US Endoscopy: Revamped SOP Worth the Work

OUTSTANDING QUALITY AND REGULATORY TEAMS

All of the extra work and hours required to devise a new standard operating procedure (SOP) can be daunting. As US Endoscopy (Mentor, OH) was reaping the rewards of success, its quality and regulatory team realized that its compliance system needed to be taken to the next level.

“Being a successful medical device company, we're challenged with obtaining double-digit growth, finding and training people, and getting them through the learning curve in a compliant manner,” says Anthony Siracusa, vice president of manufacturing operations. Coupled with new product introductions, the company has been confronted with properly training employees on the production floor and documenting the effectiveness of that training. “That led us to take a hard look at our work instructions on the shop floor.”

The quality, regulatory, and process engineering teams came together to develop a better training method about a year and a half ago. Their combined efforts led to the firm's enhanced work instructions, a three-part tool that replaces the company's old SOP and work instructions on the shop floor.

The first part of the instructions includes device background and use, a section with digital pictures, and documentation on workstation setup and operation. This is a big improvement on the previous SOP, which contained five simple steps to build a device. “Now, we highlight the way the device is used and what's critical to quality in the device” specific to an operator at a particular step, says Siracusa.

Second, at the workstations, employees must document the number of nonconformance occurrences on a quality inspection control sheet. Past efforts to gather and document these data couldn't be quantified. “Now we have a running baseline,” says Siracusa. “Every month, we put the number of defect occurrences in Pareto form.”

The third part of the instructions is a portfolio, which sits at each workstation operation to document the effectiveness of the training. Employees must read the work instructions. They must understand how the device is used and what aspects are critical to quality. They also must be able to perform the operation on their own. All of this training takes place at the point of use to ensure fewer gaps in training documentation. The process allows the production technician to take ownership of the process, along with helping to maintain proper documentation compliance.

Having a more detailed method obviously creates more work, and this was the team's main challenge in implementing the working instructions. The process of writing up the information about the product itself and its use was much more lengthy than the previous SOP. The team also had to run the old and new systems in parallel during the transition phase and to document that within the quality system.

Siracusa has seen success with the enhanced work instructions, which have also been well accepted on the shop floor. “We're much more compliant with training effectiveness sign-off. I have a great baseline now of a product family's nonconformance rates,” says Siracusa. “We run anywhere from 0.02 to 0.04% in field deficits.”

The quality engineer is in charge of summarizing the information generated at the end of each month and putting it into Pareto form. Using such charts provides more-specific baseline data than was available before and has helped the team improve in certain areas. “In the past, we weren't sure where to apply our efforts, because we'd go back and not have a good count,” says Siracusa, adding that the team is now seeing fewer repeat nonconforming occurrences on the shop floor.

“I feel it has been an effective tool in reducing process variation by providing clear and concise instructions to both experienced and new production technicians,” adds Don Terriaco, quality assurance manager.

There's still more work to do. The team's next step is to make the work instructions more efficient. Siracusa has suggested automating data collection because the team currently manually collects the data sheets every month, enters data, creates charts, and delivers the charts back to the shop floor. “The amount of work that it creates on the front and back end is probably our most current challenge.”

Despite all the extra work, the quality and regulatory team has been able to see the long-term benefit of the new system. “They've gone above and beyond in being ready to work through the nuances of an old system, and they have been open-minded in accepting a new system, knowing that the net benefit is really going to overcome the work that's required and involved,” says Siracusa.

The US Endoscopy Team

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