Competence, Awareness and Communication (Training)

1. Purpose

This document provides the process for establishing competence, proving awareness and communication and defines the provision of adequate resources, recruitment, performance management and training and provision of Production and Service facilities.

2. Approval

(Version at end of page)

Signed V19;  06/09/2024 SZ

3. Scope

The process covers requirements for staff and interested parties that impact the QMS and regulatory requirements.

This Policy must be read-with and comply with the Protection of Personal Information Act 04 of 2013, ("POPI"), the Company POPI Policy, PAIA Manual and processing of personal information envisaged under this Policy must be done in accordance with the aforementioned.

4. Responsibilities

Approval: Author of the document, Henry Manyike

Changes: Author of the document, Simangele Zungu

5. Definitions

Training - Organized activity aimed at imparting information and/or instructions to improve the recipient's performance or to help him or her attain a required level of knowledge or skill.

Competence- The quality of being competent or capable of performing an allotted function. The quality or condition of being legally qualified to perform an act. The mental ability to distinguish right from wrong and to manage one's own affairs. 

 Communication - the act or process of using words, sounds, signs, or behaviors to express or exchange information or to express your ideas, thoughts, feelings, etc., to someone else. human communication. nonverbal communication.

Interested parties - this could be contractors, community workers, customers

6. Abbreviations

Internal Training - Training done in house e.g. SOPs

KPI - Key Performance Indicators

NCCA - Non Conformance Corrective Action

QMS - Quality Management System

SOP - Standard Operating procedure

n/a - not applicable

HR - Human Resources

7. References

ISO13485 clauses 6.1, 6.2, 5.5.3 

8. Procedure

The resource requirements are reviewed in the management review.

8.1 Human Resources (clause 6.2)

Job functions and roles are defined under responsibility and within the procedures of SOP’s (Standard Operating Procedures) and in the letters of appointment – refer Letter of Appointment 

ALL staff can refer to FORMS, POLICIES & OTHER PROCESSES which are held in the Google Drive in the HR folder. 

8.2 Competence and Training

Management recruit suitable staff as required for the roles to be performed and KPI's are established and agreed.

Management are responsible for ensuring that the training needs of their employees are identified and actioned as per SKILLS DEVELOPMENT PLAN, or any other training identified during KPI assessment. 

 On-the-job training is to be supplied by Managers and training records (including on-the-job training) are kept in the Training File.

8.3 ESSENTIAL REQUIREMENTS

The Organization

• 1. determines the necessary competence of person(s) doing work under its control that affects the performance and effectiveness of the quality management system;

  2. ensures that these persons are competent on the basis of appropriate education, training, or experience;

• where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness of the actions taken;

• retains appropriate documented information as evidence of competence with;

• progress of all training and development recorded and competence determined – refer training file.

8.4. Training

i. For New Employees an INDUCTION is followed on the HR Policies ,on their role on the quality and safety is provided to newly recruited personnel -  the  ACKNOWLEDGEMENT PROCESS can be used to verify the activity. 

ii. Training appropriate to the duties assigned to employees is identified and provided by the Manager; are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives

iii. The concept of Quality Assurance and all the measures capable of improving its understanding and implementation are provided by the Manager in consultation with the Management Representative, in the role to maintain the system

iv. Training could be through the use of consultants or suppliers, as experts in the specified area.

v. Visitors or untrained personnel are escorted by trained employees where appropriate, the prescribed protective clothing requirements are ensured by following the standard Operating procedures, where applicable.

vi Temporary staff may not complete training where supervision is followed to ensure the requirements are followed.

8.4.1 Action

a) Training is planned and recorded in the SKILLS DEVELOPMENT PLAN.

b) POLICIES and other relevant training is completed by making use of documents such as Training Records & Induction. For policies the ACKNOWLEDGEMENT PROCESS is used and for record keeping purposes.

c) Types of TRAINING:  

• If in house training then a TRAINING RECORD is completed and concluded after point 3 is completed

• If Offsite Training then certificates or proof of payment is provided as evidence of training and again a TRAINING RECORD is completed and concluded after point 3 is completed by the Manager.

8.4.2 ACKNOWLEDGEMENT PROCESS

The process to acknowledge understanding and implementation:

1. Save or Move Word or .pdf into ‘HR POLICIES & FORMS  FOLDER in Google DRIVE.

2. If Word, go to > “Open with” > open in Google Docs. OR If PDF, go to > open with Google docs.

3. Go to "More Actions" (top right hand corner). > Click "Share" > Insert an email address  (either in the address book or enter the email address). The attachment will be already on the email template. 

• Add in “Message” and paste the Google link to FORM – refer point (5)

4. To get the Google “ FORM ” in the  ‘HR POLICIES & FORMS' in the google DRIVE, click and open the ‘Form’ if not in PREVIEW then click Preview (picture of an eye) top right hand corner or go to  the ‘HR POLICIES & FORMS  in the google DRIVE and open / click on the Response “Sheet” then go to> “live form”

5. Highlight and copy the http// at top of the form in Google and paste into “Message” block after your message e.g. please read the attachment and if understood please complete the form herewith – if you do not understand then call me and once we are complete you can complete the form, kind regards …

6. Close all Google tabs. Complete., 

7. A list of acknowledgements will be populated in the Google ‘Sheet’ ACKNOWLEDGEMENT PROCESS  in the google DRIVE.

8.4.3 Records

1. Records on TRAINING MATRIX   are indicated on the matrix as; Indicate whether in-House (IH), External (ET), Internal formal (IF) or Awareness (A) training 

2. Some Records of training are found in TRAINING RECORD (Responses 1) i.e. REGISTER in the Google DRIVE FOLDER   

3. Some training records are an attendance sheet which is scanned and saved / filed

4. An option is also to keep a copy of proof of payment and/or invoice, if applicable

5. Records can be saved as a pdf on the DRIVE 

6. Records of training are found in TRAINING FILE 

7. Some training records are an ATTENDANCE REGISTER which is scanned and filed in a Google DRIVE folder

8. An option is also to keep a copy of PROOF OF PAYMENT and/or invoice, if applicable

9. TRAINING Records can be saved as a pdf or filed in Personnel file

REFER to Google Drive TRAINING 

8.4.4 Training Competence Criteria

Type of assessment (as determined by the Manager dependent on the significance of the Training in regards to the effect on the QMS) 

• Assessment methods such as Test (Te) - oral or written, On-the-Job Observation (Otj) to determine Competence.

• For a written or oral test, a pass mark is set at not below 80%, if not achieved, the rewrites/retraining is done until the required pass mark is achieved. 

•  A record for the above assessment is recorded into a Competency Assessment form, Certificate (Ce), Attendance Register.

•  Where the result indicates not yet competent, the above process is repeated or retraining is done until a required result of competency is achieved.

8.5 Awareness (6.2)

Persons doing work under the organization’s control are aware of the following from awareness induction:

•     the quality policy and relevant quality objectives;

•     their contribution to the effectiveness of the quality management system, including the benefits of improved performance;

•     the implications of not conforming with the quality management system requirements.

8.6 Communication

The organization determines the internal and external communications relevant to the quality management system through SOP Internal & External Communication

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 supplier performance, and any other quality related matters, are reported to management and as part of the Data Analysis 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 20, 22.01.2026 - HJM - Pt 8.4.3 Added hyperlink for training matrix for 2026 together with hyperlink for training records. Pt 11 Corrected hyperlinks for the Training matrix, Request and Record sheet. 

Revision 19, 06/09/2024 SZ - 8.1 - Approval by HM

Revision 18, 11/04/2024 HJM - 8.1 - Correction of clause from 7.1.2 to 6.2 Human Resources

Revision 17, 28.07.2023 - NT - updating 8.4.4 Training Competence Criteria wording.

Revision 16, 17.05.2022 - NT - approval by HM
Revision 15, 19.11.2021 - NT - adding the Skills Development Plan Link 

Revision 14, 11.11.2021 - NT - signed off from TNA

Revision 13, 11.08.2021- TNA - updating responsibilities / deletion of sentence from definitions

Revision 12, 03.02.2021- TNA - New format with Responsibilities, Risk based approach, Approval and Records added and new google site format.  Updating numbering and amending links and forms

Revision 11, Digitally signed on 12.10.2020 by NT

Revision 1-10, unknown due to google site change to new google site

 11. Records

Name                       Retained by/ in Retention period Hard copies Destroyed by

TRAINING MATRIX                       Google DRIVE             indefinite             n/a  

TRAINING REQUEST FORM                         Google DRIVE       indefinite     n/a

TRAINING RECORD (Responses 1) i.e. REGISTER            Google DRIVE       indefinite             n/a