How Statistical Process Control Helps Medical Device Manufacturers Maintain Quality

business meetingStatistical process control (SPC) has proven to be an effective means for original equipment manufacturers (OEM) of medical devices to maintain and even improve product quality. SPC utilizes statistical methods, quantitative and graphic analysis of measurements, to evaluate and assess the stability of a process and the resulting quality of its production. Manufacturers that implement the process can reduce time to market, increase production, and take the guesswork out of quality control.

Statistical process control is nothing new to manufacturers or industry. In 1924, a statistician at Bell Laboratories, William A. Shewart, developed the control chart and the concept that a process could be in statistical control. SPC proved to be a better and more efficient way to monitor product quality without compromising safety.

Today, advanced SPC software is widely used as a quality tool throughout many industries. SPC is an effective way to drive continuous improvement. By monitoring and controlling a process, we can assure that it operates at its fullest potential. As a method to measure and effectively control the quality of the manufacturing process, it’s considered by many as second to none. Quality data is collected in the form of product or process measurements or readings from various machines or instrumentation. The data is collected and used to evaluate, monitor and control a process.

SPC is ideal in mass production of medical devices for the program allows continual output through the use of control charts rather than inspecting each individual lot of a device. FDA also allows product release using SPC as long as the process is well-documented and thoroughly reviewed. This eliminates interruptions in production, and also facilitates the detection of trends and defects earlier on, which further reduces rework, retooling, and material waste.

SPC methods are also predictive tools that should be a part of a manufacturers’ mature predictive maintenance program. Well-designed, it can monitor process performance and maintain control with only periodic adjustments when necessary, and to also ensure not to over adjust. Regular monitoring of a process can save unnecessary inspection and adjustments. This information allows for a proactive response rather than a reactive response when it may be too late or costly.

Control charts, clear and uncomplicated graphs of process information, are the key to an effective SPC program. Using control charts aid quality control analysts to monitor processes and identify any variation in the performance. Data from a stable, controlled process will only display common cause variation, i.e., only that variation which is inherent to the process. Control charts are based on aggregate past data that can be measured and predicted to determine how a process will vary (within limits of common cause variation) in the future. An unstable process will display a special cause variation, i.e., a non-random variation in the data. Quite simply, control charts are robust tools for understanding process variability and to analyze process performance.

Finally, statistical process control is instrumental where precision matters in the production of components. Statistical analysis allows quality control analysts and engineers alike to analyze data, and to control and monitor production and procedures during validation and verification.

Implementing a well-designed and comprehensive SPC system will improve your product quality. An SPC system benefits manufacturers and companies by providing historical benchmarks to relate to daily and long-term process performance of products, which will in turn, greatly aid the release and delivery of a safe and effective medical device to the marketplace.

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Plastic Products Catalog

BMP Medical is a quality manufacturer of plastic consumables and plastic products for research and medical diagnostic laboratories. Our products are manufactured to the highest quality standards. We offer a wide selection of products sold through the world’s premier laboratory distributors.

Non-Sterile and Sterile Centrifuge Bottles

  • Available with standard caps for low-speed work and sealing caps for high-speed applications
  • Caps have a built-in gripper to facilitate removal from the rotor
  • Extra thick walls for durability-resistant to most chemicals
  • Wide mouth design makes filling and decanting easier
These precision molded centrifuge bottles are available in polycarbonate or polypropylene. For low speed applications the bottles provide excellent value for large volume/large batch centrifugation procedures. For high-speed work, the easy-to-use Noryl® (Noryl® is a registered trademark of General Electric Company) sealing caps with silicone O-rings enable leak-free processing at high centrifugal forces over long durations. Bottles must be filled to 80% of capacity. Centrifuge bottles may be autoclaved at 121ºC at 15 psi for 20 minutes. Caps should be placed on the bottles without engaging the threads. Bottles are qualified to the rated g-forces using Sorvall® (Sorvall® is a registered trademark of Kendro Laboratory Products) and Fiberlite® (Fiberlite® is a registered trademark of Piramoon Technologies Inc.) high-speed rotors, tested at 20ºC, with bottles filled to 80% of capacity. Failure to use the correct rotor cushion or adapter will shorten the life of the bottle and may prevent achievement of the maximum rated RCF and/or bottle failure. Prolonged autoclaving and reuse may cause stress cracks, crazing or bottle discoloration.
centrifuge bottle
Sterile Centrifuge Bottles 
 
centrifuge bottle
Non-sterile Centrifuge Bottles

Cytology Funnels Category

BMP Medical Cytology Funnels for the Shandon CytoSpin® Centrifuge BMP Medical Cytology Funnels are the functional equivalent of the Thermo Shandon CytoFunnel®. Fully compatible with the Shandon CytoSpin Centrifuge, BMP Medical Cytology Funnels can be used to deposit a thin layer of cells in a clearly defined area of a microscope slide. The filter card absorbs any excess fluid. Operation is identical to those supplied by Shandon and easy-to-follow instructions are included in each pack. All products sold in case quantities only.


 

metal cytology funnel clip

Metal Cytology
Funnel Clips

Double Cytology Funnels

Double Cytology Funnels

Single Cytology Funnels

Single Cytology Funnels

Hemodrop Blood Dispenser

The Hemodrop is designed to reduce the risk of exposure to bloodborne pathogens in the Hematology laboratory. To prepare a manual differential smear, a drop of blood needs to be dispensed onto a glass slide from the specimen tube. Simply puncture the rubber stopper with the Hemodrop, and then invert and press gently onto the slide. A single drop of blood will be dispensed and the slide is ready. No more removing the stopper and manually putting a drop on the slide to test blood.  
hemodrop
Hemodrop

Multipurpose Containers

These high-quality non-graduated lab containers are designed for the collection, transport, and storage of specimens and samples. Tight fitting lids prevent leaks and odors. Ideal for storing biologically hazardous samples for terminal autoclaving before disposal. Molded from various materials. The stackable containers are resistant to freezing and boiling.


centrifuge
Translucent Multipurpose
Containers

Polypropylene Beakers

Resistant to most commonly used laboratory reagents, including a variety of strong acids, bases, and organic solvents, these high quality polypropylene beakers are the premier choice for scientific laboratory applications. All beakers are transparent for clear content visibility and graduated for easily estimating volumes. Molded-in pouring spouts, and a rolled lip, for a dripless working environment. Autoclavable to 121ºC ( 248ºF).
centrifuge
Polypropylene Beaker

Specimen Collection

For specimen collection and transport, this system provides disposable products for the convenient collection, delivery, and testing of urine specimens. A plastic cup is provided for specimen collection and the pressure sensitive patient identification labels have ample writing space. The lightweight transport rack is small and easy to carry yet provides space for up to 20 tubes with labels and caps. The tubes are made of sturdy polystyrene and are safe for centrifuging. The flared top permits the use of a midget urinometer ensuring a tight cap fit. 

centrifuge

Commode Specimen
Collection Systems

urine container

24 Hour Urine Containers

urine container

24 Hour Urine Containers with Spout

Tissue & Ultra Tissue Grinders

We offer two lines of tissue grinders for the clinical lab and research lab. The standard product is all plastic and is designed to grind softer tissues such as liver and spleen. The Ultra tissue grinder line has a vitrified tip and is designed for tougher material such as muscle or bone. Both lines are delivered sterile sealed Tyvek® (Tyvek® is a registered trademark of DuPont) package.

tissue grinder

Tissue Grinders

ultra tissue grinder

Ultra Tissue
Grinders

Urine Sedimentation System

BMP Medical, a manufacturer of diagnostic products, has a full line of urinalysis disposables. We offer the components separately, or in various kit sizes and configurations. The line is built around our 10-chambered Decislide which is made out of optically clear acrylic. It can take 10 individual samples on the same slide eliminating the need for a new slide for each sample.

 

Urine Sedimentation

Urine Sedimentation
System