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 ISO 13485. This procedure also describes the process for determining, providing and maintaining the work environment to achieve conformity to product requirements.
(Version at end of page)
Signed V28 rb 15.07.2024
The process covers all documents, processes and products as define in the SOP.
Approval: Author of the Document, Marelize Robertson
Changes: Author of the Document, Rachel Belcher
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
Reference
ISO 13485 Clauses 6.3, 6.4
Documents
External Providers SOP QMS Site
SOP Competence, Awareness and Communication QMS Site
Infrastructure and Environment SOP QMS Site
Non-Conformance Corrective Action SOP QMS Site
Office Zones Table SharePoint
Warehouse Zones Table SharePoint
Kitchen Zones Table SharePoint
Bathroom Zones Table SharePoint
Cleanroom Environment Table SharePoint
Production SOPs SharePoint
Pest Risk Assessment SharePoint
First Aid Equipment list SharePoint
Production Cleanroom Cleaning SOPs SharePoint
Cleanroom Policy SharePoint
Pest Control SDS SharePoint
General Hygiene Policy SharePoint
Reder to Infrastructure and Environment SOP under number 7. References and Documents.
The organisation 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 organisation shall document the requirements for the work environment and the procedures to monitor and control the work environment.
The organisation 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.
Medical checks may be performed on pre-employment and at regular intervals should there be an effect on preservation of the product.
Contamination controls include:
The control of contaminated or potentially contaminated product to prevent contamination of other product, the work environment or personnel - refer to quarantine SOP.
For sterile medical devices the control of contamination includes bioburden testing and therefore microorganisms or particulate matter are documented. This ensures that the required levels of cleanliness are maintained during assembly and packaging processes.
For personnel entering the cleanroom environment refer to policy 1012 - Policy on Cleanroom Hygiene - Personnel. This policy is included on Share Point refer to number 7. References and Documents.
For personnel working in the office and warehouse environment refer to policy 1013 - Policy on General Hygiene - Personnel. This policy is included on Share Point refer to number 7. References and Documents.
The Envision facility is divided into several zones, each of which is one of several types: office, warehouse or cleanroom, kitchen or bathroom. The location of these zones is described in the site layout included at the end of this document. The location of records is provided by a hyperlink in the records table at the bottom of this page.
Office zones include:
Boardroom
Operations office
Finance office
Reception
Reception passage
Production office
Receiving/Dispatch workstation
Rep work area
Technical services office
Office zones must be cleaned according to the Office zones table refer to number. 7. Reference & Documents "Office Zones Table".
Warehouse zones include:
Non-sterile quarantine
Sterile Quarantine
Receiving area
Dispatch area
Main warehouse
Warehouse passage
Technical services workshop
Technical services spare part store
Warehouse zones must be cleaned according to the Warehouse Zones table refer to number 7. Reference & Documents "Warehouse Zones Table".
Kitchen zones include:
Main kitchen
Rep's kitchen
Kitchen zones must be cleaned according to the Kitchen Zones table refer to number 7. Reference & Documents " Kitchen Zones Table".
Bathroom zones include:
Reception bathrooms
Technical services bathroom
Rep area bathroom
Bathroom zones are to be cleaned according to the Bathroom Zones table refer to number 7. Reference & Documents "Bathroom Zones Table".
Cleanroom zones include:
Clean passage
MAL entry
PAL entry
PAL gowning
Preparation room
PTH 1
Packaging cleanroom
PTH 2
Secondary packing room
Different sections of the cleanroom environment have different cleaning requirements. For zones 1,2,3,4,5,7 Refer to number 7. Reference & Documents "Cleanroom Environment Table".
Production SOPs applicable for cleaning:
SOP004P - Cleanroom floor clean
SOP006P - Cleanroom wall_door_window clean
SOP007P - Cleanroom work surface clean
SOP008P - Cleanroom wash basin_lockers_SOB_cleaning
SOP0010P - Pass through hatch clean
SOP0011P - Secondary Packaging room clean
SOP0012P - Cleanroom cleaning solution
For zones 6 and 8:
Clean weekly according to SOP0010P - Cleanroom pass through hatch clean. This policy is included on the Cloud Drive Folder - Standard operating procedure
For zone 9:
Clean monthly according to SOP0011P - Secondary packing room clean. This policy is included on the Cloud Drive Folder - Standard operating procedure
SOPs indicated in the tables above are included at the bottom of this document in the file section.
Google Record Forms that is completed to check compliance:
Records are kept through forms. Each type of zone has a separate form. All cleaning activity in these areas must be recorded using the forms:
The response logger is available on the Google Drive reference number 11. Records - "Cleaning Records"
All staff working in the warehouse need to wear closed shoes
Safety equipment is maintained by the Office Administrator.
Emergency contact details shall be kept on display at the entrances (main reception and reps entrance) of the building and at the guard house.
Health & Safety appointments
The Heath & Safety "SHE REP" is Denise Pienaar
Only one Safety representative is required
Training is provided as per requirements refer to QMS SOP Competence, Awareness and Communication.
Safety committee meeting:
At least one formal health and safety meeting will be held every six months; however a management meeting may include a health and safety meeting at the discretion of Top Management Team.
With only one representative present the representative will meet with the COO, other Managers may be included depending on the nature of the agenda and department.
An agenda is emailed in a meeting request by the SHE REP to the COO, who will RSVP attendance.
Record of the meeting request sent to the COO will be uploaded to Share Point.
The minutes of the meeting (outcome and action items) will be uploaded onto the OHS Folder on Share Point by the chair person.
A TRELLO action plan is generated by the chair person for follow up on Actions, which are also covered in the following OHS meeting; the objective of meeting is to ensure that the company is meeting its targets and objectives and to highlight any areas that require attention or improvement.
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 or the evacuation leaders 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 exits are clearly signed and attention drawn to them by staff for visitors and contractors.
In the event of fire or safety incident, the three most important actions are, in chronological order, to:
Contact the dedicated fire coordinator or first aider(s)
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
Raise the incident with management
Complete an IOD from within 7days and submit
Complete a Health & Safety Incident on the Non Conformance Corrective Action FORM in SOP Non-Conformance, Deviations and Concessions & Corrective Action
Compliance: Draft General Health and Safety Regulations as Gazetted on 28 October 2005 (Government Gazette, No. 28162).
The Regulations require that at least one first aider is required for every 100 persons employed at a particular site and if at least 10 people are employed at a site. Thus, the Organisation appoints one first aider, who is as follows:
Name: Marelize Robertson
Title: Production QA & RA Manager
Cellphone number: 072 929 6563
The first aider must have a valid first aid certificate included in their training file. As a contingency, other first aiders will undergo similar first aid training and their respective certificates shall be kept in their respective training files. Any fist aider must attend to an incident that he or she may come across. In the event of a medical emergency the following procedure should be followed:
1. The injured person or the first person to become aware of the injured person (in the event of unconsciousness) is to notify the closest first aider immediately.
2. The first aider must then assess the severity of the emergency. If the severity is such that the first aider and equipment present can without reasonable doubt effectively treat the injured person, then the first aider must immediately proceed to do so.
3. In a minor event the injured person must then seek professional medical advice once stable and in a major event the first aider can appoint someone to contact the ambulance. If the training and equipment available are insufficient, emergency response must immediately be contacted and emergency medical services engaged.
5. In the event of emergency services being contacted, the first aider must provide what assistance is possible with the training and equipment available to stabilise the injured person. Under no circumstances may the first aider provide care that is beyond the scope of their training should it pose any risk to the injured person.
6. Upon resolution of the emergency, the first aider must ensure that any first aid equipment used is replenished within 48 hours.
All accidents, incidents and near misses relating to safety incidents, fire or to fire drills must be entered into the non-conformance system refer to number 7. Reference & Documentation "SOP Non-Conformance, Deviations and Concession & Corrective Action".
The first aid equipment, which shall be kept in the production office, consists of a first aid kit that complies with Regulation 7 and has the following contents refer to number 7. Reference & Document "First Aid Equipment List"
Pest control is provided by Servest and is arranged and managed by the Office Administrator.
The service level agreement is available on Share Point and the provider is approved on the External Provider List refer to number 7. Reference & Documents.
Types of pests managed::
Rodents - bait boxes
Flying insects - fly zapper
Cockroach and Ants
Poison control
Refer to the details on the packaging or contracts material safety data sheets
Frequency of change
Monthly check as per the SLA.
Indication of change
A sticker will be place on the box / bait with the date of placement and a job card is issued
Pest Sightings
Follow and record - refre to number 7. Reference and Documents "SOP Non-Conformance, Deviation and Concessions & Corrective Action".
The non-conformance will be processed on the Trello non-conformance other board
Pest Risk Assessment refer to number 7. Reference and Documentation " Pest Risk Assessment".
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 and canteen area. These bins will be emptied as part of the cleaning regimen.
Office and Administrative Paper Waste
Small bins are be placed in all offices and administrative areas, for the collection of office paper waste, which is recycled by a third party
Paper & label off-cuts, reel ends, etc from production
All paper waste generated in the production areas is collected with other production waste that is recyclable and removed on a continuous basis as part of the production activity
Medical & Chemical waste
Dye penetration waste and cleanroom cleaning solution is discarded by an outsourced facility.
A certification will be provided to the Office Administrator
Sharp bins and containers with medical waste is collected by
Production SOP005P - Waste Management in the cleanroom
Production SOP0046P - Isolation and destruction
Waste collection:
The Office Administrator 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 Preventative Action Risk Assessment refer Document.
The analytical reviews of the cleanliness (Facility & Personal Hygiene, Waste & Pest Control) and any other quality related matters, are reported to management and as part of the input to management review refer Data Analysis. Health & Safety is reported and monitored separately
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 28; 15.07.2024 - RB - Change over to SharePoint Site
Revision 27; 08.12.2022 - MR - Updating 8.2. OHS chair person, and procedure and 8.4 First Aiders, Updated 8.5. Operations Manager - Office Administrator, Updated 9.1. Trend analysis - section not applicable to cleanliness removed, Tables linked in number 11.Records and referenced above. 8.1.1. Duplicate moved to Infrastructure and Maintenance SOP. Linked Infrastructure and Hygiene SOP. Updated Number 7. to References and documents - Linked SOP's . 11. Records updated - documents added and linked
Revision 26.07.2022 - MR - Updated the Policy on cleanroom_V2 and linked the policy & updated 11. Records section: Added the Cleanroom policy and linked.
Revision 25; 25.05.2022 - MR - DK 25.07.2022 - 1. Purpose updated, 8.1.2 Updated;
Revision 24; 09.03.2022 - MR - Updated safety committee meeting:
Revision 23; 14.02.2022 - MR - Office zones update
Revision 22; 14.10.2021 - MR - Updated responsibilities, Records, SOP location
Revision 21; 13.10.2021 - MR - Updated 8.4
Revision 20; 05.08.2021 - MR - Reviewed
Revision 19, 24.06.2021 - TNA - New format with Approval, Scope, Responsibilities and revision history added and new google site format. Updating forms and links
Revision 18; Digitally signed on 16.09.2020 by WJW
Revision 1-17, unknown due to google site change to new google site
Name Retained in Retention period Hard copies Destroyed by
Cleaning records Google Drive 5 years N/A (Back up to server)
OHS Records
OHS Trello Board Trello
OHS Meeting
Minutes
Training records
Servest Job Cards Share point
Trello Non-conformance other Trello