Risky Business: Correct and Prevent
Risky Business: Correct and Prevent
One of the most important tools of a quality system relates to your investigation of the cause of internal reworks and remakes. FDA and DAMAS both require a corrective action process for handling of customer complaints and non-conforming product. See the FDA Parts 820.90 and 820.100 and DAMAS Specification Section 4.14. You must have a system in place to define what constitutes a complaint or non-conformity and show that they are processed in a uniform and timely manner. Complaints can include turnaround time, delivery time, remakes, and similar issues.
It’s important to develop a corrective action process that’s simple since employees will avoid documenting complaints and non-conformances if the process is complicated and perceived to be burdensome. Convey to managers and all employees that the corrective action process is simply adding a little structure to problem solving. Use electronic media whenever possible to simply this recordkeeping. The Corrective Action/Preventive Action (CAPA) program consists of:
• Root-cause analysis.
• Determination of the scope of the problem.
• Implementation of the corrective measures.
• Communication of the method to identify the defects and necessary corrective actions to prevent a non-conforming finished product.
• Follow-up of corrective measures to ensure efficacy.
CAPA relates to procedures used to determine what corrective action needs to be taken and is taken after recognition of a nonconformance. The non-conformances can be a remake, complaints from your dental clients that don’t necessarily result in a remake or your complaints with your suppliers. Feedback forms that are sent out with cases would be a part of the complaint process. You will need to implement CAPA whenever negative feedback is received.
Also, you need to document remakes. That may be done in your computer system or you may have a manual system for documenting remakes. You just need a process for recording these issues. If you don’t, you need to begin to document complaints from your dental clients and remakes. Your written quality manual and standard operating procedures for the handling of complaints must include the data sources for these complaints. They could be calls from dental clients, e-mails, feedback sheets, patients calling you, information given to drivers, etc.
After you identify the root cause of the problem, then you must take corrective action to correct it and you need to document that action. You then can document what preventive action you’re going to take to prevent re-occurrence of the problem. Remember that the root cause must be traceable to people, materials, or equipment. Of course, a fourth root cause could be a doctor error, but it also requires follow-up.
The nonconformance may be a result of equipment failure, materials failure, employee error, or incorrect information from the dental client. Of course, there may be other issues, but these are the main functions that could be the root cause of the failure. You need to identify the root cause so you can determine the corrective action necessary. Once the root cause has been determined and the corrective action is determined, you must communicate all product and quality problems to individuals directly responsible for assuring product quality and the prevention of quality problems.
The best method of analyzing if your corrective action system is working is to calculate your remake rate and look for a downward trend. If the remake rate continues to climb, then you need to analyze your manufacturing processes and take appropriate action.
