CLEANLINESS (Facility & Personal Hygiene, Waste & Pest Control), HEALTH & SAFETY

1.Purpose

This document provides the process for Product, Premises, facilities and Utilities observing good distribution practices for cleanliness, Hygiene and safety and controlled infrastructure and environment  for  distribution practices

This document covers the procedure for the practices that must be followed for Product, Premises, facilities and Utilities cleanliness, Hygiene and safety including Pest Control and Waste management in compliance of ISO13485

2. Approval

(Version at end of page)

Signed V22  FS 14.02.2024 

3. Scope

The process covers all documents and process and products as define in the SOP

4. Responsibilities

Approval & Changes:: Author of the document, Alexis Arhondonis, medicines; RP SC Rudolph-Shortt

5. Definitions

Cleanliness - Good Hygiene Practices within the Facility, infrastructure and environment and Personal Hygiene to ensure the product is  preserved and protected from contamination

6. Abbreviations

SHEQ - Safety, Health, Environment and Quality

NCCA – Non Conformance Corrective Action Record

SOP – Standard Operating Procedure

DoC – Declaration of Conformity

COA – Certificate of Analysis

7. References

ISO13485 Clause 6.3, 6.4

SOP External Providers

SOP Non-Conformance, Deviations and Concessions & Corrective Action

SOP Competence, Awareness and Communication

DRIVE MSDS folder

8. Procedure

8.1 General

8.1.1 Infrastructure and Environment (6.3 )

The organization documents the requirements for the infrastructure needed to achieve conformity to product requirements, prevent product mix-up and ensure orderly handling of product.

Infrastructure includes, as appropriate:

a) buildings, workspace and associated utilities;

b) process equipment (both hardware and software);

c) supporting services (such as transport, communication, or information systems).

The organization shall document requirements for the maintenance activities as defined below

8.1.2 Work Environment and Contamination Control (6.4)

The organization documents the requirements for the work environment needed to achieve consistent and safe handling and storage of the products to ensure preservation of products. If the conditions for the work environment can have an adverse effect on product quality, the organization shall document the requirements for the work environment and the procedures to monitor and control the work environment.

1. The organization documents the requirements for health, cleanliness and clothing of personnel if contact between such personnel and the product or work environment could affect medical device safety or performance.

2. Medical checks may be performed on pre-employment and at regular intervals should there be an effect on preservation of the product.

3. Pandemic or Occupational Biological hazards - Personnel  to follow the Pandemic or Occupational Biological hazards POLICY

8.1.3 Personnel Hygiene Control

1. Personnel Hygiene control is where staff are expected to arrive at work in attire suitable to ensure preservation of product, eating, drinking, chewing or smoking in the storage areas should be prohibited.  In general, any unhygienic practice within the operational areas or in any other area where the product might be adversely affected, should be forbidden.

2. Personnel should be instructed to use the hand-washing facilities.

8.1.4 Facility Hygiene Control

• Staff are responsible for cleanliness in their area.

• All bins are cleared daily.

• The Stores are to be kept clean, tidy and orderly by the staff working in the area. The stores supervisor may request additional cleaning to be performed by the cleaning staff.

• Cleaning staff are to clean floors and empty bins on a daily basis.  Cleaning staff are also responsible for cleaning walls, windows, fittings as per schedule.

• If any maintenance of furnishings, fittings or equipment is required, then it is to be reported to the Manager concerned in order for the maintenance to be arranged. This preservation includes identification, handling, packaging, storage, and protection and also applies to the basic parts of a product.

• Cleaning agents MSDS is available through management as a reference of safety and how to handle a spillage refer DRIVE MSDS

Areas

A - Administration / office and reception areas, Kitchen and ablutions,

B – Warehouse

C - Pharmacy

8.2 Hygiene Activities

The following are guidelines for Cleaning as the attached Cleaning Schedule: It is IMPORTANT that the cleaning utensils are cleaned and stored before and after use

1. FLOORS

   • The floors on both ground and first floor are swept and mopped everyday and cleaned with detergent and water using the labeled instructions.

2. WINDOWS

   • Clean using a clean cloth, wipe the insides of windows once a month clean with Windowlene® using the labeled instruction.

3. DOORS

   • Once a week clean, wipe the doors with Handy-Andy® and a damp cloth.

4. TOILETS

   • Using a toilet brush everyday clean with recognized standard toilet cleaning detergent Handy Andy using the labelled instruction.

   • The ablutions are checked 3 times a day - 07.30am /  12.00pm / 16.00pm

5. ABLUTION BASINS

   • Daily clean using a clean cloth wipe the basins with Handy-Andy® using the labeled instruction®.

6. KITCHEN SINK AREA

   • Continuously clean with diluted sunlight liquid

7. TABLES / DESKS

   • Once a week clean with furniture polish or damp cloth using the labeled instruction

Please refer to video overview of the SA Health Cleaning schedule under Documents\Hygiene Safety\ SA Health Cleaning Schedule.  Warehouse Cleaning Schedules  

8.3 Safety

1. All staff working in the warehouse need to wear safety boots provided by the company.

2. Operation of forklifts must be by licenced personnel only.  Records of the licences are kept by the HR Manager.  Licence cards are kept on the Employees person.

3. Safety equipment is maintained by the SA Health and the Warehouse Manager assures maintenance through periodic inspection by an outside Contractor

4. Training is provided as per requirements refer SOP Competence, Awareness and Communication

5. In the event of fire or safety incident, the three most important actions are, in chronological order, to:

   • Raise the incident immediately to management

   • Summon the fire brigade or ambulance

   • Evacuate the building in the event of a fire or attend to the patient in the event of a safety incident

For call contact numbers refer:

Name: Steven Boyd - 079 886 2722

Title: Operations Director

8.4 Fire

1. The preservation of life shall override all other considerations, such as saving property and extinguishing the fire. If a fire is discovered, the alarm shall be raised immediately however small the fire. All staff are empowered to raise a fire alarm if they believe there is a fire; no authority should be sought from any other person.

2. It is the Warehouse Manager's responsibility for summoning the fire brigade

3. Staff must not put themselves at risk to fight a fire. NEVER fight fires in laboratories or other areas where highly inflammable materials are held.

4. Evacuation of the building must start as soon as the alarm sounds. Staff should be familiar with the procedure through the staging of regular fire drills. All occupants, on evacuation, should report to pre-determined fire assembly points.

5. Fire emergency notices are displayed on the factory notice board.

6. Fire exits are clearly signed and attention drawn to them by staff for visitors and contractors.

Fire Evacuation Floor Plan

8.5 First aid

Signage for the position of the first aid box must be clearly marked

All accidents, incidents and near misses, relating to safety incidents, fire or to fire drills must be entered into the non-conformance system refer SOP Non-Conformance, Deviations and Concessions & Corrective Action

8.6 Pest Control

1. Pest control is managed by Pro Pest Services, refer Contract in the Google Drive, and is arranged and managed by the Operations Manager

2. Supplier is approved by SOP External Providers

3. Position of baits / boxes : refer to layout diagram

4. Poison control; Refer to the details on the contract and material safety data sheets

5. Frequency of change; Every 6 weeks

6. Indication of change; A sticker will be placed on the box / bait with the date of placement

7. Pest Sightings; Follow and record SOP Non-Conformance, Deviations and Concessions & Corrective Action

Material Safety Data Sheet

Position of bait boxes are indicated below

8.7 Waste Management

• 1. General Domestic Waste

     • General office bins stored inside the office areas and office kitchens house all general waste. Plastic bags are placed in the change rooms. These bins will be emptied daily into larger general green bins.  Once a week these bins will be cleaned by the cleaning staff using a mild detergent.  This wash water will only be disposed of into the effluent drainage system.

  2. Office and Administrative Paper Waste

     • Small bins are be placed in all offices and administrative areas, for the collection of office paper waste. These bins will be emptied once a day by the cleaning staff.

  3. Waste collection: 

     • General waste, admin waste and other materials in the green bins are collected by the Municipality once a week

  4. Medical Waste collection:

     • The Key Accounts Controller arranges for medical waste to be collected from the Customer Sites (hospitals / clinics) using an outsourced company - Compass Waste or Spilltech depending on price with evidence  of a disposal certificate or dismantled with evidence of a photo record where the parts are disposed with general waste.

5. Recycling

• Recycling of cardboard cartons takes place on site where the cartons are broken down and stored for collection by Impact (Mondi) when load ready

9. Risk Based Approach

In the event of non compliance follow SOP  NON CONFORMANCE CORRECTIVE ACTION

Risk Based Approach Report

[Risk Assessment to is found in SOP PREVENTIVE ACTION RISK ASSESSMENT   refer Document]

9.1 Trend Analysis and Continual Improvement

The analytical reviews of supplier performance, and any other quality related matters, are reported to management and as part of the input to management review refer Data Analysis

The Trend analysis may identify any potential and recurring incidents, where corrective action must be reported at the management review to facilitate continual improvement.

 10. Revision History

Revision 22, 14.02.2024 - FS -Added hyperlink to 8.6.3

Revision 21, 27.08.2022 - AA - Inclusion of  medical product dismantle point 8.7.4

Revision 20, 19.08.2021 - AA -27.05.2022 SCR new Bait box layout

Revision 19, 19.08.2021 - AA - updating information under section 8.7 - Recycling / adding new link for Pest Control Contract / updating information re  8.2.  item 1.Floors

Revision 18, 13.05.2021 - AA - inserting Pest Control link

Revision 17, 03.05.2021 - AA - Approved

Revision 16, 03.05.2021 - TNA - amending links to cleaning schedule and cleaning video and cleaning drive folder and Responsibility

Revision 15, 28.04.2021 - TNA - New format with Approval / Scope / Responsibilities, Risk based approach and Records and revision history added and new google site format.  Amending of Links and forms

Revision 14,  Digitally signed on 06.07.2020 by AA

Revision 1-13, unknown due to google site change to new google site

11. Records

Name Retained by/ in Retention period Hard copies Destroyed by

Documents\Hygiene Safety   Google Site indefinite n/a