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...
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...
Is your company recognized by its suppliers as a Customer of Choice? What exactly does this distinction mean and why is it important? A Customer of Choice is a customer recognized by many of its suppliers as a preferred customer for a number of reasons. From their talented workforce and integrated management systems to their global processes and approach to supplier collaboration, customers that can achieve this distinction can unlock new sources of competitive advantage with the help of their suppliers.
When suppliers recognize that they have a Customer of Choice on their hands, they have a tendency to go out of their way to service that particular customer’s needs. In these situations, suppliers will assign their most talented employees, allocate scarce resources, provide additional discounts, prioritize production capacity, give early access to new products, and go out of their way to solve customer problems so that their customers can … Read more...
Organizations love to make design changes to their products on a regular basis. Any firm producing a product, be it the Tesla Model S or McDonald’s French fries, strives to introduce incremental improvements to add new features, reduce costs, comply with the latest regulations, and remain competitive. Sometimes these changes have an impact on suppliers.
- Tesla just released its Version 8 software that introduces over 200+ enhancements for the Model S Autopilot technology. Some of these changes will have an impact on Tesla’s suppliers due to integration between purchased components and Tesla’s design.
- In 2008, McDonald’s formally announced it changed its recipe for French Fries by changing to trans-fat-free oil to address general health concerns over cardiovascular disease. Imagine the impact of this change to the supplier providing the trans-fat oil from a capacity, inventory, and profit standpoint.
The impact that design changes have on suppliers is significant. Let’s take … Read more...
Have you ever stopped to think about how important your suppliers are to your business? Do you view suppliers as business partners and an extension of your business, or do you see them as a reactive service provider that exists to fulfill demand?
All too often we tend to treat supplier relationships as contractual agreements rather than mutually beneficial partnerships. This behavior grossly under-estimates the tremendous benefit suppliers can provide to your firm’s day-to-day operations. This “servant” paradigm is not the right way to go about conducting business with suppliers for a number of reasons. Instead, let’s talk about three key reasons why we need a fundamental shift in our thinking away from the supplier “servant” paradigm to suppliers being members of a critical department in your organization – a key business function that adds value for your customers on a daily basis.
Reason # 1: Start with Trust
Relationships … Read more...