Authoritative Quality Specifications
This library contains the single, authoritative sources for Quality Unit–approved acceptance criteria, limits, and decision requirements used across the Sawgrass Nutra Labs Quality Management System (QMS).
These specifications define what is acceptable. They do not describe how work is performed.
All specifications contained in this library are owned and governed by the Quality Unit (QC/QCO), approved under QMS change control, and enforced through Quality Assurance (QA) procedures.
1. Purpose of This Library
The Authoritative Specifications Library exists to prevent duplication, uncontrolled interpretation, and inconsistent application of quality requirements across business domains.
Acceptance criteria, limits, and decision logic are defined once in controlled specifications and are referenced by SOPs, work instructions, and records. No execution document may redefine or restate these requirements.
2. Governance & Authority
- Owner: Quality Control (Quality Unit)
- Approver: Quality Control Operations (QCO)
- Change Control: Quality Management System (QMS)
- Requirement Authority: QC-REQ-IDX
The Quality Control Requirements Index (QC-REQ-IDX) defines which specification types are authorized to contain Quality Control requirements. Specifications outside this library are not valid sources of acceptance criteria.
3. How These Specifications Are Used
These specifications are:
- Referenced by Quality Assurance SOPs and review activities
- Executed by applicable Business Domains (e.g., BENCH, PROD, WH, PKG)
- Reviewed as objective evidence during audits and inspections
- Used by the Quality Unit to support independent quality decisions
Specifications are physically housed in a neutral, centralized library to ensure consistent access while preserving Quality Unit ownership and authority.
4. Specification Categories
Specifications are organized by requirement type, not by execution domain. Each category contains one or more authoritative specifications.
- Product & Material Quality
- Process & In-Process Controls
- Sampling & Acceptance Logic
- Analytical & Measurement Acceptance
- Environmental & Facility Controls
- Stability & Lifecycle Quality
- Disposition & Decision Frameworks
- Data Integrity & Records Acceptance
5. What Does Not Belong in This Library
The following document types are intentionally excluded from this library:
- Standard Operating Procedures (SOPs)
- Work Instructions (WIs)
- Test methods or step-by-step procedures
- Batch records, forms, logs, or templates
- Training materials
These documents may reference authoritative specifications but may not define acceptance criteria or decision logic.
This page provides orientation-level information describing the purpose, ownership, and use of Quality Unit–approved authoritative specifications. Authoritative requirements are defined exclusively within the individual controlled specification documents and governed through the QMS.