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COMPLIANCE
BLOG ARTICLES
Principles, Practices, & Insights


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 &...
Raimund Laqua
5 min read


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...
Raimund Laqua
3 min read


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...
Raimund Laqua
4 min read


A Safety Management System for Everyone
Adopting a Safety Management System (SMS) has typically required significant resources, large teams, and expensive technologies and...
Raimund Laqua
5 min read


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....
Raimund Laqua
8 min read


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...
Raimund Laqua
1 min read


Compliance Beetle Template
Turtle diagrams are often used to document processes in support of ISO standards and guidelines. However, they tend not to include...
Raimund Laqua
1 min read


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...
Raimund Laqua
3 min read


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...
Raimund Laqua
1 min read


Emergent Uncertainty
As systems improve we expect that the certainty of meeting objectives increases. Instead, what often happens is that systems become more...
Raimund Laqua
1 min read


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...
Raimund Laqua
2 min read


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...
Raimund Laqua
2 min read


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...
Raimund Laqua
3 min read


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...
Raimund Laqua
2 min read


Tyrannical Compliance
Companies often consider compliance as a "necessary evil" rather than a "necessary good." They sometimes feel they are forced to comply...
Raimund Laqua
4 min read


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...
Raimund Laqua
4 min read


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...
Raimund Laqua
3 min read


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...
Raimund Laqua
3 min read


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...
Raimund Laqua
4 min read


Overcoming Compliance Silos
Increasingly standards and regulatory bodies are promoting a holistic approach to compliance. However, many companies still implement...
Raimund Laqua
4 min read


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...
Raimund Laqua
2 min read


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,...
Raimund Laqua
2 min read


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...
Raimund Laqua
3 min read
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