Company:

TEBITA AMBULANCE PRE-HOSPITAL EMERGENCY Document No. : TA/OP/003

MEDICAL SERVICES
Title:
Corrective and Preventive Action Procedure Revision No. 01 Page 1 of 10

ISSUE HISTORY
Issue
ADDRESSED Description of Change
REQUIREMENT Originator Effective Date
Document
1 Number
Revised as per ISO 9001:2015 Document Title
ISO 9001: 2015, Clause 10.1, 10.3 Continual Improvement
ISO 9001: 2015, Clause 10.2 Corrective Action
ISO 9001: 2015, Clause 6.1.1 and 6.1.2. , 10.3. Preventive Action

CONTENTS PAGE NO.

ISSUE HISTORY 1
ADDRESSED REQUIRMENT 1
CONTENTS 1
1. PURPOSE 2
2. SCOPE 2
3. PROCESS OWNER 2
4. INVOLVED 2
5. PERFORMANCE MANAGEMENT 2
6. DEFINITIONS & ABREVIATIONS 2
7. PROCEDURE 3
7.1 PROCESS FLOW CHART 4
7.2. DESCRIPTION OF PROCESS STEPS 5
7.3 SUPLEMENTARY ISSUES 6
8. RECORDS 8
9. DISTRIBUTION 8
10. RELATED DOCUMENTS 8

Approval

Name: Signature: Date:

PURPOSE
 Company:
TEBITA AMBULANCE PRE-HOSPITAL EMERGENCY Document No. : TA/OP/003
MEDICAL SERVICES
Title:
Corrective and Preventive Action Procedure Revision No. 01 Page 1 of 10

 The purpose of this procedure is to assure continual improvement of the quality

management system by eliminating existing and potential sources of nonconformities. It
uses as a means to review nonconformities, avoid their recurrence and to prevent
potential problems before their occurrence.
1. SCOPE
 The procedure uses to determine and implement actions needed; record the results of
corrective actions needed and review the effectiveness of the actions taken. It is
applicable to all system related issues that need formal corrective and preventive actions.

2. PROCESS OWNER:

 Management Representative
3. INVOLVED:
 Concerned Department, Division or Service
4. PERFORMANCE MANAGEMENT

 Ensuring continual improvement of the QMS by taking effective corrective and

preventive actions
 Preventing recurrence of nonconformities by determining their root causes and taking
actions
 Implementing appropriate corrective actions and reviewing their effectiveness

5. DEFINITIONS AND ABBREVIATIONS:

6.1 Definitions
6.1.1 Preventive action: Action taken to eliminate the causes of a potential
Nonconformity, defect or other undesirable situation in order to prevent occurrence.
6.1.2 Corrective action: Action taken to eliminate the root causes of an existing
nonconformity, defect or other undesirable situation in order to prevent recurrence.

Notes 1: Both the Preventive and corrective actions may involve changes in procedures
and systems to achieve continual improvement at any stage of the quality loop.

Nonconformity: Non fulfillment of a specified requirement.

6.1.4 Defect: Non-fulfillment of an intended usage requirement or reasonable

expectation, including one concerned with safety.

Note: The basic difference between “nonconformity” and “defect” is that specified
requirements may differ from the requirements to the intended use.

6.1.5 Repair: Action taken on a nonconforming product so that it will fulfill the intended
usage or requirements although it may not conform to the originally specified
 Company:
TEBITA AMBULANCE PRE-HOSPITAL EMERGENCY Document No. : TA/OP/003
MEDICAL SERVICES
Title:
Corrective and Preventive Action Procedure Revision No. 01 Page 1 of 10

requirements

6.1.6 Root cause: The originating source of a nonconforming Effect. Root causes are not
always easily identified and can require careful analysis of product specification and
all related processes, operations and quality records
6.1.6 Act: Primary responsibility is allocated to a person or group of persons to
accomplish a specific process/activity which results in a specific output.

6.1.7 Involved: Contributory responsibility is allocated to a person or group of persons to

accomplish a specific process/activity, which results in a specific output.

6.2 Abbreviations

ACT: Action
GM: General Manager
COM: Committee
FLW: Flowchart
INF: Informed
MR: Management Representative
INV: Involved

7. PROCEDURE
7.1. Process Flow Chart
 Company:
TEBITA AMBULANCE PRE-HOSPITAL EMERGENCY Document No. : TA/OP/003
MEDICAL SERVICES
Title:
Corrective and Preventive Action Procedure Revision No. 01 Page 1 of 10

Input Process Responsibility Out put

GM MR COM
 Quality audit report 1  Reviewed &
Review & registration of registered
 Other customers
complaints actual/potential nonconformities actual/potentia
l non-
 Management review out
conformities
put
 Complaint registration
ACT
form
(
TA/OF/019) ,Suggestion
form (TA/OF/017)
 Satisfaction measurement
output
 Registered actual/potential 2  Assigned
non-conformities Assigning department, service head or committee
 Suggestion logging sheet group (department
(TA/OF/018) ACT INV INF head or
 Corrective action service or
initiation form division
(TA/OF/021) head)
 Responsible person/Group 3  Identified
 Filled Corrective action Investigating the root causes of root causes
initiation form actual/potential nonconformities INF INV ACT
TA/OF/021)

 Identified root causes  Evaluated

5 root causes
No No
Reject Evaluating the
ACT INV INF
identified root

causes

Yes
 Evaluated root causes 6  Corrective/
Determining the corrective/preventive preventive
INF INV ACT
action to be taken action
proposal
 Corrective/preventive 7  Approved
action proposal proposal
NO Approval of
ACT INV INF
the proposal
Implementing the proposed
corrective/preventive action
Yes
 Approved 8  Implemented
corrective/preventive corrective/pr
action proposal eventive
INF INF ACT
 Proposal implementation action
plan (TA/OF/024)
 Company:
TEBITA AMBULANCE PRE-HOSPITAL EMERGENCY Document No. : TA/OP/003
MEDICAL SERVICES
Title:
Corrective and Preventive Action Procedure Revision No. 01 Page 1 of 10

 Implemented 9 Go to 6.  Measured &

corrective/preventive evaluated
action action
Measure & evaluate the
INF ACT INF
No
effectiveness of the

Yes
 Reviewed action 10  Compliance
 OFI follow up and Compliance report report
clearance report INV ACT INF
(TA/OF/023)

7.2 Description of Process Steps

 Company:
TEBITA AMBULANCE PRE-HOSPITAL EMERGENCY Document No. : TA/OP/003
MEDICAL SERVICES
Title:
Corrective and Preventive Action Procedure Revision No. 01 Page 1 of 10

FLW Process Steps

1 Every nonconformance should not activate corrective action program. To qualify, the
nonconformance must be quality system relevant .The resolution of the issue must improve
a quality system program or must improve the results from a quality system program to
qualify for formal corrective action.
To assist in trend analysis and in management review, nonconformities that qualifies
formal corrective/preventive actions are classified as follows:
 Customer complaints and concerns
 Quality system issues
 Internal and external audit findings
The management representative shall use records to see if any trend exists which show a
potential problem could arise. Typical examples of where information may be found and
used for such analysis are:
 Problems with stake holders ( Apprenticeship and
cooperative training)
 Training and assessment process problems, wastage levels

 Customer complaints and customer surveys

 Quality records
2 General Manager shall form a committee to investigate the root causes of actual/potential
problems together with the MR. The committee shall form from management group or
dept., service & divisions that all directly accountable to the General Manager
When required, the Department may form a team to investigate the root causes of
nonconformities and proposes corrective actions. A corrective action shall be concerned
3
with finding out why the nonconformity occurred and making sure that the problem does
not occur again.
Analysis of the causes may suggest some solutions for instance .Preventive methodologies
are review of customer need and expectation, satisfaction measurement, risk analysis, trend
analysis, process control, data analysis. If the analysis of the cause become beyond the
capability of the Department, Division or Service head, the analysis will be subcontracted to
other body as per the purchasing procedure.
4 The evaluation shall be in terms of the potential impact on such aspects as operating costs,
cost of non-conformances, performance, dependability, safety and customer satisfaction.
5 When the identified root causes has no potential impact on aspects stated in the process step
number four, the General Manager will reject and record the reasons for rejection.
6 The proposed corrective action shall involve in finding the cause of particular problem and
then putting in place the necessary actions to prevent the problem recurring. If the
determination of the corrective/preventive action to be taken become beyond the capability
of the Department, Division or Service head, he/she will subcontract the determination of
corrective/preventive action to other body as per the purchasing procedure.
7 Approval of corrective /preventive action proposal requires remarkable thought. The
decision on the remedial measures to be adopted shall depend on a comparison of the
 Company:
TEBITA AMBULANCE PRE-HOSPITAL EMERGENCY Document No. : TA/OP/003
MEDICAL SERVICES
Title:
Corrective and Preventive Action Procedure Revision No. 01 Page 1 of 10

FLW Process Steps

practicability and economics of the various alternatives
8 Prioritize the corrective action. The action taken shall be in line with the magnitude of the
problem and the likely risks associated with not implementing any corrective action.

9 The Department or Service head shall monitor and evaluate effectiveness of the
implemented corrective/ preventive actions.
10 Compliance report shall be documented and action taken shall be followed up within a
reasonable period to find out whether it has worked. Depending on the seriousness of the
action taken, the Management representative in conjunction with General Manager will
present the compliance report to the management review committee.

7.3 Supplementary issues

7.3.1. In the case of actions that require urgent response, the Department, Division or
Service Head in consultation with the General Manager and MR shall take actions and
report immediately.
7.3.2. Every nonconformance should not activate corrective action program. To qualify, the
nonconformance shall be quality system relevant. The resolution of the issue must
improve a quality system program or must improve the results from a quality system
program to qualify for formal corrective action.
7.3.3. Management representative is responsible for reviewing each submitted
nonconformance to decide if the issue meets the specified corrective action
qualification criteria.
7.3.4. Customer suggestion Box is opened every Twice per month by the assigned
committee.
7.3.5. The Committee has three members, one chair person the MR and the other two are
assigned by General Manager.
7.3.6. The keys of the customer suggestion box are kept in the Management
Representative office in safe place.
7.3.7. For those nonconformance’s that qualify for formal corrective action, the following
four steps shall be followed.

1. Investigate
Describe each nonconformity or group of similar nonconformities in detail. To assist in
trend analysis and in management review, classify the nonconformities. Listed below are
recommended classification categories:
 Customer complaints and concerns,
 Internal and external audit findings
 Quality System issues

When initiating a corrective action:

 Company:
TEBITA AMBULANCE PRE-HOSPITAL EMERGENCY Document No. : TA/OP/003
MEDICAL SERVICES
Title:
Corrective and Preventive Action Procedure Revision No. 01 Page 1 of 10

 Specify the individual or group responsible for investigating the nonconformity to

determine the root cause and corrective action needed to prevent recurrence.
 Determine how the effectiveness of the corrective action will be measured and describe
the conditions that must exist in order to close the corrective action.
 Specify a completion date for the corrective action.

2. Implement
Prioritize the corrective action
Update and communicate the procedures to reflect the corrective action and
implement the change.

3. Performance Measure
Measure the effectiveness using the criteria specified when the corrective action was
initiated.

4. Evaluate
Use the measurements as objective evidence to determine if the corrective action eliminates the
root causes of the nonconformity. If the evidence is favorable, close the corrective action.

8. RECORDS:
The MR is responsible for all records, i.e.
 Compliance report
 Investigation review report
 Management review report
 List of nonconformities
 Proposed corrective /preventive actions

9. DISTRIBUTION:
 General Manager
 All Departments, Divisions and Services

10. RELATED DOCUMENTS:

 Company:
TEBITA AMBULANCE PRE-HOSPITAL EMERGENCY Document No. : TA/OP/003
MEDICAL SERVICES
Title:
Corrective and Preventive Action Procedure Revision No. 01 Page 1 of 10

DOCUMENT TITLE DOCUMENT NUMBER

 Customer/employee suggestion form TA/OF/017
 Customer/employee suggestion logging sheet TA/OF/018
 Complaints Registration Form TA/OF/019
 Complaints Registration Logging Sheet TA/OF/020
 Corrective/preventive action initiation form TA/OF/021
 Root cause & action to be taken Notification & approval form. TA/OF/022
 OFI follow up and Clearance Report TA/OF/023
 Corrective, Preventive Proposal Implementation Plan TA/OF/024
 Corrective preventive proposals progress report TA/OF/025
 Complaints handling procedure TA/OP/006
 Management review procedure TA/OP/005