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4.15 Management Review Chipsy-LAB4.15

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Ahmed Said
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17 views6 pages

4.15 Management Review Chipsy-LAB4.15

Uploaded by

Ahmed Said
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOC, PDF, TXT or read online on Scribd
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Management Review

Chipsy-LAB.4.15
Document Approval

Done By Reviewed By Approved By

Name : Name : Name :

Position : Position: Position :

Signature: Signature: Signature:

Issue / REV Date: Issue No / Rev. No: 1 / 0 Next Rev. Date:

(Amendment Table)
Issue No. Issue Date Amendment No.
Document No.: Chipsy-
LAB.4.15

Management Review Page 2 of 6

Chipsy-LAB.4.15 Issue/ REV Date :

Issue No./Rev. No : 1/0

Sections Included in this Document / Change History

(Document No. changed from 4.14 to 4.15)

1. Purpose
2. Scope
3. Responsibilities/(3. D. Quality Management System Manager changed to Quality
System Manager (QSM))
4. Background
5. References
6. Procedure/( 6. A. 2., 4., & 5. Quality Management System Manager changed to
Quality System Manager; 6. A. 3. added "recommendations for improvement")
7. Definitions
8. Records
9. Supporting Documents
10. Attachments/( IGC-LAB.10 & 11 updated to IGC-LAB.11 & 12)

1. Purpose

Management performs, as a minimum, annual reviews to determine the fitness and


effectiveness of the quality system in achieving the stated quality objectives. This
procedure establishes the method by which management reviews are performed within
the [Name].

2. Scope

This procedure applies to [Name] quality system.

3. Responsibilities

1. [Third Level Manager]:


Document No.: Chipsy-
LAB.4.15

Management Review Page 3 of 6

Chipsy-LAB.4.15 Issue/ REV Date :

Issue No./Rev. No : 1/0

o provides information for review,

o assists in investigation of action items, and as directed

o ensures implementation of any system change identified in their respective


area.
2. [Second Level Manager]:
o provides requested information as needed,

o may assist in the review activities, and

o Ensures action items and plans issued are investigated and identified
system change completed in their respective area.
3. [First Level Manager]:
o conducts management review, assigns action items and plans and approves
system changes; and
o Designates personnel to assist in the management review activities.

4. [Quality System Manager (QSM)]


o coordinates and collects the information for the management review,

o assembles summary report and documents action items and plans,

o monitors implementation of system changes approved as a result of action


items and plans, and
o maintains management review reports.

4. Background

None (FDA)

5. References

EAL-G3, Internal Audits and Management Review for Laboratories.


Document No.: Chipsy-
LAB.4.15

Management Review Page 4 of 6

Chipsy-LAB.4.15 Issue/ REV Date :

Issue No./Rev. No : 1/0

6. Procedure

1. Management review
1. As a minimum, an annual review of the quality system is performed. The
predetermined schedule covering the elements of the International
Organization for Standardization and the International Electro technical
Commission (ISO/IEC) 17025 is found in Section 10 of Attachment A.
This review examines the quality system and determines if it meets the
conditions set by the agency and the standards. The review will serve as a
guide in making future determinations towards the effectiveness and
direction of the quality system. The quality system may need to be
modified due to changes that have or are expected to take place in the
organization, facilities, staffing, equipment, activities or workload.
2. The Quality System Manager assimilates the needed information and
records for the review and forwards them to the [First Level Supervisor],
[Second Level Supervisor], [Third Level Supervisor].
3. The review consists, but is not limited to the following:
 suitability of policies and procedures;
 reports from managerial and supervisory personnel;
 outcome of recent internal audits;
 effectiveness of previous actions taken;
 corrective and preventive actions;
 assessments by external bodies;
 results of interlaboratory comparisons or proficiency tests;
 changes in the volume and type of the work;
 client feedback;
 complaints;
 recommendations for improvement, and
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LAB.4.15

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Chipsy-LAB.4.15 Issue/ REV Date :

Issue No./Rev. No : 1/0

 Other factors, such as quality control activities, resources and staff


training.
4. The [First Level Supervisor, Second Line Supervisor] consolidates the
findings and distributes the report to the [Second Line Supervisor, Third
Line Supervisor] and [Quality System Manager]
5. If needed, a corrective action form is initiated for identified action items
and plans by the QMS Manager for the assigned personnel to complete.
Investigation is undertaken and findings submitted to the [First Level
Manager, Second Level Manager] and [Quality System Manager].
6. Action items and plans are closed when the results of the investigation are
implemented or are judged as having no added value to the quality system.

7. Definitions

Effectiveness - Effectiveness results when system requirements are routinely met.

Management review - Management review is the evaluation of the quality system by


management to determine its effectiveness, suitability and future direction.

Requirement - A requirement is a declared, implied or routine need or expectation.

Suitability - Suitability is the property of a system with attributes that address the
requirements for quality outlined in ISO/IEC 17025.

8. Records

Management Review Report


Action items and plans

9. Supporting Documents

Volume II, Section 1, Chipsy-LAB.4.11 Corrective Action Procedure


Volume II, Section 1, Chipsy-LAB.4.12 Preventive Action Procedure

10.Attachments
Document No.: Chipsy-
LAB.4.15

Management Review Page 6 of 6

Chipsy-LAB.4.15 Issue/ REV Date :

Issue No./Rev. No : 1/0

1
Attachment A: Management Review Schedule (PDF , 52 kb)
2
Attachment B: Management Review (PDF , 30 kb)

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