DATA ANALYSIS

1. Purpose

To provide assurance that data gathered in monitoring and measuring activities will be organised, summarised and analysed to provide information for management action.

2. Approval

(Version at end of page)

Signed V15 MR 23.01.2023 - DK - 23.01.2023

3. Scope

This procedure applies to all data gathered as part of the firm's operations in order to demonstrate the suitability and effectiveness of the QM system and to provide information for continuous improvement. The process covers data analysis as required by the relevant SOP.

4. Responsibilities

Approval: Author of the document, Marelize Robertson

Changes: Author of the document, Dean Kowalski

5. Definitions

Improvement: The act or process of making something better, the quality of being better than before, an addition or change that makes something better or more valuable.

Quantitative Data: Is based on numbers, countable or measurable.

Qualitative Data: Relating to, measuring, or measured by the quality of something rather than its quantity.

A Certificate of Compliance (CoC): A document certified by a competent authority that the supplied good or service meets the required specifications. Also called certificate of conformance, certificate of conformity.

6. Abbreviations

SOP - Standard Operating Procedure

QMS - Quality Management System

MGM - Management meeting

QA - Quality Assurance

QC - Quality Control

7. References & Documentation

References

ANALYSIS OF DATA - ISO 13485 CLAUSE 8.4.

Documentation

SOP Non-Conformance Corrective Action (NCCA)

SOP Change Management

SOP Preventative Action

SOP Audits

SOP Customer Focus, Feedback and Complaints

SOP External Providers (Purchasing & Supplier Management)

Environmental and Product Monitoring

SOP Warehousing, Preservation, Identification & Traceability

Monitoring & Measurement of Products & Processes

Improvement Actions

8. Procedure

8.1. Process Requirements

The organisation reviews records from procedures such as Purchasing, Change Control, Non-Conformance, Customer Complaints & Feedback, Internal & External Audits to determine, collect and analyse appropriate data to demonstrate the suitability, adequacy and effectiveness of the quality management system.

The methods used, including statistical techniques and the extent of their use include graphs.

The analysis of data includes data generated as a result of monitoring and measurement and from other relevant sources and include, at a minimum, input from:

a) feedback;

b) conformity to product requirements;

c) characteristics and trends of processes and product, including opportunities for improvement;

d) suppliers;

e) audits;

f) service reports, as appropriate.

If the analysis of data shows that the quality management system is not suitable, adequate or effective, the organisation uses this analysis as input for improvement and as an output from Management Review. From the Management Review it can result in a Change Control, Non-Conformance, Corrective Action and/ or Preventative Action to implement the action necessary to ensure the effectiveness of the QMS is maintained. 

8.2. Process Management process

The data that is used as a basis for discussion or interpretation during the management meeting, will be evaluated and will enable management to make a decision.  Action will be taken, if necessary, from the data analysed.  

The data is gathered from the Microsoft forms and Share Point as per individual SOP that serves as input, the master data is saved on the Share Point in a folder. Data is populated separately and enables the person responsible to make use of pivot tables and any sort of graph for displaying purposes on the presentation. All the reports and summaries relayed to the analysis of data issued to management are reviewed.

Management Review Presentations

Analytical techniques for quantified data:  Statistical techniques are used fort gathering and calculating statistical data from quantitative data, take into account random sampling error and variation.

Analytical techniques for qualitative data: This should be based upon objective, referable evidence. Data resulting from opinions should be identified as such. 

8.3. Conformity of Product

8.3.1.  Sterilisation: Eye packs will be released once the CoC is received from the steriliser. A link to the CoC is saved with each works on the manufacturing software in the ''Aux'' tab.   

8.3.2. Environmental & Product monitoring: Master data is available refer to 11. Records

8.3.3.  Warehouse monitoring temperature: Master data available refer to 11. Records

9. Risk Based Approach

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.

10. Revision History

Revision 16; 15.07.2024 - RB - Change over to SharePoint Site

Revision 15; 2023.01.23 - MR - 23.01.2023 - DK - Nr. 8.3 CoC definition moved to nr. 5, Nr. 8.3. Mastar data moved to 11. Records of CoC and linked;  Updated file location mentioned 

Revision 14; 20.12.2022 - MR - 20.12.2022 - DK - 7. Changed to References and documents;  

Revision 13; 29.09.22 - MR - DK - 29.09.2022 - Changed 1. Purpose,  Updated 5. Definitions added Qualitative and Quantitative, Updated 6.  Abbreviations - Added MGM, QC and QA,  Updated 8. Procedure - added 8.2 and 8.3 ;  removed examples of graphs

Revision 12; 14.10.2021 - MR - Updated Responsibilities

Revision 11; 05.08.2021 - MR - Reviewed

Revision 10, 24.06.2021  - TNA - New format with Approval, Scope,  Responsibilities, Risk based approach and Records added

Revision 9, Digitally signed on 23.01.2020 by WJW

Revision 1-8, unknown due to google site change to new google site

11. Records

Name Retained in Retention period Hard copies Destroyed by

Warehouse Monitoring Temperature SharePoint N/A N/A

Environmental monitoring SharePoint N/A N/A

Product monitoring SharePoint N/A N/A

CoC Master Data SharePoint N/A N/A

Management Review Meeting SharePoint N/A N/A

Master data processed for Presentation SharePoint N/A N/A