Integrated Mock FDA Inspection — QMS Family Pack Architecture
Architecture & Design Intent Edition

This mock inspection evaluates the architectural design of a QMS Family Pack within the context of the enterprise Quality Management System (QMS). Quality authority, decision rights, and governance are established upstream at the enterprise level through the Quality Unit, with Quality Control Operations (QCO) retaining sole and non-delegable authority for quality-impacting decisions. This Family Pack does not create, redefine, or redistribute Quality authority. Its purpose is to translate enterprise Quality requirements into process-specific control intent, required evidence, and bounded execution expectations, while preserving strict separation between regulatory WHAT, operational HOW, and task-level execution mechanics.

Table of Contents

Section I — Purpose of QMS Family Packs

1. What is a QMS Family Pack?

A QMS Family Pack is a governing SOP-level document that defines WHAT must be controlled within a Business Process domain. It establishes regulatory scope, control intent, required evidence, and role accountability, but does not define task-level execution.

2. Is a Family Pack intended to function as a traditional procedural SOP?

No. A Family Pack is an architectural SOP-level control document. It functions as the authoritative SOP for the process by defining regulatory scope, control intent, required evidence, and accountability. It intentionally does not include step-by-step task instructions, which are maintained separately to allow execution flexibility without altering compliance requirements.
WINs contained within the QMS Family Pack provide high-level control sequence describing the logical order in which controls are applied to achieve the required compliance outcome. This sequence establishes control flow and accountability without prescribing detailed task mechanics, system navigation, or operator actions.

Section II — WHAT vs HOW Architectural Boundary

3. How does the organization distinguish WHAT from HOW?

WHAT-level requirements originate from Quality Control (QC) specifications and controlled Quality requirements, which define acceptance criteria, limits, and regulatory expectations. QMS Family Packs apply these QC-defined requirements to a specific Business Process domain by defining control intent, required Auditable Artifacts, and governance boundaries. HOW-level execution is defined through the WIN layer and detailed Execution Guides, preserving separation between rule definition and task execution.

4. What content is explicitly excluded from QMS Family Packs?

Family Packs do not include: step sequencing, tool usage, system navigation, screenshots, or physical task instructions. These elements are intentionally excluded to preserve architectural integrity.

Section III — Family Pack Content Expectations (WHAT)

5. What content must exist in every QMS Family Pack?

Each QMS Family Pack must define: referenced regulatory anchors applicable to the process domain, scope and operational boundaries, control intent derived from QC-defined requirements, role-level responsibilities, required Auditable Artifacts (AAs), and governance inheritance from the enterprise QMS. Detailed regulatory interpretation and clause mapping are maintained at the higher enterprise level and are not redefined within individual Family Packs.

6. How is compliance demonstrated through a Family Pack?

Compliance is demonstrated through the existence and integrity of required Auditable Artifacts generated through execution. The Family Pack defines what evidence must exist, not how the evidence is physically created.

Section IV — WIN Layer Role & Governance

7. What is the purpose of a WIN?

A WIN defines WHEN a control is executed, WHO executes it, WHAT outcome is required, and WHAT evidence is produced. WINs operationalize Family Pack requirements without redefining regulatory intent.

8. Why are WINs governed differently than SOPs?

WINs do not define acceptance criteria or regulatory requirements. They enforce already-approved controls and may be updated to improve execution efficiency without altering compliance intent.

Section V — Execution Instructions (EI)

9. What are Execution Instructions?

Execution Instructions define HOW tasks are physically performed, such as system steps, equipment operation, or local workflow details. They are operational aids, not quality control documents.

10. Why are Execution Instructions lightly governed?

Execution Instructions do not alter control intent, acceptance criteria, or required evidence. Light governance allows continuous improvement without triggering unnecessary regulatory change control.

Section VI — Change Control & Governance Model

11. What changes require formal Family Pack change control?

Changes that affect WHAT is controlled, regulatory scope, required evidence, role accountability, or governance inheritance require formal SOP-level change control.

12. What changes do not require Family Pack change control?

Changes limited to task sequence, tooling, system navigation, or efficiency improvements that do not alter control outcomes or evidence requirements do not require SOP-level change control.

Section VII — Inspection Defensibility & Maturity

13. How does this architecture reduce inspection risk?

This architecture prevents procedural drift, enforces consistency across sites, simplifies audit traceability, and allows operational flexibility without compromising compliance.

14. If two operators perform a task differently, is that a compliance issue?

No. Variability in HOW is acceptable provided required controls are executed and required Auditable Artifacts are produced in accordance with the Family Pack.

15. Who is accountable for Family Pack effectiveness?

Quality Control Operations retain accountability for control sufficiency and regulatory alignment. Quality Assurance executes and maintains the system under delegated authority in accordance with QMS governance.

Section VIII — WIN Layer & Execution Guide Architecture

16. Are Work Instructions (WINs contained within the QMS Family Pack?

Yes. Each QMS Family Pack contains a defined WIN layer. WINs provide high-level operational HOW that enforces the governing SOP requirements of the Family Pack. WINs do not include detailed task mechanics, screenshots, system navigation, or equipment-specific instructions.

17. What is the intended scope of WINs within the Family Pack?

WINs define WHEN a control is executed, WHO performs it, WHAT outcome must be achieved, and WHAT Auditable Artifacts are generated. WINs stop short of prescribing step-by-step task execution to preserve architectural separation and execution flexibility.

18. Why are detailed execution steps not included in WINs?

Detailed execution steps vary by system, site, tooling, and operational context. Embedding such details within governing documents would create unnecessary change-control burden without improving regulatory control.

19. Where are detailed task execution instructions maintained?

Detailed Execution Guides are maintained outside the QMS Family Pack. These guides provide task-level HOW such as screen navigation, system-specific steps, equipment handling, or local workflow details. Execution Guides are anchored to the governing Family Pack through references to Sections 5 through 8.

20. How is alignment maintained between Execution Guides and the Family Pack?

Execution Guides may not redefine control intent, acceptance criteria, required Auditable Artifacts, or governance boundaries. All Execution Guides must produce the AAs defined in Section 5 and operate within the authority and governance defined in Sections 6 through 8 of the Family Pack.

21. Why are Execution Guides governed differently than Family Packs and WINs?

Execution Guides do not establish regulatory requirements or quality decision authority. They exist to optimize task execution while preserving stable compliance controls. Light governance allows continuous improvement without altering the validated control architecture.

22. If an Execution Guide conflicts with the Family Pack or a WIN, which prevails?

The QMS Family Pack and its WINs prevail. In the event of any conflict, execution must stop and the issue escalated in accordance with Quality Management System governance.

Before reviewing this Family Pack, how is Quality authority structured in this organization?

Quality authority is established at the enterprise level through the Quality Management System (QMS) and the Quality Unit. Quality Control Operations (QCO) retain sole and non-delegable authority for quality-impacting decisions, including acceptability, disposition, and release. This authority exists independently of any individual Process Family Pack.

Does this QMS Family Pack establish or redefine Quality authority?

No. This Family Pack does not establish, redefine, or redistribute Quality authority. It inherits authority, governance, and decision rights from the enterprise QMS. Its purpose is to define HOW enterprise Quality requirements are applied within a specific Business Process domain.

What is the relationship between the enterprise QMS and this Family Pack?

The enterprise QMS defines Quality structure, authority, and governance rules. This Family Pack is a subordinate, domain-specific control document that translates enterprise Quality expectations into process-specific control intent, required evidence, and execution boundaries.

Final Auditor Conclusion:

The organization has implemented a deliberate, mature, and inspection-defensible architecture that separates regulatory intent from execution mechanics. QMS Family Packs define WHAT must be controlled, while execution layers provide flexibility without erosion of compliance.