Best Flow Chart Template

Tuesday, June 9th 2020. | Sample Templates

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How to Implement a Statistical Process Control Program

Medical Device & Diagnostic Industry MagazineMDDI Article Index How to Implement a Statistical Process Control Program

Medical Device & Diagnostic Industry MagazineMDDI Article Index An MD&DI  March 1998 Column PROCESS CONTROL An MD&DI  March 1998 Column PROCESS CONTROL Manufacturers can increase the odds of beating the competition to market by developing an SPC program that allows for continual release of product. Manufacturers can increase the odds of beating the competition to market by developing an SPC program that allows for continual release of product. In the medical device industry, increased competition and limits on insurance price reimbursement have forced a cost-reduction philosophy in what was once a highly profitable business. Manufacturers now need to retain or improve time to market and quality while keeping costs down. Further, FDA regulatory enforcement issues concerning items such as generic drugs, silicone breast implants, and heart valves have increased FDA scrutiny and tightened regulations.1 Such responses have slowed release to market, which in turn has reduced profits. Medical device firms are now focusing on improving their processes to shorten time to market and improve product quality. In the medical device industry, increased competition and limits on insurance price reimbursement have forced a cost-reduction philosophy in what was once a highly profitable business. Manufacturers now need to retain or improve time to market and quality while keeping costs down. Further, FDA regulatory enforcement issues concerning items such as generic drugs, silicone breast implants, and heart valves have increased FDA scrutiny and tightened regulations.1 Such responses have slowed release to market, which in turn has reduced profits. Medical device firms are now focusing on improving their processes to shorten time to market and improve product quality. One way to improve a process is to implement a statistical process control program. Typically used in mass production, an SPC program enables a company to continually release a product through the use of control charts rather than inspecting individual lots of a product. As long as a device company maintains meticulously reviewed and signed documentation of its process, and the process is within specification, FDA will allow product release using SPC. This will reduce time to market by eliminating interruptions in production. SPC enables a company to detect trends and defects earlier in production, thereby reducing inspection, rework, and scrap costs. SPC is usually represented by a control chart, which is a simple graph of process information.2 The use of graphs to understand processes, improve efficiencies, and reduce costs began when Walter Shewhart introduced the control chart at Bell Labs in 1924.3 One way to improve a process is to implement a statistical process control program. Typically used in mass production, an SPC program enables a company to continually release a product through the use of control charts rather than inspecting individual lots of a product. As long as a device company maintains meticulously reviewed and signed documentation of its process, and the process is within specification, FDA will allow product release using SPC. This will reduce time to market by eliminating interruptions in production. SPC enables a company to detect trends and defects earlier in production, thereby reducing inspection, rework, and scrap costs. SPC is usually represented by a control chart, which is a simple graph of process information.2 The use of graphs to understand processes, improve efficiencies, and reduce costs began when Walter Shewhart introduced the control chart at Bell Labs in 1924.3 Implementation of an SPC program and its corresponding control charts appears relatively simple. Utilization of control charts as a mechanism for product release, however, requires a bit more. Control charts are data collection tools that require an operator and/or a computer to tabulate the data and plot them accordingly. Strict compliance becomes necessary when manipulating and plotting these data if they are going to be used to release product. In this sense, the use of control charts is no different from the use of any other inspection operation. Regardless of what data are being collected, the chart is a graphical representation of process performance data used to control the manufacture and support the release of a medical device, and hence must be controlled to the same extent as other release documents.3 Implementation of an SPC program and its corresponding control charts appears relatively simple. Utilization of control charts as a mechanism for product release, however, requires a bit more. Control charts are data collection tools that require an operator and/or a computer to tabulate the data and plot them accordingly. Strict compliance becomes necessary when manipulating and plotting these data if they are going to be used to release product. In this sense, the use of control charts is no different from the use of any other inspection operation. Regardless of what data are being collected, the chart is a graphical representation of process performance data used to control the manufacture and support the release of a medical device, and hence must be controlled to the same extent as other release documents.3 THE SPC SYSTEM THE SPC SYSTEM Prior to initiating an SPC program, all aspects of the process must be planned and documented in an appropriate format. An outline mechanism such as a flowchart would be useful to complete this step. This activity is usually handled by a diversified group from within the organization with knowledge of process, SPC, and good manufacturing practices (GMPs). This group should outline all aspects of the program, from selecting control chart sites to archiving the completed charts. Next, a control charting standard operating procedure (SOP) or company guideline should be developed and approved prior to initiating the program. Either method will ensure that chart development and maintenance are handled consistently. Prior to initiating an SPC program, all aspects of the process must be planned and documented in an appropriate format. An outline mechanism such as a flowchart would be useful to complete this step. This activity is usually handled by a diversified group from within the organization with knowledge of process, SPC, and good manufacturing practices (GMPs). This group should outline all aspects of the program, from selecting control chart sites to archiving the completed charts. Next, a control charting standard operating procedure (SOP) or company guideline should be developed and approved prior to initiating the program. Either method will ensure that chart development and maintenance are handled consistently. The purpose of the flowcharting or brainstorming session is not to redevelop SPC. SPC is a commonly used technique, and its use and benefits can be reviewed in many quality assurance journals. The working group should have a basic understanding of SPC and realize that it is developing a system built on using the charts and ensuring control of the ancillary activities that support them. The specifics will vary according to each individual company, but the following are areas that may be addressed as part of maintaining an overall SPC system that can be used for product release: Responsibilities. Preliminary engineering activities, including process and characteristic selection, chart selection, sampling frequency, subgroup size, and control limit calculations. Control chart preparation. Documentation of standardized chart templates/SOPs. Out-of-control engineering notification and investigation. Changing control limits. Review and approval process. Archiving of data and charts. Computerized control charts. Training. The purpose of the flowcharting or brainstorming session is not to redevelop SPC. SPC is a commonly used technique, and its use and benefits can be reviewed in many quality assurance journals. The working group should have a basic understanding of SPC and realize that it is developing a system built on using the charts and ensuring control of the ancillary activities that support them. The specifics will vary according to each individual company, but the following are areas that may be addressed as part of maintaining an overall SPC system that can be used for product release: Responsibilities. Preliminary engineering activities, including process and characteristic selection, chart selection, sampling frequency, subgroup size, and control limit calculations. Control chart preparation. Documentation of standardized chart templates/SOPs. Out-of-control engineering notification and investigation. Changing control limits. Review and approval process. Archiving of data and charts. Computerized control charts. Training.

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