News

Supplier Equipment Qualification and Its Impact on Packaging Specifications - SQA Services

Talia Landman — Wed, 03 Sep 2025 16:30:23 GMT

In the life sciences industry, packaging is far more than a box or a seal. It is a validated system—a safeguard designed to maintain sterility, preserve product integrity, and meet the rigorous requirements of ISO 11607 and FDA regulations. Yet one of the most overlooked risks in this space comes from a seemingly routine event: changes to supplier equipment.

When a supplier installs new machinery or modifies an existing production line, even the smallest variation can compromise critical packaging requirements such as seal strength, barrier properties, and consistency of sterile barrier performance. These shifts, if left unchecked, can lead to compliance issues, product recalls, or worse—risks to patient safety.

Why Equipment Qualification Matters

More organizations are recognizing that equipment qualification is no longer optional. A structured approach using IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) ensures that packaging systems can consistently deliver validated outcomes.

For example, a qualification effort might uncover that machine settings are gradually drifting outside optimal ranges. Left unaddressed, this drift could result in variable seal integrity, putting sterility at risk. By catching such issues early, companies can prevent costly findings during audits and avoid downstream consequences like recalls.

Building Supply Chain Resilience

Equipment qualification is more than just “checking a box” for compliance. It is about:

Protecting patients by ensuring packaging maintains sterility and safety.
Safeguarding product performance so that quality is preserved across global markets.
Strengthening the supply chain by embedding resilience into packaging validation systems.

Companies that view packaging validation as a living system, rather than a one-time requirement, are better equipped to adapt to supplier changes and regulatory pressures. This proactive mindset is what separates resilient organizations from those constantly playing catch-up.

Key Questions to Consider

To evaluate your readiness, ask yourself:

Are all of your suppliers’ equipment qualifications documented and aligned with your packaging requirements?
Do you have visibility into how supplier equipment changes might impact sterile barrier performance?
How frequently do you revalidate packaging specifications after process or equipment changes?

Meet SQA Services at the Generis Medical Device Summit

Supplier equipment changes may seem routine, but their impact on packaging performance can be profound. Treating equipment qualification as a strategic, ongoing process helps ensure compliance, reduce risk, and ultimately protect patients.

SQA Services will be at the Generis Medical Device Summit in Chicago, Illinois October 27-28. Contact us today to schedule a meeting with our team!

Importance of Requirement Consumption by Supplier for Product Launch - SQA Services

Talia Landman — Tue, 12 Aug 2025 19:08:43 GMT

Bringing a new device to market is one of the most critical milestones for any manufacturer. It’s a driver of growth, innovation, and improved outcomes. In the highly regulated medical device industry, it’s a process with zero margin for error. From concept design to commercial release, every step must comply with strict FDA, ISO 13485, and other global regulatory requirements, while ensuring the device performs safely and effectively for patients.

A successful launch doesn’t just depend on a groundbreaking design – it hinges on whether every supplier in the supply chain fully understands and can meet requirements before production begins.

This is where Requirement Consumption Review (RCR) assessments play a vital role.

What is Requirement Consumption Review (RCR)?

In the medical device sector, RCR is a strategic early involvement process designed to confirm that a supplier has fully “consumed” and can execute all contractual, technical, and quality requirements of a new product build. This involves a cross-functional review—including quality, manufacturing, regulatory, and engineering teams—focused on validating manufacturing capabilities, compliance readiness, and risk mitigation before the first production run.

SQA Services manages RCRs worldwide for medical device manufacturers, acting as an independent partner to align suppliers with client expectations and ensure compliance with regulatory and quality standards.

Why RCR is Critical for New Medical Device Launches

When launching a new medical device, the stakes are uniquely high—patient safety is directly impacted by product quality. An RCR assessment helps safeguard quality, compliance, and timelines by:

Mitigating manufacturing risks and improving first-pass yields during validation and pilot runs.
Identifying and addressing design-for-manufacturability issues before they cause downstream quality problems or regulatory delays.
Ensuring suppliers are prepared for the PPAP process and other industry-specific qualification requirements.
Verifying alignment between supplier capabilities and critical-to-quality characteristics defined in the device’s design history file.
Preventing nonconformances during early builds that could trigger costly rework, delayed submissions, or recalls.

The RCR Process for Medical Devices

Preparation: SQA and the supplier review purchase orders, drawings, quality documentation, and regulatory requirement. This process also includes identifying high-risk components, sterile barrier considerations, and inspection needs.
RCR Day: A collaborative review (on-site or virtual) where client, supplier, and SQA work through a medical-device-specific checklist. This list covers contract compliance, product design features, build plans, inspection/test protocols, CAPA processes, workmanship, property/tooling management, and packaging validation.
Action Plan: SQA delivers a detailed report outlining corrective actions for both supplier and client. Follow-up ensures all actions are completed before production ramps up.

The Bottom Line

By uncovering potential risks, resource gaps, and compliance issues early, RCR assessments help ensure that new medical devices are launched on time, in compliance, and to the highest quality standards. This not only accelerates time-to-market but also protects patients, strengthens regulatory confidence, and reduces the likelihood of costly post-market issues.

In the competitive and highly regulated medical device industry, Requirement Consumption by the supplier is a patient safety imperative. It provides the structured, collaborative framework to make it happen.

Protect your next device launch from preventable setbacks

SQA Services partners with leading medical device manufacturers to deliver robust RCR assessments that safeguard compliance, quality, and patient trust.

Why PPAP Is Critical for Medical Device Manufacturing - SQA Services

Talia Landman — Mon, 04 Aug 2025 20:05:49 GMT

In the highly regulated, patient-critical medical device industry, consistent quality, safety, and performance of components and finished products is essential. Even minor variations in materials, dimensions, or manufacturing processes can compromise product integrity, put patient safety at risk, and result in costly recalls or regulatory delays.

That’s where the Production Part Approval Process (PPAP) comes in.

What Is PPAP and Why Does It Matter in MedTech?

Originally developed for the automotive sector, PPAP has become a powerful quality assurance tool in the medical device industry. Its structured, standardized approach verifies that a supplier’s production process consistently produces parts that meet all defined specifications.

In medical device manufacturing—where tolerances are tight and compliance is critical—PPAP helps ensure:

Full alignment between supplier capabilities and customer expectations
Traceable, documented validation of each component or process
Reduced risk of late-stage product failures and recalls
Increased confidence in both regulatory compliance and product performance

PPAP also aligns with global quality standards and regulatory expectations such as FDA requirements, ISO 13485, and guidelines from other health authorities.

SQA’s PPAP Managed Program: A Smarter Approach

SQA Services is a recognized leader in delivering PPAP support to global supply chains in regulated industries. Our PPAP Managed Program is designed to help medical device manufacturers and their suppliers implement, execute, and continuously improve PPAP efforts, especially when internal resources or expertise are limited.

We break our support into three key phases:

PPAP Readiness Assessment: A one-day on-site evaluation to determine whether a supplier has the infrastructure, documentation, and training needed to properly execute PPAP. If gaps are found, SQA provides tailored support to build readiness.

Initial PPAP Execution: Hands-on guidance at the supplier site, where SQA’s quality experts train, monitor, and assist in completing the supplier’s first PPAP submission. This ensures a compliant and complete process from the start.

Ongoing Review and Remediation: As the supplier gains experience, SQA shifts to reviewing submitted PPAPs, identifying gaps, and recommending or implementing corrective actions to ensure compliance and consistency.

Why Medical Device Companies Choose SQA

Implementing PPAP effectively doesn’t just reduce regulatory risk—it can save time and money across the supply chain. With SQA’s help, clients benefit from:

Fewer delays and rework
Lower scrap and recall rates
Improved supplier accountability and transparency
Reduced quality control costs through upfront process control
Stronger alignment between suppliers and internal quality teams

By working directly with your suppliers, SQA enables your supply chain to consistently meet specifications and deliver quality from start to finish.

Interested in learning more? Reach out via the contact us form on our website or email us at SQA-quality@sqaservices.com.

SQA President & CEO Michael Guymon Shares Insights on Supply Chain Quality - SQA Services

Talia Landman — Fri, 18 Jul 2025 19:14:14 GMT

In a recent episode of Bridge the Gap, hosted by Dale Zwizinski and Adam Jay from Revenue Reimagined, Michael Guymon, President & CEO of SQA Services and former leader at SpaceX and Rocket Lab, shares his insights on building systems that don’t crack under pressure—and what go-to-market teams can learn from high-stakes industries.

Global Regulatory Updates Q3 & Q4 2024

Talia Landman — Tue, 06 May 2025 18:40:00 GMT

SQA Regulatory Surveillance Summary for 3Q/4Q 2024

By: Laurel Hacche and Debra Cortner

SQA Regulatory Surveillance Summary for May and June 2024 - SQA Services

Gabe Silk — Fri, 18 Oct 2024 15:31:43 GMT

SQA Regulatory Surveillance Summary for May and June 2024

By: Laurel Hacche, Rocio Cabeza, and Debra Cortner

SQA Regulatory Surveillance Summary for March and April 2024 - SQA Services

Gabe Silk — Thu, 01 Aug 2024 12:03:19 GMT

SQA Regulatory Surveillance Summary for March and April 2024

By: Laurel Hacche, Rocio Cabeza, and Debra Cortner

SQA Regulatory Surveillance Summary for January and February 2024 - SQA Services

Gabe Silk — Mon, 03 Jun 2024 15:18:29 GMT

SQA Regulatory Surveillance Summary for January and February 2024

By: Laurel Hacche, Rocio Cabeza, and Debra Cortner

SQA Regulatory Surveillance Summary | Monthly Update 2024 - SQA Services

Gabe Silk — Mon, 26 Feb 2024 15:57:17 GMT

SQA Regulatory Surveillance Summary for Quarter 4, 2023

By: Laurel Hacche, Rocio Cabeza, and Debra Cortner

SQA News | Fall 2023 - SQA Services

Gabe Silk — Thu, 21 Dec 2023 19:36:09 GMT

Wins & Challenges

October marked an incredible year since joining SQA Services. I regularly reflect upon how blessed I am to be a part of this organization. We are a mighty team providing indispensable services to many of the most influential companies in the world. Earlier this year, we took time as a leadership team to precisely define our vision for SQA: “We protect through quality.” You will begin to see this mantra seep into our marketing materials and presentations. As we finalize our strategic business plan for 2024, our efforts are focused on enhancing our current and future abilities to deliver the highest quality services and protect our clients and their consumers.

2024 & Beyond

Q4 and MICCS Success

As we embark into Q4, we have just celebrated our most productive quarter in company history and, by serving more clients in more ways, we are on pace for 2023 to be our biggest year ever. We are excited to continue this trend into 2024 and beyond!

Q3 also saw the completion of one of our biggest technology infrastructure projects in recent history. Our widely popular tablet-based inspection app (MICCS) was completely rebuilt to enable enhanced rapid scalability. What started several years ago as a custom solution for a single client has now expanded across numerous clients and projects. As the user base grew, we encountered challenges managing multiple configurations of the software each time we implemented a change. Therefore, our Digital Services Team developed a new architecture that allows clients to deploy a customized solution in a fraction of the time. This is a big win for our company and opens the doors for some very interesting new ways to leverage this technology.

On a personal level, Q3 was also a very busy quarter for me, packed with travel to see as many clients as possible. With trips to Illinois, New York, Florida, Washington, Florida again, the Netherlands, and France, I was able to meet with some of our most critical current and future clients in the Pharmaceuticals, Cosmetics, Aerospace, and Automotive industries with key members of the SQA Team.

Continuing the theme of the last two newsletters, I wanted to highlight lessons I learned from previous roles that I plan on leveraging with SQA. This article focuses on my time at Rocket Lab.

Aiming High

The company initially attracted me with their business plan. The Electron rocket was developed to solve a very specific market need, filling a void left after the retirement of the SpaceX Falcon 1. One analogy used by the Rocket Lab sales team compares a city bus to Uber. We knew it was cheaper for our clients to launch their satellite on a competitor’s rideshare than a dedicated Electron launch. However, the rideshare was the equivalent of taking the city bus: you have to wait for the next available launch. If you’re late, the rocket does not wait for you. Your precious cargo gets loaded in with dozens of other payloads, and you get dropped off in the general vicinity of the orbit you wanted. The Electron, although slightly more expensive, is dedicated to you. Your payload is the only priority, and it takes you exactly where you want to go at the exact moment you are ready. At SQA, we embrace a similar mindset. There may be companies out there that perform quality audits or source inspections marginally cheaper than we do, but those companies often feel like hopping on a crowded city bus. You’re forced to follow a predefined route at a predefined schedule. Opportunity for collaboration and customization is limited. With SQA, we aim even higher than the Uber comparison. We aspire to be the client’s chauffeur service, understanding their needs and nuances of their schedules and priorities. We make sure they get exactly where they are trying to go, following their preferred route, in style and comfort.

“Against All Odds”

Another trait I admire about Rocket Lab is that they punch above their weight class. During my time there, we only had about 500 employees, most of whom were based out of New Zealand. It’s hard to fathom a leading space launch company founded on a small island with essentially zero aerospace industry. The New Zealand government didn’t even have its own space agency until 2016, ten years after Rocket Lab was founded. This “against all odds” origin story formed the culture of the company, embracing the idea that significant innovation would be consistently required to have a chance of competing on a global level. Geographic factors aside, SQA shares some of this “against all odds” philosophy. Some of our competitors are large, established organizations. According to some metrics, there’s no reason a small, family-owned company out of Palos Verdes, CA should be able to compete with them. However, through our continued excellence and relentless innovation, we do. We’ve been able to build partnerships with numerous Fortune 100 companies and industry leaders, much to our competitors’ dismay.

Our Dedicated Team

The final attribute I’d like to highlight is perhaps the timeliest. On September 19, Rocket Lab suffered an anomaly during its ninth launch of the year. For those outside the launch industry, “anomaly” is a nice term we like to use when the mission fails. When you’re already an underdog, blows like these can be very difficult to recover from. However, it’s not the first time Rocket Lab has experienced an unfortunate setback, and the team knows they can regroup, improve, and get back on track. Perseverance in the face of adversity is not optional. It is essential. SQA has dealt with its fair share of setbacks. The most recent major challenge was the fight for survival in a global pandemic. This was exceptionally difficult for a business that relies on deploying people onsite at manufacturing locations around the world. Through it all, the team focused on our clients’ needs on-site, and adapted to the changing environment. Though we hope our next challenge is less formidable than a global pandemic, we know we have a battle-hardened team that will persevere when others give up.

Questions And Feedback

It has been an absolute pleasure meeting many of our clients, employees, and associates over the past year. If we have not had the opportunity to get to know each other, I strongly encourage you to reach out to me at mguymon@sqaservices.com so we can schedule some time to meet. As always, I would love feedback on the types of information that you all would like to hear about every quarter. Please be open and honest with your thoughts, and I’ll see what we can do to ensure this is something you all look forward to receiving several times a year.

—-

Onward & Upward,

Michael Guymon

President / CEO

Out & About with Team SQA

Commencing with immense gratitude, we extend a special thank you to SQA Advisor Jeff Luckey for his recent visit to our headquarters. Jeff, who retired from The Boeing Company in January 2017 after three decades of dedicated service, shared his wealth of knowledge on the future trajectory of the Aviation Industry. Currently at the helm of JGI Consulting LLC., Jeff continues to contribute his expertise, assisting industry associates in navigating and positioning their businesses for the challenges and opportunities that lie ahead. We deeply appreciate and feel honored to have Jeff as a valued advisor on the SQA team.

SQA Services’ month-long philanthropic journey with the Foodbank of Southern California was a tremendous success! Thanks to your generous support, we raised over $2000 and collected canned goods to aid the mission of providing healthy, nutritious food to the community’s hungry residents and to ensure that no individual goes hungry, not even for a single day. On Friday, October 20th, SQA assembled a dedicated team to travel to the mobile pantry location in Long Beach and assisted in the distribution of donated items and fresh produce grown in The Foodbank of Southern California’s community gardens and urban farms. Let’s continue to spread kindness and make an impact! #SQAcares

In the dynamic landscape of 2023, SQA embarked on a journey of knowledge and collaboration, participating in a series of conferences that proved instrumental in our growth. These gatherings served as vibrant platforms for the exchange of ideas, experiences, and industry insights. Engaging with diverse perspectives at each conference enriched our understanding of quality practices and innovation. It was a year where we not only shared our expertise and services, but also absorbed valuable lessons from fellow professionals across various sectors. The collective wisdom gained from these conferences has undoubtedly fueled our commitment to excellence and positioned us at the forefront of cutting-edge quality solutions. As we reflect on the events of the past year, we look forward to applying these learnings in shaping a future marked by continuous improvement and advancement.

Finally, SQA ended the year with our annual Supplier Excellence Committee Meeting! During the recent SEC gathering, we successfully brought together talented individuals united by a shared passion for quality. The event provided a platform for the exchange of experiences, principles, and ideas, contributing to the advancement of both SQA and its community.

As we reflected on the challenges and opportunities of 2023, active participation and engagement from our SQA advisors played a pivotal role. Contributors shared their valuable experiences and insights with quality leaders from diverse industries, fostering a cross-pollination of perspectives. Additionally, discussions explored innovative approaches to address quality challenges, identify applicable tools from various industries, and encourage out-of-the-box thinking for continuous quality improvement. This collaborative experience has undoubtedly enriched our collective knowledge and propelled us toward further excellence in the realm of quality.

Quality PERSONified

Meet SQA Sr. Project Coordinator, Joy Callejo

Joy Callejo graduated from the University of California, Davis with a Bachelor’s in International Relations, and minors in Public Health and French. She started off her career in healthcare, amid the pandemic, working in quality improvement programs. Joy has been working with SQA since January 2022 with various Critical Manufacturing programs such as Blue Origin, Commonwealth Fusion Systems, L3 Harris, and now SpaceX and Google. She firmly believes in protecting through quality, but also showing kindness to all those that she works with. During her spare time, she likes to play video games and play sports (tennis, basketball, ultimate frisbee—you name it!)

Associate Spotlight

Meet SQA Associate Dwayne Elkins

Dwayne Elkins had always been around manufacturing. His Grandpa and many aunts and uncles were machinists or QC inspectors in different manufacturing sectors and he was introduced to their roles in various ways over the years. After graduating from Cal Poly SLO in 2000 with an Industrial Technology degree with a focus on packaging development, he started his career as a cold calling salesman of packaging equipment. This was not what the plan was. Like so many of us in quality, he did not go and seek his first quality role, rather, if found him. A phone call was received with the question, “can you do technical writing?” Mr. Elkins always had a passion for writing and had even one some minor local awards for some fiction stories, so he figured let’s put the two together (technical understanding and the ability to write), and see what happens. Next thing you know, a quality manager quits, and he found himself Quality Manager of a high volume Tier II automotive manufacturer related to airbag production. From there he studied different quality standards, ended up in different regulatory roles in various industries (Aerospace, Medical Device, Pharma), and now services clients by designing, consulting, and auditing for various quality standards. Mr. Elkins career and personal travel have taken him to 49 states, 18 countries, and 5 continents.

Mr. Elkins resides in Southern California with his family and enjoys spending time with his beautiful wife and son, enjoys collecting and selling sneakers, and loves to go see a good live Rock ‘n’ Roll show. ????????????????

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How can we help you?

SQA facilitates the realization of supplier quality goals. This is accomplished by implementing programs designed to provide a unique blend of talented subject matter experts, innovative technology solutions, superior service, and unmistakable value.

Join us online for a one-to-one webinar
and discover how we can benefit your organization.

Email improve@sqaservices.com to learn more!

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