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risk management


Introduction –

A Risk Based Process Improvement Program (RBPIP) is a method of applying the ISO 9001:2015 standards to an organization’s everyday activities.  By adopting RBPIP, an organization can create a competitive advantage in a marketplace that is crowded with competition. Creating RBPIP alone is not sufficient to insure maximum benefits, it will need to be implemented with tools appropriate to disseminating the program throughout the organization, from the executive suite to the front line interacting with product, customers and vendors.  The key to maximizing initiatives this powerful is insuring everyone in the organization is aware of and capable of adopting these processes easily into their daily activities, not saving up the activity for the times right before audits.  Every company has a Quality Culture:  how Quality influences the way they do their everyday job tasks.  RBPIP, when implemented from the top down and the grassroots up, will ensure a culture of systematic and continuous improvement, and not just compliance.

Summary –

Dealing with defects and problems has always been clear for thousands of years: human intuition pushes to fix wounds, and illness. Actions taken to prevent illness and wounds is discretionary. It also requires making changes to life’s routine processes (process improvement), which costs efforts and resources, and has no guarantees. Same is true in business and industry.

The challenge over the last 30+ years, has been on how to choose which processes to improve. The 1994 version of ISO 9001 pointed to the evaluation of risk as the method. Even the ISO 9001:2015 2015 does not directly ask for a risk assessment prior to taking corrective action. In fact, the close proximity of Nonconformance and Corrective Actions in clause 10.2 poses a risk of some people taking action of changing processes, when such action might not be warranted.

The solution is to go back to basics: Design the product, Monitor and collect data, Evaluate data per priority rules, and perform Risk Assessment on selected candidates, finally: improve the processes that warrant improvement. In other words—horror of horrors: decouple defect prevention from defect disposition.

We are in the age of automated systems, and data analysis. Let’s use this to help use our money and time to pin-point our resources where we can get the most return. This in turn will upgrade our quality culture to a “Culture of Quality”, so that it becomes a habit.

We are calling this approach as the Risk Based Process Improvement Program, and is shown graphically below, and stands on the Four Pillars of RBPIP:

The Four Pillars – (SMDI)

  1. Specifications & Objectives: Setting
  2. Monitoring: Detecting & Dispositioning NCs
  3. Data: Collection, Analysis, Risk Detection and Assessment
  4. Improvement: Risk Based Process Improvement Program (RBPIP)

Risk Based Process Improvement Plan (RBPIP) Components

Risk Based Process Improvement Plan (RBPIP) Components –

  • Monitor products and processes against specifications and objectives, collect data
  • Evaluate data per priority guidelines
  • Collect candidates for Risk Evaluation
  • Conduct Risk Evaluation and prioritize
  • Analyze cause(s) of defects
  • Design/ Redesign process
  • Implement improved process
  • Operate new process, and monitor


I would love to have a discussion on this concept. If you would agree to join the conversation, please call, send me an e-mail, or visit our Blog.

Wali Alam

The following related PowerPoint was presented at the American Society for Quality (ASQ) as the Keynote program on January 18, 2017

You can download the presentation here

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