Archived - Annex C: HACCP Based Slaughter Inspection Program (HIP) for Swine
4.0 Statistical Process Controls
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4.1 Introduction to Statistical Process Control (SPC)
Operators of slaughter establishments are responsible for producing meat products that are consistently in compliance with the minimum food safety standards set out in the Meat Inspection Act (MIA), Meat Inspection Regulations, 1990 (MIR), the CFIA's Meat Hygiene Manual of Procedures (MOP) and the CFIA Food Safety Enhancement Program (FSEP). To evaluate and enhance an operator's ability to comply with these standards, the HIP incorporates the use of Statistical Process Controls (SPCs). SPCs are science based tools that objectively measure and improve the performance effectiveness of a manufacturing process or process step.
Under the HIP, dressed carcasses and their relevant portions must meet several performance criteria during the dressing process. These performance criteria (also referred to as standards) are measured at strategic locations in the dressing/inspection process using Evisceration Performance testing (bunging/viscera removal), Presentation Standards (abbreviated to "Presentation") testing, and Finished Product Standards (FPS) testing. Random sampling and testing of carcasses and/or their associated portions during the production shift for a pre-determined level of manufacturing performance standards provides the means to assess food safety and wholesomeness while also determining if the slaughter process is in control.
Establishments that have 2 or fewer post-mortem inspection stations (i.e. abattoirs always operating at 200 cph or less) are not required to perform the Presentation SPC procedure outlined in this annex. However, it is understood that the operator must still meet the standard for the presentation of carcasses and their parts that has been agreed with the Veterinarian in Charge. It is the responsibility of plant management to ensure that all carcasses and their parts are presented for post-mortem inspection in such a way as to permit proper examination by CFIA inspectors.
For new hog slaughter establishments or new hog slaughter operations within an existing registered establishment, operators wishing to initiate dedicated hog slaughter activities within a registered establishment shall provide a facility layout compatible with HIP requirements at the commencement of dedicated hog slaughter operations. Operators shall also design and write the employee HIP training and accreditation program prior to operations starting. A period of 2 months (60 calendar days) after the initiation of hog slaughter operations will be given to the operator to complete training and accreditation requirements of HIP employees. The traditional mode of inspection shall be implemented during the training and accreditation period. The operator shall inform the CFIA as soon as possible of his intention to implement HIP swine in order to ensure that the CFIA trains its staff and prepares accreditation activities for the operator's HIP plant trainers in a timely manner.
When a facility initiates operations under the HIP format they may elect to use the national performance standards or alternately gather and use their own in-plant data to establish their SPC performance level. If the establishment participated in the HIP National Baseline Study, the information from that data collection period may be used. The facility will be allowed 2 months to adjust its operations to meet the declared national performance standards for evisceration performance and FPS food safety and FPS other carcass defects. A maximum of six months will be allowed for an operator to meet the national AQLs for presentation of carcasses and their portions.
Due to the variation in an establishment's presentation configurations, the total number of attributes that are used to assess an AQL score may vary between facilities. In those situations where relatively fewer attributes are used to determine the AQL performance for the same presentation station, a tighter AQL, exceeding the national standard declared in Appendix G, may be negotiated by the VIC and the RVO.
If an operator wishes to gather their own in-plant data it shall be based on a minimum of 25 sample sets taken at each designated process control step and gathered over a minimum of 5 working days. Consultation and collaboration with the Area Program Specialist and the VIC shall occur during this process to ensure validity of data collection. When HIP is fully implemented in the establishment, the operator will be required to meet the minimum national performance standard at all SPC locations as noted above. Refer to Appendix G.
If it is anticipated that any of the performance standards set out in Appendix G, or as noted above, cannot be achieved in the prescribed time frames, either the VIC or the operator shall initiate discussions on this matter in advance of the closing dates and jointly consult with the RVO to determine a course of action.
4.2 SPC Product Testing
4.2.1 QA Verification
It is normally the responsibility of the plant's QA to verify that process controls are implemented correctly. This verification shall include a review of the records for timely and accurate entries, and to provide assurances that appropriate action has been taken when the standards are not met. QA (or designated equivalent) should also conduct independent tests and compare the test results with those of the plant SPC monitors.
4.2.2 CFIA Oversight
CFIA personnel will periodically monitor the plant's QA program by monitoring production activities, reviewing company records, and comparing the results of their own correlation tests with those of Plant Monitors. If there is a general difficulty in achieving consistency between independent company test results and CFIA correlation test results or it is determined that unsatisfactory or poor product/employee performance is occurring during non-testing intervals, such occurrences shall be documented on the appropriate record and corrective action shall be undertaken by the operator or at the direction of the VIC/delegate.
If a CFIA correlation test result fails to correlate with that of the plant monitor during any of the prescribed HIP process control tests, where samples are selected and evaluated on a moving line, an immediate second sample set shall be selected (with the exception of the detection of an FPS FS I defect found during an FPS FS I test) and another test shall be performed. Two consecutive non-matching correlation tests between the operator and the CFIA will require that process action be initiated by the operator (if applicable) based on the results of the second CFIA test which shall be taken as the correct score. The CFIA will monitor all of the operator's corrective action activities to ensure HIP and other CFIA program requirements are met. In the case of FPS-FS I testing any detection of an FPS FS I defect shall be officially recorded and appropriate corrective actions shall be initiated by the operator. If the operator is not in agreement with the CFIA results the operator may elect to stop the line or utilize other means of holding the carcass until the VIC can examine the defect. In this case the VIC shall decide if an FS I defect is present and the results of VIC decision shall be officially recorded and appropriate corrective actions shall be initiated by the operator.
Where any CFIA correlation tests are performed on a static sample set and there are differing outcomes between the operator and the CFIA with respect to the test results, and these differences cannot be immediately resolved, either through a retest procedure or further discussion of the initial findings, the results of the CFIA test shall be taken as the correct result. If the operator is not in agreement with the CFIA results the operator may elect to have the VIC examine the defect. In this case the VIC shall decide if a defect is present and the results of VIC decision shall be officially recorded and if appropriate, corrective actions shall be initiated by the operator.
In all such cases the operator shall investigate and reconcile the discrepancy in scoring results and report and discuss his/her findings with the VIC after all required immediate process actions have been implemented.
4.2.3 Consistent SPC Performance
If it becomes apparent from historical performance data (5 or more consecutive shifts) that an operator cannot perform consistentlyFootnote 1 at an established AQL for any of the process control steps in the HIP, and previous corrective action undertakings by the operator have not provided long term resolution of the problem, the line speed maximums for the process step(s) involved shall be re-assessed by the VIC/RVO and reset to a lower maximum level using an initial incremental reduction of 10%. If the initial line speed reduction does not provide satisfactory improvements within the first half of the shift, further reduction(s) shall be imposed until the accepted AQL for the affected process step(s) has been achieved. The line speed at which the AQL is achieved shall remain in place for a minimum of 5 consecutive working shifts.
4.2.4 Plant Personnel
Only accredited industry personnel shall perform the tests described in the HIP. The test results shall be recorded on the appropriate CFIA forms. All process actions generated by the HIP tests shall be the operator's responsibility. Such actions may be initiated by either plant production or QA personnel. The VIC/delegate shall be notified by a responsible plant person whenever the SPC test results initiate certain specific process action under the HIP.
As a general observation, production employees should be exempted from any process control testing procedure if their objectivity may be compromised when conducting these tests. If a production employee is required to perform any SPC test, they should not be influenced by the presence of a Production Supervisor. If this impartiality cannot be assured, it is recommended that QA be in charge of all SPC tests. The VIC shall review this situation in their establishment and determine what arrangement is required to produce the most reliable product evaluation results.
4.2.5 Sample Selection
One of the major principles in any SPC testing program involving the selection of samples is that each unit in the population has an equal chance of being selected for testing. This principle is supported in the HIP within the practical restraints of this inspection system and the slaughter environment.
A designated plant person shall select random times according to the plant's written program for conducting SPC tests. This person shall submit the selected times to the VIC/delegate before the beginning of each shift.
Any sample unit (carcass or its parts) adversely affected by the presence of a pathological/abnormal condition will not be used for any SPC test except Finished Product Standards testing. The next immediate trailing unit shall be substituted in lieu and scored as part of the sample set.
If the line stops during an SPC test, the remaining sample units for the test are chosen when the line restarts and the line speed returns to normal. The monitor shall ensure the tested attributes of these sample units are not affected by the line stoppage.
In the case of a prolonged line stoppage where the stoppage exceeds 2/3 of a production lot's time interval, the randomly scheduled viscera presentation test(s) for that specific lot may be waived. Waiving of all other scheduled tests during that interval is at the discretion of the VIC.
4.2.6 Frequency of Testing
Abattoirs operating normally at 200 carcasses per hour (cph) or less are not required to perform Presentation SPC procedures outlined in this annex. However it is understood that the operator must still meet the standard for the presentation of carcasses and their parts that has been agreed with the Veterinarian in Charge. For details see section 4.1 and section 6.2 of this document. When an establishment that operates at 200 cph or less proceeds to operate at a speed over 200 cph, the operator shall immediately perform Presentation SPC procedures as outlined in this annex and shall continue performing these tests during the rest of the week, even if the line speed goes back to 200 cph or less during that week. When an establishment that operates at a speed over 200 cph proceeds to operate at a speed of 200 cph or less, the operator shall continue to perform Presentation SPC procedures as outlined in this annex for a speed over 200 cph during the rest of the week.
The operator shall perform the SPC tests at the frequencies stated in table 4.1 or for table 4.1a, as applicable. When an establishment that operates normally at 100 cph or less proceeds to a speed over 100 cph, the operator shall perform SPC testing and related procedures as outlined in this annex for a speed over 100 cph during the rest of the week, even if the line speed goes back to 100 cph or less during that week. When an establishment that operates normally at a speed over 100 cph proceeds to operate at a speed of 100 cph or less, the operator shall continue to perform SPC testing and related procedures as outlined in this annex for a speed over 100 cph during the rest of the week. Also refer to the Training Module E 5.
Table 4.1 SPC Testing Frequencies
| Performed by | Test Mode | Frequency |
|---|---|---|
| Operator | Reduced (elective) | Random every 60/30 min based on lot size |
| Operator | Normal | Random every 60/30 min based on lot size |
| Operator | Tightened | 1st test within 15 min and every 15 min thereafter |
| Performed by | Test Mode | Frequency |
|---|---|---|
| Operator | Reduced mode (elective) | Random, every 30 or 60 min based on lot size |
| Operator | Normal mode | Random, every 30 or 60 min based on lot size |
| Operator | Tightened mode | 1st test within 15 min, every 15 min thereafter |
| Performed by | Test Mode | Frequency |
|---|---|---|
| Operator | Reduced mode (elective) | Random, every 30 or 60 min based on lot size |
| Operator | Normal mode | Random, every 30 or 60 min based on lot size |
| Operator | Tightened mode | 1st test within 15 min, every 15 min thereafter |
| Performed by | Test Mode | Frequency |
|---|---|---|
| Operator | Regular mode | Random, every 30 or 60 min based on lot size |
| Operator | Relaxed mode (elective) | Every 1 hr or 2 hrs based on lot size |
Once a lot size (half an hour or 1 hour production) is selected by the operator and approved by the VIC/RVO based on the facility's process control capability, it cannot be changed spontaneously. A written request shall be submitted to the VIC and a mutually acceptable implementation date must be negotiated for any change to the lot size.
Table 4.1a SPC Testing Frequencies for Small Establishments
(i.e. for abattoirs operating at 100 carcasses per hour (cph) or less)
| Performed by | Mode | Lot size | Frequency |
|---|---|---|---|
| Operator | Reduced
Table Note 2 (elective) |
One hour of production | once per half shift (if a failure, test again in half an hr) |
| Operator | Normal | One hour production | once per half shift (if a failure, test again in half an hr) |
| Operator | Tightened | 15 min of production | 1st test within 15 min, every 15 min thereafter |
| Performed by | Mode | Lot size | Frequency |
|---|---|---|---|
| Operator | Reduced Table Note 2 (elective) | One hour production | once per half shift (if a failure, test again in half an hr) |
| Operator | Normal | One hour production | once per half shift (if a failure, test again in half an hr) |
| Operator | Tightened | 15 min of production | 1st test within 15 min, every 15 min thereafter |
| Performed by | Mode | Lot size | Frequency |
|---|---|---|---|
| Operator | Regular | One hour production | once per half shift |
Table Notes
- Table note 2
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Note: Small establishments that have a reduced frequency of testing must have a lot size of one hour for purposes of rework.
4.2.7 Shift Continuity of All Statistical Process Control (SPC) Testing
The test results, test status and completed forms for all SPC testing shall remain continuous from shift to shift. Whatever the test status is at the end of a shift shall be the status at the beginning of the subsequent consecutive shift. In multiple shift establishments, the day and afternoon shifts shall be treated as separate and independent entities and shall maintain separate test results, completed forms and corrective actions for each.
4.2.8 Carcass and Carcass Parts Testing Proximity
When the various SPC carcass/carcass parts monitoring tests are being performed by either the operator or the CFIA, the proximity of the surface under evaluation shall be at approximately arm's length from the monitor.
4.2.9 Line Speed Reductions
Line speed reductions are sometimes a mandatory process action step when SPC standards are not being met and the operator is trying to regain control of their process. When this occurs, no more than one type of process control step shall initiate a line speed reduction at any one given time.
4.2.10 Lot Rework Verification
The operator shall notify the CFIA when rework is being performed on an affected lot. As well, records of rework verification and evaluation performance shall be maintained by the operator. The frequency of rework monitoring by the CFIA shall be at the discretion of the VIC. For details on lot rework procedures refer to section 11.
4.2.11 HIP Record Retention
The operator shall maintain HIP SPC records for a minimum period of one year and these records shall be available to the CFIA upon request of the VIC. SPC test records pertaining to current production and those records necessary to determine test modes shall be available to the CFIA in the evisceration area.
4.2.12 SPC Corrective Actions
All corrective actions outlined in the operator's written program shall be previously approved by the VIC in consultation with the RVO. These corrective actions may include, but are not restricted to the following:
- re-evaluation of received food animals to meet the operator's performance standards;
- analysis of process steps prior to the test location where the failure occurred;
- addition of extra accredited personnel;
- line speed reduction;
- equipment adjustment;
- replacement of personnel; and
- increase in test frequency.
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