Quality Game

SOP Review Board & SOP Last approval

100

Who is responsible for the final approval of an SOP in the Document Management System (DMS)? And is this person accountable for the content of the SOP?

The Quality Systems team is responsible for the final approval of the SOP in the DMS. However, they are not responsible for the content of the SOP — this is evaluated and ensured by the QA Responsible of the originating department.

200

How is the SOP Review Board (SRB) process initiated, and who is responsible for organizing it?

To initiate the process, the change initiator must complete the SOP Review Board Form and submit it to the Quality Systems (QS) department. The QS department then reviews the form, schedules the SRB meeting at regular intervals if needed, and ensures all relevant stakeholders are invited.

300

Under which conditions is an SOP Review Board (SRB) meeting not required?

An SRB meeting is not required if:

• The SOP is not GxP-relevant.
• The change is purely administrative.
• The change is related to a growth or start-up project before GMP-readiness.
• The change is related to any type of agreement for which an customer approval is required.
• The change originates from a Deviation Report (DR) or Corrective and Preventive Action (CAPA) that does not impact the execution of the process.

400

What checks does the Quality Systems team perform as the final approver of an SOP?

The Quality Systems team verifies:

General: 

• The SOP Review Board process was followed in accordance with this SOP

Content:

• Current template for SOPs used or main structure adapted (CHVI-5140 - Creating SOPs)
• Table of contents, numbering, and pagination are aligned between the German and English versions
• Check that only effective documents are listed in the Reference/Related Documents sections
• Verify that the documents listed in the body of the document are included in the Reference/ Documents sections

Version History:

• Ensure that at least the last three versions in the version history are listed
• Version number aligns with DMS
• In the case of a complete revision of the document, all changes must be detailed in the change log.

Properties:

• Correct document type (ONLY for version 1.0)
• English title matches German title (if, applicable)
• GxP relevant = “Yes”
• Verification of training and/or retraining assignment
• The planned effective date should fall within either the first or third week of the month, or be aligned with the document owner based on business needs

Workflow & Approval:

• QA approver added
• BioAtrium SME included in the approval workflow for shared SOPs                    

500

Which key aspects of the proposed change must be discussed during the SOP Review Board (SRB)?

The SRB must discuss:

•    Review of Proposed Document Changes

•    Input from Subject Matter Experts (SMEs) and Impacted Departments

•    Assessment of Training Requirements

•    Verification of Uniqueness and Scope Alignment

•    Decision on Formal Approval Workflow

•    Confirmation or Definition of Effective Date

Effectiveness check (CR & DR)

100

What must be the status of the Effectiveness Check (EC) record before completing the CAPA or Change Request (CR) and forwarding it to QA?

The EC record must be populated and in the status “Work in Progress” before completing the CAPA or CR and sending it to QA.

200

What is the general rule for setting the date of the Effectiveness Check (EC) for CAPAs and Change Requests (CRs)? And what must be done if the due date is shorter than recommended?

For CAPAs, the EC date should generally be set approximately six months after the implementation date. This may vary depending on the nature of the CAPA (e.g., campaign- or product-specific timing).

 For CRs, the EC must specify a timeframe of at least 30 days after implementation. 

If the EC due date is shorter than the recommended timeframe, a justification must be provided.

300

What are the key responsibilities of QA when reviewing an Effectiveness Check (EC) before closing a CAPA or Change Request?

QA must review the correctness and appropriateness of the EC content, ensure the time frame is suitable, and confirm that a justification is provided if the time frame is shorter than recommended. Additionally, QA must check that the EC is in the status “Work in Progress” before the CAPA or Change Request is closed.

400

When and how must the need for an Effectiveness Check (EC) be assessed for a change?

The need for an Effectiveness Check must be evaluated for all changes, regardless of category, and documented in a mandatory change assessment task. This task is opened by the Change Manager during the initiation phase of the change.

500

If an Effectiveness Check (EC) is required for a Change Request (CR), what key requirements must be assessed and documented in the change assessment task? And when can the EC be opened?

• Effectiveness Check parameters must be predefined, specific, and fixed to ensure consistent evaluation and avoid subjective interpretation.
• The EC must include a clearly defined timeframe.
• The assignee responsible for performing the EC must be documented.
• The EC can be opened only by QA when the CR is in the status “Ready for Closure”.

Deviation & Stand Alone investigation

100

What is the target timeframe for initiating a deviation after an event is detected?

The target timeframe for initiating a deviation is within one business day after the detection of the event.

200

What Risk Category must be selected in TrackWise for all Post Release Deviations?

For all Post Release Deviations, the Risk Category field in the Assessment tab in TrackWise must always be set to 'High', regardless of the obtained score.

300

What is the purpose of a Recurrence Analysis in deviation management, how is it structured, and what is the minimum lookback period required?

A Recurrence Analysis is a systematic evaluation to determine whether a deviation or similar events have occurred multiple times within a specified timeframe. The minimum lookback period for this analysis is 36 months.

This analysis is performed at two distinct stages:

Preliminary Recurrence Analysis:

• Conducted during the initial risk rating to assess recent occurrence trends and the potential for event recurrence under current conditions. This assessment is based on available data but does not include root cause evaluation.

Formal Recurrence Analysis:

• Performed after investigation completion, incorporating root cause determination and assessment of the effectiveness of previous CAPAs. This detailed analysis informs decisions on risk management and further preventive measures.

400

Which types of stand-alone investigations are expected to be completed within 30 calendar days of initiation, unless justified otherwise and documented?

The following stand-alone investigations, although not classified as deviations, are expected to be completed within 30 calendar days of initiation:

• Exceeded alert levels (e.g., environmental monitoring, utilities)
• Track and Trend Alert and Track and Trend Action limits exceeded (refer to GROUP-98051)
• Unexpected events or observations that should be investigated proactively to prevent escalation into a quality-impacting event

Only one extension is permitted. A second extension may be granted only as an exception, and must be justified by external factors such as delayed customer feedback or external testing.

500

What are the documentation requirements and timeline that must be evaluated during the Deviation Review Board (DRB) for regulatory and batch impact?

• For minor QIR deviations, if a regulatory impact is identified during the DRB or following RA consultation, QA-DRB must open a dedicated Global Deviation Investigation child record to document the regulatory assessment. The due date should be set five days from the deviation initiation date
• For all major and critical QIR deviations, QA-DRB must open two separate Global Deviation Investigation child records: one to document the batch impact and another for the regulatory assessment. Each record should have a due date set five days from the deviation initiation date.

GAP Assessment

100

What is the purpose of a GAP assessment, and which SOPs remain valid during the implementation of new or revised GROUP and CORP documents?

The purpose of a GAP assessment is to ensure that local procedures reflect the content of global procedures by reviewing, assessing, and aligning site SOPs with GROUP and CORP documents. During the implementation period of new or updated global procedures, the current versions of local SOPs remain valid and must be followed.

200

What key actions should be considered when implementing new or revised GROUP and CORP documents?

When implementing new or revised documents, the following actions should be considered:

• Applicability for the Visp site
• Impact on local procedures
• Additional Records needed for implementation
• Identify affected processes and Platforms/Assets
• Agree on the resources needed for implementation
• Ensure availability of tools, technology, and materials
• Assess training needs

300

What are the execution differences between GAP assessments received under GROUP-130365 and CORP-30, and what do they have in common?

• GROUP-130365 applies only to GxP-relevant global documents. The GAP assessment must be completed using the GAP Assessment Form, provided by Global QMS (GROUP-130375), uploaded to DMS, and the CHVI document must be approved by QA.
• CORP-30 requires GAP assessment documentation in TrackWise Task 1. After completion, QA must approve it in Task 2 before implementation.

Common requirement: In both cases, SMEs must classify and document the GAP Severity as Minor, Moderate (Major), or Critical

400

What are the timeline requirements for completing GAP assessments under CORP-30 and GROUP-130365?

For CORP-30 SOPs:

•    Regulatory Findings / Critical Customer Feedback: 6 weeks from the opening date of the Track Wise investigation

•    Continuous Improvement: 3 months from the opening date of the Track Wise investigation

•    

For GROUP-130365 SOPs:

•    GAP assessment must be completed during the pending release period, defined by Global QMS

•    Same timeframes apply:

Regulatory Findings / Critical Customer Feedback: 6 weeks

Continuous Improvement: 3 months

500

What are the GAP Severity Classifications, and what do they indicate about implementation timelines?

•    Minor: Minor local procedural changes or adjustments are required. No significant changes to site processes. Implementation must occur within the GAP assessment period

•    Moderate / Major: Major changes required locally that will take 3 to 6 months to implement. May involve some updates to multiple site processes.

•    Critical: Significant changes required, that will take 6 months or longer to implement. Major updates to site processes, infrastructure, or systems.