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Knowledge and Insights for Compliance Success


The Problem with Assessments
Assessments are the fuel that power both step-wise and continuous improvement engines and this is no different when it comes to risk &...
385 views


Better Compliance Done a Better Way
According to Albert Einstein: Insanity is doing the same thing over and over again and expecting different results. And yet, that is...
91 views


Are You Auditing What Really Matters?
Audits have been used for many years to confirm the integrity of financial statements and that proper accounting procedures have been...
146 views

A Safety Management System for Everyone
Adopting a Safety Management System (SMS) has typically required significant resources, large teams, and expensive technologies and...
76 views

What is Management of Change
Change can be a significant source of risk. That is why compliance programs include a risk-based process for managing planned changes....
6,152 views

How do you change culture?
There is much discussion these days about the need to create an improved safety culture particularly in high-risk, highly-regulated...
24 views

Compliance Beetle Template
Turtle diagrams are often used to document processes in support of ISO standards and guidelines. However, they tend not to include...
115 views


Confessions of a QA Manager
This is a work of fiction. Names, characters, businesses, places, events, locales, and incidents are either the products of the author's...
25 views


Why is focusing on non-conformance missing the point?
Focusing on non-conformance is the first level of compliance. This involves meeting the prescriptive part of a regulation or industry...
44 views

Emergent Uncertainty
As systems improve we expect that the certainty of meeting objectives increases. Instead, what often happens is that systems become more...
107 views


If There Is Care You Will Find Quality
Recently I spoke with a retired CEO of a successful semiconductor manufacturer who said to me when I asked him about quality, "if there...
40 views

Moving Beyond the Conformance Zone
One of the challenges companies face when addressing compliance is its dynamic nature – compliance is never at rest. Even when you decide...
126 views

The Qualitative Nature of Quality
The purpose of a quality program is fundamentally to improve the quality of something. However, with today's focus on quality systems and...
141 views


Are we there yet?
When my children were younger we would regularly go on road trips to visit family. Five minutes after leaving the house they would start...
18 views


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

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...
328 views

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...
662 views

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...
111 views


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...
52 views

Overcoming Compliance Silos
Increasingly standards and regulatory bodies are promoting a holistic approach to compliance. However, many companies still implement...
229 views


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...
853 views

Keep Your Workers and Improve
One of the key misconceptions about LEAN is that its goal is to reduce the workforce. No wonder people might resist adopting it. However,...
31 views

Does Compliance Hinder Innovation?
Innovation is necessary for growth and often requires that risks are taken. However, a common sentiment is that compliance is getting in...
186 views
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