Performance Standard:The Listeria s

Performance Standard:

The Listeria spp. environmental incidence performance standard is based on a 1 year rolling average. The performance standard has two elements. It is based on the overall results for the plant, and results by sample site.

Overall Incidence Calculation
Overall incidence is calculated by dividing the number of positive results by the total number of samples.

Incidence by Site Calculation
Incidence by site is calculated by dividing the number of positives at that site by the total number of tests of that site, over the 1-year rolling period (or less if the program is newly initiated). The current overall performance standard is 10 percent or less, for zones 2,3, and 4. It is 0% in Zone 1, if Zone 1 swabbing is done. The current individual site performance standard is 20% maximum. For example, if results from 5 of 72 total samples from zones 2, 3, and 4, collected over a 3-month period were positive, the incidence would be 7% overall, and is within the overall performance standard limits. If the cooling racks (Zone 2) swab results were positive for 2 of 12 swabs within the same timeframe, the incidence at that site would be 17%, which also meets the performance standard for an individual site.


Tracking:

Once per month the overall incidence in the plant and incidence by site must be calculated and kept on file. A spreadsheet with the permanent swab site numbers within each zone is a useful tool for this purpose, and should be maintained and available for review.

Notification:

An effective communication system for reporting positive results, and the need for corrective action, must be developed by each supplier for their internal use. Appropriate records of corrective actions must be kept. When either aspect of the performance standard is exceeded, e-mail notification to Trader Joe’s, with corrective action documentation, must be made within 7 days. The notification should include the incidence rate and the swab site description, and a very brief description of corrective actions, including follow-up swab data.

Compositing:

Compositing, or combining multiple sites on the same swab, is not allowed until:

1) A plant has met the pre-operational performance standard and advanced to operational swabbing

And

2) At least 1 month of operational swabbing has been conducted and results are within performance standards. After that time, two swab sites may be composited together for Zone 2 sites only. Any positive results require corrective action at each swab site represented within the composite.

Follow-up swabbing must be conducted individually on each site.

Compositing cannot be resumed until another 1 month of operational swabbing within performance standards is achieved.

Laboratory Testing:
Pathogen testing involves growing bacteria to extremely high levels so it is detectable. Testing for Listeria spp. or any pathogens in the same facility as food manufacturing is conducted is not permitted due to the potential for contamination. Testing may be conducted by a vendor only if the laboratory is located in a separate building with a sterilizer for disinfection of used test materials, and if the vendor obtains an annual Good Laboratory Practices Assessment by a qualified third party.


Certificates of analysis must be kept on file by the vendor for 2 years.


Swabbing Procedure

• Hands must be cleaned and sanitized prior to beginning swabbing. A sterile sponge swab, wetted with neutralizing buffer, is used for each sample.
• Swabs in plastic bags: Aseptically tear the top perforated plastic strip away from the metal rim. Place the thumb and forefinger of one hand on the tab while firmly holding the bag touching only the metal tabs. Open the mouth of the bag by pulling on the white tabs on the outside. Do not touch the inside of the bag at this point.
Swabs in plastic snap-top cups: Snap open the top of the cup without touching any of the inside surfaces or the swab.
• Put on a sanitary glove. Only the top sleeve portion and inside of the glove is contacted by the fingers to remove the glove. Place it on the
hand by touching only the top (closest to the sleeve) of the glove. At no time should anything touch the outside of the glove fingers.
• Place the gloved hand inside of the bag or cup with the sponge inside.
• Remove the sponge and swab a minimum of 1 sq. foot of surface area. (e.g. 1 foot by 1 foot)
• Place the sponge back into the bag or cup and remove the glove.
• Without touching the opening of the bag, roll the metal strip and fold the metal flaps over to seal the bag. If using a cup, place the sponge back into the cup and carefully snap the top, then pull the seal tab across the lock.
• Label the bag or cup with the zone number, swab site number, and date and time of collection, and place in refrigeration. Testing must be started within 24 hours of swabbing. Samples must be transported to the laboratory with a refrigerant (blue ice), either through a courier service or overnight shipping.

Action Limits:
Any swab results positive for Listeria spp. require immediate corrective action. Results above performance standard limits require notification to Trader Joe’s.

Corrective Action:

Zone 2
Corrective action may involve a review of cleaning practices and records, a detailed audit of the cleaning procedures, or complete disassembly and assessment of the equipment. The affected equipment is always re-swabbed following corrective action to verify it was adequate. Three consecutive samples are collected, at least 3 hours after start-up, on 3 consecutive swabbing times (one per day), following completion of corrective action. The results of all three must be within limits to justify considering the area or equipment sanitation in control.

If retest results following corrective action are out of limits, more vigorous investigation is conducted. The help of sanitation supply companies or consultants may be enlisted. Melissa Calicchia, a consulting microbiologist, offers these types of services. She can be reached at [phone]. Certified Analytical additionally offers consulting and consulting referral services for this purpose. Appropriate documentation of corrective action activities must be kept on file.

Zone 3 and 4
Zones 3 and 4 require evaluation of other factors related to general sanitation practices and operational sanitation. Swabbing is always conducted following corrective action to assess effectiveness. Three consecutive samples are collected, at least 3 hours after start-up, on 3 consecutive swabbing times (one per day), following completion of corrective action.The results of all three must be negative to justify considering the area or equipment sanitation in control.


If results following corrective action are positive, a vigorous investigation must be initiated. It may or may not involve enlisting the help of outside consultants. Appropriate records must be kept of all corrective action activities and results.

Zone 1
If Zone 1 testing is conducted, special corrective action is necessary. All activities discussed for Zone 2 must be followed. Additionally, finished product that was manufactured on the date of swab sampling must be analyzed for the presence of L. monocytogenes. It may not be released from hold unless the results for all finished product samples tested are negative.


Other Necessary Sanitation Verification Activities:
The Listeria spp. program is one element of an effective sanitation verification program. Sensory evaluation must be conducted during daily pre-operational sanitation inspection. Analysis of contact surfaces of equipment and air should also be conducted at appropriate intervals. Limits for indicator microbe loads on contact surfaces (aerobic plate count, coliforms, yeast, mold) and yeast and mold on air samples should be established and appropriate corrective actions defined. If ATP (adenosine tripolyphosphate) testing is conducted, limits for ATP levels on product contact surfaces should similarly be determined and corrective action defined.

Trader Joe’s reserves the right to conduct random, pre-operational swab auditing for Listeria spp. as a means of verification of routine results.

ผลลัพธ์ (อังกฤษ) 2:

Performance Standard: The Listeria spp. environmental incidence performance standard is based on a 1 year rolling average. The performance standard has two elements. It is based on The Overall results for The Plant, and results by Sample Site. Overall Incidence Calculation Overall incidence is calculated by Dividing The number of positive results by The total number of samples. Incidence by Site Calculation Incidence by Site is calculated by Dividing The. number of positives at that site by the total number of tests of that site, over the 1-year rolling period (or less if the program is newly initiated). The current overall performance standard is 10 percent or less, for zones 2,3, and 4. It is 0% in Zone 1, if Zone 1 swabbing is done. The current individual site performance standard is 20% maximum. For example, if results from 5 of 72 total samples from zones 2, 3, and 4, collected over a 3-month period were positive, the incidence would be 7% overall, and is within the overall performance standard limits. IF The cooling Racks (Zone 2) swab results were positive for 2 of 12 Swabs Within The Same timeframe, The incidence at that Site would be 17%, which also Meets The Performance standard for an Individual Site. Tracking: Once Per month The Overall. incidence in the plant and incidence by site must be calculated and kept on file. A spreadsheet with The Permanent swab Site numbers Within each Zone is a Useful Tool for this purpose, and should be maintained and Available for review. Notification: An Effective Communication System for Reporting positive results, and The Need for corrective Action, must be developed by. each supplier for their internal use. Appropriate records of corrective actions must be kept. When either aspect of the performance standard is exceeded, e-mail notification to Trader Joe's, with corrective action documentation, must be made ​​within 7 days. The Notification should include The incidence rate and The swab Site description, and a very brief description of corrective Actions, including follow-up swab Data. Compositing: Compositing, or combining multiple Sites on The Same swab, is Not allowed until: 1) A. The Plant has met Pre-operational Performance standard and advanced to operational swabbing And 2) At least 1 month of operational results and are swabbing has been Conducted Within Performance Standards. After that time, two swab sites may be composited together for Zone 2 sites only. Any positive results Require corrective Action at each swab Site represented Within The Composite. Follow-up swabbing must be Conducted Individually on each Site. Compositing Can Not be resumed until another 1 month of operational swabbing Within Performance Standards is achieved. Laboratory Testing: Pathogen Testing involves. growing bacteria to extremely high levels so it is detectable. Testing for Listeria spp. or any pathogens in the same facility as food manufacturing is conducted is not permitted due to the potential for contamination. Testing May be Conducted by a Vendor only IF The Laboratory is located in a separate Building with a sterilizer for disinfection of Used test materials, and IF The Vendor Obtains an Annual Good Laboratory Practices Assessment by a qualified Third Party. Certificates of analysis must be kept. on file by The Vendor for 2 years. swabbing Procedure • Hands must be cleaned and sanitized Prior to beginning swabbing. A STERILE Sponge swab, Wetted with neutralizing buffer, is Used for each Sample. • Swabs in Plastic Bags: Aseptically Tear The Top Plastic perforated strip Away from The Metal Rim. Place the thumb and forefinger of one hand on the tab while firmly holding the bag touching only the metal tabs. Open the mouth of the bag by pulling on the white tabs on the outside. Do Not Touch The Inside of The Bag at this Point. Swabs in Plastic Snap-Top cups: The Top of The Snap Open cup Without touching any surfaces or The Inside of The swab. • Put on a Sanitary glove. Only the top sleeve portion and inside of the glove is contacted by the fingers to remove the glove. Place it on The Hand by touching only The Top (closest to The sleeve) of The glove. At no time should anything Touch The Outside of The Fingers glove. • Place gloved The Inside of The Hand Bag or cup with The Sponge Inside. • Remove The Sponge and swab a Minimum of 1 sq. Foot of surface Area. (Eg 1 Foot by 1 Foot) • Place The Sponge back Into The Bag or cup and Remove The glove. • Without touching The opening of The Bag, Roll and Fold The Metal The Metal strip flaps over to Seal The Bag. IF using a cup, Place The Sponge back Into The cup and carefully Snap The Top, then pull The Seal tab Across The Lock. • Label The Bag or cup with The Zone number, swab Site number, and Date and time of Collection, and. place in refrigeration. Testing must be started within 24 hours of swabbing. Samples must be transported to The Laboratory with a Refrigerant (blue Ice), either Through a Courier Service or Overnight Shipping. Action Limits: Any positive swab results for Listeria spp. require immediate corrective action. Performance results above standard limits Require Notification to Trader Joe's. Corrective Action: Zone 2 Corrective Action Cleaning Practices and May involve a review of records, a Detailed Audit of The Cleaning procedures, or The Complete disassembly and Assessment of Equipment. The affected equipment is always re-swabbed following corrective action to verify it was adequate. Three consecutive samples are collected, at least 3 hours after start-up, on 3 consecutive swabbing times (one per day), following completion of corrective action. The results of all Three must be limits to justify considering Within The Area Control or Equipment Sanitation in. If Retest results following corrective Action are out of limits, is more Vigorous Investigation Conducted. The help of sanitation supply companies or consultants may be enlisted. Melissa Calicchia, a consulting microbiologist, offers these types of services. She can be reached at [phone]. Certified Analytical additionally offers consulting and consulting referral services for this purpose. Documentation of activities appropriate corrective Action must be kept on file. Zone 3 and 4 Zones 3 and 4 Require Evaluation of Other factors Sanitation Practices Related to general operational and Sanitation. Swabbing is always conducted following corrective action to assess effectiveness. Three consecutive samples are collected, at least 3 hours after start-up, on 3 consecutive swabbing times (one per day), following completion of corrective action.The results of all three must be negative to justify considering the area or equipment sanitation in control. . If results are positive following corrective Action, a Vigorous Investigation must be initiated. It may or may not involve enlisting the help of outside consultants. Appropriate records must be kept of all corrective Action activities and results. Zone 1 If Zone 1 is Conducted Testing, Special corrective Action is necessary. All activities discussed for Zone 2 must be followed. Additionally, finished product that was manufactured on the date of swab sampling must be analyzed for the presence of L. monocytogenes. It May Not be Released from The Hold unless Finished product results for all samples tested are Negative. Other Necessary Sanitation Verification Activities: The Listeria spp. program is one element of an effective sanitation verification program. Sensory evaluation must be conducted during daily pre-operational sanitation inspection. Analysis of contact surfaces of equipment and air should also be conducted at appropriate intervals. Limits for indicator microbe loads on contact surfaces (aerobic plate count, coliforms, yeast, mold) and yeast and mold on air samples should be established and appropriate corrective actions defined. IF ATP (adenosine tripolyphosphate) Testing is Conducted, limits for ATP levels on product Contact surfaces should be Determined and corrective Action similarly defined. Trader Joe's reserves The Right to conduct random, Pre-operational swab Auditing for Listeria spp. as a means of verification of routine results.

ผลลัพธ์ (อังกฤษ) 3:

Performance Standard:

The Listeria spp. Environmental incidence performance standard is based on a 1 year rolling, average. The performance standard has two elements. It is based on the overall results for, the plant and results by sample site.?

Overall Incidence Calculation
Overall incidence is calculated by dividing the number of positive results by the total. Number of samples.

.Incidence by Site Calculation
Incidence by site is calculated by dividing the number of positives at that site by the total. Number of tests of, that site over the 1-year rolling period (or less if the program is newly initiated). The current overall. Performance standard is 10 percent or less for 2 3, zones, and 4. It, is 0% in, Zone 1 if Zone 1 swabbing is done.The current individual site performance standard is 20% maximum. For example if results, from 5 of 72 total samples from. Zones 2 3 and 4,,, over collected a 3-month period were positive the incidence, would be, 7% overall and is within the overall. Performance standard limits. If the cooling racks (Zone 2) swab results were positive for 2 of 12 swabs within the same. Timeframe.The incidence at that site would be 17% which also, meets the performance standard for an individual site.




, Tracking Once Per month the overall incidence in the plant and incidence by site must be calculated and kept on file. A spreadsheet with. The permanent swab site numbers within each zone is a useful tool for this purpose and should, be maintained and available. For review.

.Notification:

An effective communication system for reporting, positive results and the need for, corrective action must. Be developed by each supplier for their internal use. Appropriate records of corrective actions must be kept. When either. Aspect of the performance standard is exceeded e-mail notification, to Trader Joe 's with corrective action documentation,,, Must be made within 7 days.The notification should include the incidence rate and the swab site description and a, very brief description of corrective. Actions including follow-up, swab data.



, Compositing Compositing or combining multiple sites on the same swab is not,, Allowed until:

1) A plant has met the pre-operational performance standard and advanced to operational And swabbing



.2) At least 1 month of operational swabbing has been conducted and results are within performance standards. After that. Time two swab, sites may be composited together for Zone 2 sites only. Any positive results require corrective action at. Each swab site represented within the composite.

Follow-up swabbing must be conducted individually on each site.

.Compositing cannot be resumed until another 1 month of operational swabbing within performance standards is achieved.

Laboratory. Testing:
Pathogen testing involves growing bacteria to extremely high levels so it is detectable. Testing for Listeria, spp. Or any pathogens in the same facility as food manufacturing is conducted is not permitted due to the potential for contamination.Testing may be conducted by a vendor only if the laboratory is located in a separate building with a sterilizer for disinfection. Of used, test materials and if the vendor obtains an annual Good Laboratory Practices Assessment by a qualified third, party.


Certificates of analysis must be kept on file by the vendor for 2 years.


Swabbing Procedure

.Education Hands must be cleaned and sanitized prior to beginning swabbing. A sterile sponge swab wetted with neutralizing buffer,,, Is used for each sample.
- Swabs in plastic bags: Aseptically tear the top perforated plastic strip away from the metal. Rim. Place the thumb and forefinger of one hand on the tab while firmly holding the bag touching only the metal tabs.Open the mouth of the bag by pulling on the white tabs on the outside. Do not touch the inside of the bag at this, point.
Swabs in plastic snap-top cups: Snap open the top of the cup without touching any of the inside surfaces or the swab.
* Put on a sanitary glove. Only the top sleeve portion and inside of the glove is contacted by the fingers to remove the, glove. Place it on the
.Hand by touching only the top (closest to the sleeve) of the glove. At no time should anything touch the outside of the. Glove fingers.
- Place the gloved hand inside of the bag or cup with the sponge inside.
- Remove the sponge and swab a. Minimum of 1 sq. Foot of surface area. (e.g. 1 foot by 1 foot)
* Place the sponge back into the bag or cup and remove the. Glove.
.Education Without touching the opening of the bag roll the, metal strip and fold the metal flaps over to seal the bag. If using. A cup place the, sponge back into the cup and carefully snap the top then pull, the seal tab across the lock.
- Label the. Bag or cup with the zone number swab number, site, date and and time, of collection and place in refrigeration.Testing must be started within 24 hours of swabbing. Samples must be transported to the laboratory with a refrigerant (blue. Ice), either through a courier service or overnight shipping.


Action Limits Any swab results positive for Listeria, spp. Require immediate corrective action. Results above performance standard limits require notification to Trader Joe 's.

Corrective. Action: Zone 2


.Corrective action may involve a review of cleaning practices, and records a detailed audit of the, cleaning procedures. Or complete disassembly and assessment of the equipment. The affected equipment is always re-swabbed following corrective. Action to verify it was adequate. Three consecutive samples, are collected at least 3 hours, after start-up on 3 consecutive. Swabbing times (one per day),Following completion of corrective action. The results of all three must be within limits to justify considering the area. Or equipment sanitation in control.

If retest results following corrective action are out of limits more vigorous, investigation. Is conducted. The help of sanitation supply companies or consultants may be enlisted. Melissa Calicchia a consulting microbiologist,,Offers these types of services. She can be reached at [phone]. Certified Analytical additionally offers consulting. And consulting referral services for this purpose. Appropriate documentation of corrective action activities must be kept. On file.

Zone 3 and 4
Zones 3 and 4 require evaluation of other factors related to general sanitation practices and operational. Sanitation.Swabbing is always conducted following corrective action to assess effectiveness. Three consecutive samples, are collected. At least 3 hours, after start-up on 3 consecutive swabbing times (one per day), following completion of corrective action.The. Results of all three must be negative to justify considering the area or equipment sanitation in control.


.If results following corrective action, are positive a vigorous investigation must be initiated. It may or may not involve. Enlisting the help of outside consultants. Appropriate records must be kept of all corrective action activities and, results.


Zone 1 If Zone 1 testing, is conducted special corrective action is necessary. All activities discussed for Zone 2 must. Be, Additionally followed.Finished product that was manufactured on the date of swab sampling must be analyzed for the presence of L. Monocytogenes.? It may not be released from hold unless the results for all finished product samples tested are negative.


Other Necessary. Sanitation Verification Activities:
The Listeria spp. Program is one element of an effective sanitation verification program.Sensory evaluation must be conducted during daily pre-operational sanitation inspection. Analysis of contact surfaces of. Equipment and air should also be conducted at appropriate intervals. Limits for indicator microbe loads on contact surfaces. (aerobic plate,,, count coliforms yeast mold) and yeast and mold on air samples should be established and appropriate corrective. Actions defined.If ATP (adenosine tripolyphosphate), testing is conducted limits for ATP levels on product contact surfaces should similarly. Be determined and corrective action defined.

Trader Joe 's reserves the right to conduct random pre-operational swab, auditing. For Listeria spp. As a means of verification of routine results.


.