Risky Business: More of the Quality Lean Connection - Quiz Article
Risky Business: More of the Quality Lean Connection - Quiz Article
My article titled The Quality Lean Connection appeared in this month’s Journal of Dental Technology. The summary of that article was as follows:
A quality product is the minimum requirement. Your customers expect you to be responsive, flexible, and 100 percent reliable. Use your quality system and the philosophy and techniques of lean to impact on both your product quality and on your customer perceived total quality.
The follow-up to that article is the subject of this month’s Risky Business – how quality and lean can benefit your business.
When quality is combined with lean, the quality function becomes preventive with its objective to develop quality at the source. The quality role will be to analyze cause and effect, predict failure modes, and prevent them from happening. Inspection of the product will move to a process/product auditing focus. Lean is a business improvement initiative that is applicable to the entire organization.
Development and implementation of your quality system puts in checks and balances that require behavioral change. Lean sustains change through behavioral change. How you use quality and lean to improve your business depends on how willing you are to implement change and proactively involve your workers in the change process. There’s lots of reading material out there on quality and lean so explore the possibilities within your organization and begin the journey.
The following table shows some of the elements associated with quality and lean and how those elements are addressed by quality systems and lean initiatives.
| Element | Relationship to Quality | Relationship to Lean |
| Materials | For patient contact materials, FDA registered materials must be used. Your suppliers and subcontractors, if used, must provide information that they are using FDA registered materials. Complaints against suppliers and subcontractors must be documented and reviewed by the lab at least annually to determine if the lab should continue to do business with them. An inventory and stocking procedure of first in first out should be used to ensure that the materials that have been on hand the longest are used first. Expiration dates on materials must be checked upon receipt of the materials, prior to distribution into production, and while in production areas. | An analysis of minimum inventory levels and how quickly materials flow through the process will be performed to limit inventory to use less material to create products. What are the reorder signals in the process? It is critical that you work with suppliers who can supply materials when needed so over-stocking is not necessary. How first in first out is managed is considered. Assessing the cost of floor space for inventory will help determine how much floor space is actually to be used for inventory. Methods used to coordinate receipt of and handling of incoming material shipments are evaluated. |
| Equipment | Preventive maintenance (PM) schedules must be documented according to manufacturers’ recommendations. Performance of PM is verified by the person performing the PM. Repair records are used to document repairs, who performed the repair, the cost of the repair, and details of the repair. This information is reviewed at least annually to determine if equipment should be retired due to cost of repairs. | Using 5S, you will remove equipment that is not needed on a regular basis from work areas. Also, you will evaluate which equipment is not needed in the future and can be disposed of in some manner. Value stream mapping will be used to analyze equipment engineering. Is maintenance reactive or planned? What is response time for maintenance on equipment? Are there simple maintenance activities that can be given to the operators to perform? Are modifications necessary to prevent defects? |
| Worker Involvement | Everyone is accountable for their work. The competency of workers is documented and back-up workers are assigned for all tasks. Training is determined and provided as needed to maintain competent workers. Training is tracked. | Lean assists in minimizing the work force to reduce labor costs. Cross training is provided for the development of multifunctional workers. Value stream mapping helps improve performance and work flow. Team work is necessary. Several types of teams are used: natural work teams, cross-functional teams, and teams for Kaizen events. |
| Cleanliness | Cleaning schedules are developed and documented for all work areas. Accountability for cleaning is assigned to all workers and performance of cleaning is documented. | Implementation of 5S results in the elimination of waste and through the second step in 5S – showcase or shine a good as new work area is created. |
| Standardization | Standard operating procedures are developed. Work instructions are developed. Changes to SOP’s and work instructions must go through a change process. | Establishment of standardization in all areas Increases efficiency. Through standardization areas are organized and the most efficient work flow is determined. Your goal is to produce high-quality products and services in an effective and economical manner. |
| Physical Facility | Work areas are evaluated with the workers to determine the most efficiency arrangement to produce a quality product. | Through 5S and lean principles less space is required to produce products. The flow of work throughout the receipt to shipping is analyzed to establish the most efficient use of space. |
| Customer Satisfaction | Data sources for customer complaints are determined and all complaints are documented. Frequent reviews of complaints are conducted and corrective action is taken on all complaints. Remakes are considered complaints. The root cause of remakes is determined and documented for frequent review. This information is evaluated to determine any trends in regard to failure of materials, equipment or workers. Reduction in internal reworks through analysis of root cause also reduces your material and labor costs. | You may survey your customers to find out what they want and what they consider value. Only do what customers consider value. You must align your customer value by determining which processes are value-added and which ones are non-value-added. A value-added process must meet the following criteria: The customer is willing to pay for it. It must transform the product or service in some way. It must be done correctly the first time. Anything that doesn’t meet the above is non-value-added and is therefore a waste of time. There will be, however, some non-value-added steps that are still necessary so you’re searching for the ones that are not necessary. Development and implementation of your quality system puts in checks and balances that require behavioral change. Lean sustains change through behavioral change. How you use quality and lean to improve your business depends on how willing you are to implement change and proactively involve your workers in the change process. There's lots of reading material out there on quality and lean so explore the possibilities within your organization and begin the journey. |
