Section I — Quality Control Operations (Authority)
1. Who holds final quality decision-making authority in this organization?
Quality Control Operations hold sole and independent
quality decision-making authority.
This includes decisions related to acceptability, rejection,
material or product disposition, deviation outcomes,
approval of corrective and preventive action plans,
and final product release.
Other functions may execute approved actions or provide input,
but no function may make or override quality decisions.
2. What does “sole authority” mean in practice?
Sole authority means that quality decisions cannot be delegated, shared, or overridden.
Other functions may execute tasks or provide information, but Quality Control Operations
are the only function empowered to decide outcomes.
3. Can Quality Assurance ever make a quality decision?
No. Quality Assurance performs execution and administrative activities,
but does not evaluate impact, determine disposition, or approve outcomes.
All quality decisions remain with Quality Control Operations.
3. Can Quality Assurance ever make a quality decision?
No. Quality Assurance does not hold quality decision-making authority.
Quality Assurance executes, administers, and maintains the Quality Management System,
including document control, training administration, monitoring, investigation facilitation,
and verification of compliance against approved requirements.
Quality Assurance may identify issues, escalate risks, and recommend actions,
but evaluation of impact, determination of disposition, and approval of quality outcomes
remain the sole responsibility of Quality Control Operations.
5. How does QCO exercise its authority day to day?
QCO exercises its authority through application of
approved and controlled quality specifications
defined within the Quality Control (QC) framework.
These specifications establish acceptance criteria and decision boundaries.
On a day-to-day basis, QCO applies those specifications through
deviation evaluations, impact assessments, disposition determinations,
batch record review and approval, and formal product release decisions.
QCO does not create or modify specifications through execution;
it enforces and applies them in accordance with the Quality Management System.
6. If a deviation occurs, who determines the outcome?
Quality Control Operations evaluate the impact of the deviation,
determine disposition, and approve any corrective actions.
Other functions may support investigation execution.
7. Who makes the final decision on product release?
Quality Control Operations make the final product release decision
after review of controlled records and evaluation against approved acceptance criteria.
8. Who approves corrective and preventive actions?
Quality Control Operations approve corrective and preventive actions
to ensure they adequately address quality impact and regulatory expectations.
9. How is QCO authority protected within the system?
Authority is protected by governance rules within the QMS,
document hierarchy, controlled approvals, and explicit separation
between decision authority and execution roles.
10. Can execution timelines override quality decisions?
No. Business or operational timelines do not override quality authority.
Quality decisions are made independently of schedule or cost pressure.
11. If information is incomplete, can QCO defer a decision?
Yes. Quality Control Operations may defer a quality decision
when available information is incomplete, inconclusive,
or insufficient to support a scientifically sound evaluation.
In such cases, QCO formally requires additional data,
investigation, or analysis before determining acceptability
or disposition.
During deferral, affected materials remain in a controlled status
and are not released or used.
Deferral of a decision does not transfer authority
or permit interim acceptance;
it preserves decision integrity until sufficient evidence exists
to support a compliant and defensible outcome.
12. Who makes the quality decision?
Quality Control Operations.
Section II — Quality Management System (Governance)
13. What is the purpose of the QMS?
The Quality Management System provides the governance framework
that defines quality authority, controls execution,
manages documentation and records,
and enforces escalation and change control.
It ensures quality decisions are made independently,
execution is consistent,
and compliance is demonstrated through controlled evidence.
14. Does the QMS make quality decisions?
No. The QMS does not make decisions.
It defines how decisions are governed and implemented.
15. Does the QMS execute processes?
No. Execution is performed by Quality Assurance and Operations
under approved procedures.
16. Who governs the QMS?
The Quality Unit governs the QMS framework,
while Quality Control Operations retain decision authority.
17. How does the QMS protect quality authority?
By enforcing document hierarchy, approval controls,
escalation pathways, and separation of authority and execution.
18. Are SOPs part of QMS governance?
SOPs are governed under the QMS document control framework,
but they do not define governance or authority.
19. How are changes controlled?
The QMS governs how changes are proposed, evaluated,
approved by QCO, and implemented by execution functions.
20. Does the QMS interpret regulations?
Regulatory interpretation is centralized at the system level
and translated into controlled requirements,
not interpreted independently at the SOP level.
21. Who decides deviation outcomes?
Quality Control Operations decide deviation outcomes.
The QMS governs documentation and tracking.
22. Can the QMS override QCO?
No. The QMS supports and protects authority;
it does not replace it.
23. Who makes the quality decision?
Quality Control Operations.
Section III — Quality Control (Rules)
24. What is the role of Quality Control?
Quality Control defines quality rules, controls, specifications,
and acceptance criteria used by Quality Control Operations
to make quality decisions.
25. Does Quality Control perform execution activities?
No. Quality Control does not execute SOPs, perform reviews,
or conduct operational activities.
26. Where are acceptance criteria formally defined?
Acceptance criteria are defined in Quality Control–owned specifications
and requirement documents that are approved and controlled by QCO.
27. Why are acceptance criteria not defined in SOPs?
SOPs are execution documents. Defining acceptance criteria in SOPs
would blur authority and create uncontrolled decision points.
28. Can QC change rules independently?
No. Changes to rules or acceptance criteria require evaluation
and approval by Quality Control Operations under change control.
29. Does QC have assigned personnel?
No. QC is a rule-defining function and does not perform execution,
so no personnel are assigned.
30. How does QC support consistency?
By defining acceptance criteria once in authoritative documents
that are referenced consistently across all execution areas.
31. Who approves QC specifications?
Quality Control Operations approve and control all specifications
containing acceptance criteria.
32. Does QC make quality decisions?
No. QC defines the rules; QCO applies them to make decisions.
33. How does QC relate to QCO?
QC provides the controlled requirements and acceptance criteria
that QCO uses as the basis for quality decisions.
Section IV — Quality Assurance (Execution)
34. What is the role of Quality Assurance?
Quality Assurance executes and operates the quality system
by implementing Quality Control requirements and QMS governance
through SOPs, work instructions, and controlled records.
35. Does QA make quality decisions?
No. QA supports execution and documentation,
but does not determine outcomes or dispositions.
36. Can QA release product?
No. QA may perform administrative record checks,
but release decisions are made by Quality Control Operations.
37. What does QA do when an issue is identified?
QA documents the issue, ensures procedural controls are followed,
and escalates the matter for Quality Control evaluation.
38. Can QA change specifications or limits?
No. QA executes approved requirements
and escalates change requests through the system.
39. Does QA own SOPs?
QA executes SOPs. Governance and approval are controlled
through the Quality Management System.
40. Who does QA escalate issues to?
Quality Control Operations.
41. Does QA interpret regulations?
No. QA executes approved requirements
and does not independently interpret regulations.
42. Does QA approve deviations?
No. QA supports documentation;
Quality Control Operations approve outcomes.
43. What evidence does QA generate?
Controlled records demonstrating execution,
monitoring, documentation, and escalation.
44. What should QA do if unsure?
Escalate the question or issue to Quality Control Operations.
45. Who makes the quality decision?
Quality Control Operations.
46. Why is this separation important?
Clear separation of authority, governance, and execution
ensures consistent, independent, and compliant quality decisions.
47. Can quality decision authority ever be delegated?
No. Quality decision authority is never delegated.
It remains exclusively with Quality Control Operations,
regardless of who performs execution or support activities.
48. What activities may be delegated?
Execution activities may be delegated, including data collection,
record review for completeness, investigation support,
and procedural execution. Evaluation and disposition remain with QCO.
49. Does performing a review imply decision authority?
No. Reviewing data or records is an execution activity.
Decision authority requires formal assignment to Quality Control Operations.
50. Can experience or tenure substitute for authority?
No. Authority is role-based, not experience-based.
Expertise may inform a decision, but does not confer authority to make it.
Quality Role Assignment, Authority & Execution Model
51. Who is formally assigned to quality roles in this organization?
Personnel are formally assigned only to Quality Control Operations (QCO)
and Quality Assurance (QA).
Other functions, including Operations, Manufacturing, and Supply Chain,
do not hold quality authority and do not make quality decisions.
52. What is the difference between QCO and QA?
Quality Control Operations hold independent and non-delegable
quality decision authority.
Quality Assurance operates the Quality Management System
and executes quality processes under delegated authority,
but does not determine acceptability, disposition, or release.
53. What authority is delegated to Quality Assurance?
Quality Control Operations retain accountability for the Quality Management System.
Authority to operate the system, including review and approval
of Business Domain QMS Family Packs, SOPs, and WINs,
is delegated to Quality Assurance.
This delegation supports system execution and maintenance
and does not transfer quality decision authority.
54. Does Quality Assurance’s approval of SOPs or Family Packs constitute a quality decision?
No. QA approval confirms alignment with QMS governance,
approved quality rules, and document control requirements.
Approval of documents does not confer authority
to define acceptability, evaluate impact, or determine disposition,
which remain exclusively with Quality Control Operations.
55. Under what conditions may Operations execute quality controls?
Operations may execute controls only when the applicable SOPs and WINs
have been reviewed and approved within the governing QMS Family Pack
and personnel are appropriately trained.
Operations execute defined controls but do not interpret requirements
or make quality decisions.
56. Can Operations or Manufacturing ever make quality decisions?
No. Operations and Manufacturing perform execution only.
They may identify issues, collect data, and escalate concerns,
but do not evaluate acceptability, approve outcomes,
or release product.
Business Pressure & Authority Protection
57. A shipment deadline is at risk. Can QA approve release to meet timing?
No. Business timelines do not override quality authority.
Release decisions are made by Quality Control Operations,
regardless of schedule or commercial impact.
58. A customer is waiting and asks for an exception. Who decides?
Quality Control Operations decide whether an exception is acceptable.
Customer urgency does not transfer decision authority.
59. Management asks QA to “use judgment” to move product forward. What happens?
QA does not exercise judgment on disposition.
The request must be escalated to Quality Control Operations,
as judgment on acceptability is a quality decision function.
Expert Judgment & Seniority Traps
60. A highly experienced operator states, “This result is fine.” Who decides?
Quality Control Operations decide.
Experience or tenure does not confer authority
to determine acceptability.
61. Can QA document a “recommended disposition”?
QA may document observations or factual findings,
but avoids language implying approval or disposition.
Only Quality Control Operations approve outcomes.
System Continuity & Escalation
62. If information is incomplete, can QCO defer a decision?
Yes. Quality Control Operations may defer a decision
until sufficient information is available
to support a scientifically sound evaluation.
Affected materials remain in a controlled status
until a decision is made.
63. If QCO is unavailable after hours, can QA decide temporarily?
No. Authority does not shift due to absence.
Escalation pathways ensure Quality Control Operations
remain the decision authority.
64. Why is this separation of roles and authority critical to compliance?
Clear separation of authority, governance, and execution
prevents inconsistent decisions,
protects independence,
and ensures compliance even under operational pressure.
65. Who makes the quality decision?
Quality Control Operations.
66. Can quality authority be implied through system access or workflow assignment?
No. System access, workflow roles, or task assignments
do not confer quality authority.
Authority is role-based and defined by the Quality Management System,
not by system permissions or operational responsibilities.
67. Does approving a document or record equate to approving a quality outcome?
No. Document or record approval confirms completeness,
alignment with governance, and procedural compliance.
Approval of quality outcomes, acceptability, or disposition
is reserved exclusively for Quality Control Operations.
68. How does the organization prevent Operations from interpreting quality requirements?
Quality requirements and acceptance criteria are defined centrally
within QMS governance and Quality Control–approved specifications.
Operations execute approved SOPs and WINs
and escalate questions rather than interpret requirements independently.
69. What ensures that SOPs and WINs executed by Operations are authoritative?
SOPs and WINs are authoritative only after review and approval
within the governing QMS Family Pack
by Quality Assurance under delegated authority from QCO.
Execution is permitted only after approval and training are complete.
70. Can Operations modify execution steps to improve efficiency?
Operations may propose execution improvements,
but changes must be evaluated and implemented
through the appropriate governance pathway.
Execution may not be altered in a manner
that affects control intent, required evidence,
or quality outcomes without approval.
71. How does training factor into execution authority?
Training confirms personnel are qualified
to execute approved controls.
Training does not grant authority
to interpret requirements or make quality decisions.
Authority remains defined by role, not qualification.
72. If an operator believes a control is unnecessary, can it be skipped?
No. Controls defined in approved SOPs and WINs
must be executed as written.
Concerns regarding control necessity
must be escalated through Quality governance,
not resolved through omission.
73. How does this model support consistent execution across sites or teams?
Centralized definition of WHAT must be controlled
through QMS Family Packs ensures consistency,
while controlled execution layers allow flexibility
without altering regulatory intent or evidence requirements.
74. What prevents informal practices from becoming accepted quality behavior?
Only approved SOPs and WINs define acceptable execution.
Informal practices are not recognized as compliant
and must be escalated for evaluation and formalization
through Quality governance if appropriate.
75. In one sentence, how would you summarize the quality structure?
Quality Control Operations decide,
Quality Assurance governs and operates the system,
and Operations execute approved controls
under defined procedures and training.