Blogs

We are fortunate enough to have Marnie Smith as one of our speakers for 2023 Women in Quality. Link to registration is on our events tab. Marnie is the Senior Director of Quality and Network Partners. In her role, she leads the Quality team and brings to Network Partners over 15 years of medical device experience. Marnie has experience in sustaining design, project management, supplier quality, quality management systems, CAPA, audit management, design controls, complaint handling, recalls, and manufacturing impacts on quality in a variety of class II electromechanical devices. She has her BS in Mechanical Engineering from Purdue University ...
We are fortunate enough to have Divya Gowdar as one of our speakers for Women in Quality 2023 on November 15th. Please visit our events tab for registration. An experienced Quality and Regulatory Professional, Divya has worked across multiple product portfolios in both large and small Medical Devices and Combination Product Organizations. She offers a proven track record of achievement and successful contribution in the quality management system, end-to-end product development lifecycle, risk and process management, regulatory compliance, and manufacturing operations in compliance with US FDA and other international regulations. Divya strongly believes ...
QUALITY DETECTIVES RULE. I admit it. I’m one of those true crime fans glued to forensic shows from time to time. What fascinates me is not just human nature, but the process of investigation and the tools that are used to determine the truth of events. As a Quality professional, I was often called upon to investigate why a problem occurred and to lead efforts to ensure it never happened again. Defining the problem can be tricky. Facts can be hidden. Records can be incomplete. You might get conflicting information. People can lie to avoid making themselves look bad (thank you, Joe Kenda). I found a good way to start is to answer who, what, when, where, ...

Quality Rocks

I was continuously employed for 43 years. I’m not special. I’m probably “average” by most measures of talent and knowledge. If I were completely honest, I’d even say I’m a little on the lazy side. My secret? It’s no secret. I spent my entire career working in Quality Control, Quality Assurance or both, once with EHS thrown in for good measure. We all know that job security doesn’t exist. But working in Quality turned out to be the closest thing you can probably get. My career spanned many different types of industries, from construction to aerospace. Different businesses, different requirements, ONE skill set applicable to all. A skill set that was ...

Gearing Up for Fall

It’s hard to believe that summer is already half over. Time seems to go so fast. Section elections are just around the corner. Keep an eye out for future communications about nominations for section officers. Interested in serving as a member leader for Philadelphia ASQ? Just drop me a line at jlentz@memberleader.asq.org and I’ll see you get an invitation to our next Section Leadership Meeting. How have you been spending your time this summer? Got any big plans for the fall? We’re looking forward to putting together some great programs for our members.
Today Lesley Worthington posted about giving constructive feedback on LinkedIn as part of a robust Quality culture. If you don’t know Lesley, she is a consultant who helps Quality professionals communicate better. She is definitely worth following. One of the most amazing things I ever experienced was when one of my bosses was promoted and leaving our site. He had some anger management issues, was not particularly liked by everyone, and did not always apply his vast skill set in the best way. He asked everyone who reported to him to honestly tell him what he should do better to be successful in his new role. He sat, without comment, while people took the opportunity ...
When it comes to auditing, it’s best to have no surprises. If any of your auditees feel blindsided in the closing meeting, you haven’t done your job as an auditor. I don’t know any executive who likes to feel as though they haven’t been kept in the loop during an audit. Verifying and discussing findings of nonconformity ahead of time can go a long way to getting agreement and having a smooth audit conclusion. You don’t want to get on the bad side of bosses by keeping your findings to yourself until the end. Have you ever been surprised at an audit finding in the closing meeting? What did you do about it?
MONITORING VS. MEASURING ISO 9001 requires that you plan what monitoring and measuring activities you perform and that you consider it when conducting Management Reviews. But what's the difference between them? I confess the first time I read ISO 9001 I found that a bit confusing. An online dictionary defines monitoring as: "to observe and check the progress or quality of (something) over a period of time; keep under systematic review." Measuring is defined as: "to ascertain the size, amount, or degree of (something) by using an instrument or device marked in standard units or by comparing it with an object of known size." Think of monitoring ...
There's still time to register for Delaware ASQ's webinar, "Effective Management Reviews in an ISO-Based QMS," on Thursday, July 20, 2023 from 6:30 - 8:00 pm EDT. Takeaways: Why do management reviews? Overcoming REAL obstacles to management review (including office politics) ISO 9001 requirements - what they mean, ways to conform Management Review best practices Here's the link to register: Effective Management Reviews
Great news! Our 2023 New Member Orientation presentation recording is now available in our community library. If you are new to Philly ASQ, check it out for some good information about Philly ASQ and how to make the most of your membership. If you have any questions, please contact me at jlentz@memberleader.asq.org. Janet Lentz Section 505 Membership Chair
Delaware ASQ is delighted to host Manny Veloso and Rosa Melton of CI Consulting for our May webinar, Measuring Up: Making The Most of Your Metrics. Thursday, May 18, 2023 6:30 pm - 8:00 pm EDT Link to Register: https://asq.webex.com/weblink/register/rfaa6a1cfc2d493f9f83f09670d016eb6 Manny’s hands-on approach has provided practical, real-world solutions for countless companies. Manny holds a Masters Degree in Business Administration from Rider University and a BS in Industrial Engineering from Penn State. He is a ConnEx instructor for ASQ in a variety of Six Sigma and Lean topics. Rosa brings a wealth of experience to her expanding consulting ...