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DOCUMENTATION?!?! Who needs it!


Well, actually, YOU do. And not only do you need a good trail of documentation in your business but you should also have a structured plan for WHAT to use, HOW to use it, and HOW LONG it should be stored.

Wikipedia states: “Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical or a food product manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.”

Okay, so this refers directly to the pharmaceutical or food industry which is essential to preventing illness or worse yet, death! But, what about other manufacturing sectors?  Aren’t ‘Good Manufacturing Principles’ just as important, no matter the industry?  The answer is yes!  Documenting properly, in any industry or sector, (whether by paper or computer) will directly affect good manufacturing practices.

If you are a Manufacturer or Distributor how serious are you about documentation in your business? Think about the following terms: Traceability, Standardization, Accuracy, Communication, Control, and Consistency?  These are all attributes that you should consider as you create an effective plan for documentation as they will positively result from a well thought out strategy.

Whether or not you will attain certifications such as an ISO Quality standard, you should start with some basic good practices that avoid using word of mouth on the proper processing methods. For Production, Process Sheets are an easy one to implement and remember if it is not written down, did it really happen the way it should have?  Do operators really follow your instructions on how to produce your product?  Implementing these will help ensure that products are consistently produced and controlled to the quality standards appropriate to their intended use.  Other Production documentation to consider using (or reviewing how you are currently using) is Process Flow, Quality Alerts, Approved Deviations, and Calibration Records.

Another good area to review is your Engineering right from the Concept Development to Product Launch. This area is usually well documented with Prototype, Drawing Control, Approved Tooling, Approved Packaging, and Bill of Materials and it is always best that you can go back to review this as your product cycle goes on to see changes (expected or otherwise).

Some issues that I identified at one company included a multitude of problems and they were the direct result of NO DOCUMENTATION PLAN put in place at the beginning. We could not find any of the original Engineering documentation for many products, staff had changed, and processes as initially designed and priced had changed over time.  To add to this, it was apparent that there was a lack of engineering support for a number of years to ensure accuracy at product start and communication between Production and Engineering was non-existent. Comments had been added to Work Order paperwork from production associates but no changes were being made.  Essentially, Bill of Materials were no longer accurate, and this had various resulting problems: no one really knew when the product was truly unacceptable, and since the Bill of Material was now not accurate the purchasing was directly affected and then there was the cost issue.  Many products actually cost more to make than they were being sold at.  And did I mention that NO ONE was checking Quality anywhere in the process? This required several actions to rectify but it was a direct result of not having a documentation plan in place.

Remember, effective documentation will always help you to see what a manufacturing process has been doing and enhances the visibility of the quality assurance system. It is the key to good manufacturing principles.  It will help ensure compliance to set parameters, traceability, expected quality levels, and improved communication.

Good Luck !!!  Have a great day!