Reviewing date

Standard Operating Procedure

Title: Non-Conforming
Procedures In Future
University In Egypt According
To ISO 9001:2015ISO
14001:2015,OHSAS
18001:2007 AND ISO
17025:2005
/ /2018

Dept. Name
Code #
Issue #

Quality Assurance Department

FUE-SOP-QA-004
001

Issue date

Valid from date

/2016

/2016

: 1. COVER PAGE

Approval page:
Name

Position

Sign./Date

Prepared by
Reviewing by
Approved by
Approved by
Authorized by

Issued and controlled via QA Dept.

Copy #

Stamp

Page 1 of 9

Standard Operating Procedure

Title: Non-Conforming
Procedures In Future
University In Egypt According
To ISO 9001:2015ISO
14001:2015,OHSAS
18001:2007 AND ISO
17025:2005
/ /2018

Reviewing date

Dept. Name
Code #
Issue #

Quality Assurance Department

FUE-SOP-QA-004
001

Issue date

Valid from date

/2016

/2016

Index:
Table of Contents

Page #

1. Cover page

1 of 9

2. Introduction

3 of 9

3. Abbreviations

3 of 9

4. Definitions

3 of 9

5. Purpose

4 of 9

6. Application scope

4 of 9

7. Responsibility

5 of 9

8. Flow charting

5 of 9

9. Procedures

5-6 of 9

10. Forms used

6-7-8 of 9

11. References

9 of 9

12. Summary of changes

9 of 9

Issued and controlled via QA Dept.

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Standard Operating Procedure

Title: Non-Conforming
Procedures In Future
University In Egypt According
To ISO 9001:2015ISO
14001:2015,OHSAS
18001:2007 AND ISO
17025:2005
/ /2018

Reviewing date

Dept. Name
Code #
Issue #

Quality Assurance Department

FUE-SOP-QA-004
001

Issue date

Valid from date

/2016

/2016

2. INTRODUCTION
2.2. A NCR report issued when a Service, process or procedure does not comply
with the set standards for a Service, process or procedure under inspection.
An NCR is any significant deficiency, a tool to put right things that are going
wrong, a means of stopping repeated errors.
NCRs are used to record findings from internal and external audits that require
addressing.
NCRs are usually raised from within a process team relating to their inputs
Received as outputs.

3. ABBREVIATIONS:
3.1.

SOP: Standard Operating Procedure.

3.2.

Q.A : Quality Assurance

3.3.

Q.C : Quality Control

3.4.

N.C.R : Non Conformance Report

3.5.

Q.A.M : Quality Assurance Manager

3.6.

G.M.P : Good Manufacturing Process

3.7.

OH&S: Occupational health and Safety.

4. DEFINITIONS:
4.1. None

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Reviewing date

Standard Operating Procedure

Title: Non-Conforming
Procedures In Future
University In Egypt According
To ISO 9001:2015ISO
14001:2015,OHSAS
18001:2007 AND ISO
17025:2005
/ /2018

Dept. Name
Code #
Issue #

Quality Assurance Department

FUE-SOP-QA-004
001

Issue date

Valid from date

/2016

/2016

5. PURPOSE:
This SOP describes the non-conforming procedure to:
3.2.1. Confirm that each technical department in the scope is complying with
the current GMP, GLP rules, ISO9001/2015, ISO14001/2015 and
OHSAS 18001/2007&ISO17025:2005.
3.2.2. Recognize and address any deficiencies in the systems, processes and
functions to be corrected and improved

6. APPLICATION SCOPE:
6.1. All non-conforming services, procedures, products.
6.2. Cases of non-conformance arising due to the deviation from the correct
implementation of the Quality Management System (QMS) as specified by the
ISO 9001/2015 or GLP, GCP guidelines
6.3. Cases of non-conformance arising due to the deviation from the correct
implementation of the Environmental Management System (EMS) as specified by
the ISO 14001/2015
6.4. Cases of non-conformance arising due to the deviation from the correct
implementation of the Occupational Health & Safety guidelines as specified by
the BSOHSAS18001/2007

7. RESPONSIBILITIES:
7.1. Quality team
7.2. Q.A department in coordination with the other departments

8. FLOW CHARTING: None

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Reviewing date

Standard Operating Procedure

Title: Non-Conforming
Procedures In Future
University In Egypt According
To ISO 9001:2015ISO
14001:2015,OHSAS
18001:2007 AND ISO
17025:2005
/ /2018

Dept. Name
Code #
Issue #

Quality Assurance Department

FUE-SOP-QA-004
001

Issue date

Valid from date

/2016

/2016

9. PROCEDURES:
9.1. Nonconformance in the management system:
9.1.1.In case of non-conformance arising from the implementation of the
Q.M.S according to the requirements of ISO 9001:2015 or those of GLP or
cases of non-conformance arising from the implementation of the E.M.S
according to the requirements of ISO14001:2015 or cases of non-conformance
arising from the implementation of the OH&S guidelines according to the
requirements of OHSAS 18001:2007, the Quality Assurance team in
coordination with the department concerned with the non-conformance and the
responsible person for the environmental and occupational safety system
should make the appropriate decision regarding the case of non-conformance
and issue a corrective action which is recorded in the "Corrective Action
Request Form" see attachment (10.1)
9.1.2. In the corrective action request form; the non-conformity, the
causes of the non-conformance, the needed corrective action, the due date for
executing the corrective action and the person responsible for executing it
should be recorded.
9.1.3.All data concerning any case of non-conformity that has a
corresponding corrective action should be recorded in the "Non-Conformity
and Corrective and Preventive Action Follow up Record" see attachment
(10.2)
9.1.1. NCR coding as follow:
9.1.1.1.NCR/00-00-00-0000 where as:
9.1.1.1.1.00: serial number starting from 01
9.1.1.1.2.00: date
9.1.1.1.3.00: month
9.1.1.1.4.0000: year

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Reviewing date

Standard Operating Procedure

Title: Non-Conforming
Procedures In Future
University In Egypt According
To ISO 9001:2015ISO
14001:2015,OHSAS
18001:2007 AND ISO
17025:2005
/ /2018

Dept. Name
Code #
Issue #

Quality Assurance Department

FUE-SOP-QA-004
001

Issue date

Valid from date

/2016

/2016

e.g.: NCR/01-02-04-2010; means: NCR number 01 issued

on 2/4/2010
9.2. QA responsible person receives, review and submit NC report to QA Team
for final reviewing.
9.3. QA team discusses the NC with dept. Manager and Technical manager and
evaluate NC repost to attain the final disposition and decide the end of the NC
[take decision].
9.4. Stop work using the reference equipment in case of the equipment out of
due calibration or the reference material is expired without substitute or
presence of any defect affects the correctness of test result.
9.4.1. In this case, notify the client and recall the work (partially or
completed) depending or the impact of reported NCR.
9.5. QA team, dept. Manager analyzes the NC and makes the corrective action
using the appropriate form.
9.6. Prompt a strict follow up regarding implemented CA in case of the
evaluation of the NC indicates that the non-conforming work could recur or that
there is a doubt in the compliance of laboratorys activities with its own policies
and procedures.
9.7. QA responsible person issues the corrective action and follow up these
actions as appropriate [See attachment 10.2.].
9.8. All records of NCs are controlled according to control of controlled record
procedures.

10. FORMS USED:

10.1. Non-conforming Report
10.2. NCR follow up report

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Reviewing date

Standard Operating Procedure

Title: Non-Conforming
Procedures In Future
University In Egypt According
To ISO 9001:2015ISO
14001:2015,OHSAS
18001:2007 AND ISO
17025:2005
/ /2018

Dept. Name
Code #
Issue #

Quality Assurance Department

FUE-SOP-QA-004
001

Issue date

Valid from date

/2016

/2016

10.1. Non-conforming Report

Non-Conforming Report
Date
: _______________________
NCR #: _______
Issuing dept. : _______________________
NC Source
:
Client complaint
Internal audit

Test method
Supervisor observations

Reference equipment
External audit

Prepared by: _______________________ Sign. /Date: ____________

NC description:

Reviewing and evaluation NC:

Responsible Unit:
Proposed Action:

Sign. /Date:

Name :
Suggested disposition:

Sign./Date:

Name :
Final Decision:

Department Manager:

Sign./Date:

Executive manager:

QA: _____

Follow up decision implementation through QA unit:

Action applied effectively
Action need another CA

Justification for other CA needed:

_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
QA Approval
:
Sign./Date:
Final approval
:
Sign./Date:

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Page 7 of 9

Reviewing date

Standard Operating Procedure

Title: Non-Conforming
Procedures In Future
University In Egypt According
To ISO 9001:2015ISO
14001:2015,OHSAS
18001:2007 AND ISO
17025:2005
/ /2018

Dept. Name
Code #
Issue #

Quality Assurance Department

FUE-SOP-QA-004
001

Issue date

Valid from date

/2016

/2016

10.2. NCR follow up report

Date

NCR #

Source of
NC

NC
description

Responsible

NC
evaluation

CA
taken

Responsible

Remarks

QA responsible person: ________________________

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Copy #

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Page 8 of 9

Standard Operating Procedure

Title: Non-Conforming
Procedures In Future
University In Egypt According
To ISO 9001:2015ISO
14001:2015,OHSAS
18001:2007 AND ISO
17025:2005
/ /2018

Reviewing date

Dept. Name
Code #
Issue #

Quality Assurance Department

FUE-SOP-QA-004
001

Issue date

Valid from date

/2016

/2016

11. REFERENCES:
11.1. Future University in Egypt Quality System, ISO 9001:2015ISO
14001:2015, OHSAS 18001:2007 & ISO 17025:2005

12. SUMMARY OF CHANGES:

Issue no.

Valid Date

001

Issued and controlled via QA Dept.

Pages

Summary of changes

All pages

New SOP

Copy #

Stamp

Page 9 of 9