Beruflich Dokumente
Kultur Dokumente
1. PURPOSE
1.1 To describe a method for identifying, documenting and resolving discrepancies, such as:
1.1.1 Planned and unplanned process or testing deviations, including those related to approved
procedures and methods, equipment, and facilities.
1.1.2 Non-conforming parts, sub-assemblies, or finished products.
1.1.3 Environmental monitoring results for air, water, or surface exceeding alert or action levels.
2.1 This procedure applies to discrepancies involving incoming raw materials, in-process sub-assembly,
unreleased finished product, utilities and equipment.
3. RESPONSIBILITY
3.4.3 Recommending appropriate corrective action and assuring the corrective action is
implemented in a timely fashion.
3.5.2 Determining action taken for discrepant material (i.e., proceed as scheduled, hold product for
additional testing, conduct MRB meeting).
3.5.3 Closing out Discrepancy Reports by verifying the implemented corrective action satisfies the
requirements of the corrective action identified on an approved Discrepancy Report.
3.6.3 Review of discrepancy summary and trend analysis reports for trends, recurring discrepancies,
and effectiveness of corrective actions.
3.7 Quality Assurance and Document Control are responsible for the administrative activities of the
discrepancy reporting system, including:
3.7.1 Periodic follow-up to assure timely completion of corrective actions identified in Discrepancy
Reports.
3.7.3 Retention of all records and reports required by the Discrepancy Report System.
5.1 None
6.1 None
7. DOCUMENTATION REQUIREMENTS
8. DEFINITIONS
8.1.1 Planned Discrepancy: A decision made prior to the time of an operation to deviate from an
established schedule, plan, or approved process or procedure, including manufacturing,
facility, and testing/inspection procedures. Prior to the implementation of any planned
discrepancy, approval must be obtained as required in Section 9.5.
8.1.2 Unplanned Discrepancy: A deviation from an established schedule, plan, or approved process
or procedure, including manufacturing and testing/inspection procedures, discovered during or
after an operation was performed. Unplanned discrepancies include equipment or utility
failures in facilities used for the manufacture, testing, or storage of incoming raw materials, in-
process sub-assemblies, or finished products. All environmental monitoring discrepancies are
classified as unplanned.
8.2.1 Material (1): A non-conformance discrepancy where the testing and specifications are valid.
8.2.2 Method (2): A discrepancy caused by method or procedure not yielding the specified result,
including those due to inadequate equipment or procedure validation/qualification (equipment
or procedures found inadequate or unsuitable for its intended use), inadequate test method
validation, or the establishment of specifications without adequate supporting data.
8.2.3 Document (3): This category is reserved for “Trial Use” documents or “red-lined” documents
(changes to approved documents) that are used in place of approved procedures.
8.2.6 Environment (6): A discrepancy caused by an air, surface, or water monitoring result
(including HVAC operating specifications) that exceeds alert or actions levels.
8.2.7 Schedule (7): A planned discrepancy caused by deviations from established schedules or
testing plans. Established schedules include environmental monitoring, preventive
maintenance, and calibration programs. Deviations from testing plans include the use of a
material before release testing is completed.
8.2.8 Vendor (9): A discrepancy caused by the performance of a vendor (not including supplying
materials that do not meet their specifications). Examples include changes to vendor
documentation (vendor/catalog part number or certification), packaging changes that are not
communicated prior to production, missing vendor documentation, and shipment errors.
Contract test lab errors are also included in this category.
8.2.9 Other (10): Where the cause can not be determined or more appropriately belongs in separate
category not listed..
9. PROCEDURE
Any employee identifying a discrepancy must either initiate a Discrepancy Report (DR) or notify the
area supervisor immediately of the occurrence. Personnel who initiate a DR complete the “Originator”
section of the appropriate DR form (Attachment A or B) and forward it to the area supervisor where
the discrepancy occurred for evaluation.
9.2 Originator
The originator determines the type of discrepancy and completes the first portion of the DR, providing
product, document, and equipment or system details as necessary. The originator provides a clear,
concise description of the discrepancy along with other relevant information such as the step in the
Manufacturing Batch Record (MBR) affected by the discrepancy, the time or duration of equipment
failures, or any remedial action taken as a result of the discrepancy. All comments must be objective
and without making conclusions as to the cause or impact of the discrepancy. The originator signs the
DR and then forwards it the area supervisor.
Property of Doxpub, Inc. 09-0004-SOP-1.0
All proprietary rights reserved. Page 4 of 13
9.2.1 Environmental discrepancies: The originator indicates whether the discrepancy was related to
routine environmental monitoring or environmental monitoring during aseptic processing, the
test method, the test results, and the approved alert and action levels. The originator also
provides an assignable cause if it is apparent by review of the data.
The area supervisor is responsible for determining the cause and impact of the discrepancy, and for
recommending appropriate corrective action to prevent further occurrences. After completing the
required sections, the area supervisor forwards the DR to Quality Assurance.