Nonconformance vs. CAPA: Three Key Questions

Communicating the differences between nonconformances (NCRs) and corrective/preventive actions (CAPAs) to staff can be challenging. It’s extremely important, too, that everyone fully grasps the distinctions — because consistency in using your organization’s quality management system will directly contribute to the accuracy of your metrics. Furthermore, this will impact the quality of the insights that can be generated by studying them.

In ISO 9001:2015, there is a defined progression between nonconformity, correction, and corrective action:

  • A nonconformity occurs when a requirement is not fulfilled. The result of a nonconformity, according to Hoyle (2017), is a failure to meet product requirements, carry out a task as required, or meet customer or stakeholder requirements.
  • A correction is the step taken to remedy that single nonconformity. Removing the nonconformity does not prevent the issue from happening again. The result of a correct is to prevent the nonconformity from advancing further in the process.
  • A

Learning to Love OSHA Inspections

Do you live in fear of OSHA safety inspections? Sure, you think your ducks are more or less in a row, but the spectre of surprise inspections hovers over you like a storm cloud on the horizon.

When you clean your house thoroughly from top to bottom, doesn’t a part of you kind of wish company would drop by unexpectedly?

Can you imagine actually looking forward to a surprise OSHA inspection?

It’s easier than you think, but just as maintaining a clean house takes sustained effort, you’ll have to make thorough safety management a part of your day-to-day regime. The following tips will help you prepare for and even embrace surprise inspections:

Know Thyself: It is critical to track all safety-related information and to maintain detailed documentation on your organization’s safety record. Also, note which industry category your business falls within and whether your sector is considered high-risk. The … Read more...

The ASQ World Conference for Quality and Improvement: May 18-20, 2009

The ASQ World Conference for Quality and Improvement is being held at the Minneapolis Convention Center in Minneapolis, Minnesota from May 18-20, 2009. This year, Intelex will be sending three representatives; Bevin Lyon, Daniel Marcus, and Tomas Kuras. The guys will be available for live demonstrations of our:

  • Quality Management System
  • Nonconformance & Corrective Actions Module
  • Document Control System
  • Training Management System
  • Supplier Performance Tracking Module
  • Audits Management System, and more.

If you’re already using Intelex’s software please stop by for a visit! It’s always great to catch up with clients.… Read more...

Using Technology to Cultivate a Culture of Safety

Workplace accidents and fatalities are a common occurrence, but many safety incidents could have been avoided through improved training management, accurate data reporting, internal audits, and generating a culture of safety within an organization.

The American Society of Safety Engineers has published a great, unbiased article titled “Technically Safe: Gaining 360◦ Visibility with Technology” by Peter Thiveos. The article addresses the key components of a successful safety management program, business rules and practical solutions, the value of designating a safety champion, and the benefits of using technology to improve an organization’s safety performance.

Mr. Thiveos speaks to the need for a comprehensive system that addresses multiple facets including; training and certification management, incident and observation management, records and document management, risk assessment, monitoring and audit management, and corrective action management. “While all these systems have inherent benefits independently, collectively they provide unparalleled functionality and improvements in managing, compiling and reporting … Read more...

Make Your Job Easier with the OpenPass API

Technologies has released its latest software innovation, the Intelex OpenPass
API, a revolutionary application programming interface that will enable its
users to sync and report data between multiple business management systems.

The Intelex
OpenPass API functions as a conduit for seamlessly feeding data between
multiple software programs. This means that Intelex’s environment, quality, and health & safety, and business management Software can now share data with pre-existing
business software applications; thereby, saving time and resources while
maintaining a degree of accuracy that’s difficult to achieve when data is
transmitted manually.

The City of Calgary
and St. Gobain are the first Intelex clients to take advantage of the OpenPass
API.  The City of Calgary used our
OpenPass API to import employee and location data from their pre-existing HR system
into their Intelex System. They also used the OpenPass API to export employee
injury data (i.e., incident number with date …

Another Successful EUEC

(Above: EUEC Energy & Environment Conference 2009 in Phoenix, Arizona)

(Above: Intelex's Steve Ross & Dan Marcus with Intelex Users and colleagues)

The EUEC Energy & Environment Conference was a great source for industry news and best practices, but this year's
conference was particularly relevant in light of President Obama's
proposed renewable energy initiatives, which include "Implementing an economy-wide cap-and-trade program to reduce greenhouse gas emissions 80 percent by 2050," and "Helping create five million new jobs by strategically investing $150
billion over the next ten years to catalyze private efforts to build a
clean energy future." (White House Agenda – Energy & Environment).

Information on managing Greenhouse Gas Emissions and other environmental initiatives.… Read more...

21 CFR Part 11 Compliant

21 CFR Par 11Congratulations to Energizer on becoming 21 CFR Par 11

In the digital age, electronic records and signatures have
made paper documents and hand-written signatures an increasingly rare
occurrence. To address this shift in standard business procedures, the US Code
of Regulations instituted Title 21 CFR Part 11, which legitimizes electronic
records and signatures by clearly defining the criteria under which an
electronic record or signature can be accepted as valid. 

Industries most commonly affected by Title 21 CFR Part 11
typically fall under the regulatory standards established by the USA Food and
Drug Administration. To help our clients achieve Title 21 CFR Part 11 compliance,
Intelex has added dual-signature functionality to our system. This means that
like Energizer, other Intelex Users can assign dual-signature authorization requirements to their critical business
records.…

Using Intelex’s Quality & Environmental Web Systems to Get ISO Registered

It's not uncommon to hear about
organizations working feverishly to develop effective quality and environmental
management programs so that ISO 9001 or ISO 14001 certifications can be
attained. While securing these
certifications is a great accomplishment, implementing a web-based software
application after the fact is a trend Intelex's Account Managers are not
unfamiliar with.After discussions with
organizations such as these, it’s often the case that the ISO implementation
team was unaware that web-based quality and environmental management systems can
actually help work toward this certification, as opposed to simply maintaining
a compliant status.

Intelex's web-based Quality and
Environmental Management Systems are designed to help organizations implement
ISO standards and maintain ongoing compliance. Both Intelex's Quality and
Environmental Management Systems function as frameworks enabling organizations
to define an ISO registration schedule, identify project objectives, record
policies, assign and track ISO tasks, manage all ISO-related documents, and
provide real-time implementation progress reports. …

Standard Nonconformances & Corrective Actions Reports

Six new reports for clients using the Intelex Standard Nonconformances Module have been posted on the Intelex-Exchange (to be downloaded for free).

These reports have been designed to provide an instant, real-time snapshot of your organizations standard nonconformance and corrective/preventative actions performance.

Corrective/Preventative Actions by Report ID
Standard Nonconformances by Type
Standard Nonconformances by Classification
Corrective/Preventative Actions – Last 90 Days
Corrective/Preventative Actions – This Year vs. Last Year
Report ID – Stages by Date