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 &...
top of page
Blog Posts
- Apr 23, 2020
- 3 min
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...
85 views
- Apr 22, 2020
- 4 min
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...
137 views
- Feb 27, 2020
- 5 min
A Safety Management System for Everyone
Adopting a Safety Management System (SMS) has typically required significant resources, large teams, and expensive technologies and...
71 views
- May 23, 2019
- 8 min
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....
5,081 views
- Apr 21, 2019
- 1 min
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...
18 views
- Nov 15, 2018
- 1 min
Compliance Beetle Template
Turtle diagrams are often used to document processes in support of ISO standards and guidelines. However, they tend not to include...
85 views
- Aug 20, 2018
- 3 min
Confessions of a QA Manager
We thought we were doing OK. We really did. I guess we were wrong. We consider ourselves an ethical company and take quality very...
13 views
- Aug 17, 2018
- 1 min
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...
41 views
- Aug 11, 2018
- 1 min
Emergent Uncertainty
We expect that as systems improve that the certainty of meeting objectives increases. Instead, what often happens is that systems become...
81 views
- Apr 30, 2018
- 2 min
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...
21 views
- Mar 28, 2018
- 2 min
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...
91 views
- Mar 26, 2018
- 3 min
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...
107 views
- Mar 19, 2018
- 2 min
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...
17 views
- Jan 29, 2018
- 3 min
Tyrannical Compliance
Companies often consider compliance as a "necessary evil" rather than a "necessary good." They sometimes feel they are forced to comply...
54 views
- Dec 11, 2017
- 4 min
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...
278 views
- Nov 27, 2017
- 3 min
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...
495 views
- Nov 14, 2017
- 3 min
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...
93 views
- Oct 18, 2017
- 4 min
ISO 9001:2015 – More Than Re-writing Procedures
Every company currently certified for ISO 9001 will need to re-certify against 9001:2015 by the end of 2018. This transition brings along...
36 views
- Oct 2, 2017
- 5 min
Overcoming Compliance Silos
It seems more and more that standards and regulatory bodies are promoting a holistic approach to compliance. However, many companies...
177 views
- Sep 8, 2017
- 2 min
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...
624 views
- Aug 28, 2017
- 2 min
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,...
29 views
- May 10, 2017
- 3 min
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...
138 views
bottom of page