Risk-based thinking, PDCA and the Process approach

It is much more effective if Quality is “built in” to each stage of the process, whether we are considering a manufacturing or a service organisation. The risk-based thinking approach very much applies here! An organisation needs to plan and implement actions to address risks and opportunities.
So, the key point is to have systems and procedures in place which control rejects occurring in the first place – and when a problem does occur (as it will in a real world!) take corrective action.
Risks that may impact on objectives and results must be addressed by the management system. Risk-based thinking is used throughout the process approach.
• Decide how risk (positive or negative) is addressed in establishing the processes to improve process outputs and prevent undesirable results
• Define the extent of process planning and controls needed (based on risk)
• improve the effectiveness of the quality management system
• maintain and manage a system that inherently addresses risk and meets objectives

The ISO organization says:
“By considering risk throughout the organization the likelihood of achieving stated objectives is improved, output is more consistent and customers can be confident that they will receive the expected product or service.”
Risk-based thinking therefore:
▪ builds a strong knowledge base
▪ establishes a proactive culture of improvement
▪ assures consistency of quality of goods or services
▪ improves customer confidence and satisfaction