Ensuring that product components and supplies are of top quality and delivered on time is key to running a successful business, and supplier qualification surveys need to be sufficiently broad to ensure a good result, an industry expert says. Among the topics every survey should include are inspection procedures and procurement and document controls.
Jeff Kasoff, director of quality at Medivators, begins his surveys by asking suppliers for their U.S. FDA or Health Canada registration information, if applicable, and whether they are ISO-certified. If the supplier or contractor is not ISO-certified, they must complete the remainder of the survey.
Kasoff’s survey includes a wide range of questions, beginning with organizational specifics such as a chart showing the relationship between quality and manufacturing. Then there are questions about site size, the percentage of the site that is dedicated to manufacturing, environmental issues, pest controls and more.
Survey Should Assess Quality System
The survey should also look at the supplier’s quality program and quality system, Kasoff says. “I want to see if they have any sort of quality planning function. Do they have a quality manual or something like that? Do they perform a training?” He discussed supplier qualification at a recent FDAnews webinar.
Evaluations of audit planning and procedures should include the supplier’s standard inspection document and their procedure for performing an inspection. For incoming inspections, the survey should assess the rate of rejections, documents used by the supplier and product statuses.
The survey should also look at procurement control, determining how the supplier specifies the components they purchase and how they will verify that they received the correct components.
Kasoff also asks for production qualification, “another example of something that they may not have,” he says. “How do they know that the process they’re using is one that results in product that meets my requirements?”
While in-process inspection is not required, it can be very useful, Kasoff adds. “If my supplier tells me four-week delivery and they don’t perform any in-process inspection, but they do perform a finished device …final inspection, they’re going to call me at 3.5 weeks and say, listen, Jeff, we’ve got some really bad news, none of that product is good.” With in-process inspection, any problems would be caught early on.
Other points to cover in supplier qualification surveys include design and document, finished product handling, calibration and maintenance, complaint handling and returns.
At the end of the survey, the supplier receives a rating of acceptable, conditionally acceptable or unacceptable. Kasoff recommends retaining the records of suppliers that don’t make the cut. “These are helpful to show the FDA the process for weeding out unacceptable suppliers,” he says.
Occasionally, Kasoff runs into suppliers that appear legitimate but refuse to complete the survey. To these he gives a 12-month conditional status, making sure that purchasing and quality assurance staff document that determination. Once the trial period is up, if the supplier’s performance and history are both acceptable, the rating is upgraded to “approved.” — April Hollis