Solution Summary

HACCP is a regulated business practice designed not only to ensure safety, but also to affix responsibility. In the US, FDA 21CFR Part 11 regulations must be complied with to ensure that testing results can be traced back to the individual who completed the test. Other countries have similar regulations for electronic records management and electronic signatures. In Canada, HACCP is part of the Food Safety Enhancement Program (FSEP). HACCP is also a component of ISO 22000.

In principle, a HACCP program involves the analysis of the process and identification of hazards and Critical Control Points (CCP); a plan to monitor and ensure that the CCPs are controlled and corrective actions are taken when they are not; and procedures to ensure that the HACCP system is working and well documented.

QIC has available a number of products and services to assist our clients in achieving a successful HACCP implementation. Although we can provide assistance in developing the plan, the real return on investment for our clients is derived from:

Documentation and communication of the plan throughout the enterprise, and

Collection, alarming, and documentation of the data.

To satisfy the documentation and communication objective, MasterControl™ provides an excellent platform to ensure that the HACCP plan is:

Properly completed and approved
Reviewed at the appropriate intervals
Communicated to every plan participant
Validated that the participant has read and understood the plan
That the plan is a controlled document and only the current version is made available electronically or in print
That data collected on forms is appropriately collected, stored and distributed

Collection of the data is no different from the collection of any other data, except that the gravity of an alarm is more serious. To that end, we use a sophisticated data collection engine to capture, monitor, alarm and analyze HACCP data. This way the operator does not have to learn yet another MES system, and uses a familiar data collection routine. She has more time to focus on her main job – making your product most effectively. This data collection approach not only provides consistency and ease-of-use, but also provides much more flexibility with regards to corrective action, analysis, and root cause analysis than traditional dedicated HACCP systems. This approach also provides complete compliance with 21CFR Part 11 electronic signature and electronic records management guidelines.

From an enterprise perspective, if common systems are used throughout the enterprise, products, people, or entire lines and plants can be relocated with ZERO additional training on the data collection systems.

Solutions proposed by QIC have met all of our stringent criteria for system evaluation.

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To discuss your needs, contact us at info@qic-intl.com