Quality Management Posts

Mobile Medical Apps and EQMS: The Latest Buzz

Mobile Medical Apps and EQMS: The Latest Buzz

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

I attended my first AdvaMed MedTech Conference in early October, and it was an awesome opportunity to interact and learn from the industry. There were many things I learned about the medical device industry, but one thing that really stood out for me was a session on mobile medical apps. (more…)

5 Things Life Sciences Execs Should Know About Supplier Quality in 2014

5 Things Life Sciences Execs Should Know About Supplier Quality in 2014

Matthew Littlefield, President & Principal Analyst, LNS Research

In today’s distributed, global economy, it’s typically a competitive disadvantage to not leverage the supplier network. It opens the door to cost savings, expertise, additional production capacity, geographic reach, and more. Reliance on external parties, however, does come with a number of quality- and compliance-related risks that can really make or break a product (and company). (more…)

When Does it Make Sense to Automate EQMS?

When Does it Make Sense to Automate EQMS?

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

You need to manage your quality system, and you might think you have everything under control with a manual process. But manual processes including disparate tracking systems for controlling documents, deviations, customer complaints, change controls, and other quality processes are often cumbersome and difficult to control, with limited to no visibility across processes.

So when is it necessary to bite the bullet and adopt an automated enterprise quality management system (EQMS)? The timing may not be the same for every organization, but you should examine your quality management processes and see where quality management software can help fill in the gaps, creating a more cohesive closed-loop process and better preparing you for any internal audits, regulatory inspections, or regulatory reporting. (more…)

A Market-Leading Approach to Quality Performance Management

A Market-Leading Approach to Quality Performance Management

Matthew Littlefield, President & Principal Analyst, LNS Research

Because of the competitive nature of the industry, most life sciences quality leaders are laser-focused on performance management. It not only helps to keep you in check, performance management is a critical component of continuous improvement initiatives as it provides visibility into what’s working effectively and what might require more people, processes, and technology resources.

(more…)

How to Gauge Your Quality Management Technology Maturity

How to Gauge Your Quality Management Technology Maturity

Matthew Littlefield, President and Principal Analyst, LNS Research

With pressures to drive down costs while improving innovation and the safety of products, life sciences companies need close integration between risk, quality management, and compliance. Conventionally, this connection has been facilitated by a number of homegrown and manual solutions. However, with the unprecedented complexities associated with the industry today, most organizations require something more robust. (more…)

Living a Quality Corporate Culture

Living a Quality Corporate Culture

Kari Miller, Sr. Director of Industry Solutions & Product Management, Pilgrim Quality Solutions

A culture of quality requires teamwork.  Teamwork is the natural result of working in an environment where people feel they are part of something bigger than themselves. When personal success on the job is defined by the success of that something bigger, an organization has achieved a critical ingredient for a quality culture. The company’s welfare, and therefore the employee’s welfare, is also directly tied to that of its suppliers and customers. (more…)

Quality is Everyone’s Job

Quality is Everyone’s Job

Kari Miller, Senior Director of Industry Solutions and Product Management, Pilgrim Quality Solutions

Vision, values, goals and strategy are the guiding principles of a corporation and culture culminates from them. Quality culture refers to the complete awareness, commitment, attitude, and behavior of the organization with respect to quality.  Corporate leadership must effectively communicate and more importantly demonstrate quality as an inherent value of the organization. (more…)

Crafting a Quality Culture

Crafting a Quality Culture

Kari Miller, Senior Director of Industry Solutions and Product Management, Pilgrim Quality Solutions

Most people in industry are familiar with W. Edwards Deming, Joseph Juran, Jim Harrington, and others whose ideas are usually grouped under the term Total Quality Management. However, the practices they embrace aren’t just about Total Quality Management; they are about management best practices which embrace a culture of quality.
(more…)

Measuring the Success of Training and Competency

Measuring the Success of Training and Competency

Konyika Nealy, Vice President of Quality Assurance & Validation, Pilgrim Quality Solutions

According to 21 CFR Part 211 Subpart B, Section 211.25 (Personnel Qualifications),

Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice…as they relate to the employee’s functions.

But what does an effective training program look like?  How do you measure success? (more…)

Don’t Guess on Variation and Corrective Action

Don’t Guess on Variation and Corrective Action

Mark Crawford

Jonathan D. Port, a quality management expert and owner of Beacon Quality Services LLC (www.beaconquality.com), wrote an article on understanding variation in the March 2012 issue of Quality Progress.

“Organizations with quality management systems compliant to ISO 9001:2008 are required to take action to eliminate the causes of nonconformities,” says Port. “Clause 8.5.2 defines steps required for corrective action (CA), including determination of the nonconformity cause, along with determination and implementation of necessary action to prevent recurrence. Similar wording is also present in clause 8.5.3 regarding preventive action (PA).” (more…)