Training and quality: peas in a pod

Posted on May 18, 2011 by Paul Leavoy

According to experts, though the connection can seem distant or indirect, proper training has a clear impact on quality, just as it has a clear impact on every aspect of business.

As business process design and ISO 9001 expert Chris Anderson noted in a blog post on the top ten root causes of business problems, poor training is the number one source of business issues. Two decades of business management led Anderson to place poor training ahead of poor methods, poor employee placement and poor engineering and design on the list.

“People don’t make mistakes,” Anderson insists in the post. “Systems make mistakes.”

And just as product and service quality issues arise from systemic deficiencies, employee performance — and its impact on quality — is correlative to the integrity of training management systems.

Training and quality are best thought of as peas in a pod — inseparable elements that should always be mentioned in the same sentence. Even if an organization feels it is 100 per cent where it needs to be from a quality perspective, training is essentially what got it there.

Best-in-class companies have thorough, streamlined training management programs (most often leveraged by software) that deliver measurable results. For those that overlook thorough training, it might be due to lack of time and other resources. However, such an oversight often leads to harsh ramifications: product recalls, brand damage, injuries, fatalities and bankruptcy.

First FSMA rules in effect July 3. Are you ready?

Posted on May 6, 2011 by Paul Leavoy

Earlier this week the U.S. Food and Drug Administration (FDA) announced the first set of rules under the landmark Food Safety Modernization Act (FSMA), legislation signed earlier this year which gives the FDA sweeping powers to prevent food safety disasters.

The two new rules, which take effect July 3, are pretty logical preventive measures that, in all fairness, probably should have been implemented a long time ago. The new rules are as follows:

Order on Administration Detention of Food: The first new rule gives the FDA the authority to hold food products that may be contaminated or mislabeled. Before now, the administration only had the right to detain food when it had sufficient evidence it was mislabeled or contaminated, thereby presenting a threat to humans or animals. Now if the FDA even suspects contamination or mislabeling, it can detain the product.
Rule on Imported Food: Organizations importing food now have to disclose whether another country has rejected or refused the product. With this information, the FDA will be better equipped to target foods that may pose a risk to public health.

The new regulations are the first in what will be an ongoing stream of new rules determining how the FSMA affects organizations across the U.S., but also adds to the Act’s current scope, which includes legislative components that took affect earlier this year when it was signed into law, including the following:

If the FDA determines a reasonable probability of serious adverse health consequences in any food product, it may demand records of other food products affected in a similar manner.
If the FDA finds a “reasonable probability” food has been misbranded, adulterated, or capable of generating serious adverse health consequences, it may issue a mandatory recall.
Whistleblowers who report violations or testify benefit from increased protection from any form of reprisal.
The FDA has already increased the frequency of inspections and also uses a risk-based model to prioritize inspections.

As more FSMA rules are come down the pipes in the next 12 months, and as the new requirements take effect July 3, it is up to all U.S. Food and Beverage businesses to take action now, by implementing food safety management systems, documenting detailed food safety plans, focusing on companywide hazard identification and risk mitigation (along the lines spelled out in HACCP), and prepare for a higher frequency of inspection.

Veteran product and UI design expert joins Intelex’s growing team

Posted on April 19, 2011 by Paul Leavoy

Intelex is thrilled that veteran product management and design expert Joe Di Vittorio has joined our expanding team as Vice President of Product Management. Joe will help us deliver enhanced product strategy as we enter its next phase of global growth.

Uniquely prepared to take on the challenge, Joe brings a wealth of user interface and design experience to the company. He’s helped build industry-leading software in diverse sectors, including financial risk management, 3D real estate visualization, electronic tablet-based sketching tools, and more – not to mention a sketching product, Alias Sketchbook, that was eventually ported to mobile divices and became one of the best-selling apps on iPad and iPhone.

In addition to his work in software design, Joe has a Master’s degree in a psychology with specialization in the one-of-a-kind area of Human-Computer Interaction (HCI). Read more over in our Press Room. Welcome, Joe!

Five Ws: Avoiding the nightmare of a product recall

Posted on April 11, 2011 by Paul Leavoy

Eggs. Toy trucks. Spinach. Meds. And now walnuts.

Recalls — and not the good kind — are a daily reality within an interconnected, modern global economy. But for the unprepared business, a product recall can be a logistical and PR nightmare, costing significant capital, and precious hours of downtime as well as — perhaps most significantly — irreparable damage to delicately nurtured brand image.

Since consumer activist agencies and public awareness at large tend to be a few steps ahead of legislators and regulatory bodies on public safety concerns, it is imperative businesses stay a few steps ahead of the game. For companies that rely on contract manufacturers, this can be easily achieved with a comprehensive quality management system (QMS).

Some essential questions — often rendered complex by the size and scope of large corporations — can be resolved with straightforward answers if an electronic QMS has been put into place.

For example, an electronic QMS is capable of providing quality managers the answers to what are known as the ‘five Ws’ of product recalls:

What: In the event of a product recall, the fundamental reason for the recall will narrow-down investigative work and help quality managers build a list of questions and criteria to determine who in the supply chain is responsible for the defect or issue in question.
Who: A company that relies on contract manufacturers around the world must determine which supplier within its supply chain is associated with the defective or unsafe part or product.
Where: The “who” and “where” questions are intrinsically related, for once it is established who is responsible for the issue, it can be broadly determined where the issue arose. But it is also essential to isolate where exactly — specifically within the manufacturing line of the contract supplier, for example — the defect was caused.
When: Supply chains can be complex systems, but it is important to have the capacity to determine when a defect or issue arose within the system.
Why: The other ‘Ws’ of product recalls will help a quality manager determine why a defect or issue arose. Answering this question quickly and effectively will help a business develop an action plan to respond to the product recall.

Quality managers strive for the often elusive goal of perfection but must come to grips that even in the most highly monitored systems and well-oiled machines, somewhere, somehow — by the laws of probability and human fallibility — an issue will likely arise. This probability is mitigated, however, if an electronic QMS has been implemented in the place of archaic spreadsheet- or paper-based tracking and supply chain traceability systems.