Mawj Alsama Medical Company

Procedure for Control of Non-Conformance

Doc No.: MAMC-MD-QMS-PR-14 Date: 06/02/2022

Mawj Alsama Medical Company

ISO 13485:2016

Medical Devices-Quality Management System

Address: AL NAHDA DISTRICT AL SAFA STREET, JEDDAH, 21493, KSA

PROCEDURE FOR CONTROL OF NON-CONFORMANCE

Authorized By Name Designation Date & Sign

Prepared By

Reviewed By

Approved By

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 Mawj Alsama Medical Company

Procedure for Control of Non-Conformance

Doc No.: MAMC-MD-QMS-PR-14 Date: 06/02/2022

Revision History and Approval

Rev. Nature of Changes Approval Date

Rev No.: 00 Page No. 2 of 6

 Mawj Alsama Medical Company

Procedure for Control of Non-Conformance

Doc No.: MAMC-MD-QMS-PR-14 Date: 06/02/2022

Table of Contents
1. Purpose……………………………………………………………………………………………………………………..…………………………………….....4
2. Scope……………………………………………………………………………………………………….……………….…………………..…………………….4
3. Resposibilities………………………………………………………………………………………...……………................................................4
4. Definitions……………………………………………………….…………………………………………………...…………….…………………….….......4
5. Procedure…………………………………………………...…………………………………..……………………………......................................4
5.1 Identification of Nonconformities……………………………..............................................................…….........................4
5.2 Investigation…………………………………........................................................................................................................5
5.3 Corrective Action Request.....................….…………………………….…............................................................................5
5.3.1 Analysis and Review of Non-Conformances…………………………..………………………………………………………………….5
5.3.2 Evaluation of The Need for Corrective Action……………………………………………………………………………………….……6
5.4 Implementation and Review of Corrective Action ……………...………………………………….............................................6
6. Records Or Exhibits…………………………………………..…………………………………………………………………………………….…....…….6

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 Mawj Alsama Medical Company

Procedure for Control of Non-Conformance

Doc No.: MAMC-MD-QMS-PR-14 Date: 06/02/2022

1. Purpose
The purpose of this Procedure is to establish, implement and maintain a documented process for dealing
with actual and potential nonconformity by identifying, correcting and controlling them; including the
mitigation of quality & MD-QMS consequences. In addition, this procedure identifies the authorities and
responsibilities for dealing with nonconformities.

2. Scope
This procedure is applicable to all existing and potential MD-QMS-related nonconformities, complaints and
incidents occurring or which might occur at Mawj Alsama Medical Company in conformance to its Quality,
Health & Safety Management System.

3. Responsibilities
The MD-QMS Management Representative is responsible for promoting and ensuring awareness of this
SOP at all levels and functions of Mawj Alsama Medical Company.
Department Heads are responsible for strictly implementing the control of nonconformities, including
complaints & feedbacks.
Responsible department and/or personnel are responsible for carrying out necessary correction, corrective
and preventive actions in dealing with nonconformities, complaints and incidents related to MD-QMS.

4. Definitions
Correction - Action to eliminate a detected nonconformity.
Nonconformity - Non-fulfilment of a requirement.
Corrective Action - Action taken to eliminate the cause of detected nonconformity or undesirable situation
to prevent recurrence.
CPAR - Corrective & preventive action request.
MD-QMS - Refers to the “Medical devices- quality management system”
MR - Management Representative, a person appointed to manage and monitor the implementation of the
organization’s MD-QMS.

5. Procedure
5.1 Identification of Nonconformities
All nonconformities associated with the implementation of MD-QMS shall be identified and controlled.
These nonconformities may be identified as:
• Nonconforming MD-QMS processes and practices.
• Non-conformance detected during MD-QMS internal audits.
• Noncompliance to specified legal and other requirements.
• Complaints from customer or interested parties.
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 Mawj Alsama Medical Company

Procedure for Control of Non-Conformance

Doc No.: MAMC-MD-QMS-PR-14 Date: 06/02/2022

• Incidents & other emergency situations.

• Nonconformities in MD-QMS.
• Nonconformities shall be identified, recorded, investigated and corrected using CPAR form. Each
CPAR shall be registered and monitored using the “CPAR Control Register”.
Department Heads shall ensure that required actions are in place needed to prevent:
• Recurrence of an existing nonconformities, complaints, incidents and other emergency situations.
• Occurrence of potential nonconformities, complaints, incidents and other emergency situations.
• Any work or activity associated with nonconformities, complaints, incidents and emergency
situations shall not proceed until investigations and analysis are carried out and that appropriate
corrective & preventive actions are taken.
• Records of nonconformities, complaints, incidents & emergency situations, along with its disposition
and verification results shall be maintained by the MD-QMS Management Representative and shall
be brought to the attention of the Deputy Manager with copies of relevant documents and records.

5.2 Investigation
All identified nonconformities, complaints, incidents & other emergency situations shall be investigated by
relevant personnel designated by the concerned Department Head to determine the root-cause; and that
appropriate correction and corrective action are carried out to prevent recurrence.
In the same way, all potential nonconformities shall be reviewed and analysed and that appropriate actions
are determined to prevent occurrence of nonconformities, complaints, incidents & other emergency
situations.
Details of the investigation and actions to be taken, including the due dates of implementation shall be
recorded using CPAR form.

5.3 Corrective Action Request

5.3.1 Analysis and Review of Non-Conformances
Corrective action is carried out to eliminate causes of non-conformity to avoid its recurrence. In Mawj
Alsama Medical Company, the cause of non-conformity is analysed by the respective department
personnel and necessary corrective action is determined by the department heads.
Root cause analysis can be done by using any of the following tools:

• Cause and effect diagram.

• Brain storming.
• Technical analysis.
MR shall follow-up with the respective departmental personnel for the implementation of the corrective
action. Details of corrective action carried out shall be recorded in the Corrective action request form.
Measures for the analysis and review of non-conformances identified during internal/external audit
are explained in the Procedure for Internal MD-QMS Audit. All corrections related to the quality system
documents shall be done according to another documented procedure.
5.3.2 Evaluation of The Need for Corrective Action
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 Mawj Alsama Medical Company

Procedure for Control of Non-Conformance

Doc No.: MAMC-MD-QMS-PR-14 Date: 06/02/2022

Non-conformances identified in the organization, shall be evaluated against factors like operating costs,
costs of non-conformity, product performance, satisfaction of customers and other interested parties. Non-
conformances are identified from various sources like:
• Customer complaints
• Outputs of data analysis
• Audit reports
• Outputs from management review
• Relevant quality and health & safety management system records
• Accident/Incident Reports
Non-conformances are evaluated to identify appropriate corrective action to eliminate or minimize
recurrence.

5.4 Implementation and Review of Corrective Action

MR will maintain a CAR log to follow up the status of raised NCR closure.
MR will ensure the closure and implementation of CAR within the organization.
Concerned department head along with the assigned personnel mentioned in the Corrective action request
is responsible for the corrective action decided. MR shall monitor the implementation of the corrective
action.
The results of the corrective action shall be recorded by MR in the Corrective action request form. The
departmental head is responsible to evaluate the effectiveness of the corrective action over a period of
time. The verification may occur during subsequent internal audits.
Results of corrective action and its effectiveness monitored over a period of time shall be reviewed in the
management review meeting

6. Records or Exhibits
CPAR Control Register MAMC-MD-QMS-PR-14-F-01

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