FSC-342 - HACCP Principle 3: Establish Critical Control Limits

What is Principle 3?

Establish critical limits for each preventative measure at each CCP.

What is the purpose of a Critical Limit (CL)?

To determine whether the control measure at a CCP is in or out of control.

What is the NACMCF definition of a Critical Limit?

A maximum or minimum value needed to control a hazard to an acceptable level.

What is the Codex definition of a Critical Limit?

A criterion separating acceptability from unacceptability.

Is a Critical Limit an average value?

No; it must be a maximum and/or minimum value.

What are CLs based on for biological hazards?

Microbial inactivation, toxin control, or growth prevention.

What are CLs based on for chemical hazards?

Toxicity limits, allergen presence, and established safety limits.

What are CLs based on for physical hazards?

Criteria related to injury risk.

What is the FDA physical hazard adulteration size range?

Hard or sharp objects 0.3 in (7 mm) to 1.0 in (25 mm).

Can manufacturers set stricter CLs than regulations?

Yes; they may choose to be more conservative.

What measurable parameters can be used as Critical Limits?

Temperature, time, physical dimensions, weight, line speed, visual defects.

What processing or chemical parameters can be used as CLs?

pH, moisture level, water activity, viscosity, salt concentration, sanitizer concentration, metal detector sensitivity, flow rate, presence of a screen.

Where are CLs set?

Only at CCPs.

What must CLs be suited to?

The capabilities and processes of the establishment.

What sources are used to set Critical Limits?

Regulatory standards, government documents, scientific research, industry experts, manufacturer guidelines, and in-plant studies.

What is a regulatory example for pasteurization?

161°F for 15 seconds.

What is the regulatory requirement for fully cooked poultry?

A 7-log reduction of Salmonella.

What is the slaughter requirement for meat/poultry?

Zero tolerance for fecal contamination.

What is the juice processing requirement?

A 5-log reduction of the pathogen of concern.

What must be documented for Critical Limits?

The scientific rationale and justification.

How must subjective CLs be supported?

With instructions, specifications, education, or training.

What is an appropriate example of a Critical Limit?

Process control such as minimum 160°F for 6 seconds to control Salmonella.

Why is process control preferred over end-product testing?

End-product testing is destructive, slow, costly, and may miss hazards due to sampling limitations.

What is a suboptimal example of a Critical Limit?

Setting “no pathogens detected in finished product” as a CL.

What is a deviation?

A failure to meet a critical limit; also called a nonconformity.

What does not meeting a CL indicate?

A direct hazard exists, could develop, or control is inadequate.

What is an Operating Limit (OL)?

A stricter value than a CL used as a buffer to prevent deviations.

What is the purpose of an Operating Limit?

To reduce the chance of violating a Critical Limit.

What is a process adjustment?

An action to return conditions to the OL without requiring corrective action.

Should non-safety limits be used as Critical Limits?

No; quality or economic limits must not be designated as CLs.

What is an example of CL vs. OL in pasteurization?

CL = 160°F minimum; OL = 162°F to provide a safety buffer.