D-126
Non-Conforming Results in the QC Laboratory
Original Document
Scanned document (image-only PDF)
Extracted Text
Searchable text extracted from PDF
1.0 Purpose
The purpose of this procedure is to define, evaluate, and correct Non-Conforming Results
(NCR), to prevent their recurrence, and to ensure that actions taken are effective. This
procedure will describe the processes used for initiating and processing non-conforming
results.
2.0 Scope
This procedure applies to all employees in the QC Laboratory who are involved with the
detection and correction of nonconformities, as well as with the identification of potential
improvements.
3.0 Responsibility
QC Laboratory Management is responsible for and authorized to administer this
3.1 process, which includes assigning personnel to determine causes of identified problems,
or improvement opportunities, and for assigning personnel to implement corrective
actions, as well as to verify the results of such actions.
QC Laboratory Management is responsible for ensuring that this procedure is accurate,
3.2 understood, and implemented effectively. No changes may be made to this procedure
without the authorization of QC Laboratory Management.
4.0 Definitions
NCR — Non-Conforming Result; any end value or result that does not meet a pre-
4.1 established specification or expectation
First Time Product Validation — the initial test validation performed to ensure that the
4.2 product matrix presents acceptable data for each test method to be used. This process is
typically only for strength evaluation. During a first time product validation, any
[SOP
Standard Operating © Procedure : S D O - P 1 2 N 6 o Re 0 v Page 2 of 6
Non-Conforming Results in the QC Laboratory
specific testing requirements will be determined and captured in a document for future
use when testing occurs.
4.3 Non-Conforming Categories — severity levels of non-conforming results as defined
below:
4.3.1 Minor — non-conforming result which does not lead to what is defined as major.
Minor non-conforming results usually are an isolated occurrence, do not impact
the customer, and usually are able to be resolved quickly and efficiently.
Example: un-validated test result that does not meet a preset specification or
expectation
4.3.2 Major — non-conformances which have an impact to a regulatory requirement,
may cause major delays in processes, or can be a frequently repeated minor non-
conforming result.
Example: validated test result that does not meet a preset specification or
expectation
4.4 LMS -— Laboratory Management System (i.e. ISO 17025:2017)
4.5 OOS — Out of Specification
4.6 QC — Quality Control
5.0 References
D-105, SOP, Out of Specification/Out of Trend Investigation
5.1 5.2 D-122, SOP, Laboratory Operations
QS-108, SOP, Corrective and Preventative Actions (CAPA)
5.3 5.4 QS-111, SOP, Root Cause Analysis
S30) QS-112, SOP, Core Quality Systems and Quality Events
5.6 D-103, SOP, Analytical Method Validation
D-126-F1, Form, Non-Conforming Result (NCR) Initiation
5.7
[SOP
Standard Operating Procedure SOP No Rev
Page 3 of 6
D-126
Non-Conforming Results in the QC Laboratory
5.8 D-126-F2, Form, Non-Conforming Result (NCR) Closure
6.0 Procedure
6.1 Identifying Non-Conforming Results
6.1.1 QC Laboratory personnel must report NCR observations to QC Laboratory
Management.
6.1.2 QC Laboratory Management will assess each reported NCR and determine next
steps.
6.1.2.1 If the request bears no merit and warrants no further action, the
requestor is notified as appropriate.
6.1.2.2 If the NCR meets the definition of “Minor” proceed with assignment
of an NCR number and continue to follow this SOP.
6.1.2.3. If the NCR meets the definition of “Major” do not assign an NCR
number and proceed to an OOS investigation as per SOP D-105.
6.1.3 If QC Laboratory Management or designated QC laboratory personnel elects to
pursue an action as an NCR, the issue is recorded and issued an event number as
outlined in SOP QS-112 Core Quality Systems and Quality Events. The initiator
will complete form D-126-F1 Non-Conforming Result (NCR) Initiation. Details
may include a description of the NCR, or observation, classification as minor or
major, and date reported.
6.2. Non-Conforming Test Results
6.2.1 When a non-conforming test result is observed, the below evaluation should
occur.
6.2.1.1 If the test/product matrix has been previously validated and the
correct process was followed, proceed with an OOS investigation as
outlined in SOP D-105 Out of Specification/Out of Trend
Investigation.
[SOP
Standard Operating Procedure SOP No | Rev
D-126 0 Page 4 of 6
Non-Conforming Results in the QC Laboratory
6.2.1.2 If the test/product matrix has not been previously validated, proceed
with validation for this test/product matrix (first time product
validation). Refer to SOP D-103 Analytical Method Validation.
6.2.1.3 If the result is still observed to be non-conforming after the first time
validation is successful, process with an OOS investigation as
outlined is SOP D-105 Out of Specification/Out of Trend
Investigation.
6.3 Corrective Actions
Corrective actions include ascertaining action(s) needed to identify, contain, and
6.3.1 avoid recurrence of the NCR and other quality concerns.
For each corrective action identified, QC Laboratory Management or designated
6.3.2 personnel records the source or reference information for the problem and
describes the problem in sufficient detail to all QC Laboratory Management to
determine if the perceived problem warrants further action. A CAPA may be
initiated at this time. Refer to SOP QS-108 Corrective and Preventative Action
(CAPA).
QC Laboratory Management assigns responsibilities to appropriate personnel to
6.3.3 investigate and determine the root cause(s) of the problem(s) identified, and to
follow the action taken through verification.
6.3.3.1 With assistance from other personnel, as necessary, appropriate problem-
solving methods are used to identify the root cause(s). Refer to SOP
QS-111 Root Cause Analysis. The root cause(s) attempts to determine if
the problem was incident-specific or if it is systemic (repeats are
distributed over time or happens to different employees performing the
same activity.
6.4 Root Cause Remediation
If the identified root cause(s) could have resulted in additional inaccurate testing
6.4.1 and results, ensure that the testing activities are identified, contained, and
[SOP
Standard Operating Procedure SOP No Rev
D-126 Page 5 of 6
Non-Conforming Results in the QC Laboratory
managed in accordance with the non-conforming work as described in SOP D-
122 QC Laboratory Operations. Where suspect test results have been delivered
to the customer, the customer is notified and appropriate action is taken to
address the consequences.
6.5 NCR Closure
6.5.1 When a resolution for any NCR has been determined, Form D-126-F2, Non-
Conforming Result (NCR) Closure, should be completed and submitted to
document control for finalization. Any further actions that may need to be taken
are detailed on this form.
7.0 Revision History
| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 06/01/22 | New procedure. N/A J. Sassman | - | - |
8.0 Attachments
8.1 Attachment 1 — NCR Flow Chart
[SOP
Standard Operating Procedure SOP No | Rev
; : D-126 0 Page 6 of 6
Non-Conforming Results in the QC Laboratory
ATTACHMENT 1 — NCR FLOW CHART
& es SoSy eNCrR
5 {
Open
Log
NCR OOS
Compl
Defined
Steps
IN
NCR
Resolved
1
ei rae End 1
Results \
[SOP
ION LABS Non-Conforming Result (NCR) Initiation
Form: D-126-F1 CCR No. N/A Revision: 0
| NC#R | | Copy # | | Rev#
Instructions: Use this form to describe and initiate a non-conformance report.
Description of Non-Conformance
Source / Lot of Non-Conformance
Reported By / Date
Plan
Completed By
Assigned To:
Reviewed By
QC Lab Management
Approved By at Close
QC Doc Control (DC)
[SOP
IAN LABS Non-Conforming Result (NCR) Closure
Form: D-126-F2 CCR No. N/A Revision: 0
| NCR# | | | Copy# | | | Rev# |
Instructions: Use this form to describe and initiate a non-conformance report.
Description of Non-Conformance
Closure Summary
Include as applicable: Evidence and/or statement of closure, cross references to supporting documentation, general conclusions,
outcome, etc.
Additional Actions Necessary? o Yes (Proceed with description below) oO No
Include as applicable: References to supporting documentation for additional actions.
Completed By
Reviewed By
QC Lab Management
Approved By at Close
QC Doc Control (DC)