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Class 100 audit 2015
Class 100 audit 2015
Sam Leah

Class 100 audit 2015

Audit outline for quarterly audits of Class 100 area

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Free Class 100 audit 2015 Checklist

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Information

General information

  • Audit Title (quarterly or monthly)

  • Conducted on

  • Location of audit

  • Reason for partial audit:

  • Wockhardt staff attending:

    • Sam Leah
    • Sarah Kelly
    • Helen Roberts
    • Paul Bullock
    • Stuart Oldland
    • Emma Chard
    • John Hancock

  • Additional attendees:

  • Additional attendees:

Class 100 areas - overall score

G71 corridor (from escape hatch to amp 1)

  • Satisfactory

  • Reason for non inspection

  • Was there a specific issue identified to resolve?

    • Issue identified

  • Detail of issue

  • Image of issue

  • Responsibility to resolve:

G90 (Weighing room)

  • Satisfactory

  • Reason for non inspection

  • Was there a specific issue identified to resolve?

    • Issue identified

  • Detail of issue

  • Image of issue

  • Responsibility to resolve:

G88 Cartridge line 2

  • Satisfactory

  • Reason for non inspection

  • Was there a specific issue identified to resolve?

    • Issue identified

  • Detail of issue

  • Image of issue

  • Responsibility to resolve:

G70 Cartridge line 1

  • Satisfactory

  • Reason for non inspection

  • Was there a specific issue identified to resolve?

    • Issue identified

  • Detail of issue

  • Image of issue

  • Responsibility to resolve:

G69 Ampoule line 2

  • Satisfactory

  • Reason for non inspection

  • Was there a specific issue identified to resolve?

    • Issue identified

  • Detail of issue

  • Image of issue

  • Responsibility to resolve:

G68 Ampoule line 1

  • Satisfactory

  • Reason for non inspection

  • Was there a specific issue identified to resolve?

    • Issue identified

  • Detail of issue

  • Image of issue

  • Responsibility to resolve:

G73 Corridor (between double doors and air shower)

  • Satisfactory

  • Reason for non inspection

  • Was there a specific issue identified to resolve?

    • Issue identified

  • Detail of issue

  • Image of issue

  • Responsibility to resolve:

G67 Freeze drier (and entry airlock G72)

  • Satisfactory

  • Reason for non inspection

  • Was there a specific issue identified to resolve?

    • Issue identified

  • Detail of issue

  • Image of issue

  • Responsibility to resolve:

G66 Vial line

  • Satisfactory

  • Reason for non inspection

  • Was there a specific issue identified to resolve?

    • Issue identified

  • Detail of issue

  • Image of issue

  • Responsibility to resolve:

G65 Weighing bays

  • Satisfactory

  • Reason for non inspection

  • Was there a specific issue identified to resolve?

    • Issue identified

  • Detail of issue

  • Image of issue

  • Responsibility to resolve:

G64 corridor (next to autoclaves)

  • Satisfactory

  • Reason for non inspection

  • Was there a specific issue identified to resolve?

    • Issue identified

  • Detail of issue

  • Image of issue

  • Responsibility to resolve:

Air Shower

  • Satisfactory

  • Reason for non inspection

  • Was there a specific issue identified to resolve?

    • Issue identified

  • Detail of issue

  • Image of issue

  • Responsibility to resolve:

G30 Final change

  • Satisfactory

  • Reason for non inspection

  • Was there a specific issue identified to resolve?

    • Issue identified

  • Detail of issue

  • Image of issue

  • Responsibility to resolve:

G29 / G28 Secondary change

  • Satisfactory

  • Reason for non inspection

  • Was there a specific issue identified to resolve?

    • Issue identified

  • Detail of issue

  • Image of issue

  • Responsibility to resolve:

G27 Glove removal

  • Satisfactory

  • Reason for non inspection

  • Was there a specific issue identified to resolve?

    • Issue identified

  • Detail of issue

  • Image of issue

  • Responsibility to resolve:

G26 Male primary change

  • Satisfactory

  • Reason for non inspection

  • Was there a specific issue identified to resolve?

    • Issue identified

  • Detail of issue

  • Image of issue

  • Responsibility to resolve:

G24 Female primary change

  • Satisfactory

  • Reason for non inspection

  • Was there a specific issue identified to resolve?

    • Issue identified

  • Detail of issue

  • Image of issue

  • Responsibility to resolve:

Additional issues?

  • Extra points raised?

  • Was there a specific issue identified to resolve?

    • Issue identified

  • Detail of issue

  • Image of issue

  • Responsibility to resolve:

Class 100 audit 2015
Sam Leah

Class 100 audit 2015

Audit outline for quarterly audits of Class 100 area

Use this Template
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