6 Most Asked Questions from Tuesday's Life Sciences Webcast

On Tuesday, June 27, LNS Research hosted the webcast, “The New Path to Performance: Quality in Manufacturing for Life Sciences.” The presentation explained how manufacturers can surpass “conformance” in quality management to achieve higher levels of performance in operational and financial metrics.

Click here to speak with Dan Jacob

Q1. How should a quality department be involved in process control?

A1. This is a great question and hits at the heart of some of the challenges industry faces in design transfer and continuous improvement. Quality should be engaged, starting early in development, to collaboratively develop the process control plan leveraging knowledge of risks and quality events experienced in previous similar products. It should also identify, assess, and control the new, unique, and difficult risks presented by the current product. The process control plan should be prioritized based on risk and an assessment of critical parameters/characteristics. One challenge is late engagement in the development process, which is a roadblock to continuous improvement. This should be married to aggressive continuous improvement program that actively works to prevent risks rather than just monitoring defect levels.

Q2. You showed a picture of how to connect quality and manufacturing, but how do we really make that work? We have a few different systems, and they don’t talk right now.

A2. LNS typically recommends that organizations adopt a role-based data mastery approach when connecting Information Technology (IT) and Operational Technology (OT) processes. For instance, the Non-Conformance (NC) process is an overlap area between Manufacturing Operations Management (MOM) and Enterprise Quality Management Software (EQMS). Given that many NC's are generated by manufacturing quality personnel in the context of other MOM data including Inspections, there is value in Mastering NC's from within MOM.

However, manufacturing NC data is also critical to corporate quality, quality reporting, connections to corrective actions, and regulatory requirements. Manufacturing NC's are not the only types of quality NC's. This means that a MOM system isn’t likely an effective data master for the entire NC process. Therefore, it may be determined that although manufacturing NC's are initiated from within MOM, at some point in the NC workflow the EQMS system becomes the “system of record;" the data master. Decisions regarding when to transition data mastery is individualized and should weigh EQMS and MOM system capabilities and deployment landscape as well as the user roles and use scenarios.

Q3. You showed a picture of ISO 13485:2016. How does that connect to this?

A3. ISO 13485:2016 is a standard update featuring many new requirements. Among these, there are requirements for improved design transfer and risk management across operations. In fact, these align very well to the framework as well as the specific best practices discussed.

While the research provides a good model for these aspects of ISO 13485:2016 adoption, quality leaders should also leverage the opportunity provided by ISO 13485:2016 to gain executive priority for a quality strategy that delivers operational and financial performance.

Q4. Your last example was about mergers and acquisitions. That’s a tough one for us because we’ve acquired several companies and not all from the same industry. How have you seen people address this?

A4. There are truly many approaches here, but here are a few comments. M&A creates substantial risks for a life sciences company because the risks inherent in the acquired company aren’t truly known until they are acquired and a full assessment is possible. Just like any acquisition, there are usually a few unexpected surprises. Also, leaving each business unit independent from a quality perspective often results in repeat problems and wasted effort.

While there are several approaches, it’s important to develop a plan that considers organizational structure, leadership, competencies, processes, and technology, and drives toward consistency. Approaches to quality are not exactly the same across industries, but a flexible, unified approach that permits sharing lessons learned and continuous improvement is a good approach.

Q5 How can Project Managers be effective in driving the QA initiatives in a Complex Matrix organization? 

A5. Great question. This can be challenging because in a matrix organization the people executing the QA initiatives often report to multiple functions, and rarely to the project manager themselves. Frankly, this is where leadership support for quality, and a culture of quality, are very important. Top management can make this much easier to improve quality by publicly stating their support for quality initiatives, publicly encouraging and prioritizing quality work, and driving cross-functional engagement top down by insisting that functional leaders actively participate in quality. Regular leadership review of quality improvement projects, led by top management, is valuable here.

Even without this, it is still possible to drive QA initiatives. The business case journey and maturity models are excellent tools to help gain consensus with other functions and ultimately drive to active top management champions. Feel free to reach out with specifics on your project.

Q6. Can you provide the complete list of best practices included in the survey?

A6. Absolutely. The best practices and their percent adoption are listed in the back of the recent ebook on Supplier Quality Management, found here. There will also be an accompanying research report for this webcast, which will also include this material.