On April 18, 2018, INTELEX will kick off the 2018 EHSQ Alliance Conference. The conference will provide EHSQ professionals with an opportunity to network, collaborate and discuss how innovation in their respective industries and organizations can help them … Read more...
What is the MDSAP program?
In Singapore in 2012, the International Medical Device Regulators Forum (IMDRF) began development of a Medical Device Single Audit Program (MDSAP). MDSAP allows approved auditing organizations to conduct a single regulatory audit of a medical device manufacturer. This single audit expands the scope of the audit to previously unaudited areas of large organizations, standardizes a consistent auditing model, and replaces as many as five separate . It also satisfies the regulatory requirements of the authorities participating in the program – even ISO 13485:2016. MDSAP focuses on defined and linked processes and is based on requirements for risk management. The goals of MDSAP are:
- to improve audit effectiveness and the influence the audit can have on outcomes that improve patient safety, and
- to reduce the resource demands on both regulatory bodies and auditees in organizations having to comply with a variety of global standards and .
Why is it time for a Quality Management System revolution?
The world is more complex than it used to be. Businesses around the globe rely heavily on one another through densely intertwined supply chains. Human biases lead to … Read more...
In late November, a group of Intelex employees made the 100-kilometer trek from Toronto to Cambridge, Ont. to the Toyota Motor Manufacturing Canada (TMMC) Inc. plant. The highly cross-functional team included members from Sales, Marketing, Consulting and Implementation, Sales Engineering, Customer Engagement, Customer Success, and Product Management. We wanted to gain insight, first-hand, into the activities within a world-class automotive manufacturing company that exemplify an integrated EHSQ management system – before the impending holiday season and 2018 bomb cyclone made headlines!
The team prepared extensively for the tour. We wanted to maximize our learning while on site and help retain this information long-term. We looked at the history of Toyota to discover why it had become so successful and capable of producing award- winning quality products, while exceeding customer expectations. We learned that each vehicle manufactured at Toyota’s TMMC plant goes through over 4,800 quality checks before leaving the facility! … Read more...
Life sciences organizations, including pharmaceuticals, and medical device manufacturers, constantly look for ways to reduce risk, increase patient safety, and achieve operational excellence. To be successful in these three areas, pharmaceutical and medical device manufacturing companies need to have robust management systems in place. This is even more critical than in other industries where the breadth of regulatory requirements is not as vast.
Transforming their QMS to the cloud can help them achieve these strategic objectives. Along this digital transformation journey, software validation can be a challenge with varying degrees of intricacy across organizations. Causes can range from lack of experience and expertise to the complexity of internal and external stakeholders involved. Ultimately, no one wants to receive a 483 from the FDA due to noncompliance with 21 CFR 11, which will put an organization in a bind and ultimately impact patient safety.
As pharmaceuticals and medical device manufacturers look … Read more...
Managing risk for life science organizations is often seen as simply a way to achieve and maintain industry compliance, and not as a means to improving operational performance.
That’s far from the perception in other industries, where effective risk management also supports continuous improvement and competitive differentiation.
Industry leaders in risk management are committed to continuous improvement programs, which drive down risks on existing products. The reality today is that the changing nature of risks requires adopting effective strategies to properly prioritize and mitigate them.
Arguably life science manufacturers should adopt a similar approach that takes advantage of best practices from across industries.
To that end, manufacturers should focus on:
Using a single unified framework for risk management
A unified framework allows the ability to compare risks, and execute continuous improvement measures. Many possible risk models exist, such as failure modes/failure effects/causes/controls/verification, or hazards/harms/controls/consequences. A unified model allows manufacturers to … Read more...
On February 8, 2017, I delivered a presentation to 138 attendees on Integrated Management Systems (IMS) at the monthly ASQ Toronto section meeting. To learn more about IMS, read The Case for EHSQ Integrated Management Systems. The audience consisted of a broad range of experts including CQEs, CQAs, CQIAs, CSSGB, CSSBB, management consultants, auditors, among others.
As part of the introduction, I asked the audience how many people have either heard about or were already familiar with Integrated Management Systems and I’d say about 40% of the audience raised their hands – which is a good sign! I was actually only expecting about 10 to 20 people to raise their hands. This definitely demonstrates that Integrated Management Systems is of interest to quality management professionals. The concept of an IMS becomes even more important because of the harmonization of standards due to the recent changes in ISO 9001:2015, ISO … Read more...
Have you ever wondered if there is a better way to manage your organization’s management systems using an Integrated Management System? Silos and disparate systems should be a thing of the past. Between the Quality Management System (QMS), Safety Management System (SMS), and Environmental Management System (EMS), there is abundant opportunity to eliminate inefficiency and duplication of activities especially in more complex organizations with multiple business units.
To learn more, watch this webinar hosted by ASQ (American Society for Quality) where Peter-Elias Alouche discusses:
- The importance of the customer’s perspective
- Why businesses should integrate their management systems
- What is an EHSQ Integrated Management System anyways?
- What are some of the opportunities to start integrating management systems today
- The importance of culture
Whenever you assess or improve the effectiveness of your organization’s management system(s), you need to think about your customers and what they want. It’s easy to get caught up … Read more...