Travel is restricted, companies have moved to virtual work wherever possible, and the world is attempting to maintain some normalcy in the face of a global pandemic. While the long-term economic impact on supply chains has yet to be seen, there is still an obligation on the part of companies to attempt to maintain supplier quality activities, especially audits.
4 Pitfalls of Contract Manufacturing (and How to Avoid Them)
Contract manufacturing is on the rise, with companies from Apple to Xerox outsourcing production of their branded products. The approach is associated with several benefits like reducing overall costs and allowing companies to concentrate on core strengths like product design and marketing.
A Formula for Food Safety: HARPC = CCP + PRP + OPRP [Podcast]
There continue to be many questions around Hazard Analysis and Risk-based Preventive Controls (HARPC) and how a company’s food safety program will need to change to meet the new Food Safety Modernization Act (FSMA) requirements. Through FSMA, the FDA has basically stated that Prerequisite Program (PRPs) are now considered of equal importance as Critical Control Points (CCPs), clumping them all together and calling them preventive controls.
How to Give Good Safety Feedback
When giving negative feedback, supervisors often rely on what’s called the “sandwich” technique. We’ve all seen it. The email that goes something like this: “Hi Joe, Thanks for the extra hours last week wrapping up that project. You’re a great team player, but I’m going to need you to go ahead and add more detail to your Job Safety Analyses (JSAs). Anyways, thanks for everything, we really appreciate it.
4 Ways to Reduce Risk in Contract Manufacturing
A survey published in Pharmaceutical Outsourcing magazine reveals growing demand for contract manufacturing in the pharmaceutical industry, with over 75% of respondents indicating that they outsourced the same or more than in previous years.
Top 3 Challenges Facing Biotech Today (and How to Tackle Them)
There are many challenges facing the biotech industry today. Many issues—like those discussed below—are more fundamental, requiring a proactive approach to meet them head-on.
3 Tips for Communicating Effectively with Your Suppliers (Podcast)
Communication…it is the key to all relationships. Good communication can inspire partnership and trust. Bad communication can result in confusion and doubt. How you communicate both in your personal and professional life will determine how successful you are. There are a number of examples of how businesses have crumbled due to bad communication. Therefore, it is critical to consider how you are communicating with your external partners such as suppliers, co-packers and vendors, to ensure mutually beneficial, trusting and successful partnerships.
Elevator Pitching: How to Talk to C-levels about Quality Management
They call it the "elevator pitch". I find that kind of a silly notion, like you would be waiting in the lobby to ride the lift with any executive who pops in for work around 11am-ish. I would personally thinking you would come off a bit like a stalker, talking business when the guy is still on his first latte. I had a guy try to pitch to me in the bathroom once - it didn't go over well.
Using Three ISO Standards to Benchmark QMS and EHS Convergence
Last week, I took a lighter turn on things, talking about the lighter side of ISO. Some of the more interesting ISO standards out there, like shoe size, traffic lights, and snorkeling etiquette. I also posted a poll on the "state of the standards", and here are the results.
ISO Crazy: The Lighter Side of ISO Standards
When I first started my career, I knew nothing about ISO. In college, I got about a day's worth of ISO explanation in business school. It was summed up as, "ISO 9000 is a management standard.....Deming.....Japan....quality management.......any questions?"
Quantitative Risk Assessment in HACCP Plans – Decisions, Decisions…
Last week, I spoke about how to set up a Risk Matrix and the considerations on how to determine risk scales. I mentioned how Risk methods provide the objectivity needed for many organizations, but a team is need to ultimately make the decision.
Risk Assessment: Creating a Risk Matrix
In this day and age, Risk is the biggest buzzword in the compliance industry. We've talked about it, you can't go anywhere without hearing about it, and everyone's got a Risk-Based solution. We can no longer rely purely on "gut instinct" to execute on events, whether Quality, Financial, Social or similar areas. The world moves too fast, and one misstep can make or break you as a business. Risk provides the objective metric to help the decision-making process. But, you need to know how to use risk.
HACCP for Medical Device and Pharmaceuticals
I recently was speaking to a group of folks on the different ways to mitigate risk. While this may not seem like "exciting" dialogue, it actually provoked an interesting thought - while many organizations interpret Risk factors differently, it seems that from one industry to the next, they tend to use a singular method. One group uses FMEA exclusively, another uses HFACS or some human error risk, another uses HACCP, and so forth.