Lroo

  1. Excel packing
    US64
  2. PIC Packing
    US44
  3. PAB Packing
    US34
  4. Glass Packing
    US54
  5. Exceed E3
    US87
  6. Titan
    US94
  7. Excel Filling
    US63
  8. Month  A-E
    Jan-May
  9. Month H
    June
  10. Month J,K,L
    July, August, September
  11. Month N
    October
  12. Month P
    November
  13. Month S
    December
  14. Y56-202
    Orange
  15. Y56-203
    Red
  16. Y56-204
    Purple
  17. Y56-205
    Teal Robbins egg blue
  18. Y56-206
    Olive green
  19. Y56-207
    Yellow
  20. Excel bag failure locationsImage Upload 1
  21. 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.
  22. 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.
  23. DEFINITIONS QC manual cont.
    Reinspection - Repeating an inspection process. 100% inspection may be performed as acorrection for a discrepancy to remove defective units.
  24. 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.
  25. 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.
  26. DFU's manually
    DFU's Y36-002-123 / 0061512345 manually verified for production by Quality Operations.
  27. 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
  28. NDC
    SAP
    LAF
    • National Drug Code
    • Systems Applications & Products
    • Label Accountability Form
  29. PTRA

    QCRV

    EBR
    Production Test Run Area

    Quality Control Release Verification

    Electronic Batch Records
  30. PO

    PQ

    MWO
    Process Order

    Process Qualifications

    Manufacturing Work Orders
  31. DMI

    DSMS
    Discrepancy Management Interim

    Discrepancy Management system
  32. C O R E
    • Customer Focus
    • Operational Excellence

    • Revenue Growth
    • Employee Commitment
  33. DMO
    Demand Maintenance Order
  34. DMAIC
    Define, Measure, Analyze, Improve & Control
  35. DMAIC Philosophy
    D=What is broke  , M=How broke ?, A=Why 

    I=Fix it!, C= Keep it fixed.
  36. RCA= Root Cause Analysis
    Objective evidence=based on facts / Proof

    Subjective = No proof
  37. DMAIC
    Define, Measure, Analyze, Improve and Control
  38. MMI

    PPDR
    Master Manufacturing Instructions

    Product Process Deviation Report
  39. PPDR  / MES / ERF
    • Product Process Deviation Report
    •  
    • Manf. Execution Systems

    Event Report Form
  40. CAPA

    CORE
    Corrective / Prevention Action Program

    Customer focus, Operational excellence, Revenue growth, Employee-commitment.
  41. Repacked
    Case #-####(LX001) openbox, #units needed to be repacked due to it not glued securedly. Done with Quality  Operations Oversight.
  42. PTL , FFS, HVLD
    • Puncture-through Label
    • Form, Fill, Seal.
    • High Voltage Leak Detector.
  43. Excel Container Spec
    Spec-1000262
  44. Excel Packing
    SOP-1000837
  45. Excel Filling
    SOP-1000769
  46. Excel Tray-loader
    SOP-1002747
  47. Excel production MMI
    MMI-100059
  48. Excel Daily Equipment inspection
    SOP-1001071
  49. WI-Quality Manual
    SOP-1001695
  50. Work Center Excel
    • pkg=EXL1200P
    • Overwrap=EXL1200O
    • Excel Fill=EXL1200F
    • PCuff=EXL1202
  51. DAF
    Visual defects that could affect function
  52. KAIZEN
    Sino-Japanese word meaning "Improvement"
  53. ALCOA
    • Attributable
    • Legible
    • Contemporaneous
    • Original
    • Accurate
  54. 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
  55. 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
  56. 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
  57. GMP CFR 21
    Part 210  211
  58. DSMS Quality Procedures decision tree
    COP-QP-8000025

    SOP-MD-2014820

    DSMS QUAUS-COP decision tree.
  59. scale LR
    Zero set to 10pcs load ten dfu's or 10 Labels then menu to store. Remove then place items to weigh.
Author
dizzod
ID
322298
Card Set
Lroo
Description
RCVG locations
Updated