CQAC 6S SELF INSPECTION REPORT

• Zone Area

  Select Inspection Services Compliance RM/IFB Retention Storage (QA Warehouse) Document Storage  (RM/PM/Compliance) QA Packaging Storage room (Tools and Office Supplies / Disposal Area) QA Packaging Room 1 Stability Office Retention Samples/ Batch Record Area/Instruments Room (Reach in, walk in chambers) QA Operations QAO Services CDDC office /Vault Micro QA Packaging Room 2 1st floor - SQM 2nd floor - SQM RM Area 1 RM Area 2 Dissolution Area HPLC area 1 HPLC area 2 HPLC area 3 AAS area Products Area 1 Products Area 2 Digestion room Instrument room

  • Inspection Services
  • Compliance
  • RM/IFB Retention Storage (QA Warehouse)
  • Document Storage  (RM/PM/Compliance)
  • QA Packaging Storage room (Tools and Office Supplies / Disposal Area)
  • QA Packaging Room 1
  • Stability Office
  • Retention Samples/ Batch Record Area/Instruments Room (Reach in, walk in chambers)
  • QA Operations
  • QAO Services
  • CDDC office /Vault
  • Micro
  • QA Packaging Room 2
  • 1st floor - SQM
  • 2nd floor - SQM
  • RM Area 1
  • RM Area 2
  • Dissolution Area
  • HPLC area 1
  • HPLC area 2
  • HPLC area 3
  • AAS area
  • Products Area 1
  • Products Area 2
  • Digestion room
  • Instrument room

• Conducted on

  Date

• Inspected by

Scoring Criteria

• 3 - Complied 2 - Partially complied 1 - Not Complied
  N/A - Not applicable

SORT

• 1) Free from unnecessary items/work in progress removed from the area.

  3

  2

  1

  N/A

• 2) Red tagging is implemented.

  3

  2

  1

  N/A

• 3) All obsolete documents are routinely purged.

  3

  2

  1

  N/A

STRAIGHTEN

• 1) Needed items and their designated locations are easily visible and clearly marked or labelled

  3

  2

  1

  N/A

• 2) Critical levels for inventory can be visually identified.

  3

  2

  1

  N/A

• 3) Area well organized. Most items in designated location. Aisles neat and clear.

  3

  2

  1

  N/A

• 4) Tools have a designated location. Tools are labeled.

  3

  2

  1

  N/A

SHINE

• 1) Everything in area is clean & functional (floors, walls, ceiling, equipment, waste containers).

  3

  2

  1

  N/A

• 2) Equipment and utilities are free of leaks.

  3

  2

  1

  N/A

• 3) All bulletins are orderly and updated. It is easy to read what is posted.

  3

  2

  1

  N/A

STANDARDISE

• 1) Standards for visual controls and labelling have been established, documented and followed

  3

  2

  1

  N/A

• 2) 6S checklists for all areas are available and followed.

  3

  2

  1

  N/A

• 3) Visual controls in place and updated

  3

  2

  1

  N/A

SUSTAIN

• 1) 6S training is understood and part of onboarding program

  3

  2

  1

  N/A

• 2) Leaders understand, teach, and reinforce 6S key themes.

  3

  2

  1

  N/A

• 3) Team leaders discuss 6S topics during Tier 1 meeting.

  3

  2

  1

  N/A

SAFETY

• 1) Safety, warning, and emergency signs are adequately posted in the workplace

  3

  2

  1

  N/A

• 2) Visual Monitoring of safety incident is in place and updated.

  3

  2

  1

  N/A

• 3) Assigned/designated safety personnel known by all employees.

  3

  2

  1

  N/A