Response Time. This time is really a direct result of the time associated with the above categories, which can be disruptive to say the least. And that’s for the audits you know about. When it comes to customer, FDA, GFSI, and other unannounced audits, sometimes “disruptive” is the least of the challenges.
What Makes These Issues So Challenging?
It’s the position of this article that the majority of audit challenges stem from the fact that most FSQA operations still operate very manually today. We hear all of the time about food safety folks having to spend their time entering versus analyzing data. Or having to sort through hundreds of supplier documents to find the one or two that require action. Or didn’t realize key fields in forms were missing until the auditor found it. Or, at the time of the audit, requested sanitation records are missing—presumably filed in the wrong folder. Or the GFSI revision log is incomplete. Even when electronic systems are in place there can often still be issues if the various systems in different facilities don’t “talk” to each other, i.e., integrate the data.
But there is a better way. Emerging FSQA technology innovations can help streamline and improve overall FSQA and help you be audit-ready on demand.
How Does FSQA Automation Work?
For the purposes of this article, audit readiness is more than simply being able to produce electronic documents. Additionally, audit readiness means supporting all of the programs on which you’re being audited.
There are a variety of food safety and quality automation technologies on the market today—and companies must evaluate which solution best meets its needs. But to be audit-ready on demand, some key capabilities to look for in a technology solution are described below. These are focused around the ability to say what you do, do what you say, make sure it works, and make sure it’s documented—in other words, the key pillars of audit readiness.
Say What You Do. Some FSQA automation solutions allow you to define all of your regulatory, third party, customer, and internal requirements within the system—GFSI code and customer specifications, for example. This can also include defining the food safety plans/components that support these requirements, like HACCP/HARPC, SOPs, and PRPs. Data sources—data from cooling equipment, or from internal/external labs, for instance—can also be defined and integrated into some solutions.
Do What You Say. Look for technology solutions that have workflow engines and automated task schedulers to ensure that the tasks associated with your requirements/programs are completed according to schedule. These solutions often have auto-notifications as well so that notices can be sent, for example, to a supplier that its GFSI audit certificate is due—or to a line manager reminding him/her that the metal detectors must be calibrated at a certain time.
Make Sure it Works. Some FSQA automation solutions have verification engines that analyze all data—such as safety assessments from mobile forms or test results from a lab—in real-time to the requirements and specifications defined in the system. If results are out of spec, alerts are issued. Some systems can then automatically generate a timely CAPA and track it to completion.
Make Sure it’s Documented. The beauty of automation is that if you have the capabilities described in the above pillars from a single vendor, which is ideal, or have the solutions integrated if they are from separate vendors, every component discussed in the above pillars can be time/date stamped, with eSignatures where required, and accessible through a central repository of data as part of your permanent FSQA record. If using cloud solutions, then every document, test result, CAPA, and more from every facility can be accessed with a secure login from any or computer anywhere and at any time.
Key Audit Readiness Benefits
By adopting FSQA automation technology with these capabilities, you can be audit-ready on demand with the following key benefits.
- Your food safety plans, specifications, approved vendor programs, and the like are carried out on time and according to plan. Tasks happen when they are supposed to, and issues are dealt with in a timely, preventive manner.
- You have immediate access to all audit documents on demand, an “audit on a laptop,” if you will. Because records can be time/date stamped (and, in many cases with 21 CFR Part 11 compliant eSignatures), you have unalterable records for greater audit efficacy.
- Audit documentation can be easily reported on and organized by type of audit, including not only your regulatory, GFSI, customer, and internal audits, but also reporting against internal Key Performance Indicators, or KPIs.
- If you are using cloud-based FSQA automation, with configurable security, you have the opportunity for greater transparency and visibility. A food co-packer, for example, could allow a customer access to a set of data pertaining to that customer’s requirements—which could then, in turn, potentially reduce the number of that customer’s onsite audits. Or, an ingredient supplier might allow its third-party auditor, under various schemes and potentially FSMA, to access
- portions of its records. The value of this is that because of technology configurability, this upstream, downstream, and internal visibility is completely up to the company and can provide as much or as little transparency as fits within an organization’s policies and culture.
- Almost all FSQA audit schemes and best practices call for continuous improvement. With automation, your safety, quality, and operations management have access to a centralized repository of FSQA information across the entire company—from all facilities and products—from which true performance trending can take place.
- Last, the overall cost and disruptions associated with audits are significantly reduced. Automation can eliminate days and weeks gathering the legendary “forklifts full of binders,” prevent you from finding incomplete records the night before the auditors show up, and mitigate damage to customer and consumer confidence.
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