The purpose of the Jira Event Management (QMS) process is to provide a controlled, consistent, and compliant mechanism for identifying, documenting, evaluating, escalating, and closing quality-related exception events that may impact:
Jira Event Management serves as the system of record for quality exceptions and Quality Assurance (QA) decision-making, including formal escalation to CAPA and Change Control when required.
This process ensures that:
This process applies to all personnel and functions involved in GMP-related activities, including but not limited to:
The Jira Event Management process applies whenever an observable condition, signal, or finding indicates a potential deviation from expected controls, approved procedures, or regulatory requirements.
The Jira Event Management system is intentionally designed to separate routine execution evidence from quality exception evaluation and decision-making.
Routine Execution Logs document the performance of routine operational or oversight activities. These logs may be paper-based or electronic and may reside in systems such as:
Routine Execution Logs serve as evidence that work occurred. They are not used to document quality decisions.
A Quality Event is created in Jira when a Routine Execution Log or direct observation identifies an exception signal.
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(To be completed in later iterations)
Document Status: Draft – In Controlled Development
Jira Event Management uses three standardized work types to manage quality-related activities. These work types are intentionally limited to ensure clarity, consistency, and regulatory compliance.
A Quality Event represents an observable exception signal that may impact product quality, material status, data integrity, safety, or regulatory compliance.
A Quality Event answers the question:
A CAPA is used to address systemic, repeat, or high-risk issues identified through Quality Events.
CAPAs are always:
Change Control manages intentional changes that may affect quality, safety, or compliance.
Change Controls ensure that changes are:
A Quality Event must be created whenever an observable condition, signal, or finding indicates that activities, materials, systems, or data are not operating as expected.
This section defines objective decision rules to ensure that Quality Events are raised consistently and without reliance on individual judgment.
---A Quality Event must be created when any of the following occur:
Users are not expected to determine impact, root cause, or regulatory significance at intake.
That responsibility belongs to Quality Assurance.
---A Quality Event is not required for routine activities when:
Routine walkthroughs, inspections, and oversight activities are documented using Routine Execution Logs.
There is no requirement to create a Quality Event to document that a walkthrough or inspection occurred.
---If multiple issues are observed during the same activity:
Quality Assurance will determine whether additional events are required during review.
---When creating a Quality Event, users are responsible for:
Each Quality Event must be classified using a three-layer model to ensure consistent interpretation, trending, escalation, and regulatory reporting.
The classification model separates:
The Event Category defines the regulatory meaning of the issue.
Exactly one Event Category must be selected. QA may update the category during review.
The BPO Domain identifies the business process owner responsible for the area where the event occurred.
Exactly one BPO Domain must be selected.
The Quality Event Sub-Type identifies the specific exception signal that triggered the Quality Event.
Only one Sub-Type may be selected. If multiple conditions are observed, select the primary signal and describe secondary observations in the Description.
Sub-Types are controlled lists aligned to process-family Operational Guides.
Scenario: Returned product received with damaged packaging.
QA will determine disposition, escalation, and final classification.
---Quality Assurance (QA) and Quality Control (QC) play distinct but coordinated roles within the Jira Event Management process. This section defines how QA and QC activities are documented, escalated, and controlled to ensure independent oversight and regulatory compliance.
---Quality Control personnel perform routine testing, monitoring, and oversight activities as part of normal operations.
QC activities are documented through Routine Execution Logs, which may include:
QC is responsible for identifying and escalating any exception signal observed during routine activities.
Quality Assurance is responsible for independent evaluation, decision-making, and disposition of Quality Events.
QA responsibilities include:
QA may identify Quality Events through routine oversight activities, walkthroughs, audits, or reviews.
---Findings identified by QA or QC during routine oversight are handled the same way as findings identified by Operations.
Segregation of Duties is enforced to ensure that no individual can identify, evaluate, and approve the same quality issue.
The following controls apply:
The Event Source identifies who observed or identified the exception signal.
This may differ from the Jira Reporter, who created the record.
This distinction supports:
Routine QA oversight activities (e.g., walkthroughs, audits, reviews) are documented using Routine Execution Logs.
Once a Quality Event is submitted in Jira, it enters a QA-controlled workflow. This workflow ensures that all exception signals are consistently reviewed, evaluated, and appropriately dispositioned.
Users are not expected to manage events after submission. All post-submission actions are governed by Quality Assurance.
---All Quality Events, CAPAs, and Change Controls use a common QA-controlled workflow.
| Status | Purpose | Primary Owner |
|---|---|---|
| Submitted | Event formally logged and awaiting QA review | QA |
| Under QA Review | QA evaluation and impact assessment | QA |
| QA Dispositioned | QA decision documented | QA |
| Closed | Event completed and approved | QA |
During Under QA Review, QA performs an independent evaluation, which may include:
QA may request additional information from the originator or subject matter experts as needed.
---Following evaluation, QA documents a disposition decision. Possible outcomes include:
When escalation is required:
The original Quality Event remains open until escalation linkage and initial disposition are complete.
---A Quality Event may be closed only when:
Users may receive notifications when:
Users are not required to take further action unless contacted by QA.
---Corrective and Preventive Action (CAPA) records are used to address systemic, repeat, or high-risk issues identified through Quality Events. CAPA is not an intake mechanism; it is a controlled response initiated by Quality Assurance (QA).
A CAPA may be initiated by QA when one or more of the following conditions exist:
CAPA initiation is a QA decision based on evaluation of one or more Quality Events.
---CAPAs are created only by authorized QA personnel.
When required, a formal investigation is conducted to identify the true root cause of the issue.
QA determines:
Root cause analysis focuses on system failures, not individual error.
---Based on investigation outcomes, QA defines:
Actions must be:
CAPAs require verification that actions taken were effective.
Effectiveness checks may include:
A CAPA may be closed only when:
CAPA closure represents QA confirmation that the system has been brought back into control.
---If implementation of corrective or preventive actions requires a controlled change, a Change Control record is initiated and linked to the CAPA.
Change Control records are used to manage intentional, planned changes that may impact product quality, safety, data integrity, or regulatory compliance.
Change Control ensures that changes are evaluated, approved, implemented, and verified in a controlled and documented manner.
A Change Control record is required when a proposed change may affect:
Change Control may be initiated as:
Change Controls are created only by authorized Quality Assurance / Quality Systems personnel.
QA performs or coordinates a risk assessment to evaluate the potential impact of the proposed change.
Risk assessment may consider:
The outcome of the risk assessment determines the required level of control and verification.
---Changes must be approved by QA and other designated stakeholders prior to implementation.
Implementation activities may include:
After implementation, QA verifies that:
A Change Control may be closed only when QA confirms successful implementation and verification.
---Routine Execution Logs document the performance of routine operational or oversight activities. These logs may be paper-based or system-based and are maintained outside of Jira.
Purpose:
Document verification that incoming materials meet identity, condition,
and documentation requirements at receipt.
Scope:
All GMP materials received from suppliers or internal transfers.
Control Addressed:
Prevents introduction of damaged, incorrect, or undocumented materials
into inventory.
Bare Minimum Fields:
Purpose:
Document receipt, control, and segregation of returned finished goods.
Scope:
All finished goods returned after release or distribution.
Control Addressed:
Prevents reintroduction of potentially compromised product.
Bare Minimum Fields:
Purpose:
Verify that storage conditions remain within defined environmental limits.
Scope:
All temperature- or humidity-controlled warehouse storage areas.
Control Addressed:
Prevents material or product degradation due to environmental excursions.
Bare Minimum Fields:
Purpose:
Confirm that materials are stored in locations consistent with their
approved status.
Scope:
Quarantine, Released, Rejected, and Hold storage areas.
Control Addressed:
Prevents unintended use or distribution of non-released material.
Bare Minimum Fields:
Purpose:
Verify that physical inventory matches system inventory records.
Scope:
Materials subject to periodic inventory reconciliation or cycle counting.
Control Addressed:
Detects loss, mislabeling, undocumented movement, or data discrepancies.
Bare Minimum Fields:
Purpose:
Verify that material handling equipment is fit for use in GMP areas.
Scope:
Forklifts, pallet jacks, and other handling equipment used for GMP materials.
Control Addressed:
Prevents material damage and safety incidents during handling.
Bare Minimum Fields:
Purpose:
Document execution of manufacturing steps in accordance with approved
batch records.
Scope:
All GMP manufacturing batches.
Control Addressed:
Ensures traceability and documented execution of approved manufacturing processes.
Bare Minimum Fields:
Purpose:
Verify critical process parameters meet defined acceptance criteria
during manufacturing.
Scope:
Defined in-process control points for manufacturing operations.
Control Addressed:
Detects process drift or loss of control prior to batch completion.
Bare Minimum Fields:
Purpose:
Confirm manufacturing equipment is suitable for use before and after
production activities.
Scope:
All GMP manufacturing equipment.
Control Addressed:
Prevents cross-contamination and equipment-related deviations.
Bare Minimum Fields:
Purpose:
Verify removal of materials, labels, and documents from previous operations.
Scope:
All manufacturing line changeovers.
Control Addressed:
Prevents product mix-ups and cross-contamination.
Bare Minimum Fields:
Purpose:
Document abnormal observations identified during manufacturing operations.
Scope:
All manufacturing shifts.
Control Addressed:
Ensures abnormal conditions are not overlooked.
Bare Minimum Fields:
Purpose:
Document execution of packaging operations in accordance with approved
packaging records.
Scope:
All GMP packaging batches.
Control Addressed:
Ensures traceability and documented execution of approved packaging processes.
Bare Minimum Fields:
Purpose:
Verify removal of prior materials, labels, and components from packaging lines.
Scope:
All packaging line changeovers.
Control Addressed:
Prevents labeling errors and product mix-ups.
Bare Minimum Fields:
Purpose:
Verify control and reconciliation of printed packaging materials.
Scope:
All printed labels and packaging components.
Control Addressed:
Prevents mislabeling and labeling discrepancies.
Bare Minimum Fields:
Purpose:
Verify critical packaging parameters meet requirements during operations.
Scope:
Defined in-process checks during packaging.
Control Addressed:
Detects packaging errors prior to batch completion.
Bare Minimum Fields:
Purpose:
Document receipt, identification, and custody of laboratory samples.
Scope:
All GMP samples received for testing.
Control Addressed:
Prevents sample mix-ups, loss, or undocumented handling.
Bare Minimum Fields:
Purpose:
Document execution of laboratory testing per approved methods.
Scope:
All GMP analytical testing activities.
Control Addressed:
Ensures traceable and compliant execution of test methods.
Bare Minimum Fields:
Purpose:
Verify laboratory instruments are qualified and within calibration.
Scope:
All laboratory instruments used for GMP testing.
Control Addressed:
Prevents generation of invalid analytical data.
Bare Minimum Fields:
Purpose:
Confirm analytical methods perform as expected when used.
Scope:
Method verification, transfers, or suitability checks.
Control Addressed:
Ensures analytical methods produce reliable results.
Bare Minimum Fields:
Purpose:
Document independent review of laboratory test results.
Scope:
All GMP analytical results.
Control Addressed:
Ensures accuracy, completeness, and independent oversight.
Bare Minimum Fields:
Purpose:
Document completion of scheduled environmental monitoring activities.
Scope:
All environmental monitoring programs and locations.
Control Addressed:
Ensures environmental monitoring is performed as required.
Bare Minimum Fields:
Purpose:
Document collection and identification of EM samples.
Scope:
All EM sample types (air, surface, personnel, utilities).
Control Addressed:
Ensures traceability and integrity of EM samples.
Bare Minimum Fields:
Purpose:
Document review and trending of environmental monitoring results.
Scope:
Periodic EM data review.
Control Addressed:
Detects loss of environmental control or adverse trends.
Bare Minimum Fields:
Purpose:
Document response to EM alert or action level excursions.
Scope:
All EM results exceeding defined limits.
Control Addressed:
Ensures timely response to contamination risk.
Bare Minimum Fields:
Purpose:
Document routine facility walkthroughs to identify conditions that may
impact product quality, safety, or compliance.
Scope:
All GMP and GMP-adjacent facility areas.
Control Addressed:
Detects facility-related risks before they impact operations or product.
Bare Minimum Fields:
Purpose:
Verify utilities supporting GMP operations remain within defined limits.
Scope:
Utilities such as HVAC, water, compressed air, and power.
Control Addressed:
Prevents utility failures from impacting product quality.
Bare Minimum Fields:
Purpose:
Document completion of planned or corrective facility maintenance.
Scope:
Facility maintenance activities affecting GMP areas.
Control Addressed:
Ensures maintenance activities are traceable and completed as required.
Bare Minimum Fields:
Purpose:
Document pest control monitoring and inspection activities.
Scope:
All pest control devices and monitored areas.
Control Addressed:
Prevents pest-related contamination risks.
Bare Minimum Fields:
Purpose:
Document completion of routine sanitation activities.
Scope:
Cleaning and sanitation of GMP areas and equipment.
Control Addressed:
Prevents contamination through effective sanitation.
Bare Minimum Fields:
Purpose:
Verify correct preparation and use of sanitation chemicals.
Scope:
All sanitation chemical preparations.
Control Addressed:
Ensures effective and safe sanitation practices.
Bare Minimum Fields:
Purpose:
Verify effectiveness of sanitation activities.
Scope:
Post-cleaning inspections and verification checks.
Control Addressed:
Confirms sanitation meets acceptance criteria.
Bare Minimum Fields:
Purpose:
Document sanitation-related observations or deviations.
Scope:
All sanitation activities and inspections.
Control Addressed:
Ensures sanitation issues are identified and escalated.
Bare Minimum Fields:
Purpose:
Document periodic review of user access to GMP-relevant computerized systems.
Scope:
All GMP-impacting systems (e.g., ERP, LIMS, EM, CMMS).
Control Addressed:
Prevents unauthorized access and supports data integrity controls.
Bare Minimum Fields:
Purpose:
Document review of audit trails for GMP-relevant systems.
Scope:
Defined audit trail review periods and systems.
Control Addressed:
Detects unauthorized or inappropriate data changes.
Bare Minimum Fields:
Purpose:
Verify successful backup and recovery controls for GMP systems.
Scope:
All GMP-impacting computerized systems.
Control Addressed:
Ensures data availability and integrity.
Bare Minimum Fields:
Purpose:
Document system incidents or outages affecting GMP activities.
Scope:
All GMP-impacting system interruptions.
Control Addressed:
Ensures system-related risks are identified and escalated.
Bare Minimum Fields:
Purpose:
Document ongoing review of supplier performance.
Scope:
Approved suppliers providing GMP materials or services.
Control Addressed:
Detects supplier-related quality risks.
Bare Minimum Fields:
Purpose:
Verify supplier documentation remains current and approved.
Scope:
COAs, specifications, agreements, and quality documents.
Control Addressed:
Ensures supplier documentation supports material acceptance.
Bare Minimum Fields:
Purpose:
Document receipt and review of supplier change notifications.
Scope:
All supplier-initiated changes affecting GMP materials or services.
Control Addressed:
Ensures supplier changes are assessed prior to impact.
Bare Minimum Fields:
Purpose:
Document completion of supplier audits or assessments.
Scope:
All supplier qualification and monitoring activities.
Control Addressed:
Ensures suppliers meet quality requirements.
Bare Minimum Fields:
Purpose:
Document routine safety inspections and observations.
Scope:
All facility areas and activities.
Control Addressed:
Identifies safety risks before injury occurs.
Bare Minimum Fields:
Purpose:
Document safety incidents or near misses.
Scope:
All safety-related events.
Control Addressed:
Ensures safety risks are identified and addressed.
Bare Minimum Fields:
Purpose:
Verify completion of required safety training.
Scope:
All personnel subject to safety training requirements.
Control Addressed:
Ensures personnel are trained for safe operations.
Bare Minimum Fields:
Purpose:
Document control of access to GMP and restricted areas.
Scope:
All access-controlled facility areas.
Control Addressed:
Prevents unauthorized access to GMP operations.
Bare Minimum Fields:
Purpose:
Document visitor and contractor access to the facility.
Scope:
All visitors and contractors.
Control Addressed:
Ensures controlled and traceable access.
Bare Minimum Fields:
Purpose:
Document security-related incidents.
Scope:
All security events impacting the facility or systems.
Control Addressed:
Ensures security risks are identified and escalated.
Bare Minimum Fields:
Purpose:
Document routine QA oversight activities.
Scope:
All QA walkthroughs and oversight reviews.
Control Addressed:
Provides independent QA oversight of operations.
Bare Minimum Fields:
Purpose:
Document internal or external audit findings.
Scope:
All audit and inspection activities.
Control Addressed:
Ensures audit findings are captured and addressed.
Bare Minimum Fields:
Purpose:
Document periodic review of quality metrics and trends.
Scope:
Quality data across all domains.
Control Addressed:
Detects emerging quality risks.
Bare Minimum Fields:
Purpose:
Document periodic management review of the quality system.
Scope:
Formal management review activities.
Control Addressed:
Ensures leadership oversight of quality performance.
Bare Minimum Fields:
Purpose:
Document verification of CAPA effectiveness.
Scope:
All CAPAs requiring effectiveness checks.
Control Addressed:
Ensures corrective and preventive actions are effective.
Bare Minimum Fields:
This Jira Event Management process is designed to provide a clear, scalable, and compliant framework for managing quality-related exception events while preserving the integrity of routine execution systems.
---| Layer | Purpose | System |
|---|---|---|
| Routine Execution | Document that work occurred | Logs (paper or electronic) |
| Exception Management | Evaluate and decide on issues | Jira – Quality Events |
| Systemic Response | Correct and prevent recurrence | Jira – CAPA & Change Control |
This process is governed by Quality Assurance.
Routine execution remains governed by existing operational procedures and systems.
---During inspections, this system should be explained as follows:
This approach ensures:
The following enhancements may be implemented without changing the core design:
Document Status: Final — Ready for Implementation, Training, and Inspection