With the COVID-19 pandemic defining our ‘new normal’ and companies working on how to best utilize the ‘virtual’ space, the ability for the Brand Owner to be onsite for Contract Manufacturer production runs might be compromised.  Building trust with your Contract Manufacturer early in the partnership could very well define the limits of quality you will see in the finished product.  But what do we mean when we say Quality?  Is it a product measurement against a specification?  Is it a clean facility that follows GMP’s, possibly even to the point of certification by a third-party?  Is it good documentation so there is always a way to trace product?  Is it good customer reviews?  No Form 483’s?

There are so many different ways to measure ‘Quality’ that one could get overwhelmed with all the avenues to pursue.  I’d like to submit to you here a very simplified definition of ‘Quality’ that, if followed, will encompass all of the above, and more.  That definition is:

Quality = Every Product Released to be Sold has met 100% of all the Finished Product Specifications

Notice I did not say ‘Every Product Made’ or ‘has met the Gold Standard’.  Those are impossible for even the most reliable Contract Manufacturer to promise.  What is does mean, however, is that every product released to be sold falls within the range of acceptable, salable product as defined by the Brand Owner.  A smart Brand Owner will work with the Contract Manufacturer to define the ranges of acceptability, which can be based on customer needs, published standards, and process capability.  In order to set the ranges of acceptability, three things need to be in place: Gold Standard, Release Specifications and Control Limits.  The first one is solely the Brand Owner’s responsibility; the second a collaborative effort between the Brand Owner and Contract Manufacturer; the third is the sole responsibility of the Contract Manufacturer.  Let’s take a deeper look at each one.

Gold Standard - If you’ve been following my previous articles here, you will know that the Gold Standard is your target product.  It is exactly in the middle of all your product specs and represents the product you’d like your customers to get every time they purchase.  The Brand Owner is solely responsible for creating the Gold Standard and defining all the specifications that are critical to producing it.  Note the word ‘critical’ above.  When defining the specifications, be careful not to over-define them.  Stick with the reason for being for your product and basic customer needs for a consumable; it needs to be safe to consume, meet all the label requirements, and be appealing for the customer to purchase. When you consider setting a specification, go back and ask yourself if it directly addresses one of those three items.  If it doesn’t, then you are over-defining your product and making it more difficult for the Contract Manufacturer to consistently meet.

Release Specifications – Once you’ve defined all the critical characteristics of your product, you can begin to set Release Specifications.  These are the ranges for the product that, when all are within the stated ranges, the product can be considered salable goods.  Setting Release Specifications should be a collaborative effort between the Brand Owner and Contract Manufacturer, as they should be set based on the critical characteristics as well as the capability of the process.  In other words, if a Brand Owner sets a Release Specification of 4-6 (arbitrary units) for a property that is critical to the safety of the product, but the Contract Manufacturer knows the process can only deliver 3-7 consistently, you are better off looking for another Contract Manufacturer.  Conversely, if the property is not a safety or label claim issue, then the two parties should work together to decide whether 3-7 is acceptable while not compromising the integrity of the product.  Release Specifications are ultimately the Brand Owner’s decision but working with the Contract Manufacturer will ensure your product will meet them 100% of the time.  Please note that the Gold Standard AND Release Specifications must be set prior to authorizing any salable goods production run of your product.

Control Limits – Control Limits are the sole responsibility of the Contract Manufacturer.  While they are not critical to making salable product, having them in place is a way for the Line Operator or Quality Control Specialist to adjust the process before it has a chance to drift into a non-salable goods condition.  Control Limits are based on collecting data from numerous production runs and performing a simple statistical analysis to determine how capable the system is at making Quality Product (i.e. salable goods).  If we use the Release Specification example above we can see how setting Control Limits can be a useful tool on the production floor.  Let’s say the Brand Owner accepts the 3-7 range as the Release Specification for the product.  After running multiple batches of the product and collecting data, it is determined the process is capable of making product in the 4-6 range 95% of the time.  That means up to 5% of the results could be 3 or 7.  Since those are at the ends of the Release Limits for salable products, having a ‘trigger point’ for the Line Operator to adjust the process to bring it back to 5 would be useful.  In this case if we set the Control Limits at 4-6 then the Line Operator would make a process adjustment each time he saw a reading of 4 or 6.  This method of ‘fine tuning’ the process during a production run will ensure the product will almost never measure a 3 or 7. 

Setting Control Limits requires collecting data from multiple production runs, so it is not something that can be set prior to production like Gold Standard and Release Specifications can.

There are numerous ways to measure ‘Quality’ in a finished product.  Using the Gold Standard/Release Specifications/Control Limits is a method that will ensure finished product meets the Brand Owner’s, and customer’s expectations 100% of the time.  It does require work upfront and later on during production, but the benefits of lower scrap rates, lower customer issues, and lower costs means the Brand Owner, Contract Manufacturer and Customer all win.