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Knowledge and Insights for Compliance Success

Compliance Capabilities

Compliance is often organized into isolated functions that are separate from the production management structure. However, we know that...

Proactive Compliance

Compliance is much more than checking boxes and addressing non-conformance when it is discovered. It is about experiencing the benefits...

Compliance Goals

When we think about compliance we should also think about the goals we want to achieve. An important distinction we can make is between...

Compliance Chain Analysis

Harvard Business School's Michael E. Porter introduced the concept of a value chain in his book, " Competitive Advantage: Creating and...

What Will People Be Doing 20 Years from Now?

It is common nowadays to come across articles that claim that robots and AI will take over people's jobs. Some might even argue that this...

Tyrannical Compliance

Companies often consider compliance as a "necessary evil" rather than a "necessary good." They sometimes feel they are forced to comply...

The State of Digital Transformation

It is easy to be sympathetic with those developing digital technologies that are frustrated with the relatively slow adoption of digital...

Crossing The Ethical Chasm of Data Mining

Collecting evidence is an important aspect in providing assurance of compliance. This evidence often comes in the form of data and plenty...

Are You Being Nudged Into Compliance?

The answer is yes and you have been for some time. Nudging is broadly used today in many domains including governments to addresses...

Compliance Helps Companies Stay Within The Lines

Someone once asked the question, "why do cars have brakes?" The answer given was, "so they can go fast!" What brakes do for cars is what...

Compliance Compass To Make Certain You Are Always in Compliance

The Hoshin Kanri method is a popular LEAN approach used to align strategy with outcomes. It uses what is called an X-Matrix that...

API RP 1173 – Taking Ownership of Your Obligations

"Pipeline process management includes determination of needs throughout the pipeline life-cycle, provision of sufficient human and...

Four Steps to Proactive Compliance

More companies are becoming aware that they are too reactive when it comes to compliance. In my previous blog, I discussed four misuses...

Four Misuses of Audits

Audits were first adopted by financial institutions to identify and prevent fraud. Their focus was to test the integrity of accounting...

Ethical Compliance

Technology is advancing faster and further than our ability to keep up with the ethical implications. This applies also to the systems using

Problem with Risk Scores

Risk scores are commonly used to support risk-based decisions and are usually derived from a semi-quantitative analysis of the underlying...

Risk-Based CAPA?

Many companies are in the midst of adopting changes introduced by ISO 9001:2015. One of the most significant of these, is incorporating...

5 Ways Risk Management Has Changed

Recent revisions to compliance standards and regulations have introduced changes to the way we think about and manage risk. You can look...

Operational Risk: Where do risks come from?

Risk-based thinking is at the center of recent changes to compliance standards, guidelines, and regulations. One of the areas where...

RISK: Losing Your Social License

All too often companies find that they are only one accident, one explosion, one fatality, or one recall away from not only losing their...

ISO 9001:2015 – More Than Re-writing Procedures

Every company currently certified for ISO 9001 will need to re-certify at some point in time. This is an opportunity to go beyond just...

Overcoming Compliance Silos

Increasingly standards and regulatory bodies are promoting a holistic approach to compliance. However, many companies still implement...

Moving Compliance to the Performance Zone

Compliance is often viewed as a cost of doing business. However, instead of viewing compliance only as an expense and something to...

Why You Need a Compliance Architect

In a world of competing and overlapping compliance demands, siloed departments, and numerous stakeholders the role of an architect is...