorities for the 

management of nonconforming work within the ORS laboratory’s quality 

documents with actions (including halting of work and withholding of test 

reports, as necessary) defined and taken when nonconforming work is 

identified. These actions are based upon the risk levels established by the 

laboratory.

The laboratory quality documents will include designation of authority for 

resumption of work if halted.
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.4.9

Revision #: 02

Revised:

05/15/2019

Title: 

Control of Nonconforming Work Page 2 of 4

For the most current and official copy, check QMiS.

4. Background 

If properly executed, quality control parameters can monitor the various 

aspects of data quality on a routine basis. In instances where performance 

falls outside acceptable limits, the data produced can be questioned and, after 

investigation, a determination made as to its validity. The laboratory’s internal 

quality assurance program is the principal recourse available for ensuring that 

only a quality product is released. Quality control parameters and quality 

assurance elements are defined in the laboratory’s quality management 

program. These identified quality control parameters are the critical elements 

that would cause a nonconforming product if not met.

5. References 

A. ISO/IEC 17025:2017, General requirements for the competence of 

testing and calibration laboratories, Section 7.10

B. AOAC International Guidelines for Laboratories Performing 

Microbiological and Chemical Analysis of Food, Dietary Supplements, 

and Pharmaceuticals: An Aid to Interpretation of ISO/IEC 17025:2017; 

August 2018.

C. SOP-000133 Control of Non-Conforming Processes, Services, or 

Products (ORA-Level)

6. Procedure 

Identification of nonconforming work or problems with the management system 

or with testing activities can occur at various places within the management 

system and technical operations. Examples are customer complaints, quality 

control (QC), instrument calibration, checking of consumable materials, staff 

observations or supervision, test report checking, management reviews, and 

internal or external audits.

A. Identified nonconformances with any procedure, process, quality control 

parameter or customer requirement are recorded in QMiS (ORA’s 

Quality Management information System). This process involves 

documenting the nonconformance, evaluation of the significance or 

impact the nonconforming work has on the quality system, technical 

operations, and data reported, and any remedial actions taken. 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.4.9

Revision #: 02

Revised:

05/15/2019

Title: 

Control of Nonconforming Work Page 3 of 4

For the most current and official copy, check QMiS.

B. When the evaluation (based upon the significance of the nonconforming 

work) indicates that it could recur or that there is doubt about the 

compliance of the laboratory’s operations with its own policies and 

procedures, the corrective action procedures outlined in ORA-LAB.4.11 

shall be promptly followed. 

C. Corrections will be performed immediately, together with any decisions 

about the acceptability of the nonconforming work.

D. Dispositions or actions taken on a nonconforming work product are 

based upon an impact analysis on previous results and include one of 

the following:

1. Rework – action taken on nonconforming product so that it will fulfill 

the specified requirements;

2. Redone – action taken to re-collect sample or reanalyze (redo) 

sample to bring the product into conformance;

3. Use as is – approving the use of nonconforming product without 

rework or redoing, a disclaimer is made that the product was 

accepted and the quality requirements that the product did not meet 

are specified; and

4. Unable to use – action taken if unable to resolve the problem. The 

receiver is notified that the data cannot be reported.

E. Data, reports, and actions are not released until the problem is resolved 

and verified by management. The sample may need to be reanalyzed or 

re-collected or the inspection redone. If unable to resolve the problem, 

the receiver is notified that the laboratory data cannot be reported or 

accepted; with disclaimers made that the product did not meet quality 

standards.

F. When a non-conformance has been identified and the validity of 

previously-reported data is in question, a corrective action with 

investigation will be opened, the customer is notified, and if possible,

the product brought into limits by rework or reanalysis to confirm the 

validity of what was reported. 

G. If in error, a corrected report will then be sent to the customer. The 

corrected report must be identified as an amended or corrected report.

H. A customer supplied product (sample) which is lost, damaged or 

otherwise unsuitable will be annotated in the web application, such as 

Field Accomplishment and Compliance Tracking System (FACTS) or 

Laboratory Information Management System (LIMS), and reported to 

the customer verbally or electronically.
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.4.9

Revision #: 02

Revised:

05/15/2019

Title: 

Control of Nonconforming Work Page 4 of 4

For the most current and official copy, check QMiS.

7. Glossary/Definitions 

Nonconformance – This is a departure of a quality characteristic from its 

intended level or state that occurs with enough severity to cause an associated 

product or service to not meet a specification or requirement.

8. Records 

A. QMiS Nonconformance or Corrective Action records.

B. Records of communications with the customer

9. Supporting Documents 

A. ORA Laboratory Manual, Volume II, ORA-LAB.4.11 Corrective Action

10. Document History 

Revision

#

Status*

(D, I, R) Date Author Name and Title Approving Official Name and Title

1.3 R 02/06/12 LMEB LMEB

1.4 R 05/08/14 LMEB LMEB

02 R 05/15/2019 LMEB LMEB

* - D: Draft, I: Initial, R: Revision

11. Change History 

Revision 

# Change

02

Added Background. Moved process order for smoother flow. Changed Responsibility 

wording from “laboratories “ensure” to “designate”; added document/record actions are 

part of entire process. Referenced OQMS-level SOP. Other revisions as needed to align 

with recently-revised ISO and AOAC standards.

12. Attachments 

None