Change and Risk-Based Thinking

In product design as well as manufacturing, any form of change invites risk

Management of change is a safety-related phrase from the chemical process industry that is adaptable to risk-based thinking. The basic premise is that anything new, different, or nonroutine (such as repairs or replacement of equipment, and process startups) creates a safety risk.

This principle was recognized more than 80 years ago at the Ford Motor Co. “The point is that a condition is temporarily presented which departs from the routine,” notes Edwin Norwood in Ford Men and Methods (Doubleday, Doran, 1931). “That is the thing that must be continually guarded against—accidents which may occur in the face of the unusual.” This is why, for example, work permits are often required for activities like welding, confined-space entry, and equipment maintenance. In the latter case, lockout-tagout excludes all forms of mechanical, thermal, and electrical energy from the system while workers are in contact with it.

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Assessing Risk of Change

Nicely done! The assessment of changes has been one of the weakest part of supplier, design and process control. Too often, seemingly 'minor' changes have negative or even catastrophic results form unintended or unknown changes or unkown effects. The baffling thing is the persistent and virulent resisitance by the 'changers' to assess and propely verify & validate their changes. ISO does have a section that addresses this situation directly and explicitly (7.3.7, control of design and development changes) and many customers mandate that suppliers notify them of any change to the supplied product, yet 'changers' still resist. In almost every organization that I've been in, I've met with this resistance. It persists even in the face of overwhelming evidence of the damage done by un-tested changes. Certainly not every change ceates a negative result and this can lull the changer into a false sense of superiority over physics. When presented with evidence that the cost of the 1 change that resulted in a negative consequence far outweighs the savings of the 9 un-assessed and untested changes, too many changers maintain a firm belief that it won't happen to them. (Of course the fact that the negative consequence doesn't happen to them escapes them; it happens to the organization and the customers.)