Quality System Work Instruction
10-10-0101: Management Review
rev-12a00 - Approved by: QMR
1.0 Purpose and Scope
The purpose of this work instruction is to define management review process of the quality
system’s performance. The process includes scheduling, meeting agenda, retention of
documents, and management of follow-up actions.
1.1 Definitions
MRT – Management Review Team
QCS – Quality Compliance System: Online system to manage & report quality compliance
QMR – Quality Management Representative
1.2 Discussion
The company’s executive management team reviews health and performance of the quality
program at intervals sufficient to ensure suitability and effectiveness. The meetings are based
on a review of performance data within the QCS system. Performance and improvements are
discussed. A list of improvements are agreed to and scheduled as corrective actions.
Records of review meetings are retained within QCS and include agenda, minutes, corrective
actions, and other supportive documents.
The reviews shall be conducted by a management review team (MRT), comprised of the
Executive Sponsor and Executive Management, with review meetings chaired by the Quality
Management Representative (QMR). Optionally, informational experts can be invited to
provide added clarity and insight.
WI 10-10-0101_12a00
UNCONTROLLED IF PRINTED
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Quality System Work Instruction
10-10-0101: Management Review
rev-12a00 - Approved by: QMR
2.0 Work Instructions
01 - Management Review Process
Plan
Management Review
1
Follow-up
QCS 1.0 / Mgmt Responsibility
QMR
Schedule
Meetings
--maintain
records
schedule
& agenda
minutes,
attendance,
C&P actions
agenda
distribution
3a QMR
Chair
Meeting
--maintain
records
presenter
notification
QCS 10.0 Corrective Actions
scheduled
actions
4
2
advanced
copies
Presenters
Prepare
Reports
follow-up
actions
CAT
agenda &
notification
actions
CORRECTIVE
ACTIONS
3b
MRT
presentations
Access
Quality
System
QCS
Performance Reports
QCS SYSTEM
Reporting
figure: 10-88-0102_10a00
STEP
RESPONSIBILITY
verified
improvements
QMR - Quality Management Representative
MRT - Management Review Team
CAT – Corrective Action Team
QCS – Quality Compliance System
ACTION
Plan
Schedule Manage Review Meetings & Maintain Records
Using online QCS 01. Management Responsibility / Tab New or Open
1
QMR
a) Schedule Meetings ( 2 per year, plus addition if req’d)
- title (descriptive)
- description
- date, time, location
- attendees
b) Create Meeting Agenda
- store as attachment
c) Notify Presenters
- Topics defined within company’s Procedure 1.2 Management Reviews
WI 10-10-0101_12a00
UNCONTROLLED IF PRINTED
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Quality System Work Instruction
10-10-0101: Management Review
rev-12a00 - Approved by: QMR
STEP
RESPONSIBILITY
ACTION
Plan
Presenters Prepare MRT Reports / topics defined by company’s Procedure
a) Review Data and Trends
- QCS provides many of the MRT reports.
2
Presenters
b) Prepare “high level” Status Report
- What has changed since last meeting
- Hint: Use online QCS reports & screens for presentation
c) Prepare Recommendations
- Based on data, identify recommendations, for improvements.
d) Advance copies of reports
- Using online QCS, 01. Management Responsibility / Open Tab
- Select appropriate meeting
- Attach Report
Management Review
Chairperson Responsibilities
3a
QMR
a) Chair Meeting per Agenda
- Presentations based on company’s procedure 1.2 Management reviews
includes previous action items & current status
- MRT Discussion of stability & effectiveness of Quality System
- MRT Follow-up Actions are identified for scheduling
- Meeting Minutes
b) Retain Meeting records on QCS
- Using online QCS, 01. Management Responsibility / Open Tab
- Select appropriate meeting
- Attach Meeting Minutes
- Create & Schedule C&P Actions for MRT Follow-up Actions
Management Review
MRT Responsibilities per Agenda
3b
MRB
a) Presentations provide information of Quality related trends & recommendations
b) Discuss stability & effectiveness of Quality System, based on presentations
c) Follow-up Actions are identify, and previous actions reviewed for completion
Follow-up Action
Managed by QCS 10.0 Corrective and Preventive Actions
4
CAT
WI 10-10-0101_12a00
Using QCS and Company Procedures, Manage Corrective Actions
a) Planned - root-cause analysis & corrective action plan
b) Approved – by MRT, plan, funds and resources
c) Implemented – per approved plan
d) Audit Results – was root-cause problem corrected
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Quality System Work Instruction
10-10-0101: Management Review
rev-12a00 - Approved by: QMR
3.0 References
3.1 Normative References - The following reference contains provisions which through
reference in this text, constitutes provisions of this document. References, which are
subject to revision, should always be used in the most recent form.
QSP 01.1 Management Review Meetings
QSP 10.1 Corrective and Preventive Actions
WI 10-10-1001 QCS – Corrective and Preventive Action Process
3.2 Informative References - The following references are included as bibliographic
information, which may contain material useful for execution of this document. References,
which are subject to revision, should always be used in the most recent form.
WI 10-10-0001 QCS – Access to Online Compliance System
3.3 Documentation/Records - The implementation of this document requires the use of the
below listed forms or reasonable facsimiles thereof and may result in records as so
indicated in addition to retained completed forms. References, which are subject to
revision, should always be used in the most recent form.
QCS – Quality Compliance System
WI 10-10-0101_12a00
UNCONTROLLED IF PRINTED
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