| SOP | WIN | AA Doc ID | Type | Frequency | Description (Purpose, Scope & Audit Focus) |
|---|---|---|---|---|---|
| SOP-QCP-SAMPLE | |||||
| WIN-QCL-SAMPLE-PLAN | AA-CHK-QCL-SAMPLE-PLAN-EVT | CHK | Per Sampling Event |
Purpose: Verify approved sampling plan and authorization prior to collection. Scope: All laboratory and in-process sampling activities. Auditor Focus: Approved plans and adherence to sampling requirements. |
|
| WIN-QCL-SAMPLE-COLLECT | AA-REC-QCL-SAMPLE-COLLECT-BCH | REC | Per Sample |
Purpose: Document sample identity, quantity, and collection conditions. Scope: All samples collected for laboratory testing. Auditor Focus: Sample traceability and documentation completeness. |
|
| WIN-QCL-SAMPLE-CHAIN | AA-LOG-QCL-CHAINCUSTODY-EVT | LOG | Ongoing |
Purpose: Maintain chronological custody traceability of samples. Scope: All sample transfers and storage events. Auditor Focus: Unbroken chain of custody. |
|
| WIN-QCL-SAMPLE-LABEL | AA-CHK-QCL-SAMPLE-LABEL-EVT | CHK | Per Sample |
Purpose: Verify correct labeling and traceability prior to testing or storage. Scope: All collected laboratory samples. Auditor Focus: Label accuracy and traceability. |
|
| SOP-QCL-TEST | |||||
| WIN-QCL-TEST-METHOD | AA-CHK-QCL-METHOD-VERIFY-EVT | CHK | Per Test |
Purpose: Confirm correct approved test method and revision. Scope: All laboratory testing activities. Auditor Focus: Method control and compliance. |
|
| WIN-QCL-TEST-EXEC | AA-REC-QCL-TEST-RESULT-BCH | REC | Per Test / Batch |
Purpose: Record raw data, calculations, and final test results. Scope: All laboratory test executions. Auditor Focus: Data integrity and result traceability. |
|
| WIN-QCL-TEST-OOS | AA-REC-QCL-OOS-INVEST-EVT | REC | Per Event |
Purpose: Investigate and disposition OOS/OOT results. Scope: All nonconforming laboratory results. Auditor Focus: Investigation rigor and conclusions. |
|
| WIN-QCL-TEST-REVIEW | AA-CHK-QCL-TEST-REVIEW-EVT | CHK | Per Test |
Purpose: Verify technical and QA review of test results. Scope: Completed laboratory test data. Auditor Focus: Independent review and approval. |
|
| SOP-QCL-DATA | |||||
| WIN-QCL-DATA-ENTRY | AA-REC-QCL-DATA-ENTRY-EVT | REC | Per Entry |
Purpose: Ensure controlled data entry with attribution. Scope: All laboratory data entry activities. Auditor Focus: User attribution and traceability. |
|
| WIN-QCL-DATA-REVIEW | AA-CHK-QCL-DATA-REVIEW-EVT | CHK | Per Dataset |
Purpose: Perform secondary review for accuracy and completeness. Scope: Laboratory datasets. Auditor Focus: Data integrity and review independence. |
|
| WIN-QCL-DATA-CORRECT | AA-REC-QCL-DATA-CORRECT-EVT | REC | As Needed |
Purpose: Document justified data corrections with audit trail. Scope: Laboratory data requiring correction. Auditor Focus: Transparency and approval of corrections. |
|
| WIN-QCL-DATA-ARCHIVE | AA-LOG-QCL-DATA-ARCHIVE-APR | LOG | Per Archive Event |
Purpose: Confirm data retention and archival. Scope: Completed laboratory records and datasets. Auditor Focus: Retention compliance and accessibility. |
|