S tandard t andard O perating p erating P rocedure rocedure Title: N on- on - C C onforming o nforming P r ocedur ocedur es I n Future Un ive iversity rsity I n Egypt According To I SO 9001:20 9001:20 15 15 ISO I SO 14001:20 15 15 ,OH ,OH SAS 18001:20 18001:2007 07 AND I SO 17025:2005 Reviewing date
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D ept. Name Nam e Code # I ssue #
Quality Assurance Department FUE-SOP-QA-004 001
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: 1. COVER PAGE
Approval page: Name
Position
Sign./Date
Prepared by Reviewing by Approved by Approved by Authorized by
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S t andard O p erating P rocedure Title: N on- C o nforming P r ocedur es I n Future Un iversity I n Egypt According To I SO 9001:20 15 I SO 14001:20 15 ,OH SAS 18001:2007 AND I SO 17025:2005 Reviewing date
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Index: Table of Contents
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1. Cover page
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2. Introduction
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3. Abbreviations
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4. Definitions
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5. Purpose
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6. Application scope
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7. Responsibility
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8. Flow charting
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9. Procedures
5-6 of 9
10. Forms used
6-7-8 of 9
11. References
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12. Summary of changes
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S t andard O p erating P rocedure Title: N on- C o nforming P r ocedur es I n Future Un iversity I n Egypt According To I SO 9001:20 15 I SO 14001:20 15 ,OH SAS 18001:2007 AND I SO 17025:2005
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2. I NTRODUCTI ON 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. NCR’s are used to record findings from internal and external audits that require addressing. NCR’s are usually raised from within a process team relating to their inputs Received as outputs.
3. ABBREVI ATI ONS: 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. DEFI NI TI ONS: 4.1. None
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S t andard O p erating P rocedure Title: N on- C o nforming P r ocedur es I n Future Un iversity I n Egypt According To I SO 9001:20 15 I SO 14001:20 15 ,OH SAS 18001:2007 AND I SO 17025:2005 Reviewing date
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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. APPL I CATI ON 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
None 8. FL OW CHARTING:
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S t andard O p erating P rocedure Title: N on- C o nforming P r ocedur es I n Future Un iversity I n Egypt According To I SO 9001:20 15 I SO 14001:20 15 ,OH SAS 18001:2007 AND I SO 17025:2005 Reviewing date
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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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S t andard O p erating P rocedure Title: N on- C o nforming P r ocedur es I n Future Un iversity I n Egypt According To I SO 9001:20 15 I SO 14001:20 15 ,OH SAS 18001:2007 AND I SO 17025:2005 Reviewing date
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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 laboratory’s 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 NC’s are controlled according to control of controlled record
procedures.
10. FORM S USED : 10.1. Non-conforming Report 10.2. NCR follow up report
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S t andard O p erating P rocedure Title: N on- C o nforming P r ocedur es I n Future Un iversity I n Egypt According To I SO 9001:20 15 I SO 14001:20 15 ,OH SAS 18001:2007 AND I SO 17025:2005 Reviewing date
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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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S t andard O p erating P rocedure Title: N on- C o nforming P r ocedur es I n Future Un iversity I n Egypt According To I SO 9001:20 15 I SO 14001:20 15 ,OH SAS 18001:2007 AND I SO 17025:2005 Reviewing date
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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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S t andard O p erating P rocedure Title: N on- C o nforming P r ocedur es I n Future Un iversity I n Egypt According To I SO 9001:20 15 I SO 14001:20 15 ,OH SAS 18001:2007 AND I SO 17025:2005
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11. REF EREN CES : Quality System, ISO 9001:2015ISO 11.1. Fu tur e Un iversity in Egypt 14001:2015, OHSAS 18001:2007 & ISO 17025:2005
12. SUM M ARY OF CH ANGES:
Issue no.
Valid Date
001
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Pages
Summary of changes
All pages
New SOP
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