To run a successful business, you want to make and distribute products that are at the right quality standard and that comply with the regulations of the countries of sale. I guess nobody will argue with that. But what do “Quality and Compliance” mean, in practice?They are often separated under different functions inside the same company. Why?Let’s look at … [Read more...] about Quality and Compliance of Imported Products
Quality
Understanding the context of your process
Context, the first lens of the 6CON process development framework, provides the development team with critical information against which they can readily make informed decisions. Context, by itself, does not eliminate the failure modes we have mentioned, but it is the foundation for the rest of the work to come, reducing the likelihood of the failure modes. The components … [Read more...] about Understanding the context of your process
The Purpose and Importance of Audit Trails
It is a general principle that well-managed audit trails are key indicators of good internal business controls. Over the last few decades, audit trails have transitioned from manual to automated electronic logs that make this historical information more accurate, readily accessible, and usable. This article will define an audit trail, what should be included, the importance … [Read more...] about The Purpose and Importance of Audit Trails
PFMEA: Learn How to Remove Error From a System With This 10 Step Guide
What is PFMEA? Process Failure Mode Effect Analysis explainedProcess Failure Mode Effect Analysis (PFMEA) is a Six Sigma methodology designed to identify risk and rate critical failure modes of a given process.PFMEA is traditionally applied to operating processes within the manufacturing industry and was developed with the notion that such processes are rarely … [Read more...] about PFMEA: Learn How to Remove Error From a System With This 10 Step Guide
ISO Certification and Risk Management Practices
ISO Certification Standard is an essential Certification for all major industry sectors and companies of any size and nature of work. There are numerous business benefits from getting an ISO Certification for an organization.Depending on the area of operation, the organization can choose from a wide variety of ISO Certification Standards for them to transform their business … [Read more...] about ISO Certification and Risk Management Practices
Unleashing the potential of internal audits: a review and research agenda
Research on internal audits of quality management systems is scarce, and no clear study exists that could guide practitioners in improving the auditing practice and help researchers advance existing knowledge. Thus, the aim of this paper is to review empirical research on internal audits of ISO 9001 to synthesise advice for increasing the value of internal audits and to … [Read more...] about Unleashing the potential of internal audits: a review and research agenda
Unleashing the potential of internal audits: a review and research agenda
Research on internal audits of quality management systems is scarce, and no clear study exists that could guide practitioners in improving the auditing practice and help researchers advance existing knowledge. Thus, the aim of this paper is to review empirical research on internal audits of ISO 9001 to synthesise advice for increasing the value of internal audits and to … [Read more...] about Unleashing the potential of internal audits: a review and research agenda
Determination of external and internal issues – The PESTEL Method (Part 2)
In this post, the second part of this title, I am going to describe a method, called PESTEL, which can be very useful for organizations to identify, analyze, prioritize and determine the relevant external issues, in accordance with Sub-clause 4.1 of the different management system standards.In the first part I commented on the need for the management system standards, in … [Read more...] about Determination of external and internal issues – The PESTEL Method (Part 2)
The Principles and Implementation of Lean Improvement
To succeed in today's hyper-competitive environment, organizations must strive to improve continuously. But, because that's easier said than done, forward-thinking business leaders have developed several structured improvement methodologies over the years. One of the most widespread is an approach that grew out of the Japanese automotive industry, Lean manufacturing. … [Read more...] about The Principles and Implementation of Lean Improvement
“DOCUMENTATION” IS A DIRTY WORD
I just skimmed through another 20 page planning document, written in old-school “requirements specification”-ese with a hefty dose of ambiguity. You know, things like “the Project Manager shall…” and “the technical team will respond to bugs.”There’s a lot of good content in there. It’s not easy to get at, though… for each page I want to understand, I can expect to spend between … [Read more...] about “DOCUMENTATION” IS A DIRTY WORD
Internal Auditing and Risk Determination
I've read through a few posts about this clause but I still don't think I quite get it.Currently we are ISO 9001 and transitioning over to IATF 16949 and I'm trying to make a 3 year audit calendar to spread out a few of our audits over this three year period.I believe that some processes can be audited every 2 or 3 years due to strong documentation and previous audits showing … [Read more...] about Internal Auditing and Risk Determination
Improving Quality, Decreasing Costs
Digital transformation initiatives that aim at getting manufacturers to Industry 4.0 have been around a while and will assuredly continue to be with us for quite a while longer. But what can often get lost by manufacturers in the push to digital transformation are the reasons why one would want to undertake this journey in the first place, which in turn should all boil down to … [Read more...] about Improving Quality, Decreasing Costs
Quality Metrics Reporting that Leads to the Best Behaviors
Quality metrics reporting includes reporting organizational costs, on-time delivery, non-conformance rates, lead times, cycle times, and profit.Organizations benefit when quality metric reporting occurs at the executive, operational, and supplier levels so that the best organizational actions or non-actions happen; however, this often does not occur.Commonplace reporting … [Read more...] about Quality Metrics Reporting that Leads to the Best Behaviors
Face of Quality: KPI Fundamentals
Peter Drucker, the famed author, educator, and management consultant, said “Efficiency is doing things right, effectiveness is doing the right things.” Whether individually or organizationally, the key to short and long-term success is to focus on the most important issues.The problem confronting many organizations is determining where to focus their efforts and how to measure … [Read more...] about Face of Quality: KPI Fundamentals
How to Measure Success with Key Performance Indicators (KPIs)?
Key performance indicators or KPIs are the important metrics for any organization to measure its success. They are used to evaluate the effectiveness of a company's strategy and operations. These indicators provide a clear picture of how well the company performs against its goals.A key performance indicator dashboard helps managers and employees understand the current state of … [Read more...] about How to Measure Success with Key Performance Indicators (KPIs)?
Quality Management Definitions: A Useful Resource
For ease of reference, we offer a round-up of quality management definitions – including commonly used terms in both project management and quality management circles.Below we’ve included:general quality definitionsdefinitions of some key ISO 9001 termsdefinitions of a range of quality management tools and techniques.General quality management definitionsThe following … [Read more...] about Quality Management Definitions: A Useful Resource
Supplier Selection Process
Suppliers are an integral part of any business, especially manufacturing. Supplier selection is the process of finding the right supplier for your business. It encompasses all the steps taken to find, select, and work with a supplier. Supplier selection is an essential part of making your product successful. The key to selecting the best suppliers is understanding what you … [Read more...] about Supplier Selection Process
What is a Business Process Improvement Methodology?
Business process improvement is a management practice that helps leaders leverage several tools and techniques to analyze their processes and uncover areas where improvement in accuracy, quality, and efficiency can be achieved. The leaders then work with process operators to redesign those processes to improve productivity and gain the expected improvements. Business process … [Read more...] about What is a Business Process Improvement Methodology?
Finding root causes, Part 1: 5-Whys
Last week I talked about what a "real root cause" actually is, but I didn't say much about how to find them. Maybe a couple more words would be helpful. There are several tools you can use to dig out a root cause from under a big pile of symptoms. The simplest one is called a "Five-why analysis," and you can think of it as "problem-solving by a bright, persistent … [Read more...] about Finding root causes, Part 1: 5-Whys
A Guide to Quality Risk Management
The main aim of any risk management plan is to make an adverse event less likely to be fatal to your business and reduce the damage done by similar threats when they happen again. All organizations should use risk identification, assessment and management to capitalize on their strengths and evaluate weaknesses.Similarly, quality management is a process that ensures your … [Read more...] about A Guide to Quality Risk Management