With the onset of food safety from Farm to Fork, you can expect the audit force to be having breakfast with you soon. The development of 3rd party audits to assure vendor compliance to food safety aspects of food manufacturing has obviously been a boon for the auditing companies. In the past, companies that inspected their vendors did so with in-house auditors and bore the expense of the audit. In the last 5 years there has been an influx of companies offering 3rd party audits, each with their own twist so that a vendor with multiple customers requires multiple audits, and the vendor has to pay to be audited by each. This is an obvious win:win situation for the audit firm and a No Win for the vendor. Not only does the vendor have the cost of paying the auditor, but the vendor bears the cost of preparing for the audit, having people available for the auditor, all create a financial burden.

A typical response to this is that if the vendor is operating correctly, then there should be no problem providing all the records at any time they are requested for review. If life were so simple. Unfortunately the auditors are human, the vendors are human and the employees are human. I say unfortunately, because as we expand the number of control points that are checked and documented, as we expand the number of people doing the checking, the review of data and as we expand the number of auditors auditing the data, we create a much larger probability for errors of omission, transposition and neglect. There is also a tremendous cost associated with the effort of daily data collection and verification.

This is 2003. HACCP was developed 40 years ago so we could put men in space and keep them healthy. The task was accomplished, yet today we still fight what seems a never-ending pile of paperwork for HACCP documentation, process control documentation, quality assurance documentation and production documentation.

The time has come for a Virtual Audit.

A Virtual Audit is possible today. Over the past few years, there has been the development of paperless software for HACCP, for laboratory data, for production controls, etc. Each of these provides an island of information that exists somewhere waiting for someone to use it. ERP was to be the answer for manufacturers until they found that there was a gap between the ERP software providing data for upper management and the production floor. These systems are data hungry and often require hours of data entry because they do not get and give information to the production floor. ERP systems are generally forced from the top down to provide top management the information for costs and control of inventory, production and ingredients. They do not start with the process floor and work their way up.

The system required to provide a Virtual Audit is one that automatically takes data from key process points whenever possible. It may require the push of a button or the toggle of a switch to transmit the data. When these two alternatives are not possible, a computer entry on a hand-held or an industrial computer on the floor is generated. The program takes the continuously flowing data and compares it against standards such as historical data, pre-set limits, time demands, and other variables. Based on the continuous review, the data is either accepted meaning the control point is in control, or the data indicates that the control point is not in control. An out-of-control situation immediately results in an alert being sounded. That alert can be manifested in many ways dependent on the severity of the control point being violated. A process line can be stopped, or product diverted, a visual alarm or a sound alarm can be generated, a supervisor can be paged, a manager can be emailed and the operator receives instant notification that a corrective action is required and the steps to take to perform that action. An employee training record can be recalled to show who has the authority and/or responsibility to take corrective action by training or designation. A QuickTime movie can show how to make the correction, if desired, and a documentation record is generated.

At the end of the production run, the production manager can pull up a screen with a schedule of products produced that shows the data collected at all control points; shows that established limits were met or not; that corrective action did or did not occur and the product status of the product. The manager clicks a box and hits submit. There is not a pile of papers that has to be leafed through, there is not the hunt for employees to fill in missing data, there is not the hunt for missing sheets and there is not the concern that the manager will miss an error. An exception report is created that informs the manager of every exception that occurred at each control point, the corrective action taken and who did the corrective action.

The Exception Report becomes the information for the auditor. It is not necessary for an auditor to spend hours scouring through page after page, notebook after notebook or even spreadsheet after spreadsheet looking for the missed data that invokes an ever-expanding search. There is no reason for the auditor to spend endless hours trying to find that missing piece of information because if the exception report does not show it to be missing, it is there.

I call this a “Virtual Audit” because with the exception of an on-site auditor seeing what amounts to a snapshot of the process floor on a particular day, this audit can be done at any computer in the plant, it can be done at the auditor’s home office with authorized access, it can be done in a Starbuck’s that has wireless access, a hotel room, a Kinko’s. They pick the place. If you want to really dress it up, a real-time snapshot of the plant in still or video can be provided.

Obviously this information is not just for auditors. Its primary importance is for the daily minute to minute operation of a processing plant. The system is providing real-time information for real-time decisions. The information is available at computer access points on-site and off-site that makes it amenable to multi-plant connectivity. Much more information can be obtained in this system than is necessary for auditors. A link for a customer to view a designated digital COA that shows the results from the control points for that customer’s product. It can show CCP’s being satisfied, lab test results from both in-house and 3rd party labs, weight control data. You and the customer pick the points to be viewed. You authorize the release of the data. When your customer is looking at the same data every day that the auditor sees once a year, they may realize that they don’t need that 3rd party auditor. The COA is virtual. After the product is manufactured and all the control points are satisfied, you release the data to your customer. The customer can have access to their product results. Each production run results are stored there for their use. No more paper COA’s to create, fax and re-fax when misplaced.

SENTRY9000 is a means to eliminate paper from the processing floor, but that is only one of its many attributes. The SENTRY9000 system utilizes the capability of a computer for assisting in managing work flow rather than just gathering data and storing it on a hard disk that provides little more than a paper filing system. It takes the data from the floor and analyzes it to insure that it is appropriate for the system being monitored. It takes action when the data is not appropriate. These attributes of the SENTRY9000 system are the means to provide managers more time to manage and less time for paper review, that automatically creates steps for corrective actions, that provides Just-In-Time training for line employees for specific tasks, that administers training records for employees for specific training and designates which employees have ability or authority to administer specific action. This is all done in Real-Time. What is happening on the floor can be viewed on a PC monitor on-site or off-site as it happens.

Training records are part of the SENTRY9000 system and they provide for a digital photo of the employee, the training they have received and the authorizations they have for taking corrective actions. In addition, we can provide Just-In-Time training via QuickTime movies that instruct employees how to do tasks such as clean an unusual piece of equipment, or how to operate a piece of equipment, or how to do SPC weight measurements. This is also a part of plant security.

In addition to routine processing steps, individual modules are available for managing specific processing demands. The ARMS or Allergen Risk Management System works in two ways. One is by monitoring cleaning and sanitation of systems in regard to ingredients considered as allergens and the other is by scheduling. The two aspects of the system work hand-in-hand with specific verification requirements for a process.

The ARMS system also works well in two other areas of food manufacturing. One is for SSOP compliance is FSIS inspected plants to meet the regulatory requirement for documenting and inspecting the cleaning process. The other is for Kosher plants to monitor the ingredients and equipment used for Kosher items.

A LIMS or Laboratory Information Management System is also available. The design of the LIMS is very broad and its capabilities range from a large commercial lab application to a small in-house lab application. In addition, the data generated for your samples by third party labs can be sent directly into the SENTRY9000 system. The LIMS is capable of receiving data automatically, semi-automatically or manually to provide a base for decision making by the LIMS that can be transmitted to the various entities requiring HOLD & RELEASE information.

The LIMS can also deliver a digital means for tracking and monitoring routine pest control applications by in-house personnel or by third party pest control companies. This provides the data needed to meet the food safety aspects required for application of pesticides, monitoring of rodent trap and bait station activity, and provide a digitized record of all pest control activity.

SENTRY9000 is a dynamic, robust management system that can operate with any food manufacturing system. The advantages of SENTRY9000 are 1) it is customized to fit the needs of an individual plant, 2) it is modular and different parts can be added as needed, 3) all results are Real-Time and available on and off-site, and 4) SENTRY9000 can make decisions based on actions occurring right now.

It is time to transition into the world of digitized information management that: increases efficiency, improves the bottom line, offers a positive impact on ROI, and provides a manager that never sleeps, takes breaks or goes on vacation.

This is not Star Wars. This is SENTRY9000! When selecting a system that will provide you with minute-to-minute decision-making and Virtual Audits, there are several key points to consider:

1. Does the system adapt to your process?
2. Does the system provide Real-Time data?
3. Does the system analyze the data and take actions?
4. Does the system require proprietary equipment?
5. Does the system require extensive employee training?
6. Does the system communicate with ERP, MRP and LIMS systems?
7. Does the system meet federal requirements for digitized record keeping?
8. Does the system require internal or external on-site support?
9. Is the system modular so you can add components?
10. Is it a robust system or just a means to paperless data collection?

The efficiencies are apparent. Direct labor costs are reduced, paper; printing and copying costs are reduced; efficiency just by elimination of repetitive writing tasks has to improve and maybe most important, the disappearance of blank cells on forms that were not completed or the complete absence of a form for that run. Very few employees have a full-time job of recording data, and even if they do, priorities change during a manufacturing run for many different reasons. Just where on that priority line does completing the cell on that form occur, and do you grade the employee for getting the forms correct or for filling in the blanks?

The Virtual Audit is here for you, your management staff and your customers, today!

July 2003