HACCP Deviations

What is a deviation?

One type of HACCP system deviation occurs when a critical limit is not met at a Critical Control Point.  For example if the critical limit for a cooking CCP is that the internal temperature of the product must be at least 145°F for at least 4 minutes, there is a deviation when:

• The internal temperature does not reach 145°F,
• The internal temperature is at 145°F or higher for less than 4 minutes, or
• The cooking is done correctly, but is not documented (no record is kept).

Another type of deviation occurs when a verification activity shows that monitoring is being done incorrectly.  For example:

• A calibration test shows that a thermometer is inaccurate,
• Observation of a person monitoring a CCP shows that the person is monitoring incorrectly, or
• A review of records shows that record-keeping is not being done properly.

What are the consequences of a deviation?

It is important to realize that not all process deviations mean that a product is unsafe.  However, you MUST take and document corrective actions that include the four activities described in section 417.3 of the HACCP regulation.  These activities are:

• Identifying and eliminating the cause of the deviation
• Ensuring that the CCP is back under control after the corrective action is taken
• Preventing a re-occurrence of the deviation
• Making sure that no unsafe product enters commerce

Corrective actions MUST be thoroughly documented.  These actions may include such actions as destroying product, holding product and testing it, re-processing product, or recalling a product.

What should I do first when I realize that a deviation has occurred?

First, hold all affected product and, if possible, make sure that it does not enter commerce.  If the affected product is in commerce, you may have to recall it.  Remember that the “affected product” is all products in the same HACCP plan category since the last time monitoring indicated that the critical limits at the CCP for that plan were met.

Next, evaluate the safety of the affected product.  Gather as much information as you can about product. For most deviations, it is very helpful to know the amount of product involved and its time/temperature history.  It may also be useful to have the product formulation handy, because the amount of salt and/or sodium nitrite in the product may affect safety.

Who should I call for help?

Each state has individuals who are designated as HACCP Contacts and/or Coordinators.  These people can provide technical advice and assistance, or they can direct you to the appropriate expert.  People on the Contacts list are generally in the state meat inspection program and can best provide answers about applicable regulations and recalls, while coordinators are usually affiliated with the university in that state.  Coordinators tend to be more involved in scientific research and extension and usually are experienced in helping processors evaluate deviations and justify the corrective actions taken.

• Wisconsin processors:
  the Contact person is

Steve Steinhoff
Meat Safety & Inspection Bureau
WI Department of Agriculture
Trade & Consumer Protection
P.O. Box 8911
Madison, WI 53708-8911
Phone: (608) 224-4701
Fax: (608) 224-4710
steven.steinhoff@datcp.state.wi.us

• and the Coordinator is

Dr. Steve Ingham
University of Wisconsin Madison
Dept of Food Science 1605 Linden Dr.
Madison, WI 53706
Phone: (608) 265-4801
Fax: (608) 262-6872
scingham@factstaff.wisc.edu

What can you expect a deviation to cost?

Expenses that you may incur in resolving a deviation may include loss of discarded product, costs of a recall, or costs of product testing.  Chemical and microbiological tests can be expensive.  Also, you may have to devote considerable time to performing corrective action and it may take your state’s HACCP Coordinator a couple of days to evaluate your deviation.

The bottom line for handling deviations
When you have a deviation, follow these five steps:

1. Maintain or regain control of the product.
2. Gather as much information about the product as possible.
3. Share this information with an expert and get help.
4. Make sure your inspector agrees with your corrective action before you release any product to commerce.
5. Keep very detailed records of the deviation and your corrective actions.