In-Process Deviation Response Specification
This specification defines the Quality Unit–approved requirements governing response, escalation, and control when in-process deviations occur during GMP manufacturing or packaging operations.
Authoritative Quality Control specification defining in-process deviation response and decision authority. This document does not define deviation investigation procedures, CAPA execution, or manufacturing instructions.
1. Purpose
To establish Quality Unit–approved requirements for responding to in-process deviations in a timely, controlled, and risk-appropriate manner to protect product quality and ensure GMP compliance.
2. Scope
This specification applies to all deviations, excursions, or unexpected events occurring during GMP manufacturing or packaging operations that may impact process control or product quality.
Applicable Business Domains include:
- Production (PROD)
- Packaging (PKG)
- Quality Control (QC)
- Quality Assurance (QA)
- Engineering & Facilities
3. Ownership & Governance
- Owner: Quality Control (Quality Unit)
- Approver: Quality Control Operations (QCO)
- Change Control: Quality Management System (QMS)
- Requirement Authority: QC-REQ-IDX
- QC-REQ-IDX Reference: QC-IPC-004
In-process deviation response requirements defined in this specification shall not be modified outside approved QMS change control.
4. In-Process Deviation Response Requirements
| Response Element | Requirement | Applicability |
|---|---|---|
| Deviation Identification | In-process deviations shall be promptly identified and recognized when acceptance criteria or control limits are exceeded. | All GMP operations |
| Immediate Control Actions | Appropriate immediate actions shall be taken to prevent further impact to product quality or process control. | All in-process deviations |
| Quality Notification | Quality Assurance or Quality Control shall be notified when in-process deviations occur. | Deviations impacting CPPs or acceptance criteria |
| Impact Assessment | Deviations shall be evaluated to assess potential impact on product quality, process integrity, and compliance. | All in-process deviations |
| Controlled Continuation | Continuation of processing following a deviation shall require Quality Unit review and approval where quality impact is possible. | Deviations with potential quality impact |
In-process deviations shall not be dismissed or corrected without appropriate quality evaluation and documentation.
5. Decision Logic
- Minor deviations with no quality impact may be addressed and documented without halting operations, subject to Quality Unit oversight.
- Deviations with potential quality impact require pause, escalation, or controlled continuation as approved by the Quality Unit.
- In-process deviations may result in rejection, rework, or further investigation depending on impact assessment.
- Final determinations regarding deviation response and disposition reside with the Quality Unit.
6. Escalation Requirements
Quality Assurance must escalate to Quality Control or QCO when any of the following occur:
- Deviation involving a critical process parameter
- Repeated or trending in-process deviations
- Deviations with unclear or potentially significant quality impact
- Disagreement regarding deviation severity or response
7. Records & Evidence
Records supporting compliance with this specification include, but are not limited to:
- In-process deviation records and notifications
- Impact assessments and quality evaluations
- Quality Unit approvals for continued processing
- Investigation, deviation, and CAPA records