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Month J,K,L
July, August, September
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Y56-205
Teal Robbins egg blue
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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 Quality Operations.
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DFU's manually
DFU's Y36-002-123 / 0061512345 manually verified for production by Quality Operations.
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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 Quality Operations
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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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DMAIC
Define, Measure, Analyze, Improve & Control
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DMAIC Philosophy
D=What is broke , M=How broke ?, A=Why
I=Fix it!, C= Keep it fixed.
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RCA= Root Cause Analysis
Objective evidence=based on facts / Proof
Subjective = No proof
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DMAIC
Define, Measure, Analyze, Improve and Control
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MMI
PPDR
Master Manufacturing Instructions
Product Process Deviation Report
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PPDR / MES / ERF
- Product Process Deviation Report
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- Manf. Execution Systems
Event Report Form
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CAPA
CORE
Corrective / Prevention Action Program
Customer focus, Operational excellence, Revenue growth, Employee-commitment.
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Repacked
Case #-####(LX001) openbox, #units needed to be repacked due to it not glued securedly. Done with Quality Operations Oversight.
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PTL , FFS, HVLD
- Puncture-through Label
- Form, Fill, Seal.
- High Voltage Leak Detector.
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Excel Container Spec
Spec-1000262
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Excel Packing
SOP-1000837
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Excel Filling
SOP-1000769
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Excel Tray-loader
SOP-1002747
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Excel production MMI
MMI-100059
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Excel Daily Equipment inspection
SOP-1001071
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WI-Quality Manual
SOP-1001695
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Work Center Excel
- pkg=EXL1200P
- Overwrap=EXL1200O
- Excel Fill=EXL1200F
- PCuff=EXL1202
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DAF
Visual defects that could affect function
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KAIZEN
Sino-Japanese word meaning "Improvement"
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ALCOA
- Attributable
- Legible
- Contemporaneous
- Original
- Accurate
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Quality Operations: The organizational unit designated to be responsible for establishing and maintaining quality oversight through processes and testing of
- · incoming raw materials,
- · in-process testing,
- · release testing, and
- · stability testing of the finished product
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Verified BY:
an individual verifies that information associated with a task is complete, accurate, and follows GDP. Verified by includes initials/signature and date to demonstrate completion
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Witness By:
an individual is present and witnesses that the task is complete, accurate, and follows GDP at the time of occurrence. Witnessed by includes initials/signature and date to demonstrate completion
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DSMS Quality Procedures decision tree
COP-QP-8000025
SOP-MD-2014820
DSMS QUAUS-COP decision tree.
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scale LR
Zero set to 10pcs load ten dfu's or 10 Labels then menu to store. Remove then place items to weigh.
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