3 Questions about Management Review - ISO 9001 and IATF 16949

jackerman64

Corp Quality Sys *****
#1
FIRST:
Could someone please provide some examples to help me understand the difference between some bulleted items in 9.3.2 - Management Review Input Requirements.
Many seem redundant or severely overlapping and I don't understand why they are called out so many times in so many ways.

For example, what is the difference between:
9.3.2 C2. The extent to which quality objectives have been met VERSUS
9.3.2 C3. Process Performance.
Our quality objectives are our KPI's which indicate how our processes are performing – I’m not grasping any difference unless for 9.3.2 C2... Are they asking that I perform additional math and state: Our goal was 90%, we hit 80% so the extent we reached our objective was 88.89%? :confused:

SECOND:
What is the difference between:
9.3.2 C3. ... and Conformity of Products... VERSUS
9.3.2 C4. Nonconformities... VERSUS
9.3.2 C5. Monitoring and Measuring Results VERSUS
9.3.2.1 d. Product Conformance

NC’s and CA’s would also be covered in 9.3.2 C1, 9.3.2 C4, 9.3.2 C6 and (I think) 9.3.2 E (CA Verifications) which, altogether encompass the results of 9.3.2 C5 if the results do not meet requirements. :frust:

THIRD:
6.1.2 b2 states
"The organization shall plan how to evaluate the effectiveness of these actions."

How do you accomplish this evaluation for each Management Review and how do you report it in Management Review?

Most of our Risk Analysis is done within FMEA's and Process Maps (which include Risk Identification, rating and Mitigation, as necessary).

It's not feasible to review these each month for every product and procedure.
I think I'm missing the point - there must be a simplified way.

CALGON :mg: Take me away.....
 
Elsmar Forum Sponsor
#4
It's not feasible to review these each month for every product and procedure.
I think I'm missing the point - there must be a simplified way.


That might be your real problem. Management review isn't supposed to be a tactical, grass roots review. It's meant to be somewhat strategic in nature - maybe quarterly is more appropriate...
 

AMIT BALLAL

Super Moderator
#5
I am trying to answer based on my knowledge and understanding of the standard, as follows:

An answer to your first question:
Quality objectives are derived from the quality policy. And effectiveness and efficiency measures are defined to measure the performance of a process.
For some organizations, those are different. Since your KPIs are also your quality objectives, review of these KPIs will fulfill both (9.3.2.C.2 and 9.3.2.C.3)

An answer to your second question:
I don't see there is any difference between 9.3.2.C.3 and 9.3.2.1.d.
9.3.2.1.c.4 asks for nonconformities and corrective actions which can be related to product conformance or others (such as Internal audits, customer audits, etc.).
9.3.2.C.5 asks for monitoring and measurement results which can be various parameters as defined by your organization about what you'll monitor measure (in clause 9.1.1.a)

Nonconformities and corrective actions against will be covered under 9.3.2.c.4.
Customer complaints will come under 9.3.2.C.1, Corrective actions and towards these complaints and its effectiveness will come under 9.3.2.c.4.
I don't think 9.3.2.c.6, 9.3.2.c.5 and 9.3.2.e are relevant here. 9.3.2.e is to check the effectiveness of actions taken against the risks and opportunities identified (in 6.1) against Issues (4.1) and needs and expectations of interested parties (4.2).

An answer to your third question:
9.3.2.e asks to review the effectiveness of actions taken to address risks and opportunities.
You need to review whether any actions taken found ineffective and any other actions need to be taken.

No need to review on monthly basis, do what is appropriate for you. We have defined that after every 6 months, we'll review issues, needs, and expectations of interested parties, risk registers.

I hope this helps.
 
Thread starter Similar threads Forum Replies Date
J Management Review Questions - Determining Key Measures Management Review Meetings and related Processes 4
Q Asset / Tooling Management - Two Questions Manufacturing and Related Processes 3
S ISO 14971 Risk Management - Questions for Hazard identification ISO 14971 - Medical Device Risk Management 2
L Auditing Top Management - Meeting Competency Requirements and Questions to Ask General Auditing Discussions 11
S DMR (Device Master Record) Management and Index questions Other US Medical Device Regulations 18
K Software Configuration Management Audit Questions Quality Assurance and Compliance Software Tools and Solutions 8
R VDA 6.3 - Two Project Management Questions VDA Standards - Germany's Automotive Standards 1
K Sample Questions for Auditing Management Rep , Internal Audit and Reg. Compliance Internal Auditing 7
A ISO 27000 (Information Security Management Systems {ISMS}) Basic Questions IEC 27001 - Information Security Management Systems (ISMS) 8
M A few Questions on ISO 20000 - IT Service Management System (ITSMS) IT (Information Technology) Service Management 8
M European Commission Questions Risk Management Standard ISO 14971 - Medical Device Risk Management 7
V 18001 2nd stage 3rd party Top Management Questions (Training Assignment) General Auditing Discussions 8
L Top Management - Internal Audit Questions to Ask Internal Auditing 17
M Internal Audit for ISO 14001 - Questions for Management Internal Auditing 12
O Audit Frequency and Management Commitment questions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
M ISO 14971 Risk Management questions and comments ISO 14971 - Medical Device Risk Management 38
H Top Management and CEO - What questions will be asked during audit? General Auditing Discussions 4
P Global Shop Software ERP management system questions Quality Assurance and Compliance Software Tools and Solutions 5
K What are the common questions during surveillance audit for top management? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
Q Internal Audit Questions - Does anyone have sample questions for Management Internal Auditing 16
Watchcat Raising new questions of safety and effectiveness Other US Medical Device Regulations 4
G Microsoft Office 365 Business plan questions Business Continuity & Resiliency Planning (BCRP) 10
N Simple statistics questions on labor data Statistical Analysis Tools, Techniques and SPC 2
J IATF CB Auditor questions Internal Auditor Competence IATF 16949 - Automotive Quality Systems Standard 19
lanley liao Questions regarding the change of critical suppliers and key personnel Oil and Gas Industry Standards and Regulations 5
H Existing cloud based medical device - questions regarding improving the processes IEC 62304 - Medical Device Software Life Cycle Processes 6
W How do you phrase your internal audit questions? Internal Auditing 3
C UDI Questions on Control Units Other US Medical Device Regulations 6
M NFPA 70 electrical harness questions Various Other Specifications, Standards, and related Requirements 2
L Project Managers - Questions For You Career and Occupation Discussions 0
B Toyota PPAP Process - Three Questions APQP and PPAP 5
A Internal Audit Questions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
K Two FDA questions regarding UDI (and potentially 803.52 MDR) Other US Medical Device Regulations 0
D Signature Matrix questions ISO 13485:2016 - Medical Device Quality Management Systems 4
D ECO (Engineering Change Order) process questions ISO 13485:2016 - Medical Device Quality Management Systems 7
C 8.5.1.1 Control of Equipment, Tools, and Software Programs - Questions about the extent of control of NC programs AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
D Rules for Paper Forms outside of an eQMS - 3 Questions (ISO 13485) Document Control Systems, Procedures, Forms and Templates 9
D Shipping and recall questions ISO 13485:2016 - Medical Device Quality Management Systems 2
D Questions regarding process validation ISO 13485:2016 - Medical Device Quality Management Systems 15
M Quality Metrics Questions Lean in Manufacturing and Service Industries 2
K FDA Premarket Cybersecurity Guidance - 4 questions Other US Medical Device Regulations 5
A Some questions about voluntary consensus standards in traditional 510(k) submission US Food and Drug Administration (FDA) 6
T AMS2570E certification equipment questions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
Mr Roo ISO 9001 - 7.1.3 Infrastructure - questions concerning evidence ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
K AS9100 - 7.3 - Are these black and white questions with specific correct answers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
M Medical Device Identification & Codes - Article 27 Requirements questions EU Medical Device Regulations 1
Q VDA 6.3 questions vs IATF 16949 clauses VDA Standards - Germany's Automotive Standards 0
I Questions to ask when auditing for Organizational Leadership and Planning for the QMS? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A ISO13485:2016 name and ownership changes questions ISO 13485:2016 - Medical Device Quality Management Systems 3
C CQA Test Questions Bank General Auditing Discussions 1

Similar threads

Top Bottom