DATA ANALYSIS

1. Purpose

This document provides the process for analysis of data.

This document covers Internal auditing in compliance with ISO13485.

This procedure provides the process for Analysis of Data collected from / through the Quality Management system. The purpose of the procedure is to define the process to analyse data from monitoring and measurement for continual improvement and input to management review.

2. Approval

(Version at end of page)

Signed V2 NG 18.02.2025

3. Scope

The process covers data analysis as required by the relevant SOP

4. Responsibilities

Approval: Bruce Manuel

Changes: Nicholas Gilbert

5. Definitions

Improvement; 

improving something

 : 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

6. Abbreviations

SOP - Standard Operating Procedure

QMS - Quality Management System

7. References

ISO13485 clauses 8.4

SOP Non Conformance Corrective Action (NCCA)

 SOP Change Management

SOP Management Review

8. Procedure

ANALYSIS of Data (ISO13485 8.4)

8.1 PROCESS 

The organization reviews records from procedures such as Purchasing, Change Control, Non Conformance, Customer Complaints, Customer 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 organization uses this analysis as input for improvement and as an output from Management Review

8.2 BACKGROUND

Analysis is a basis for discussion or interpretation such as "statistical analysis." It is rendering something meaningful from a mass of data.

Evaluation is a judgment, an action taken with the analyzed data. With the evaluation of analyzed data we might make a decision.

a·nal·y·sis əˈnaləsəs/ noun

detailed examination of the elements or structure of something, typically as a basis for discussion or interpretation.

"statistical analysis"

synonyms: examination, investigation, inspection, survey, study, scrutiny; More ◦the process of separating something into its constituent elements.

synonyms: examination, investigation, inspection, survey, study, scrutiny; More ◦the identification and measurement of the chemical constituents of a substance or specimen.

e·val·u·a·tion əˌvalyəˈwāSH(ə)n/ noun 1.the making of a judgment about the amount, number, or value of something; assessment.

"the evaluation of each method" synonyms: assessment, appraisal, judgment, gauging, rating, estimation,consideration;

analysis, examination, checkup, workup, test, review/ "proper evaluation of the results is critical"

Resources are provided to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements; which for imports is through Certificate of Conformance or Analysis (CoC, CoA).

Certificate of compliance; 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.

Certificate of Analysis; A document issued by a regulatory or quality assurance entity verifying the adherence to product specifications and standards of production of certain products such as food products and drugs. The certificate usually includes the actual test results performed on the product batch.

The analysis may follow:

Deductive reasoning starts with a general theory, statement, or hypothesis and then works its way down to a conclusion based on evidence. Inductive reasoning starts with a small observation or question and works it's way to a theory by examining the related issues

The data maybe;

Results maybe

qualitative which refers to the method of collecting descriptive (non- numerical) data, with the common instrument used to collect data from interview and observation, or

quantitative, which refers to  method of collecting numerical data

'Semiotics' basically refers to any theory or study of signs and their usage, where a 'sign' is either an index (representing causation), an icon (representing sentience, i.e., sensory information), or a symbol (representing sapience, i.e., arbitrarily standing for a thought, an idea, a concept, etc.)

'Hermeneutics' is a narrower concept, referring generally to the activity or discipline of interpreting written materials. ... As such, written texts are symbolic and semiotic artifacts, and the process of interpreting their meaning is hermeneutics

Graphs;

There are several different types of charts and graphs. The four most common are probably line graphs, bar graphs and histograms, pie charts

Bar graphs to show numbers that are independent of each other. Example data might include things like the number of people who preferred each of Chinese takeaways, Indian takeaways and fish and chips.

Pie charts to show you how a whole is divided into different parts. You might, for example, want to show how a budget had been spent on different items in a particular year.

Line graphs show you how numbers have changed over time. They are used when you have data that are connected, and to show trends, for example, average night time temperature in each month of the year.

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  ]

10. Revision History

Revision 2 NG 18.02.2025 Change of Ownership

Revision 1 HJM New 05.09.2024

11. Records

Name   Retained by/ in   Retention period                                   Hard copies Destroyed by

None n/a n/a n/a