Management Review

Deviations - the failure to fulfil a specified requirement in terms of processes, standards and regulations as prescribed by the Pharmacy Act and the Medicines Act and addressed by the Responsible Pharmacist - managed through NON CONFORMANCE AND CORRECTIVE ACTION for CAPA;

Improvement Action - the act of improving or the state of being improved or something that improves, esp. an addition or alteration

Review - Activity undertaken to determine the suitability, adequacy and effectiveness of the subject matter to achieve established objectives.

Management Review - A review carried out in order to confirm that the Management System is effective and entrenched and that all elements of ISO 13485 and Pharmacy requirements (GWP) are adhered to. The review will also set-up and assess company goals and objectives.

Nonconformity - is any failure to meet a requirement

Preventive action - Action taken to prevent the occurrence of such non-conformities, generally as a result of a risk analysis

6. Abbreviations

PCA - Preventative and Corrective Action

CAPA - Corrective and Preventive Action

GWP - Good Wholesale Practice (Medicines)

SHEQ - Safety, Health, Environment and Quality

NCR – Non Conformance Record

NCCA - Non Conformance Corrective Action

7. References

ISO13485 clauses 5.6

NON CONFORMANCE AND CORRECTIVE ACTION

8. Procedure

MANAGEMENT REVIEW (ISO13485 Clause 5.6)

8.1 PROCESS

At least one formal management review will be held at least annually; however a management meeting may cover a management review at the discretion of management team
The attendees will be the management team with a quorum of at least 3 persons (including the Responsible Pharmacist for GWP review)
An agenda is emailed (copy & paste INPUTS below) by the management representative or Responsible Pharmacist to all the management team (records of attendees to be recorded in the minutes)
1. After the meeting Minutes of the meeting covering the OUTPUTS below and is saved and placed in a Google DRIVE folder: MOM
2. An ACTION PLAN is generated by the Management Representative for follow up on Actions , which is covered in the management meeting; the objective of the actions are to ensure company is meeting its targets and objectives and to highlight any areas that require attention or improvement.
3. Note that in the event a CORRECTIVE ACTION is required then a NCCA is generated

Refer ACTION PLAN

8.2 Review input

The input to management review shall include information on;

a) feedback;

b) complaint handling;

c) reporting to regulatory authorities;

d) audits;

e) monitoring and measurement of processes;

f) monitoring and measurement of product;

g) corrective action;

h) preventive action;

i) follow-up actions from previous management reviews;

j) changes that could affect the quality management system;

k) recommendations for improvement;

l) applicable new or revised regulatory requirements.

8.3 Review output

Records of the management Review meeting, or a report from the meeting, and activities for improvement recorded and monitored by the administrator to ensure timely closure. For any Corrective actions a non conformance maybe followed as per NON CONFORMANCE AND CORRECTIVE ACTION

The output from the management review shall include any decisions and actions related to;

a) improvement needed to maintain the suitability, adequacy, and effectiveness of the quality management system and its processes; ACTION PLAN (Click Action Plan)

b) improvement of product related to customer requirements;

c) changes needed to respond to applicable new or revised regulatory requirements;

d) resource needs.

The above points may also apply to any adhoc meeting to review any resource requirements or SHEQ (Safety, Health, Environment & Quality) matters.

ACTION PLAN with allocated responsibilities and deadline dates from the management meetings are recorded and followed up at the next management meeting

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 internal audits, and any other quality related matters, are reported through Data Analysis to management and as part of the input to management review.

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 16, 20.06.24 - AA Addition of Action plan item 8.1.3.3

Revision 15, 21.09.2021 - AA Process changed to a annual management review as management are intimately involved

Revision 14, 19.08.2021 - AA Updating Responsibilities

Revision 13, 03.05.2021 - AA Approved

Revision 12, 23.04.2021 - TNA - New format with Approval. Scope, Responsibilities, Risk based approach and Records added and new googlesite format. Amended links and forms.

Revision 11, Digitally signed on 07.12.2020 by SCR

Revision 1-10, unknown due to googlesite change to new googlesite

11. Records

Name Retained by/ in Retention period Hard copies Destroyed by

Google DRIVE folder: MOM Google DRIVE indefinite n/a

ACTION PLAN Google DRIVE indefinite n/a