Over-pack = Give Money to Your Customers, Under-fill = Give Money to The Regulators
If you fill packages, you already understand the importance of controlling fill processes. Over-pack is just giving away product, and in high-volume operations this quickly adds up to tens or hundreds of thousands of dollars. But if you under-fill, the fines and damage to your reputation are even more costly.
GainSeeker® Suite is the corporate standard in some of the largest food and packaging companies in the world. This market leadership is no accident. GainSeeker links compliance with process control, giving you a statistically robust solution for:
- NIST 133 - Net contents control and MAV tracking
- Overpack reported in dollars and cents – by product, by line, by lot, etc.
- Lot genealogy
- Roving data acquisition
- FDA 21 CFR Part 11 compliance
- ISO 22000 / HACCP data acquisition, analysis, and compliance monitoring
- Validation services
NIST 133 – Weight, volume & count control
The first task of any Net Contents program is to meet the requirements of NIST Handbook 133 and other governmental regulations for compliance to net content declarations on packaged goods. However, the NIST 133 standard doesn’t specify limits for overfilling – that’s your problem!
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This puts you between a rock and a hard place. On one hand, your fill weights must be above the Maximum Allowable Variance (MAV). At the same time, you need the average fill to be over, but as close as possible to the label declaration. The classic method of meeting the regulation is to shift the curve up, so that the average is at or above label, and the lower tail is just above MAV. But this means giving away product. The GainSeeker approach allows you to tighten the curve, so that there are no MAVs and less overpack.
GainSeeker Suite streamlines data collection by connecting directly to all brands and models of scales and balances. If your equipment can communicate with a computer, GainSeeker can acquire that data. And with GainSeeker you can incorporate simple or complex calculations to derive volume, whether immediate or “roaded”.
As each new measurement is entered into the system, GainSeeker Suite applies real-time statistical tests to this data and alerts you immediately if a process change is detected.
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Beyond reacting to real-time alerts, you can also use GainSeeker Suite’s powerful analysis tools to pinpoint sources of variation in your fill processes. Automated tools make it easy to discover which fill heads, material suppliers, operators, product lines, and other variables have the greatest impact on process variation – individually or in combination. Armed with this information, you can make good decisions on process improvements that reduce process variation and shift average fill weights closer to the declared label weights.
Overpack Reported in Dollars and Cents – by Product, by Line, by Lot, etc.
One reason why GainSeeker Suite is so widely used in food and packaging industries is that it easily converts raw data (such as overpack weights) into something everyone understands: money.
Imagine the impact in a monthly business review when you can report “Last month we gave away $43,221.53 of product” instead of “Last month we had an average overpack of 22g per product”! GainSeeker can accurately calculate your overpack costs by linking directly to your cost accounting system and your production systems.
GainSeeker ’s analytical tools then make it easy to identify the products, lines, shifts, etc. with the highest cost of overpack.
Lot Genealogy (Farm to Fork)
Food and packaging companies need to answer questions like these:
- Do different lots of raw material significantly impact process variability?
- If we have to recall all products made with a particular lot of raw material, can we identify all of the production lots that need to be recalled
- Can we identify which customers received a production lot that is being recalled?
GainSeeker ’s Lot genealogy makes it easy to search for a specific raw material lot number and identify all the products made with this lot of material. Automated variation analysis can quickly compare the impact of different material lots on process variability, which you can trace back to various raw material suppliers, or forward to various customers. Theme I
Roving Data Acquisition
In a wash-down environment where fluid and cleansers may damage electronic measurement equipment, your best solution may be to run GainSeeker on a PDA or handheld computer – the most portable and least expensive platform available for GainSeeker .
If you have to hose down the floor, the PDA can stay safely in your pocket – at a fraction of the cost of a hardened workstation. GainSeeker runs on your PDA as a wireless client in a Windows Terminal Services or Citrix environment, eliminating the delay and hassle of synchronizing your PDA with the network. You can even connect wirelessly to digital balances with a very modest investment in hardware.
FDA 21 CFR Part 11 compliance
Under the US Food and Drug Administration, part 11 of Title 21 of the Code of Federal Regulations (21 CFR Part 11) establishes the criteria under which electronic records and electronic signatures will be considered equivalent to paper records and handwritten signatures.
Manufacturers of products that are regulated by the FDA must apply this rule to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted. GainSeeker Suite supports 21 CFR Part 11.
ISO 22000 / HACCP data acquisition, analysis, and compliance monitoring
ISO 22000 / HACCP (Hazard Analysis Critical Control Point) defines a system for ensuring the safe production and packaging of food.
GainSeeker leverages your existing HACCP data by using modern statistical techniques to help you improve process stability over time.
GainSeeker Suite allows you to:
- record measurements for variable data in a database for easy analysis and reporting
- immediately identify unstable conditions using statistical alarms (which are much more sensitive than pass/fail data)
- analyze and report results based on product lines, point in process, shift, operator, etc.
- track on-time data collection by department, shift and operator to ensure compliance with safety standards
Validation services
Rigorous validation and verification processes are used to develop GainSeeker Suite. A complete validation kit is available to assist you in validating GainSeeker Suite at your facility.
In addition, Hertzler consultants can work with you to ensure that your GainSeeker deployment meets regulatory compliance guidelines.