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...
Increasing public concern for food quality and global sourcing of food products is moving the entire food and beverage industry towards creating better ways and means of ensuring the safety of what we eat.
It’s also driving the creation of an interconnected global system for the production and distribution of food. During the last decade, many public and private standards for food safety and quality have been developed around the world and today there are more worldwide standards than ever before. The trend is clear – food safety is top of mind concern on a global scale.
With the finalization of Food Safety Modernization Act (FSMA) and compliance Preventive Controls rules for large companies already announced, the increased need for integrated supply chain management has become paramount.
What are the most important trends impacting food and beverage companies today?
Source: LNS Research Food and Beverage industry survey data
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.