INFRASTRUCTURE & ENVIRONMENT

1. Purpose

This document provides the process for Infrastructure and Environment.  This procedure describes the process for determining, providing and maintaining the infrastructure needed to achieve conformity to product requirements in compliance with ISO13485.

2. Approval

(Version at end of page)

Signed V9 RB 15.07.2024

3. Scope

The procedure describes the process for determining, providing and maintaining the infrastructure needed to achieve conformity to product requirements. 

4. Responsibilities

Approval: Author of the document, Marelize Robertson

Changes: Author of the document, Dean Kowalski

5. Definitions

Infrastructure:   Building, lights, floors, windows, perimeter, equipment relevant to the operations / SHEQ

Environment:  The working condition appropriate to GMP / requirements of the product e.g. cleanliness, storage conditions

Rework:  The action of redoing a production procedure for an item / batch in order to correct a defective / faulty aspect/s (eg: packaging /  labelling / out of specification) mainly in regards to disposable products

Repair:  Is to restore (something damaged, faulty, or worn) to the original safety and performance condition to put the item back into acceptable working order again

Maintenance :  This is required for preserving the condition of an item (infrastructure, machinery, products) 

Refurbishment:  The process used to return medical devices to a condition of safety and effectiveness comparable to when new and without significantly changing the equipment's performance, safety specification and/or intended use as in its original registration (eg: sharpening scissors)

6. Abbreviations

GMP - Good manufacturing, distribution, storage, stock management practices

SHEQ - Safety, Health, Environment and Quality

NCCA – Non Conformance Corrective Action

SOP – Standard Operating Procedure

OHS - Occupational Health and Safety.

ODM: Original Device Manufacturer

7. References & Documents

References

ISO13485 Clause 6.3 Infrastructure & 

ISO 13485 Clause 6.4 Work Environment and contamination control

ISO 17141 Cleanrooms and associated controlled environments - Biocontamination Control - relevant to 6.4.2. Contamination Control 

Documents

• Sales, Customer related processes & Returns QMS Site

• Warehousing, Preservation, Identification & Traceability SOP QMS Site

• Non-Conformance, Deviations and Concessions & Corrective Action QMS Site

• Envision Africa Drawings Share Point

• Infrastructure Definition Share Point

• Infrastructure Requirements Share Point

• 1013 General Hygiene Policy Share Point

• 1012 Cleanroom Policy Share Point

• Production SOPs Share Point

8. Procedure

8.1. Infrastructure (6.3.)

To ensure and achieve conformity to product requirements, Envision Africa documents the requirements for the infrastructure to prevent cases such as product mix-up and ensure orderly handling of product.  The organisation can deal proactively with potential non-conforming products, defective lots and ensure product quality and gain customer satisfaction. 

8.1.1. The buildings, workspace and associated utilities are clearly outlined as per the Envision Africa Drawings under nr. 7 References and Documents ensuring a proper workflow and that processes are handled within different departments accordingly. 

8.1.2. Prevent Product mix-up by following 8.8. Handling of quarantine products SOP and 8.3 Returns SOP refer to section 7. References and documents. 

8.1.3. The infrastructure requirements that have been identified can be viewed within the infrastructure requirements document - refer to nr7. References and Documents- Infrastructure requirements.

8.1.4. Provide the infrastructure needed to control the work environment 

8.1.5. Provide the infrastructure for monitoring & measurement 

8.1.6.  Identify maintenance activities that could affect quality, and maintain records

8.1.7. Other requirements refer to the Warehousing, Preservation, Identification and Traceability SOP under nr. 7 References and Documents 

8.2. Work Environment and Contamination Control

8.2.1. Additional to this refer to the Policy's General Hygiene and Cleanroom Policy

8.2.2. To prevent contamination of the work environment, product, or personnel Production SOPs need to be followed refer to nr. 7 Reference and documents - Production SOPs

Bioburden SOP

Assembly SOP

Gowning SOP etc. 

8.3. Maintenance

• 1. Under Infrastructure and Environment, the organisation provides requirements for the maintenance activities, including the interval of performing the maintenance activities, when such maintenance activities, or lack thereof, can affect product quality. As appropriate, the requirements apply to equipment used in operation, the control of the work environment and monitoring and measurement and records of such maintenance are maintained.

  2. Work environment and contamination control follows above however if any maintenance, or preventative maintenance of furnishings, fittings or equipment is required, then it is to be reported to the Office Administrator in order for the maintenance to be arranged. 

  3. This preservation includes identification, handling, packaging, storage, and protection and also applies to the basic parts of a product

  4. Suppliers are approved by SOP External Providers 

  5. Preventive maintenance activities include equipment, vehicles, computers, facility checks by management on a regular basis. The ideal preventive maintenance program would prevent all equipment failure before it occurs. 

Maintenance requirements: -

In the event of and non-conformance finding then SOP Non-Conformance, Deviations and Concessions & Corrective Action SOP is followed  

Infrastructure is maintained by using a Preventative Maintenance Program for HQ Maintenance and improvement can be logged on Trello to be actioned - refer to section 11. Records: HQ Maintenance and Improvement. 

Production maintenance and OHS (Pest Control & Waste control) etc. is carried out as per SLA with the outsourced parties.

Records of maintenance performed are maintained and when appropriate analysed by the relevant person. 

Preventative maintenance schedules may be changed based on the analysis of data at the management review or as per the outsourced party's availability. 

The office administrator is responsible for making sure that these are up to date and being actioned accordingly. 

8.4. Control of Monitoring and Measuring Equipment (7.6)

1. Where there is monitoring and measurement  undertaken, the monitoring and measuring equipment needed to provide evidence of conformity of product to determined requirements.

2. The  procedure to follow to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements is as per the planned maintenance below.

3. As necessary to ensure valid results, measuring equipment is to:

   • a) be calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards: when no such standards exist, the basis used for calibration or verification is recorded.

   • b) be adjusted or re-adjusted as necessary: such adjustments or re-adjustments shall be recorded

   • c) have identification in order to determine its calibration status;

   • d) be safeguarded from adjustments that would invalidate the measurement result;

   • e) be protected from damage and deterioration during handling, maintenance and storage.

4. Calibration or verification is performed as detailed in the table below.

   •  In addition, the validity of the previous measuring results are assessed and recorded when the equipment is found not to conform to requirements. 

5. Appropriate action is taken in regard to the equipment and any product affected and SOP Non-Conformance, Deviations and Concessions & Corrective Action is followed.

6. Monitoring and measurement software is used for Temperature Monitoring and Access Control

• • As require,  procedures for validation of the application of computer software used for the monitoring and measurement of requirements is reported. Such software applications is to be validated prior to initial use and, as appropriate, after changes to such software or its application.

  • The specific approach and activities associated with software validation and re-validation is to be proportionate to the risk associated with the use of the software, including the effect on the ability of the product to conform to specifications.

9. Risk Based Approach

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

9.1. Trend Analysis and Continual Improvement

An analytical review is reported monthly to management and this forms part of the input through Data Analysis to management review 

The Trend should pick up any potential and recurring incidents, where corrective action must be reported at the management review to facilitate continual improvement.

10. Revision History

Revision 9; 15.07.2024 - RB - Change over to SharePoint Site

Revision 8; 19.12.2022 - MR - 19.12.2022 - DK - Changed nr. 7 Heading;  Linked Trello Renewal board & HQ Maintenance under 11. Records;  Updated Envision Africa Drawings under number 7;  Added ODM under definitions; nr6;  Removed old office drawing; Infrastructure Definition document linked under nr. 7 and updated;  Updated 8.1. Procedure; Updated  3. Scope;  11. Added SLA , 7. Added Infrastructure requirements and linked 

Revision 7; 08.12.2022 - MR - 8.1. Section added from Cleanliness and Hygiene(Duplicate), Updated 11. Records - Share Point, Linked Envision Africa Building drawing

Revision 6; 25.05.2022 - MR - Purpose updated; 6.  Abbreviations; 8.1 .  Added Trello link & Updated

Revision 5;  14.10.2021 - MR - Updated Responsibilities, Infrastructure & Environment, Records

Revision 4; 30.08.2021 - TNA - addition of 4 new definitions

Revision 3; 05.08.2021 - MR - Reviewed

Revision 2;  24.06.2021 - TNA - updating links and forms

Revision 1; new 19.01.2021

11. Records

Name Retained in Retention period Hard copies Destroyed by

Production Maintenance SharePoint N/A N/A

Service Reminder/ Renewal Trello N/A N/A

HQ Maintenance and Improvement Trello N/A N/A

Planned Maintenance Register SharePoint N/A N/A

SLA (Production /OHS) SharePoint N/A N/A

Bioburden Product Testing SharePoint N/A N/A

Bioburden Environmental Testing SharePoint N/A N/A