A New Paradigm to Lower the Risk of Vendor Qualification. 2nd Half.

Last time I posed the problem that every company struggles to solve, insuring quality raw materials and components.  Even intensive on-site audits cannot always find major vendor problems.

To get to the solution we have to answer this question, why don't vendors always comply with the regulations.  My answer, based on years of auditing and operations management, is that by far the most common reason is lack of knowledge of the regulations through-out the organization. 

I'm not talking here about a general understanding of requirements.  I mean a deep Knowledge of the details of how to comply with the regulations as they are exemplified in the company’s procedures – not just that the packaging room needs to be inspected before packaging operations begin; but that previous materials have been removed, packaging and labeling materials inspected, extraneous materials removed, documentation, etc.

Sure, there is generally someone in most vendor organizations who knows the regulations.  But in poorly performing companies the attitude is often that regulatory compliance is up to the Quality Department.

My proposition is that once everyone in an organization knows the regulations as they apply to their jobs, DOING the job right is straightforward.  The biggest hurdle to overcome is disseminating detailed Knowledge of what needs to be done to all the employees. 

How can one use this relationship to assist with the problem of supplier qualification?  What if it were possible to objectively measure what all the employees of a supplier know about GMPs?  That deep Knowledge plus a broad snapshot of the supplier based on an audit will give you a strong measurement of the supplier's performance.

The next question is how does one measure that Knowledge.  Knowledge is not so easily measured in an audit.  You can check training records.  Usually you will see who sat through what training class, or who was checked off as proficient in on-the-job training.  There is rarely any indication of what people actually KNOW.

So how could we effectively measure the Knowledge of all of a supplier's employees?  Well, technology gives us an edge today that didn't exist not too long ago.  Computer Based Training provides a reliable, and relatively cheap way to assure that all employees have a minimum skill level. 

Online GMP courses train and test any employee who has access to the internet.  Learning Management Systems track who knows what, and make the results easily visible to management.

If you as a customer insist that suppliers test their employees and provide you with verification that all their employees have passed their GMP courses, then you can have a high degree of confidence that the supplier has the Knowledge to make compliant products.  You as a customer can have independent access to the training verification reports.  When your auditors cross-check the training reports against the names on batch records, the vendor suddenly becomes completely transparent.

There's another advantage when everyone in an organization is passing the same tests, peer pressure.  It's not easy for one person to bypass a GMP requirement when everyone around knows that it's the wrong thing to do.

Requiring your vendor to give their employees online, verified GMP training insures that they have a deep Knowledge of the regulations.  This doesn't really cost any incremental money because this is something the vendor should be doing anyway.  Combining the visibility of an online Computer Based Training system with an audit can make your supplier's quality program truly transparent.