Tag you’re it…Supplier Quality

Tag you’re it…Supplier Quality

The childhood game of ‘tag’ is fun, I still enjoying playing with young children.  However, in business the game of ‘tag’ is often used as an excuse for pushing responsibilities on to vendors/suppliers.  How many times have you heard ‘the vendor didn’t process a document’ or the ‘supplier forgot to consider local or regional requirements?’  Your Supplier Quality program is the key to success whether using a Contract Manufacturer and Distribution Organization (CMDO) or Contract Research Organization (CRO) or even hiring a consultant.

Companies may have a strong Supplier Quality process for manufacturing (GMP) processes.  Others might have legal agreements to cover services, ranging from distribution to clinical and post-market safety (PharmacoVigilance Agreements-PVA) without truly defining/understanding what they want/need from the supplier.  Do you integrate your Supplier Quality program into your new product development process?

Vendor qualification evolves throughout the product life-cycle management, starting at concept through Post-market support.  Requiring cross-functional and intra-functional handoffs through the different phases of the project (See https://www.consultwing.com/product-development-tplc).  Identifying and qualifying suppliers helps expedite the timelines utilizing their resources and expertise.  Choosing wisely with long-term needs provides organizations detailed understanding of development cost and transitional planning for successful market launches.

Global Supplier Quality Program

Treat your suppliers as a new product; defining requirements, outputs, along with measurable KPIs for improvements and auditing will minimize finger-pointing and enhance the utilization of your suppliers.

Consult Wing has helped organizations through the integration of all aspects of their Product Life Cycle Management:

  • Project design; focusing on deliverables, decision rights and communication
  • Risk Management; focusing on patient and product risk determination and decision-making
  • Quality System infrastructure support, including Supplier Quality

Let us help you align, achieve, and sustain your business and quality processes.

What is Essential is Invisible to the Eye

What is Essential is Invisible to the Eye

Reading bedtime stories continues to be an important communication tool for young (and old) people.  Antoine de Saint-Exupery’s classic, The Little Prince was part of the cycle for each of my children and now grandchildren.  The great secret from the fox to the Little Prince, “It is only with the heart that one can see clearly; what is essential is invisible to the eye” is a critical message for all of us, young and old(er).  And it is vital for those working in regulated industries.

Circumstances are often presented in 2-D; a news story on your screen or emails from team members reporting delays in a project.  Verifying the facts is time-consuming but a necessity to understand the events; truly resolving the issues requires an in-depth look.

Opportunities for improvement are like icebergs; what you see is about half of the issues; what lurks below could be at the root-cause of the problems.

Without exploring and addressing what is below the surface you are doomed to repeat the tragedy of Titanic.  Are there ‘icebergs’ in your company?  Let Consult Wing help you get to the ‘heart’ improvement opportunities; helping you help your patients. We have assisted in start-up and Fortune 200 companies from design to commercialization.  Please visit us www.consultwing.com

Striving for perfection

Striving for perfection

The greatest life lesson occurred while in my High School Geometry class.  During discussions of hyperbolic equations, the teacher turned around from the board to profound that, “Man is like a hyperbola, always striving to their asymptote.”  It took me years and immersion into Buddhism to truly understand what he was conveying.

In hyperbolic geometry the lines of the curve never intersect with the axis (asymptote) as shown below:

Just as the Great Buddha stated; “The harder you search for something, the further away it gets”. 

Focusing on a perfect outcome, just like a hyperbola can consume time and your sanity.

Let’s take a practical example when developing a new product or process.  Ideally, you want to manage the outcome, but you also have timelines and resource constraints.  Here is when risk management becomes a great tool for balancing your approach.  Risk Management like a hyperbola assumes that there is no such thing as a zero risk.  You can control risks, however, there are uncontrollable factors (human, manufacturing, tolerances) that prevent a risk-free product or process.

The organizational challenge is understanding the risk factors, then determining the effort(s) to reduce any catastrophic failures to minimize the outcome risks, whether patient safety, manufacturing validation or controls within your Quality System. As shown in the chart below, for each activity your organization performs, determine what are the risks you are willing to accept based on the amount of activities the group can expend. 

Risk Management should be the first tool used when initiating any project, whether a new drug or device or implementing a new process; gaining acceptance on the risk tolerance when developing project plans. While we strive for zero risks, we must accept that an infinite amount of time will not lead to a zero-risk situation.

 Does your organization integrate Risk Management into new product/process development cycle? Let Consult Wing help you understand that integrating the right tools will help you manage the Product Lifecycle and risk management for your organization.  We strive to bring the right balance and tools to meet your needs. 

If one has to jump a stream and knows how wide it is, they will not jump. If they don’t know how wide it is, they’ll jump and six times out of ten times make it.  Risk Management helps you understand the width of your tasks and where/when to jump!!

Quality is not Overhead

Quality is not Overhead

Three days after starting a new job, I met the CEO in the elevator and introduced myself. Without skipping a beat, he said he was familiar of who I was, stating that I was that highly paid “Quality Overhead”. I was brought in to help turn around the Quality area. About 2 months later, I had the opportunity to meet with CEO again, this time not as Overhead, but as someone to proactively update the company’s approach to Quality and tools to expedite product development and commercialization. It became clear during my first week at the company that the problems were not a lack of quality or the Quality area, but lack of business centric quality processes.

The events that proceeded my second meeting with the CEO were lack of defined deliverables as products made it through the development process. Defining roles, responsibilities and clear deliverables during product development enables unified approach, focusing team members to work cross-functionally on commercialization efforts. The CEO became an enthusiast of process, metrics and deliverables; transforming an overhead mentality into Quality as a key member of Product Life-Cycle Management.

The Quality role should not be thought of as a policeperson or overhead, but as an active business partner. Utilizing tools familiar tools in evangelizing proactive practices versus reactive compliance. The example transformation was achieved using basic root-cause analysis tools. The issue was not lab failures, but in not clearly defining the deliverables in transferring product from pilot plant to manufacturing sites, including testing requirements. While there was a clear failure, the root cause went much deeper. Defining a phased approach for deliverables helped each organization prepare for short-term and long-term requirements. This successful process reduced cycle-time and elevated ‘at-risk’ project for Management Review. You could learn from this example by checking out our website: https://www.consultwing.com/product-development-tplc/

Example of Phased Approach Product Development with Deliverables

Come back to our site and blog for continuing stories on transforming Quality from “overhead” to engaging business partners. At Consult Wing, we help organizations align, achieve and sustain.

Business Centric Solutions for meeting Regulatory Requirements

Business Centric Solutions for meeting Regulatory Requirements

Struggle with explaining Regulatory Requirements to upper management?  Regulated industries have two masters: the regulators and CEOs; so why not develop strategic tools to serve both? Let’s use a process approach to determine how well your current practices meet your organizational needs:

Defining business practices that meet Regulatory requirements is key for delivering product, services and reputation to your company.  Consult Wing has over 35 combined years experience in aligning, achiving and sustaining Business Centric solutions.  Give us a call to discuss how we can help your organization.