1. Quality management systems – Requirements6
Planning
6.1
Actions to address risks and opportunities
6.2
Quality objectives and planning to achieve them
6.3
Planning of changes
In Clause 9: the
organization is required
to consider risks and
opportunities when
determining what
needs to be monitored,
measured, analyzed and
evaluated
In Clause 4: the
organization is required
to determine risks that
can affect its ability to
meet objectives”
In Clause 6: the
organization is required
to plan and take action
to address risks and
opportunities
Risk
The concept of “Risk” is emphasized in new edition of ISO 9001, especially when used in relation to function of organizational planning.
Evaluation of risk;
Planning for risk;
What is acceptable?
What is unacceptable?
What is the probability?
What is severity?
How to avoid, mitigate or eliminate risk?
Opportunities
Encountered problems can be considered as an opportunity for improvement. Of course there are other ways to find opportunities. We can use special tools like SWOT analysis to list both opportunities and risks (see example in chapter 5).
To implement requirements in clause 6.1 we can use different tools like SWOT for identification of risk and opportunities, FMEA to define actions to avoid, mitigate or eliminate risk or some other tool.
In Clause 5: top
management are
required to commit to
ensuring Clause 4 is
followed
In Clause 8: the
organization is required
to have processes which
identify and address
risk in its operations
In Clause 10: the organization is required to improve by responding to changes in risk and opportunities

2. 6.1 Inventive principles that address risk and risk based thinking
There are several inventive principles in TRIZ that address risk and risk based thinking:
#9 Preliminary Anti-action (failure analysis and prevention techniques);
#10 Preliminary action (preparing in advance like preventive maintenance);
#11 Beforehand Cushioning (prepare emergency beforehand to increase reliability of the system);
#22 Blessing in Disguise (how to avoid, block or eliminate effects of harmful functions);
#39 Inert Atmosphere (i.e. risk based audit);
#40 Composite materials (dealing with risk using combination of different tools).
One of very useful TRIZ tools is Anticipatory Failure Determination (AFD)which is a tool for analyzing, predicting and eliminating failures in systems, products, and processes. 
References:
Svetlana Visnepolschi, How to Deal with Failures (The Smart Way), Ideation International Inc.,
Stan Kaplan, Svetlana Visnepolschi, Boris Zlotin and Alla Zusman, New Tools for Failure and Risk Analysis Anticipatory Failure Determination (AFD) and the Theory of Scenario Structuring, Ideation International Inc. 2005, ISBN ,
Philip B. Crosby explaining what should top management do for reliable organization

3. TRIZ tools for RISK management
References:
Svetlana Visnepolschi, How to Deal with Failures (The Smart Way), Ideation International Inc.,
Stan Kaplan, Svetlana Visnepolschi, Boris Zlotin and Alla Zusman, New Tools for Failure and Risk Analysis Anticipatory Failure Determination (AFD) and the Theory of Scenario Structuring, Ideation International Inc. 2005, ISBN ,
Separate conflicting requirements using “SEPARATION PRINCIPLES”
“TRIM” a system of unnecessary elements (less parts, higher reliability of a system)
Use “Anticipatory Failure Determination “(AFD) tool to identify possible failure points in a system.

4. EXAMPLE: how to reduce risk of Alcohol related traffic fatalities
Solution could be:
DON’T DRINK AND DRIVE
Example above shows how to use segmentation principles to separate causes of problem and how to identify which inventive principles can be used as sources for solution.
Select separation between conditions principle
These inventive principles have been used by inventors to solve similar problems.

5. 6.2 Quality objectives and planning to achieve them
We are going to show how QMS operates on strategic and operational level using PDCA approach.
Each management level is using its’ own PDCA loop. Both loops are connected and synchronized by information exchange.

6. P D C A QMS Top management Process owners
Plan: establish the objectives of the system and its processes, and the resources needed to deliver results in accordance with customers' requirements and the organization's policies;

7. P D C A QMS Top management Process owners
Do: implement what was planned;

8. P D C A QMS Top management Process owners
Check: monitor and (where applicable)
measure processes and the resulting
products and services against policies,
objectives and requirements and report the results;

9. P D C A QMS Top management Process owners
Act: take actions to improve performance, as necessary.

10. Business plan with quality objectives
QMS
Top management
Process owners
5.2
Quality policy
8.1
Target values P
6.1 and 6.2
Business plan with quality objectives
8.1
Action plan
6.1
Quality plan
Actions
FMEA,
SWOT D
Top management shall establish, implement
and maintain a quality policy and establish quality
objectives at relevant functions, levels and
processes needed for the quality management
system. C A

11. Business plan with quality objectives
QMS
Top management
Process owners
5.2
Quality policy
8.1
Target values P
6.1 and 6.2
Business plan with quality objectives
8.1
Action plan
6.1
Quality plan
Actions
FMEA,
SWOT D
The organization shall plan actions to address these risks and opportunities. C A

12. P D C A QMS Top management Process owners Quality policy Target values
5.2
Quality policy
8.1
Target values P
6.1 and 6.2
Business plan with quality objectives
8.1
Action plan
Actions
6.1
FMEA,
SWOT
Quality plan
Managing organization
according to Quality policy and objectives D
8.2 to 8.5
Operations as planned
The organization shall plan, implement and
control the processes needed to meet
the requirements for the provision of products
and services C A

13. P D C A QMS Top management Process owners Quality policy Target values
5.2
Quality policy
8.1
Target values P
The organization shall implement planned arrangements, at appropriate stages, to verify
that the product and service requirements have been met and control nonconforming output.
6.1 and 6.2
Business plan with quality objectives
10.2
8.1
Corrective
actions
Action plan
Actions
6.1
FMEA,
SWOT
Quality plan
9.1.3
Managing organization
according to Quality policy and objectives
Analyzing
data D
8.2 to 8.5
8.7
Operations as planned
Control of
nonconformities
Check
8.6
Check
Nonconformance C
9.2
Internal audits A
Customers

14. P D C A QMS Top management Process owners Quality policy Target values
5.2
Quality policy
8.1
Target values P
6.1 and 6.2
Business plan with quality objectives
10.2
8.1
Corrective
actions
Action plan
Top management shall review the organization's
QMS, at planned
Intervals.
Actions
6.1
FMEA,
SWOT
6.1
Quality plan
9.1.3
Managing organization
according to Quality policy and objectives
Analyzing
data D
8.2 to 8.5
8.7
Operations as planned
Control of
nonconformities
Check
8.6
Check
Nonconformance C
9.2
Internal audits
9.3
Management review
Analyzing results and action taking A
Customers
9.3.3
9.1.2

15. P D C A QMS Top management Process owners Quality policy Target values
5.2
Quality policy
8.1
Target values P
6.1 and 6.2
Business plan with quality objectives
10.2
8.1
Corrective
actions
Action plan
Actions
6.1
FMEA,
SWOT
Quality plan
9.1.3
Managing organization
according to Quality policy and objectives
Analyzing
data D
8.2 to 8.5
8.7
Operations as planned
Control of
nonconformities
Check
8.6
Check
Nonconformance C
9.2
Internal audits
9.3
Management review
Analyzing results and action taking A
Customers
9.3.3
9.1.2

16. Practical example PLAN DO CHECK ACT Company owners Top management
Process owners
Project manager and experts
Corrective & preventive actions
Quality policy C
Business plan with quality objectives A
NOT OK
PLAN
Approval
Targets
Analysis
of NC OK
Approved
business plan
Process plan
Action plan
Work according to plan
Work according to plan DO
Work according to plan
Non
conformance
Checking
Checking
Quarterly
Checking
monthly
CHECK
Prototype production
(vendor)
Audit
report
Auditing
Non
conformance C A
Checking
Analyzing results
Monthly
Quarterly
Customer
Annual report
Non
conformance
ACT
Annual management review
Checking
Customer satisfaction feedback
Analysis of customer perception of quality