Are you worried about a noncompliance issue and the impending corrective action plan? Do not fret, as you can use Zip Checklist to assure future compliance and achieve proper standing with the FDA with their corrective action plan templates.
Corrective action plans are a vital part of fixing problems in the food industry. If noncompliance is discovered at your business, it is your duty to file a sufficient corrective action plan and then carry it out. While this would be an arduous process in most circumstances, the Zip Checklist task management system can keep the disturbance of a corrective action plan minimal and help maximize the benefits of correcting the noncompliance. Zip Checklist has an inbuilt system for corrective action plans that will help you, as a manager, keep track of where things are in the process, who’s involved, and who’s responsible. There are a few more tips regarding recording keeping here.
Corrective action plans are meant to ask why a problem went wrong, address the root cause, and establish a plan for fixing the noncompliance. While this may seem simple at first, it isn’t. Often the appearance of an issue is not, in itself, the problem that needs fixing. A common way to find the cause of the problem is to ask why repeatedly until you get to the fundamental issue. It is not helpful to only address the surface manifestation, so this fundamental issue is the one you must aim towards in your corrective action plan. Looking closely at the reports employees enter through Zip Checklist is another way to help dig toward the cause. If the employee was unsure of the responsibilities they had, that could be a training or communication issue that could be solved with alerts or more rigorous checklists. With the corrective action plan, you will be providing a plan and schedule to correct the noncompliance. This is also, fundamentally, a way of establishing accountability, so take this chance to look into the mechanisms you have for accountability within your own system already.
Your corrective action plan should include a clear statement of the problem. This includes, but is not limited to, who was involved, what processes were being used, what was affected, and who was affected. The more information you can include in this section, the better you can address the specifics of a problem and communicate to the FDA that you are serious about correcting this issue. A lack of information or context could prevent the issue from being realistically evaluated and addressed. With Zip Checklist, you can collect notes directly from who was involved in a single comment section. You can also make sure the corrective action plan, in each draft state, is uploaded through the Zip Checklist app for every employee to see without worries of excessive paper.
Lastly, list the sequence of actions you and your employees will take to respond to this. Each action must be considered for its amount of necessity and cost, but do not ignore a necessary action simply out of financial concerns. For each step, establish who is responsible, when it is to be completed, and a way to measure progress. There should also be a final due date at the end, for which all steps are to be completed. For each action consider how it will address the root cause and prevent such incidents in the future. Most actions are simply corrections to the system of your business and that is simple through Zip Checklist. Remotely modify your employee’s tasks from anywhere, and you will be able to manage the situation. If an action needs to be taken care of first each day, mark it as a priority. If an employee was not attentive enough and forgot a crucial check, use an alert. Each action will be easy to implement and count on continuously, as Zip Checklist allows you to reuse checklists daily, weekly, and monthly. While a proliferation of online templates can be found for the corrective action plans, Zip Checklist comes with one pre-installed template to assist you in this process.
The FDA lists seven requirements for corrective action plans that they expect businesses to follow when drafting and seeing them through. It is best to follow these requirements carefully and put real thought into your corrective action plan, as the FDA is likely to follow up on it.
The first step is to analyze your data. All of the information you pulled earlier, the who, what, where, when, why, how of the situation should be collected, curated, and categorized to make sure everyone involved knows precisely what went wrong and how. Document how this insufficiency affected your business, including the possibility of customer complaints through reviews on Yelp or Google.
While steps two and three – investigate the cause, and identify necessary actions – were mostly covered above, there are some other important things to note. Nearly every major noncompliance is a structural problem and needs to be addressed structurally. Though it may be tempting to make it look like this will be a quick and easy solution, be realistic in your timeline for fixing this issue and moving forward.
The FDA’s fourth requirement, validate effectiveness, is relatively straightforward. Check back on the dates you set the actions as due and make sure they were actually implemented. You can use the Zip Checklist app to keep track of each employee’s progress on completing their responsibilities in light of the noncompliance. You can track the effectiveness and keep the audit trail for the corrective action plan for a year with Zip Checklist.
Step five is similar, implement and record changes, but contains a key piece of advice - record. Document everything you changed to prove to the FDA that actions were taken and achieved real results. Print out your checklists both before and after through Zip Checklist to show them the changes.
Everyone relevant to the noncompliance should receive the information you collect as part of the corrective action plan process. Any relevant changes should be rolled out everywhere they are needed to prevent the same problem from occurring elsewhere. This is simple with Zip Checklist, where you can update everyone’s repeating checklists to reflect the new standard.
The final step is to submit for management review. Higher level management will need to get involved to sign off on the corrective action plan and relegate the funds necessary to carry out the steps in the corrective action plan. This is really just an extension of the last step to keep everyone updated, but is particularly important in this circumstance.
While it may all seem complicated, corrective action plans can be dealt with in a cinch with Zip Checklist, using their built-in template. It will be simple to address the problem and get back to business better than before.
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