Standard Operating Procedure

Title: Housekeeping Audit Procedure

______________________________________________________________________________________

Department Quality Management Document no QMS-105

Prepared by: Date: Supersedes:

Checked by: Date: Date Issued:

Approved by: Date: Review Date:

Document Owner
Quality Assurance Manager
Affected Parties
All Quality Assurance Colleagues and pro duction/process teams.
Purpose
The level of Housekeeping is an indication of someone s attitude towards GMP and Quality. This means:
i Thinking SAFETY FIRST.
i Thinking GMP COMPLIANCE
i Wearing uniform and hairnet correctly .
i Minimising the amount of equipment k ept in areas.
i Not cluttering areas with unnecessary items or personal belongings .
i Emptying bins and removing waste .

YOU ARE DIRECTLY RESPONSIBLE FOR GMP IN YOUR AREA

Scope
To outline the procedures for Housekeeping Audits .

Definition
DR Deviation Report System
Housekeeping Auditor A person who is trained to perform Housekeeping audits.
Housekeeping Audit A process of checking an area for GMP Compliance
Housekeeping Coordinator A person nominated by th e Team, who is responsible for the Housekeeping
Coordination role.
GMP Good Manufacturing Practice

Related Documents
Housekeeping Audit Check Form-425 Analytical Laboratory
Form-430 Production Services
Sheets
Form-435 Electrical and Mechanical Workshop
Form-440 Warehouse
Form-475 Dispensary
Form-485 Production
EHS-010 Environmental, Health and Safety - Risk Management

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Standard Operating Procedure
Title: Housekeeping Audit Procedure
______________________________________________________________________________________
i Calibrations
i Safety.
i Clothing worn correctly /No jewellery
i General maintenance of area i .e. chipped or flaking point
i GMP procedures
i Environmental, health and safety issues
Each area will also have items that are only applicable for that area .

2.4. Housekeeping audits by QA St affs will be conducted in the presence of the Process
Manager.

2.5. At the end of the audit any action items will be discussed with the area manager .

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3.1. There are prepared checklists for the following area to keep record of the audit .
Form-425 Analytical Laboratory
Form-430 Production Services
Form-435 Electrical and Mechanical Workshop
Form-440 Warehouse
Form-475 Dispensary
Form-485 Production

3.2. The Checklists are divided into 3 sections: GMP Items, EHS Items and Area Specific Items .

3.3. All Proc and Support teams should utilise the checklists as specified above for each
individual team.

3.4. The Housekeeping Auditor should complete all Sections as indicated in each audit checklist .

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4.1. Audit details including action items and general comments are entered in the audit report .
Any deviat ion for non compliance a deviation report to be raised and report forwarded to
appropriate manager/s.

4.2. It is the responsibility of the area manager concerned to take action to rectify any findings of
the audit. DR must be completed within one week of the au dit or a work order submitted . If
something has to be made or it is a big job , an action plan must be put into DR follow up
tasks to complete the action item .

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5.1. A Deviation Report (DR) will be raised by the Housekeeping Auditor /QA
Representative/Process Manager:

5.1.1. For GMP non -compliance if a cross (X) is recorded . Comment must be made in the
Comments column and a DR rose i mmediately following the completion of the audit ,
if the non-compliance cannot be corrected during the same shift as the audit .

5.1.2. For an EHS non -compliance - immediately following the completion of the a udit, if
the non -compliance cannot be corrected during the same shift as the audit .
An EHS item is identified and Reported to the EHS team immediately .

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 Form-445
Issue Date:
EHS Workplace Inspection Checklist
(Ref. SOP QMS-080)
Code for Checklist :
O = Observation, i.e. observed during the audit
R = Rectified immediately
N/A = Not applicable or not observed / not covered at this audit
DR = Deviation Report

Use Risk Assessment Matrix on Page 6 of Inspection Checklist to document and rate identified hazards

WORK ENVIRONMENT
Item Code Comments
Is lighting adequate for the tasks completed?
Is the noise level too high/ hearing protection in place if required?
Is appropriate PPE easily available for tasks if required?
Is thermal comfort satisfactory?
Is the layout of the areas satisfactory?
Is there safe access / egress?
Are floor surfaces adequate for the tasks completed?
Are there dusts / fumes / odours?
Is there a confined space within the area? Does it require entry?
Is there pallet racking / are they inspected regularly?
Other Comments

WORK ORGANISATION
Item Code Comments
Does the workflow look right and allow smooth task completion?
Is the right equipment available for the job?
What is the rate of work?
Does the operator work alone? If so, are there additional
communication measures in place?
Are jobs rotated regularly?
Other Comments

FIRE AND EXPLOSION HAZARDS

Item Code Comments
Are flammable materials used in the area? If so are there
adequate precautions / controls?
Are there potential sources of ignition within the work area
?
Are extinguishers in place with appropriate signage& clearly
marked for type of fire?
Have extinguishers been recently serviced ?
Do employees know location of extinguishers?
Do employees know location of exits and evacuation procedure ?
Are there adequate direction notices, evacuation maps and signs
for Fire Exits?
Do exit doors easily open from inside?
Are exits clear of obstructions?
Are evacuation instructions available and displayed ?
Other Comments

ELECTRICAL HAZARDS
Item Code Comments
Are there broken plugs, sockets or switches?
Are there frayed or damaged or strained leads?

File Location: Date Printed: Page 23 of 26

 Form-445
Issue Date:
EHS Workplace Inspection Checklist
(Ref. SOP QMS-080)
Are there energy saving practices/ equipment in place?
Other Comments

HAZARDOUS SUBSTANCES
Item Code Comments
Do employees know where to access MSDS?
Do employees know how to dispose of used chemicals and
containers?
Are there sharps / appropriate disposal containers readily

Are all containers clearly labelled?

Is storage suitable for different chemical types?
Are chemicals of incompatible classes stored separately?
Are cabinets located more than 3 metres from ignition sources?
Is appropriate PPE available and worn by employees?
Is there appropriate ventilation?
Is there an emergency shower / eye shower? Are they tested?
Other Comments

FIRST AID
Item Code Comments
Are employees aware of location of First Aid kits / rooms?
Do employees know first aid / emergency procedure?
Are cabinets and contents clean, orderly and adequately stocked?
Other Comments

SLIP TRIP AND FALL HAZARDS

Item Code Comments
Are surfaces even No cracks, holes, frayed carpet or other trip
hazards?
Are floor surfaces slippery?
Are walkways adequately lit and clearly marked?
Are walkways unobstructed?
Are stairways fitted with handrails and grip tape if needed ?
Is there unobstructed vision at intersections, stairs and risers?
Is the housekeeping standard good?
Is there adequate fall protection for high work?
Is work required at heights or in areas with limited/ confined
space?
Other Comments

WASTE HANDLING
Item Code Comments
Are appropriate bins available for various waste types?
Is waste separated for recycling where possible?
Is waste removed / emptied regularly?
Other Comments

EHS MANAGEMENT SYSTEM

Item Code Comments
Are employees aware of EHS policy?
Do employees know how to identify and report a EHS hazard?

File Location: Date Printed: Page 25 of 26