PRODUCTION

  • Scoring Instructions: Do not combine like exceptions, count each exception individually. Example: 4 trash receptacles not in designated location. This is not counted as 1 exception because it is trash receptacles. It is counted as 4 exceptions because of the number of occurrences a trash receptacle was not in its designated location.

1-SORT (Distinguish between what is needed and not needed)

  • 1) Is there a designated RED TAG location? Have items been identified for disposal?

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  • 2) Needed equipment, tools, supplies & parts are present and within the work area. Unnecessary items are removed to proper storage.

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  • 3) Is all trash, rubbish, etc. disposed of? Are receptacles in designated locations?

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  • 4) No unneeded, out of date, or out of place material on work stations, walls, bulletin boards, etc.

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2-SET (Have a place for everything and everything in its place)

  • 5) All permanent and staging locations for moveable items are clearly defined and items are in their proper location. Example: Cart storage, rolling bins, ladders, etc.

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  • 6) Shelves and storage areas are organized, clear boundaries are divided, and labeled. There are no uncertainties about where items are stored. Example: ingredients, packaging, chemicals, etc.

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  • 7) All items are put away immediately after use to its specified location. Frequently used items are stored at the point of use.

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  • 8) GMP aisle ways, workstations, equipment, and locations are clearly indicated.

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3-SHINE (Clean and look for ways to keep things clean and organized)

  • 9) Floors, walls, stairs, and visual aids are free of debris (no oil, dirt, chips, etc.) and organized? There is evidence of cleaning being performed in constant manner.

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  • 10) Equipment in the area is free of debris (no oil, dirt, chips, etc.) and organized? There is evidence of cleaning being performed in constant manner.

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  • 11) Stairs, exits, and aisle ways are clearly marked to facilitate work flow and escape routes.

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  • 12) Lighting in the work area is bright and adequate (no bulbs out, no loose light fixtures)

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4-STANDARDIZE (Maintain and monitor the first three categories)

  • 13) Where appropriate, are all documents present updated, appropriately located, and well organized.

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  • 14) Work area is labeled in a uniform manner (pictures, labels, color codes, etc.)

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  • 15) Visual organization methods are being used where appropriate (shadow boards, floor marking, etc.) and tools are placed in a manner that minimizes unnecessary movements such as walking, bending, or reaching

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  • 16) Checklist for cleaning is current and available. (Review PMC or posted checklist)

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5-SUSTAIN (Stick to the 5S rules)

  • 17) Has yearly 5S training been conducted for all employees. (Review source of training and employee roster)

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  • 18) Have monthly 5S audits been performed? (Review last 5S audit performed)

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  • 19) Were all items on previous audit corrected (Review AIP List)

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  • 20) The 5S's have become a way of life - there is noticeable continuous improvement.

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