GMP and Quality Management

by David Markovitz, Senior Consultant, GMP Institute

How are Good Manufacturing Practices viewed in your organization?  As federal regulations that must be complied with or as useful guidelines which can help your manage your business to achieve better quality and productivity, which in turn leads to greater profits?

How is Quality Management (QM) viewed in your organization?  As another program with no relationship to management structure or philosophy, or as a systematic approach to managing a business which integrates GMP's as a part of the foundation upon which are built the tools and techniques of process improvement?

The answers to the above questions can rarely be answered in the black and white terms offered as choices.  In many cases, GMP's get a lot of attention in a company in response to an audit, either by regulatory agencies or by customers.  The same hold true for QM.  Lots of attention is given to quality management if a crisis exists.  Two examples are Xerox and Harley-Davidson.  Both companies cite their attention to quality management philosophies in helping them climb from the abyss they were facing in their respective businesses in the early 1980's.  Often times, it is the customer demanding quality management from it's suppliers which causes attention in organizations.  A case in point is Motorola.  After winning the Malcolm Baldrige National Quality Award, Motorola began asking their suppliers to begin using quality management principles and actually apply for the Baldrige award themselves in order to remain a Motorola supplier.

GMP's and QM have a lot in common.  They both represent knowledge which can lead an organization to riches.  Yet they both seem ignored by many managers unless there is some external pressure to pay attention to them.  Furthermore, how many organizations have embraced GMP's and QM together - integrating them both in their overall management philosophy?  I'm afraid we could count these without using many fingers.  

How can we help managers gain a better understanding that both GMP's and QM, fully integrated and used together, can help achieve a robust thriving business?

Let's start with the language most managers understand - money.  When asked to cite the aim of their organizations, many managers respond by saying " To make a profit", to "To make money", or even "To make more money".  This response leads to the next question - What do these profits enable you to do?  The answers usually include:

These are all good answers - for without profits, organizations cannot achieve those things listed above.  Let's focus on the last item - providing innovative products and services to meet and exceed our customers' expectations.

Many organizations have begun talking about their commitment to their customers.  The number one retailer in the United States today, Wal-Mart, cites exceeding customer expectations as the aim of the company.  David Glass, Chairman of Wal-Mart, says that value is the key to exceeding their customer's expectations.  He defines value as the delicate balance between price and quality products and services.  The higher the quality products and services they can offer at the best price, enables them to become more profitable.

If David Glass is right, then the focus must be on improving the quality of your products and services without raising the price.  This leads to the next question - What must you do to raise the quality of your products and services without raising costs?  The answer is to work to improve the methods by which you produce your products and services.  This is where GMP's and QM come into the picture.  The fundamental basis of GMP's is to operate your company in a State of Control - prevent contamination, mix-ups, errors.  Many mixups, errors and contamination can be traced to methods which were not understood, were not properly documented or were not documented at all. The fundamental basis of QM is to reduce variation which leads to the reduced probability for contamination, mix-ups and errors.  QM presents proven methods not only to stabilize a process, but to actually improve the process on a continual basis.  

What occurs in your organization when your methods and processes are improved and yield predictable results?  Trouble decreases - rework is decreased, scrap goes down, contamination is reduced, fewer mix-ups and errors - there are fewer crises and fewer fires to extinguish.  People can concentrate on the work at hand, with fewer interruptions and distractions.

With less trouble and confusion in your operation, what happens to your costs?  They go down.  By working to improve the methods and processes thereby raising the level of quality of your products and services, you reduce your costs.  Improved quality and cost savings too!

What happens to productivity when output increases and costs decrease?  Productivity rises.  Now higher productivity combined with lower costs leads to a condition sure to bring smiles - increased profits!

This closes the loop (see diagram).  With higher profits, now you can provide a good return on investment to your shareholders, invest in long term growth strategies like R&D focused on innovation, work to gain market share, and provide jobs to improve the economy.  This chain reaction can start anywhere, but ultimately focuses on the aim of exceeding customer expectations and is fueled by people working together to improve the methods and processes in order to improve the quality of your products and services at the right price.  Profits are an outcome of this chain reaction.

This chain reaction should help your managers understand where GMP's and QM fit into the business chain of running a successful business.  They should also see where both need to be integrated as a fundamental way of life, and not as disparate programs.  How we teach and train people in the concepts of GMP and QM is critical to the perception that both offer solutions critical to the success of a business.

Let's examine one aspect of managing methods to achieve improvement.  GMP's require us to maintain thorough documentation of our procedures.  We're also expected to follow those procedures.  We're also expected to follow those procedures.  Unfortunately, organizations with the GMP compliance paradigm usually conduct a one-time ceremony where Standard Operating Procedures (SOP's) are written and compiled in a three ring binder with proper authorizations and signatures.  These binders are then distributed to the appropriate managers and supervisors, who then proceed to place the binder on a shelf or bookcase.  The real value is missed since the people expected to follow those procedures are excluded from the process.  Oh, sometimes they'll be given the binder and told to read these.  Often, reading these procedures is like reading a foreign language since the stated procedure bears little resemblance to what the current system is capable of doing.  The problem here is that these SOP's are often written by "experts", professional people who know how the procedure should be done.  These people are rarely given the time to work with the operators of the process to discover how the procedure is currently being performed.

Quality Management techniques can help here.  One approach is to document the procedure by a team of the "right people."  The right people would include technical experts, professional staff, and the people closest to the process, the people doing the work.  This team can work together to develop the "current best approach" and document this as the SOP.  Flowcharts can be used extensively to document a process in a graphical, easily understood manner.  These flowcharts can also be subsequently used as training tools, helping orient new people into the job.  This team should meet on a regular basis to review and update this SOP.  If the team is using quality management methods and striving to continuously improve their processes to improve the quality of their products and services, these SOP's will need updating to reflect the improvements.  Furthermore, the people doing the work are more likely to ensure that they follow the SOP, since they "own the process" and gain an understanding that standardization meets the fundamental basis of QM in reducing variation of methods used in the production of products and services.  This also is a goal of GMP to have consistent performance to produce consistent product quality.

This demonstrates only one example where Good Manufacturing Practices and Quality Management strategies can be viewed as one system.  There are countless opportunities and examples that exist throughout most organizations.  Our challenge is to demonstrate that practicing GMP's and Quality Management strategies can produce effective bottom line results.  The chain reaction pictured on in the diagram should help you to do that.