Quality Management Systems Strategy

Our Quality Management Strategy recognizes a number of management principles that can be used by senior management as a framework to guide their organis\zations towards improved performance. The principles cover: customer focus, leadership, involvement of people, process approach, system approach to management, continual improvement, factual approach to decision making, and mutually beneficial supplier relationships.

Quality Management provides suitable guidance to build upon Quality Assurance standards to achieve business benefits for all stakeholder groups and focuses on continual performance improvement to sustain customer satisfaction. The core concepts are:

continuous process improvement - driven by senior management, focused on critical process areas with explicit improvement goals
customer focus - recognizing both internal and external 'customers' and their needs and providing value to the user of the product
defect prevention and non-compliance - seeking to prevent non-conformance issues with products and services early in the development cycle and being proactively engaged in prevention
universal responsibility - recognizing that quality is not only the responsibility of quality assurance teams or reviewers, but should be totally pervasive in all aspects of the business, with everyone seeking ways to improve the quality of their own products and services.

Good Manufacturing Processes

GMPs are the basic principles of operations a food processor should follow to produce a consistent, quality food product. Specific GMP guidelines exist for specific Canadian products: soft drinks, dairy products, dried dairy products, bottled waters, nuts and principal nut products, low acid and acidified low acid canned foods, processing and aseptic packaging, processed eggs, and fermented meats.

GMPs may be divided into eight areas:

Premises – building exterior, interior, water supply and sanitary facilities.
Transportation and Storage – transportation carriers and conditions, storage facilities and conditions.
Equipment – preventative maintenance, calibration.
Personnel – training for hygiene and handling, sanitation, maintenance, written policies and programs.
Manufacturing Controls – testing for the parameters of the product (e.g. Aw, pH, solids, etc.).
Sanitation and Pest Control – written programs with all possible details.
Recall – a written recall protocol, procedures for a mock recall to test system effectiveness.
Records – records to prove all the procedures are being followed: production, distribution, shipping, and testing records. GMPs are the principles upon which any quality control/assurance program can be built and are used to effectively control any variables of production that may cause damage to the product– quality or safety for consumption.
The main focus of GMPs is product quality.

Hazard Analysis and Critical Control Points (HACCP Systems)

HACCP systems are a systematic approach to preventing hazards that may harm a consumer from occurring or developing during the course of food production. Hazards that may harm a consumer may be categorized into three areas:

Physical – wood splinters, metal, glass, plastic.
Chemical – chemical residue from cleaning, allergens, excess ingredients.
Biological – pathogenic organisms such as Salmonella and E. coli, parasites such as trichinella and crytospordim.
HACCP systems account for hazards at each step of production. They limit hazard development through an organized system of communications and procedures that handle deviations from normal conditions and limits. The systems provide corrective actions that will solve the problem quickly and efficiently. HACCP are the most confident systems to date that prove food safety to consumers.

HACCP systems rely on prerequisite programs to be support systems. Prerequisite programs are essentially GMPs. These programs require detailed record keeping to verify the information is within specifications and documents the completion of necessary job actions.

The main focus of a HACCP System is to produce a safe food product

There's a lot of excitement today in Health Care about the benefits that Lean can bring. Healthcare services are complex processes which involve diverse professional skills, varying patient needs with cutting edge technologies. Variation and Non-value added activities are inherent on the process. A high degree of both makes it challenging to anticipate and manage results. Variation and Non-value added activities also lead to patient dissatisfaction which in turn drives up costs, further convoluting the system. If you can reduce variation and Non-value added activities in a process, you can significantly reduce the amount of unacceptable outcomes or "defects" in the process.   Eliminating defects one at a time or in quantity greatly increases the level of efficiency, profitability and the patient experience. This is especially critical in an environment where patient needs are increasing while the pool of skilled resources and reimbursement for services are dwindling. The key is to apply Lean Healthcare concepts in a regulated environment driven by the unique values that surround patient care.

As a strategy, cost savings is limited because large cost savings are usually taken early, making further savings more difficult to capture.   In addition, cuts are usually made in the value-added areas (people, equipment, beds, services, etc.) which reduce the quality of the experience to the patient.   Applying manufacturing tools and techniques may seem counterintuitive or even outlandish to the healthcare professional, but as other industries have learned, it is not the tool per say, but the concept behind the tools that is important. Many hospitals have already jumped into the arena with six sigma efforts. Interestingly enough most report little to no benefit and some have even abandoned the idea all together. Why? The following list captures the main reasons:

• Lack of support from senior or middle management

• No corporate structure to deploy and monitor change

• Outdated or weak VOC data (Voice of the Customer) both internal and external  

• No corporate strategy to deploy

• Weak communications systems

• No corporate ownership of the program

• No mechanism for transfer of knowledge, best practice sharing or sustainability.

• Metrics for success

• Lack of dedicated resources

No wonder change effort fails, without these CSF's (critical success factors) in place companies should expect to fail not succeed. While some providers do in fact have some of these CSF's in place many do not.   Clearly, they have all read the wonderfully inspiring books from GE, Motorola, and others describing unprecedented success and rewards. What they missed was the how, what, where and when of the success… the strategy, the deployment and the execution .   Compared to the manufacturing and service industries, the performance management process in healthcare is far behind.   In other words, although doctors are able to cure and prevent a wider range of illnesses and provide more comfort, the cost, quality and delivery of the health service has essentially not improved significantly, in fact the chasms seems to being widening.

Healthcare has a tremendous opportunity to deploy Lean Healthcare concepts to reduce internal/external costs, improve patient safety, increase profits, reduce litigation and decrease the dependence on Government and Insurance. To accomplish this monumental task, Healthcare providers will need to turn the microscope inside and do what others, Toyota , Dell, WalMart and the like have done to be best-in-class. Lean applies to all areas of any industry especially Healthcare.

As in other industries, we can all agree that the customer should come first. In healthcare that customer is the patient, the regulatory bodies and maybe even the Insurers. They all define and drive the definition of value (i.e. what is not adding value to their needs). The product (Laboratory results) or service (patient care) can make the difference between life and death. The needs of the patient are paramount and give new meaning to Lean Healthcare. This then makes Lean even more important in this industry over manufacturing or other services.

Today healthcare is not designed to make the value stream of care flow smoothly . As with manufacturing, healthcare services are often “batch and queue”, with patients spending most of their time waiting until the right process (skilled healthcare practitioner) is available.   As a result, the value added processes are disconnected leaving the patient and the caregiver all disillusioned. The working environment is one driven by shared values and passion in delivering top quality products and services to the patient. Without Lean, healthcare will continue to have difficulty meeting the pressure to serve an increasing number of individuals at less cost. As the population ages, healthcare must find new ways to meet the demand for their services. Turnaround time (i.e. patient cycle time, service Takt time) becomes a primary measurement that must improve whether it is in the hospital facilities, post care facilities or laboratories. Further, space is at a critical premium in running all the functions within a hospital facility. Only Lean can provide a solution to all these concerns with minimal expenditures but maximum benefits.

There is one caveat, Lean can assist healthcare providers in reducing costs, improving service levels and increasing value but must do so without compromising quality of care, compliance, brand, patient safety, or conformance. This is the challenge…the opportunity. Health Care professionals are surprised to see similarities with other industries when they actually look at the benefits of applying Process Excellence methods in their environment. Once they have the 'right' knowledge they are able to see and achieve results which meet the needs of patients now and in the future.

The Case for Lean Six Sigma

The Need

American businesses are facing one of the most trying times in history.  There’s incredible pressure to do more with less and do it better.  The economic climate, the regulatory climate and the customer climate are all growing increasingly challenging.  Clearly, a new model for management is needed.  That model is lean six sigma.

• Rising  Costs of resources and materials
  
• Revenues are being squeezed – customers constantly demanding price reductions
  
• Difficulty recruiting and retaining good employees
  
• Need to be nimble
  
• Rising customer expectations
  
• Increasing international competition
  
• Increasingly complex regulatory environment

• Customer Focus – The purpose of any organization is to satisfy its customers.  This means that planning must begin with an understanding of the needs of their various customers.  Most hospitals have both patients and doctors as customers whose needs they need to consider.
  
• Process Perspective – Looking across an organization at processes instead of focusing on functional silos improves understanding of operational issues, teamwork, and efficiency.
  
• Continuous Improvement – Processes are continually improved to meet changing customer needs and reduce costs.
  
• Empowerment – Employees are empowered to improve their processes to reduce costs and increase customer service.
  
• Data-Based Decision-Making – Decisions are made on the basis of facts rather than precedent, hunches, or political machinations.