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Quality management systems – Requirements
6 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 4: the organization is required to determine risks that can affect its ability to meet objectives”
In Clause 5: top management are required to commit to ensuring Clause 4 is followed
In Clause 6: the organization is required to plan and take action to address risks and opportunities
In Clause 8: the organization is required to have processes which identify and address risk in its operations
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 10: the organization is required to improve by responding to changes in risk and opportunities
6.1 Inventive principles that address risk and risk based thinking
Philip B. Crosby explaining what should top management do for reliable organization
TRIZ tools for RISK management
• 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.
EXAMPLE: how to reduce risk of Alcohol related traffic fatalities
Solution could be:DON’T DRINK AND DRIVE
These inventive principles have been used by inventors to solve similar problems.
Select separation between conditions principle
6.2 Quality objectives and planning to achieve themWe 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.
QMS
P
D
C
A
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;
QMS
P
D
C
A
Top management Process owners
Do: implement what was planned;
QMS
P
D
C
A
Top management Process owners
Check: monitor and (where applicable)measure processes and the resultingproducts and services against policies,objectives and requirements and report the results;
QMS
P
D
C
A
Top management Process owners
Act: take actions to improve performance, as necessary.
QMS
P
D
C
A
Top management Process owners
Quality policy
Business plan with quality objectives
Target values
Action plan8.1
6.1 and 6.2
5.2
8.1
Top management shall establish, implementand maintain a quality policy and establish qualityobjectives at relevant functions, levels andprocesses needed for the quality managementsystem.
Actions
6.1
FMEA, SWOT
Quality plan
QMS
P
D
C
A
Top management Process owners
Quality policy
Business plan with quality objectives
Target values
Action plan8.1
6.1 and 6.2
5.2
8.1
The organization shall plan actions to address these risks and opportunities.
Actions
6.1
FMEA, SWOT
Quality plan
QMS
P
D
C
A
Top management Process owners
Quality policy
Business plan with quality objectives
Managing organizationaccording to Quality policy and objectives
Target values
Action plan
Operations as planned
8.1
8.2 to 8.5
6.1 and 6.2
5.2
8.1
The organization shall plan, implement andcontrol the processes needed to meetthe requirements for the provision of productsand services
Actions
6.1
FMEA, SWOT
Quality plan
QMS
P
D
C
A
Top management Process owners
Quality policy
Business plan with quality objectives
Managing organizationaccording to Quality policy and objectives
Target values
Action plan
Operations as planned
Check
Control ofnonconformities
Correctiveactions
Analyzing data
Nonconformance
Internal audits
8.1
8.2 to 8.5
9.2
8.7
9.1.3
10.2
8.6
6.1 and 6.2
5.2
8.1
Check
Customers
The organization shall implement planned arrangements, at appropriate stages, to verifythat the product and service requirements have been met and control nonconforming output.
Actions
6.1
FMEA, SWOT
Quality plan
QMS
P
D
C
A
Top management Process owners
Quality policy
Business plan with quality objectives
Managing organizationaccording to Quality policy and objectives
Management reviewAnalyzing results and
action taking
Target values
Action plan
Operations as planned
Check
Customers
Control ofnonconformities
Correctiveactions
Analyzing data
Nonconformance
Internal audits
8.1
8.2 to 8.5
9.2
9.1.2
8.7
9.1.3
10.2
8.6
6.1 and 6.2
5.2
9.3
8.1
Quality plan
Check
6.1
9.3.3
Top management shall review the organization's
QMS, at plannedIntervals.
Actions
6.1
FMEA, SWOT
QMS
P
D
C
A
Top management Process owners
Quality policy
Business plan with quality objectives
Managing organizationaccording to Quality policy and objectives
Management reviewAnalyzing results and
action taking
Target values
Action plan
Operations as planned
Check
Customers
Control ofnonconformities
Correctiveactions
Analyzing data
Nonconformance
Internal audits
8.1
8.2 to 8.5
9.2
9.1.2
8.7
9.1.3
10.2
8.6
6.1 and 6.2
5.2
9.3
8.1
Quality plan
Check
9.3.3
Actions
6.1
FMEA, SWOT
Practical example
Companyowners
Top management Process owners Project manager and experts
P LAN
Quality policy
CHEC
KAC
TD
O
Business plan with quality objectives
Process plan
Approval
Approvedbusiness plan
OK
Work according to plan
Checkingmonthly
Analyzing results Monthly
Quarterly
Action plan
Targets
Work according to plan
Checking
Customer
Customer satisfaction feedbackAnalysis of customer
perception of quality
Work according to plan
Annual report
CheckingQuarterly
AuditingAuditreport
Corrective & preventive
actions
Non conformance
NOTOK
Annual management review
Prototype production(vendor)
Checking
Non conformance
Checking
Non conformance
Analysisof NC
AC
A
C
