Draft: Ethiopian Railways Corporation (Erc)

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ETHIOPIAN RAILWAYS CORPORATION (ERC)


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May, 2018

NON-CONFORMANCE _ CORRECTIVE ACTION PROCEDURE

(SOP)

ADDIS ABABA, ETHIOPIATEL.01114702058/702051


P.O.BOX 27558/1000 FAX 011-4702044
ETHIOPIAN RAILWAYS CORPORATION

TITLE: NON-CONFORMANCE _ CORRECTIVE ACTION PROCEDURE

REF NO:ERC_QMS_SOP_ NC_CA VERSION NO: Page 1 of 13


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DOCUMENTED INFORMATION CONTROL SCHEDULE

Name of department: Quality management system improvement project


office
Documented information type: SOP

Documented information ref: ERC_QMS_SOP_ NC_CA _01

Prepared By: Hewan Getachew


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Signature:
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Reviewed By: Quality management system improvement project


office
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Signature:
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Approved By: CEO


Signature
Approval Date

Controlledcopy: circulationauthorizedby the Quality management system improvement


project office

Company proprietary information

Prior to use, ensure this document is the most recent revision. To request change, submit a
document change request to the document control representative.
ETHIOPIAN RAILWAYS CORPORATION

TITLE: NON-CONFORMANCE _ CORRECTIVE ACTION PROCEDURE

REF NO:ERC_QMS_SOP_ NC_CA VERSION NO: Page 2 of 13


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ACRONYM

Acronym Explanation
ERC Ethiopian Railways Corporation
ISO International Organization for Standardization
QMS Quality Management System
IQA Internal Quality Audit

NC Nonconformity

OFI Opportunity for Improvement


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RFA Request for Action
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NC_CA form Non-Conformance Correction Action form


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ETHIOPIAN RAILWAYS CORPORATION

TITLE: NON-CONFORMANCE _ CORRECTIVE ACTION PROCEDURE

REF NO:ERC_QMS_SOP_ NC_CA VERSION NO: Page 3 of 13


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CONTENTS
PURPOSE .................................................................................................................................... 4
DEFINITION ................................................................................................................................ 4
POLICY ........................................................................................................................................ 5
APPLICATION & SCOPE .............................................................................................................. 5
RESPONSIBILITIES ....................................................................................................................... 5
PROCEDURE ............................................................................................................................... 6
INITIATION AND COMPLETION OF CORRECTIVE ACTION ................................................................................... 6
PROCEDURE DETAILS .......................................................................................................................................... 7

FLOW CHART ............................................................................................................................ 10


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CONTROL OF NONCONFORMITY MATRIX ............................................................................... 11
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ETHIOPIAN RAILWAYS CORPORATION

TITLE: NON-CONFORMANCE _ CORRECTIVE ACTION PROCEDURE

REF NO:ERC_QMS_SOP_ NC_CA VERSION NO: Page 4 of 13


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1. PURPOSE
This procedure establishes the process to identify, track, complete the investigation
of the problem and correct the causes of existing nonconformance including
complaints in products, processes, and services in the Quality Management System,.
The cornerstone of corrective actions is written and retrievable documentation of
actions taken and follow-up monitoring to determine that corrective actions have
been performed and documented.

This procedure shall establish the requirements for:


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1. Reviewing non-conformities;
2. Determining the causes of the discovered non-conformities;
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3. Determining and implementing action needed to prevent the existence and


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recurrence of a non-conformity;
4. Records of the results of action/s taken;
5. Reviewing the effectiveness of the corrective actions taken;
6. Defining the controls and related responsibilities and authorities for dealing with non-
conforming services.

2. DEFINITION
1.1. Correction – action to eliminate a detected non-conformity.
1.2. Corrective Action - action to eliminate the cause of non-conformity and to
prevent recurrence.

1.3. Conformity – fulfillment of a requirement.


1.4. Nonconformity (NC) - failure to comply with a requirement
1.5. Opportunity for Improvement (OFI) - an observed situation which is not non-
conformity but where the results achieved may not be optimal, less than well-
organized, or over complicated.
ETHIOPIAN RAILWAYS CORPORATION

TITLE: NON-CONFORMANCE _ CORRECTIVE ACTION PROCEDURE

REF NO:ERC_QMS_SOP_ NC_CA VERSION NO: Page 5 of 13


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1.6. NC_CA form /Request for Action (RFA) - document used to:

 Record a non-conformity or an opportunity for improvement;


 Identify the root-cause of the non-conformity;
 Determine correction and corrective action.

1.7. Cause – A cause is a fundamental deficiency that results in a non-conformance


and is to be corrected to prevent reoccurrence of the same, or similar,
nonconformance.
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3. POLICY
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The delivery of ERC’s services should always satisfy customer’s requirements in


accordance with the service agreement. It is the policy of the company to identify, control
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and prevent occurrence/recurrence of services that do not conform to specified


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requirements. In addition, ERC must implement corrective actions to improve the


effectiveness of the established Quality Management System.

4. APPLICATION & SCOPE


This procedure is applicable to all organizational units and personnel; and shall cover
all corrective actions that can be done to address a nonconformity which can affect the
ERC Quality Management System.

5. RESPONSIBILITIES
a. QMS Leader/Head - ensure that this procedure is properly implemented.
b. Heads/Process Owners
o ensure that corrections and corrective actions are carried out without undue
delay
ETHIOPIAN RAILWAYS CORPORATION

TITLE: NON-CONFORMANCE _ CORRECTIVE ACTION PROCEDURE

REF NO:ERC_QMS_SOP_ NC_CA VERSION NO: Page 6 of 13


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o Ensure that all RFAs received are properly responded and submitted to the
Internal Quality Audit (IQA), and that documented information is retained.
o Ensure the effectiveness of actions taken.
c. Internal Quality Audit Team - verify if the corrections and corrective actions have
been effectively carried out.

6. PROCEDURE

6.1. INITIATION AND COMPLETION OF CORRECTIVE ACTION


1. The investigation of suspected quality problems is initiated as a result of
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quality control criteria being exceeded, specified requirements not being
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met, audit findings indicating systematic problems, or as a result of a


complaint.
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2. Corrective actions are of two kinds:


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 On-the-spot or immediate corrective action to correct or repair non-


conforming data, reporting or equipment, that are actions routinely made
by analysts, technicians and supervisors; and
 Long-term corrective action to eliminate causes of nonconformance or a
complex deficiency that are actions normally identified by audits.
3. A NC_CA form is to report the non-conformity. This form provides the steps
for a closed-loop process that includes:
a. initiation and identification of nonconformity,
b. investigation (examine extent),
c. findings and conclusions,
d. determination of cause to prevent reoccurrence,
e. corrective action taken and implemented, and
f. Follow-up by the IQA to ensure that the corrective action is a fix and
succeeded in achieving the results desired and is effective.
ETHIOPIAN RAILWAYS CORPORATION

TITLE: NON-CONFORMANCE _ CORRECTIVE ACTION PROCEDURE

REF NO:ERC_QMS_SOP_ NC_CA VERSION NO: Page 7 of 13


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4. Work is suspended and evaluated. Action is taken to identify the


nonconformance. Begin investigation to resolve the problem.
5. The findings are recorded on the NC_CA form/RFA. Examples of findings or
causes include:
 equipment failure;
 incomplete or nonexistent procedures;
 non-compliance with procedures and regulations;
 improper collection, storage, handling, or preparation;
 calculation errors or transcription errors; and
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 Lack of training.
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6. The cause and, if possible, the root cause is determined to prevent


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reoccurrence of the non-conformity and to provide a permanent solution.


7. The conclusions and actions taken are recorded on the NC_CA form. Examples
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of conclusions and actions may include:


 equipment repaired,
 procedures revised or created,
 product reworked to comply with procedures or regulations,
 correct calculation employed or transcription error corrected, and
 Proper training given.
8. The initiator’s immediate Supervisor approves the action or recommends
further action.

6.2. PROCEDURE DETAILS


1. Identification of non-conforming services
Nonconforming services may be detected through or as a result of (but not
limited to) the following:
1. Statutory and Regulatory Requirements
ETHIOPIAN RAILWAYS CORPORATION

TITLE: NON-CONFORMANCE _ CORRECTIVE ACTION PROCEDURE

REF NO:ERC_QMS_SOP_ NC_CA VERSION NO: Page 8 of 13


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2. Client Feedback
3. Audit Activities
4. Management Reviews

2. When a non-conformity is detected, implement the following procedure:


1. Document the non-conformity by accomplishing the appropriate part of the
NC_CA form/RFA;
2. Submit the NC_CA form to the Internal Quality Audit Team for review and
control number assignment. The IQA Team shall be responsible in forwarding
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the NC_CA form to the concerned unit;
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3. The initiator and the IQA Team shall coordinate on the status of actions, and
until the non-conformity is resolved;
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4. In the case of non-conformity from non-achievement of a Unit’s objective or


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target, the “Action Plan for Unmet Targets” form can be used to document
the NC. This document is decentralized.

3. When an NC_CA form is received, implement the following procedure:

i. Unit Head should acknowledge the NC_CA form by signing on the 1st page
(space provided);

ii. Perform a Root-Cause Analysis (RCA).

iii. Using the results of the RCA, formulate a correction and a corrective action.
The actions to be taken should address the identified cause/s of the NC.

iv. Provide a specific implementation date for both the correction and
corrective action;

v. Secure the approval of the Unit Head;

vi. Submit the NC_CA form to the IQA Team within fifteen (15) working days
upon receipt.
ETHIOPIAN RAILWAYS CORPORATION

TITLE: NON-CONFORMANCE _ CORRECTIVE ACTION PROCEDURE

REF NO:ERC_QMS_SOP_ NC_CA VERSION NO: Page 9 of 13


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4. Disposition and Monitoring of Correction and Corrective Action


1. The concerned Unit Head shall be responsible to carry out the necessary
corrective actions. To lower the risk of recurrence of detected NCs, and the
risk of occurrence of potential NCs, the Unit Head shall:
a. Review and approve the RCA, the correction, and the corrective action
that have been identified in the NC_CA form;
b. Monitor if actions are carried out according to the targeted
implementation date;
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c. Conduct a regular meeting regarding the results of actions taken in the
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NC_CAs, and other QMS concerns.


2. The Unit heads shall be primarily responsible in ensuring the effectiveness of
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their own actions.


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ETHIOPIAN RAILWAYS CORPORATION

TITLE: NON-CONFORMANCE _ CORRECTIVE ACTION PROCEDURE

REF NO:ERC_QMS_SOP_ NC_CA VERSION NO: Page 10 of 13


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7. FLOW CHART
NC_CA- FLOW CHART
FLOW CHART NUMBER: ERC/QMSIPO/NC_CA/WF/0001/01

Input Initiator Concerned Unit Immediate Supervisor IQA Team Output

1. 1. NONCONFORMITY
NONCONFORMITY DETECTED
DETECTED 2. review and
control number
Need of
correction assignment
action
change
Fill RFA 3. Work suspended and
Follow-up
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evaluated
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4. INITIATES NC_CA
( Supervisors, Staff)
Identifies nonconformance/
QS problem;
Documents findings
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5.
INVESTIGATION
6.1. FINDINGS/
Examine extent. CAUSE 9. REVIEW/
Note internal/ NC_CA APPROVAL
external document Immediate supervisor
observations; reviews/approves or
recommends further
areas;situations action

6. FINDINGS/CAUSE
Note findings/causes with
supporting evidence;
10. Approves or
Perform root cause analysis, if
Not Approves 6.1. FINDINGS/
required
CAUSE
NC_CA
11. SUBMISSION to document
7. DECIDE
IQA
CORRECTIVE Review; Evaluate;
No
ACTION TO Determine
TAKE effectiveness; Follow-
up &
Monitoring actions
Not effective identified

8. Corrective Action
Action taken to correct
nonconformance/problem
identified
Yes

PRODUCT
RELEASE
12. CLOSED
ETHIOPIAN RAILWAYS CORPORATION

TITLE: NON-CONFORMANCE _ CORRECTIVE ACTION PROCEDURE

REF NO:ERC_QMS_SOP_ NC_CA VERSION NO: Page 11 of 13


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8. CONTROL OF NONCONFORMITY MATRIX


Nature of NC Action/Disposition Responsibility

Delay in the perfection of  Seek approval from Project Manager


project authority;
 Revise Work plan

Change in Project Duration  Revise Project Project Manager


Implementation Plan

Exceeding the allotted  Monitor succeeding Project Manager


project budget project disbursements Finance
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 Re-align budget items
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Statement of Account errors  Retrieve the Statement of Project Manager


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Accounts Finance
 Re-issue Statement of
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Accounts with covering


explanation

Deviation from established  Investigate Human Resource Division


Code of Conduct  Refer to
superior/manager for
immediate appropriate
action

Equipment malfunction  Replace with spare Director, Supplies and


equipment Property Administration
 Rent equipment from
external service provider

Problems with utilities/  Secure remedial Director, Supplies and


facilities immediate action from Property Administration
concerned utility/facilities
provider
ETHIOPIAN RAILWAYS CORPORATION

TITLE: NON-CONFORMANCE _ CORRECTIVE ACTION PROCEDURE

REF NO:ERC_QMS_SOP_ NC_CA VERSION NO: Page 12 of 13


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APPENDIX - NON- CONFORMANCE_CORRECTIVE ACTION FORM

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