This document provides the process for Product, Premises, facilities and Utilities observed 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 and to define the practices that must be followed for Planned Maintenance including Calibration in compliance of ISO13485
(Version at end of page)
Signed V31 ML 18.11.2025
The process covers all documents and process and products as define in the SOP
This Policy must be read-with and comply with the Protection of Personal Information Act 04 of 2013, (“POPI”), the Company POPI Policy, PAIA Manual. And processing of personal information and in particular health and medical information envisaged under this Policy must be done in accordance with the aforementioned.
Approval: Author of the document, Monica Lucas
Changes: Logistics Manager/General Manager
Cleanliness - Good Hygiene Practices within the Facility, infrastructure and environment and Personal Hygiene to ensure the product is preserved and protect from contamination
SHEQ - Safety, Health, Environment and Quality
NCCA – Non Conformance Corrective Action Record
SOP – Standard Operating Procedure
DoC – Declaration of Conformity
COA – Certificate of Analysis
ISO13485 Clause 6.3, 6.4
SOP Non-Conformance, Deviations and Concessions & Corrective Action
SOP Competence, Awareness and Communication
SOP Infrastructure & Environment
The organization documents the requirements for the infrastructure SOP 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
The organization documents the requirements for the work environment SOP 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. The health information and medical checks can only be done if justifiable under employment conditions such as in this case if there is an effect on the preservation of the product and only very confidential circumstances, and only selected persons as listed will have access to such information.
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.
1. Staff are responsible for cleanliness in their area.
2. All bins are cleared daily.
3. The Stores are to be kept clean, tidy and orderly by the staff working in the area. The supervisor may request additional cleaning to be performed by the cleaning staff.
4. 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.
5. 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.
Areas
Refer OPS Folder for Warehouse Cleaning Form for the findings for the Warehouse cleaning section and the stock room cleaning. Including Cleaning Schedule for Branches
The following are guidelines for Cleaning: It is IMPORTANT that the cleaning utensils are cleaned and stored before and after use
Floors are to be swept/vacuumed and mopped/ three times a week using the correct dilution instructions as labelled on the bottle.
Windows , mirrors are to be cleaned using a clean cloth and Window-lene once a month according to the instructions on the label.
Once a month, doors are to be wiped with Handy-Andy® and a damp cloth. Glass doors are to be cleaned using Window-lene according to the instructions on the label.
Toilets are to be cleaned using bleach three times a week using labelled instructions.
Basins are to be wipe with Handy-Andy® using the instructions on the label.
The kitchen sink should be continuously cleaned with diluted sunlight liquid, using the instructions on the bottle, this includes the washing of dishes.
Clean with furniture polish or damp cloth three times a week using the instructions on the label.
The office clean up should be done three times a week, and it should also include the cleaning of all offices (Finance office, Logistic Manager’s office), cleaning of the Admin area, HR Admin store, Marketing store, Training room, the Kitchens, and the toilets. Refer to the cleaning schedule Office Cleaning Schedule. Refer to Branch Cleaning Schedule.
The cleaning of the toilets includes:
The cleaning of toilet floors, toilet seats, urinals, toilet bowls and basins with the correct chemicals
SHE bins are to collected twice a month by the cleaning company
The cleaning stuff/ Warehouse assistant should clean kitchen surfaces, appliances, cutlery and crockery using diluted sunlight and a damp cloth.
Once a month, the Kitchen cupboard and fridge should be cleaned.
· Warehouse floors should be swept and mopped with water three times a week with an All-Purpose cleaning detergent.
· Shelves and tabletops are to be dusted/wiped with a damp cloth.
· Passage ways should be clear to allow free movement. Boxes should be packed, trays should be packed neatly, and isles should be clear.
· Dustbins should be emptied daily.
· Small and loose parts/products should be sort into small plastic tubs/trays.
· Obsolete and unused products should be removed from the shelves.
· Boxes and trays should be wiped/dusted once a month.
· Warehouse walls should be cleaned once a month
· All equipment is to be always stored in the right place.
The warehouse assistance and the cleaning staff are responsible for these activities.
• Spills should be wiped after every clean
• The wash basin should be wiped with a damp cloth.
• Floors should be swept and washed three times a week, and/or immediately when a job is completed
• Shelves should be dusted and wiped daily
1.Safety equipment is maintained by the premises owner and the Warehouse and Logistics Manager monitors and records the Safety Log on a quarterly basis
2. Health & Safety appointments
§ The Heath & Safety chairperson is the General Manager
§ 16.1 and 16.2 appointments are not required
§ Safety representatives not required
3. Training is provided as per requirements refer SOP Competence, Awareness and Communication
4. Safety committee meetings, not required
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
SAFETY EQUIPMENT CHECK RECORDS
in CASE of emergency
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.
It is the safety representatives responsibility for summoning the fire brigade
Only training fire fighter staff are advised to attempt to extinguish a fire only if they consider it safe to do so.
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.
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.
Fire emergency notices are displayed on the factory notice board.
Fire exits are clearly signed and attention drawn to them by staff for visitors and contractors.
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
Pest control is managed by Pest Control Specialists, and is arranged and managed by the Warehouse and Logistics Manager at JHB Main Branch, and the Office Administrator at satellite branches.
Supplier is approved by SOP External Providers
Pests & Chemicals: Birds - not evident, Rodents - refer contract, Flying insects - refer contract
Poison control - Refer contracts material safety data sheets
Frequency - as per contract
Indication of change - A sticker will be place on the box / bait with the date of placement
Pest Sightings
Follow and record SOP Non-Conformance, Deviations and Concessions & Corrective Action
§ General office bins stored inside the office areas and office kitchens house all general waste. Once a month 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.
§ 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.
§ Any obsolete products are used as samples / training or destroyed
§ The Warehouse Manager shall supervise the collection of waste from site by approved Waste Contractor, where applicable. General waste, admin waste and other materials in the skip are collected by the Municipality.
In the event of non compliance follow SOP NON CONFORMANCE CORRECTIVE ACTION
The Risk Assessment to is found in SOP PREVENTIVE ACTION RISK ASSESSMENT refer Document
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.
Revision 31; 18.11.2025 - ML - Checked and Confirmed. Digitally signed by M
Revision 30; 12.11.2025-PM The safety log form has been updated to include a section for the branch location under point 8.3 & The office cleaning schedule link has been updated under item 8.2.1.1.
Revision 29; 15.10.2024 - ML - Spelling corrections. Checked and Confirmed. Digitally signed by ML
Revision 28; 05.10.2024 - CR - . Removed Hyperlink and Point 3 on 8.1.2 Pandemic or Occupational Biological hazards - Personnel to follow the Pandemic or Occupational Biological hazards POLICY , linked a new Office Cleaning Schedule & Formatting fixed
Revision 27; 22.11.2023 - ML - Checked and Confirmed. Digitally signed by ML
Revision 26; 22.11.2023 - CR - 8.2 Hygiene activities updated
Revision 25; 17.10.2022 - ML - Checked and Confirmed. Digitally signed by ML
Revision 24; 02.08.2021 - ML - POPI information added. Digitally signed by ML
Revision 23; 10.05.2021 - ML - Digitally signed by ML
Revision 22, 04.05.2021 - TNA - New format with Approval / Scope /Responsibilities, Risk based approach and Records and revision history added and new googlesite format. Amending links and Forms
Revision 21, Digitally signed on 22.06.2020 by ML
Revision 1-20, unknown due to googlesite change to new googlesite
Name Retained by/ in Retention period Hard copies Destroyed by
Cleaning records log / records are located in the Files held and maintained at each branch
Safety equipment record sheet Google Site indefinite n/a