Dear All,
I go along with Erasmo’s observations however I think that (though perhaps not for ISO 22000?) the practical situation is that many possible textual styles for controlling the “metal” CCP are being officially used. This is perhaps related to the variety of official definitions of “critical limit”, eg –
(1) National Advisory Committee on Microbiological Criteria for Foods (NACMCF) - One (or more) prescribed tolerances that must be met to ensure that the CCP effectively controls the biological, chemical or physical hazard
(2) Food and Drug Administration (FDA) - A maximum or minimum value to which a biological, chemical, or physical parameter must be controlled at a CCP to prevent, eliminate, or reduce (to an acceptable level) the occurrence of the identified food safety hazard
(3) USDA/Food Safety and Inspection Service (FSIS) - CLs shall, at a minimum, be designed to ensure that applicable targets or performance standards established by FSIS, and any other requirements set forth, are met.
(4) Codex Alimentarius - A criterion which separates acceptability from unacceptability
Similarly, some USA operational offerings –
(A) USFDA juice regulations (2004)
• 1.2 Metal Fragments
We can recommend several possible ways to establish control measures for metal fragments in juice.
One way involves the use of on-line metal detection equipment. With this method, the equipment continuously monitors the product after the last step at which metal inclusion is reasonably likely to occur (e.g., after bottling and sealing of the juice) at a process step designated for metal detection. The critical limit might be designated as "no metal fragments in the finished product." The following illustrates some of the elements that might be entered into your HACCP plan.
• What is the critical limit? No metal fragments in finished product (Note: FDA's Health Hazard Evaluation Board has supported regulatory action against product with glass fragments of 0.3" (7 mm) to 1.0" (25 mm) in length. See also FDA Compliance Policy Guide 555.425).
• What will be monitored? The presence of metal fragments in containers passing the CCP.
• How is monitoring done? By the use of metal detection equipment.
• How often? Continuously. Each container is subjected to detection. We recommend that you confirm that the device is operating correctly at least at the start of each production day.
• Who should perform the monitoring? Monitoring is performed by the equipment itself. We recommend that a check be made at least once per day to ensure that the device is operating correctly.
A second way to control metal fragments involves the use of a separation device such as a screen after the last step at which metal inclusion is reasonably likely to occur, at a process step designated for screening. For this approach (see example HACCP plans for Pasteurized Refrigerated Apple Juice and Not-from-concentrate Orange Juice in section VII):
• The critical limit might be designated as "screen is functional."
• Monitoring may be done by a daily visual check for screen integrity.
• We recommend that verification include periodic calibration testing to ensure that the screen retains its separation capability for metal particles of a specific size. In establishing this size, we recommend that you consider that FDA's Health Hazard Evaluation Board has supported regulatory action against product with glass fragments of 0.3" (7 mm) to 1.0" (25 mm) in length. (See also FDA Compliance Policy Guide 555.425).
A third way to control metal fragments involves visually inspecting equipment for damage or missing parts at process steps such as extraction and grinding, where such damage or loss of parts could lead to metal fragments in your juice. This approach may only be feasible for relatively simple equipment that can be fully inspected visually in a reasonable time period. Under this approach, CCPs might be identified as the fruit grinding and extraction steps in a process. The critical limit might be designated as "no broken or missing metal parts from equipment at the CCPs for metal inclusion." If broken or missing metal parts are observed, the line is stopped, the equipment is repaired and, if necessary, adjusted or modified, and the product that has moved through that area since the last inspection is placed on hold for further action as appropriate, e.g., to be run through off-line metal detection equipment, to be destroyed, to be diverted to non-food use, or to be re-run through a process that includes a metal detection step. The following illustrates the elements that might be entered into your HACCP plan.
• What is the critical limit? No broken or missing metal parts from grinding (or extraction) equipment
• What will be monitored? The presence of broken or missing metal parts on or near the grinder
• How is monitoring done? By visual check of the grinder and immediate vicinity for broken or missing metal parts
• How often? Check before starting operations each day, check at least every four hours during operation, check at the end of operations each day, and check whenever there is an equipment or other malfunction that could increase the likelihood that metal inclusion could occur.
• Who will perform the monitoring? Any person who has a thorough understanding of the proper condition of the equipment and surrounding area may perform monitoring.
• If broken or missing metal parts are observed at a CCP, the corrective action procedure would be to stop the line, repair, adjust, and modify the equipment as necessary; the product that has moved through that area since the last inspection is placed on hold for further action as appropriate, e.g., to be run through off-line metal detection equipment, to be destroyed, to be diverted to non-food use, or to be re-run through a process that includes a metal detection step.
http://www.fda.gov/F...e/ucm072557.htm(B) USDA / FSIS (2003) The HACCP plan is also to have a critical limit, such as having a functional metal detector, calibrated to a specific standard (9 CFR 417.2©(3)).
http://www.fsis.usda...ives/7310.5.htm© University of Florida D. Ground Beef
• Hazard: Metal fragments
• Control Measure: Automatic rejection of packaging containing metal fragments of sufficient size to be detected by a metal detection system
• CCP: Metal detector
The CL in this case is open to some discussion. In many HACCP plans (including those under federal regulation [a regulatory CL I suppose]), the CL is defined as the rejection size of the metal detector, and monitoring is continuous by the detector itself. Others may prefer to have an employee monitor the detector on a defined frequency to determine its operation. In this case, it may be more appropriate to indicate that the CL is simply whether the detector is operating (on vs. off), rather than the size exclusion limit of the detector. In both cases, the detector is calibrated as part of HACCP verification.
http://edis.ifas.ufl.edu/FS141Quite a range of interpretations ! Would seem that as long as you can validate, the available choice is quite wide. I suppose it’s possible that auditor’s preferences may also have some significance.
Rgds / Charles.C
