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Max Coller, Quality Systems Engineer, SMMT Industry Forum

Risk based thinking – putting the “R” into PDCA

Join the conversation: #AQMS2018

Team Leaders


“Risk” in ISO9001: 2008 or ISO/TS16949: 2009

?


“Risk” in ISO9001: 2008 or ISO/TS16949: 2009

ISO9001:2008

• 1 reference in introduction

• No mention directly to risk in the requirements (Preventive action)

ISO/TS16949: 2009

• Feasibility review (7.2.2.2) *Inferred in:

• Potential Failure Mode and Effect Analysis (FMEA)

• Contingency planning

ISO9001:2015

• 16 references in introduction

• 8 auditable requirements

IATF 16949: 2016

• 59 times the word “risk” appears

• 51 times in the requirements


“Risk” definition

Within your teams agree a definition of “Risk” and

give an example

“Risk “ =

Example :



ISO 31000 : 2018 – Risk Management Guidelines

Terms & Definitions 3.1 risk effect of uncertainty on objectives

Note 1 to entry: An effect is a deviation from the expected. It can be positive, negative, or both. Note 2 to entry: Objectives can have different aspects & categories, and can be applied at different levels Note 3 to entry: Risk is usually expressed in terms of risk sources (3.4), potential events (3.5), their consequences (3.6), and their likelihood (3.7)



A Guide to the Project Management Body of Knowledge (PMBOK Guide Fifth edition)

[project] risk… • is an uncertain event or condition that, if it occurs, has a positive or negative

effect on one or more project objectives such as •Scope •Schedule •Cost •Quality

• may have one or more causes. A cause may be a given or potential requirement, assumption, constraint, or condition that creates the possibility of negative or positive outcomes



A Guide to the Project Management Body of Knowledge (PMBOK Guide Fifth edition)

Known risks

(identified & analysed)

Plan risk responses

Manageable?

Assign contingency

reserve

Yes

No

Unknown risks

Assign management

reserve

Cannot be managed proactively


Risk Consideration

In your groups, identify an internal or external

business theme or trend.

Assess the level of risk associated with the theme along with possible actions to

address the risk.

ThemeLevel of

Risk

Possible

Actions


Risk Consideration





Categories of Objectives Levels of Risk Management Applicaiton

Note 2 to entry: Objectives can have different aspects & categories, and can be applied at different levels

Disaster recovery

plans

Project risks & issues

Technical risk - FMEA

H&S risk assessments

Contingency plans

Facilities Suppliers

Feasibility @ contract review

risks in a new contract

compliance matrix


How?

ISO 9001 : 2015 – Quality Management Systems

Planning 6.1. Actions to address risks & opportunities 6.1.2 The organization shall plan: a) actions to address these risks and opportunities; b) how to:

1) integrate and implement the actions into its quality management system processes (see 4.4); 2) evaluate the effectiveness of these actions.

Actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of products and services


How?

IATF16949– Quality Management System for organizations in the automotive industry

Planning 6.1.2.1 Risk analysis The organization shall include in its risk analysis, at a minimum, lessons learned from product recalls, product audits, field returns and repairs, complaints, scrap, and rework. The organization shall retain documented information as evidence of the results of risk analysis.


Who?


Leadership 5.1 Leadership & Commitment Top management shall demonstrate leadership and commitment with respect to the quality management system by: … d) promoting the use of the process approach and risk-based thinking; …


Who?


4.4 Quality management system and its processes 4.4.1 … The organization shall determine the processes needed for the quality management system and their application throughout the organization, and shall: a) determine the inputs required and the outputs expected from these processes; b) determine the sequence and interaction of these processes; c) determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes; d) determine the resources needed for these processes and ensure their availability; e) assign the responsibilities and authorities for these processes; f) address the risks and opportunities as determined in accordance with the requirements of 6.1; g) evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results; h) improve the processes and the quality management system.


Process Approach

OWNER

RISKS

CHECK

• product audits • field returns • repairs • complaints • scrap • rework


Process Approach



Max Coller, Quality Systems Engineer, SMMT Industry Forum

Risk based thinking – putting the “R” into PDCA



Backup


Contingency reserve vs management reserve

https://pmstudycircle.com/2012/02/contingency-reserve-vs-management-reserve/

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