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Month J,K,L
July, August, September
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Orange Y56-202
0061519527
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Purple Y56-204
0061513492
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Teal Robbins egg blue Y56-205
0061519531
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Yellow Y56-207
0061519533
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Olive green Y56-206
0061519532
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Excel bag failure locations
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DEFINITIONS QC manual
3.1. Deviation - Failure to perform one or more steps in the manner required by the applicableoperating procedure. This includes omission of required step(s), performance of operationsdifferently than required by procedure, and operation with parameters outside of tolerancesspecified in procedure.
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DEFINITIONS QC manual cont.
Nonconformance - Failure of product batch / lot to meet its specifications and proceduraldeviations. Nonconformance may be detected by testing, or may occur as a consequence of adeviation.
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DEFINITIONS QC manual cont.
Reinspection - Repeating an inspection process. 100% inspection may be performed as acorrection for a discrepancy to remove defective units.
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DEFINITIONS QC manual cont.
Repackaging - Repeating a packaging operation using standard components and procedures.Applies to outer packages only, not primary containers.
Reprocessing - Repeating one or more steps from the approved manufacturing process.3.7. Rework - New process steps, not part of the approved process, performed to salvagenonconforming product.
Rework raises issues regarding validation of the new steps and anyrelated methods, compliance with NDA, and adequacy of existing process validation. Theseconcerns cannot be satisfactorily addressed within the Discrepancy Management System;therefore rework is not undertaken without approval through the Change Control process andissuance of appropriate procedures.
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Case Damage
- Case 2-xxxx (L8000) was found damaged on the palletizer, a total a 12 or 24 units rejected and tossed.
- Reviewed and verified by process control.
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DFU's manually
DFU's Y36-002-123 / 0061512345 manually verified for production by process control.
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Sterilization tags "error reading"
J7Axxx (L88002) sterilization tags (C1) manually verified due to bar code scanner not reading information.
Reviewed and verified by process control.
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NDC
SAP
LAF
- National Drug Code
- Systems Applications & Products
- Label Accountability Form
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PTRA
QCRV
EBR
Production Test Run Area
Quality Control Release Verification
Electronic Batch Records
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PO
PQ
MWO
Process Order
Process Qualifications
Manufacturing Work Orders
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DMI
DSMS
Discrepancy Management Interim
Discrepancy Management system
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C O R E
- Customer Focus
- Operational Excellence
- Revenue Growth
- Employee Commitment
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DMO
Demand Maintenance Order
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PAB Filler # 1-5
- 1 Nozzles 1 & 2
- 2 Nozzles 3& 4
- 3 Nozzles 5 & 6
- 4 Nozzles 7 & 8
- 5 nozzles A & B
- Printed near hanger tab
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Quality Policy Manual
COP-QPM-8000001
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QC manual for discrepancies
SOP-1001695
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DSMS Quality Procedure
COP-QP-8000025
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DSMS work instructions
COP-WI-8000004
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Good Documentation Practices
COP-QP-8000044
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Start to End dates for yearly quarters
- Q1 Jan 1 - Mar 31
- Q2 April 1 - June 30
- Q3 July 1 - Sept 30
- Q4 Oct - Dec 31
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Data Integrity life cycles : Five
Creation , Processing, Review Reporting and Use, Retention and Retrieval, Destruction.
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ALCOA
- Attributable
- Legible
- Contemporaneous
- Original
- Accurate
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Final Impact assessments 5 M's and one E
- Machine
- Measurement (process / Systems)
- Man (process / systems)
- Material ( Product )
- Method (process / systems)
- Environment
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EHS:
EHS-CORP-2000044
Environment, Health and Safety Policy.
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Production Scheduling
- SOP-1001739
- Q:\Drive for the line you need
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CALN
or
Corrective Action Level Notice
- SOP-1001753
- Examples : Alert Level indicates a process drifted from normal does not necessarily require a correction action.
- Action Level Exceeding an action limit requires be taken.
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