INFRASTRUCTURE & ENVIRONMENT

1. Purpose

This document provides the process for Infrastructure and Environment.

This document covers the procedure for the practices that must be followed for compliance of ISO13485 

2. Approval

(Version at end of page)

Signed V8  ML 15.10.2024

3. Scope

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

4. Responsibilities

Approval: Author of the document, Monica Lucas

Changes: Logistics Manager/General Manager

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

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

7. References

ISO13485 Clause 6.3 & 4

SOP Non-Conformance, Deviations and Concessions & Corrective Action 

8. Procedure

8.1 Infrastructure & Environment (6.4)

Note areas related to CLEANLINESS are 1. Office (and thoroughfare), 2. Decontamination Area, 3. Store, 4.Logistics/Warehouse Area

Hygiene Areas

8.2 Temperature control & monitoring

• 1. The facility is mainly a warehouse with non temperature sensitive devices

  2. The Implants are located in an cool environment with no special temperature control & monitoring requirement

  3. The Decontamination area  in a cool environment has no special temperature control & monitoring requirement

8.3 Maintenance

• 4. Under Infrastructure and Environment the organization 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.

  5. 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 General Manager or Warehouse Manager in order for the maintenance to be arranged. 

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

  7. Supplier are approved by SOP External Providers 

  8. 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  

9. Risk Based Approach

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

Risk Based Approach Report

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 8; 15.10.2024 - ML - Checked and Confirmed. Digitally signed by ML

Revision 7; 09-10-2024 - CR - Uploaded KZN Office floor plan

Revision 6; 22.11.2023 - ML - Checked and Confirmed. Digitally signed by ML

Revision 5; 22.11.2023 - CR - Updated Hygiene Area picture, 8.1 Infrastructure & Environment; & Updated General Layout

Revision 4; 27.10.2023 - PM - Updated floorplan for Gauteng office

Revision 3; 07.11.2022 - ML -  Updated and Checked. Digitally signed by ML

Revision 2; 07.10.2021 - ML -  Digitally signed by ML

Revision 1;  10.05.2021 - ML -  Digitally signed by ML

Revision 7, 30.04.2021 - 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 6,  Digitally signed on 04.11.2020 by NH

Revision 1-5, unknown due to googlesite change to new googlesite

11. Records

Name Retained by/ in Retention period Hard copies Destroyed by

None n/a n/a n/a