WIN Execution Guide — Pre-Operation Readiness Verification

To support structured verification of equipment readiness, line clearance, documentation control, material status, and environmental conditions prior to initiating a production batch.

Scope

Applies to all production lines and equipment prior to batch start, including startup, changeover, and restart following interruption.

Section 6 — AA (Auditable Artifacts)

AA-PROD-PREOP-CHK — Pre-Operation Readiness

Equipment cleanliness and readiness verification
Line clearance confirmation
Verification of approved MMR and controlled documents
Confirmation that materials meet identity and status requirements
Escalation reference when readiness criteria are not met

Auditor focus: Production does not begin without documented readiness.

QC-REQ Anchor: QC-OPS-001, QC-ENV-002

Section 7 — WIN (Work Instructions / Control Requirements)

WIN-PROD-PREOP

Verify equipment cleanliness and readiness.
Confirm line clearance.
Verify approved MMR and controlled documents.
Confirm environmental conditions within defined limits.
Document readiness prior to batch start.

Stop-Execution Condition:

Line clearance incomplete
Equipment not in suitable state
Incorrect or outdated MMR identified
Environmental conditions outside defined limits

Control outcome: Production does not begin without verified readiness.

BPO-Owned Execution Zone — Operational Step Sequence

Pre-operation readiness verification is performed and documented before initiating any batch manufacturing activity. All defined readiness criteria must be satisfied prior to batch start.

Step 1 — Verify Equipment Cleanliness and Readiness

Confirm equipment ID matches batch documentation.
Verify cleaning completion and appropriate status labeling.
Ensure no residual materials, tools, or debris remain.
Confirm equipment is assembled correctly and ready for operation.

Step 2 — Confirm Line Clearance

Verify removal of previous product materials and labels.
Confirm absence of wrong-lot materials in the production zone.
Inspect surrounding area for stray components or documentation.
Document completion of line clearance verification.

Step 3 — Verify Approved MMR and Controlled Documents

Confirm current approved Master Manufacturing Record (MMR) is available.
Verify revision level matches production authorization.
Ensure all required controlled documents are current and accessible.
Remove and segregate outdated or superseded documents.

Step 4 — Confirm Material Identity and Status

Verify materials staged for batch meet identity and lot requirements.
Confirm material status permits use in production.
Maintain segregation to prevent mix-up or cross-contact.

Step 5 — Confirm Environmental Conditions

Verify temperature, humidity, and other defined parameters are within established limits.
Confirm environmental monitoring systems are functioning.
Document environmental status as part of readiness verification.

Step 6 — Document Readiness Prior to Batch Start

Record date, time, equipment/line identification, and verifier name.
Document readiness confirmation.
Reference escalation record if any readiness criteria were not initially met.
Obtain supervisory verification where required prior to batch initiation.

Stop-Execution Principle

If line clearance is incomplete, equipment is not suitable, incorrect/outdated MMR is identified, or environmental limits are exceeded:

STOP — DO NOT START BATCH — ESCALATE — DOCUMENT