Are you facing the daunting task of preparing for an upcoming audit? Or are you being tasked with developing a recall plan for your business? These types of events –like audits, inspections and mock recalls, are an inevitable part of being a manufacturing company, and while they can be intimidating, they certainly don’t need to be feared. Wherefour has several features (as well as many tips & tricks from our experienced team) that can help you plan, prepare, and perform well for any audit or recall situation.
One of the first and most important steps a company can take in preparation for an audit or in developing a safety recall program is to utilize a full-scale traceability system, like Wherefour that will take the guesswork and paper shuffling out of the equation. Wherefour’s easy-to-use ERP & traceability software is specifically designed for growing manufacturers and some of its key features, such as inventory control, lot tracking, and material traceability, are key components of any audit review and recall program. Utilizing a system such as Wherefour, will allow you to be prepped and ready at all times, so you can focus on managing the rest of your business.
So if you’re not familiar, let’s take a step back and go over the different types of audits. An “audit” refers to any type of inspection or examination that is used to determine if what is being observed is deemed “satisfactory” when compared to a certain set of standards. Audits can usually be separated into 2 different types: internal or external. An internal audit, which can also be called a First-Party Audit, are usually conducted by employees or managers within the organization to catch any issues that may be considered “red flags” or things that may need to be addressed –ideally before they become real problems. An external audit is an examination of your manufacturing processes from an entity outside your organization and is truly defined by there being no conflict of interest. An external audit can be further classified into Second-Party Audits, which are typically performed by a current or potential customer and/or contracted organization that is looking to evaluate your ability to be a good and reputable partner, and Third-Party Audits which are those performed by external agencies and mainly performed as a means to obtain certification, registration, or license from such agencies (i.e SQF, BRC, ISO, etc). An additional type of audit or inspection are those performed by the government, such as the FDA, where auditors are looking to determine if your manufacturing facility is adhering to all required laws and regulations.
So why do we have audits? Or better yet, why would you choose to participate in an audit? As previously mentioned, the importance of an audit is to examine if the actual process & procedures that are being performed in your manufacturing facility are truly reflective of the written policies, procedures & processes that are written in your operating manuals or company documents. The goal is to find any product, process, system, quality or data issues ahead of time and be able to determine a course of corrective action to improve any inconsistencies within the operation (including those that may occur shift to shift, day to day, person to person, etc.). Performing an audit is a proactive tool as a means to facilitate the need for ongoing process improvement within a company and as a way to obtain any needed or desired certifications, licenses, or registrations that may be of benefit to the business.
Mock recalls are equally important to examine and ultimately determine the effectiveness of your recall plan, because as the saying goes “practice makes perfect”! For example, are you able to locate the impacted item(s)? How long does it take you to locate the item(s)? Are you able to swiftly notify the appropriate personnel/entities of the necessary recall? Being able to answer these questions with haste, as well as accuracy and completeness, is essential to determining the effectiveness of your recall plan and helpful in identifying areas of the plan that may need improvement. As a general rule of thumb, it’s recommended to conduct a mock recall every 12-18 months (if not more often) to continually evaluate your plan and its effectiveness.
To be truly successful when undergoing an audit or performing a mock recall, the key is to be organized– have a system, like Wherefour, and stick to using it to ensure your records are always up to date and complete. When it comes time to have an auditor on-site, be prepared with relevant reports or documents or make certain they are available for easy retrieval. Lastly, open communication with your staff and employees is essential to the business’ success. Everyone within the organization should fully understand the standards they should be performing to on a daily basis, and should also be informed, as necessary, of any pending or potential upcoming audits. It may also be appropriate to review any relevant policies & procedures with staff on an ongoing or as needed basis, as well.
Wherefour’s easy-to-use software and full-scale traceability capabilities are an essential tool that can help your company be successful during any audit or recall situation. By utilizing the system’s inventory tracking, work order and production planning, along with features such as document storage and the comprehensive reporting functions, your company can easily generate the data you need to successfully pass audits and inspections, all while enabling your team to confidently run day-to-day operations. Since record recording is essential to any audit or inspection, you can take advantage of Wherefour’s Compliance area in order to save any relevant test results or important documents like Certificates of Analysis (COA), Ingredient Specification Sheets, Safety Data Sheets (SDS), HACCP plans, or Standard Operating Procedures (SOP) so they are readily available during the audit. You can go a step further and attach relevant tags to documents making them easy to find, or attach specific documents to certain work orders or ingredients. Additionally, the Reports area in Wherefour is useful for both audits and recalls by allowing you to quickly run a Recall Report or Production Trace Report and search transactions for an affected inventory item during a specified date range; tracing that inventory item from an incoming purchase, to its use in a work order, to outbound shipping.
And last but not least, one of the greatest resources the Wherefour ERP system has to offer is our experienced and highly knowledgeable Customer Success team that can be utilized as a resource for any audit, recall and software-related questions to help you feel fully prepared and ready to tackle anything within your manufacturing operation.
Interested in exploring how Wherefour can help your company? Reach out to the Wherefour team for a free consultation on some of the challenges your business may be facing. You can book a meeting through the chat window on this page, or visit our contact page here.