AME can setup YOUR OWN on-SITE TESTING LAb
Optimal System: Equip your team to perform your OWN testing!
AME Certified Laboratories offers a full On-Site Lab Program to provide testing for a broad range of pathogens, using multiplexing PCR to test for E. Coli 0157:H7, Salmonella and Listeria. as well as others including plant pathogens.
Why send your samples away to a lab facility and pay them to test them when your own staff can be trained to test them yourself?
Save money, time and have the ability to perform your corrective actions immediately.
• All Lab Equipment: Thermocycler(s), PC, Analytical Software, Micro Centrifuges, micropipettors, etc.
• Lab Consumables and Support
• Training on All Aspects of Environmental and Product Sampling
• Full Support from our Certified Training and Support Team
Imagine having the convenience of testing your products or facilities yourself- it never takes that much time and you get results within 1 hour. All the equipment is leased through AME so we can repair or update when you need it to keep your testing regimen going. Your own employees do all the testing, so you know it's done quickly, correctly and on your schedule.
The AME Certified PCR Laboratories predictive contamination risk analysis software solves our clients' cross contamination issues with AI/ML algorithms and analytics (Ask for details). The software supports the "ship or no-ship" decision-making model for food production organizations.
Analyzing production data in spreadsheets or outdated dashboards we have found often leads to being stymied with mountains of data that goes largely unused.
Our risk analysis software automates raw product, was water, critical control point, and finished product data and analytics in real time.
Managers are automatically alerted and notificatified so they are enabled to focus on prompt shipment and efficiency of their operations.
REAsons why an in-house laboratory is the "right" capability
Buyer "TEST & RELEASE" Requirements
Buyer "TEST & RELEASE" Requirements
Buyer "TEST & RELEASE" Requirements
- Many commercial, high-end buyers with elevated food safety standards require "TEST AND RELEASE" program test results to be submitted to them prior to shipment via on-line systems
- Antiquated testing systems require many days before test results can be reported
- Organizations sending out samples ship their products without the test results being available or before valid test results are available
- Shipping without test results is also known as "SHIP AND PRAY" with an unsupported hope that the products meet the pathogen standards of the buyers
Time is Money
Buyer "TEST & RELEASE" Requirements
Buyer "TEST & RELEASE" Requirements
- In-house laboratories are fast
- Faster results make "test and release" possible
- Sample collection is immediate
- Sample testing is right now
- Cold rooms can be smaller due to faster test turnaround times
- Repeat confirmations are faster
Your Employees Know Where to Look
Buyer "TEST & RELEASE" Requirements
Your Employees Know Where to Look
- Your employees know where the issues are located and where to test
- Your team's years of experience knows best
- Historical areas of concern are known
- Best answers come from your team members
Fast Confirmatory Testing
Outside labs don't know your process
Your Employees Know Where to Look
- Rapid confirmation testing
- Repeat testing confirms findings
- Confirmed answers are reliable
- Confidence is highest
- A combination sample: Multiple samples combined to save money and time and if an "alert" is determined, re-testing of the individual samples is fast and immediate
3rd party testing is slow
Outside labs don't know your process
Outside labs don't know your process
- Slow response time is lost money
- Fresh produce products quickly denigrate
- Slow, old-fashioned testing wastes time/money by waiting and waiting and waiting for preliminary and confirmatory test results
- Third-party labs need days
- Long turnaround times
- No weekend submissions
- No off-hours results
- Require confidential information
- Culture media tests are slow (2 to 7 days) and inaccurate (60% to 70% specificity and sensitivity)
- Cheaply-priced test results: You get what you pay for....less is always less
- Recalls (voluntary and mandatory) cost money
Outside labs don't know your process
Outside labs don't know your process
Outside labs don't know your process
- Unknowledgeable visitors inside your facility need to be told where to collect samples
- Employee escorts are needed
- Safety is an issue
- Unknown technicians running tests is a challenge (You don't know who is running your samples--skill sets, education, training, percentage of mistakes and errors)
- It may be "less-expensive" to bring in 3rd-party laboratory testing personnel to collect and test samples, but in-house personnel often know the facility issues and where to look faster and better than outside personnel
Value vs Price
Bias Conflict Claim vs ISO Certification
Bias Conflict Claim vs ISO Certification
- 3rd party labs offer low prices for conventional culture media tests
- Culture media tests are 60% to 70% specific and sensitive
- PCR testing in 3rd party labs requires culture pre-enrichment (18 to 24 hours) turnaround time
- Low price for slow, inaccurate test results doesn't balance against the value of fast, accurate test reports
- Fast, actionable data is more valuable to food production organizations as compared to days waiting for test reports
- Traditional (old-style) production management is to ship the product, then receive the food tests days after the product is enroute to the buyers or already being sold--too late to take reasonable managerial action
Bias Conflict Claim vs ISO Certification
Bias Conflict Claim vs ISO Certification
Bias Conflict Claim vs ISO Certification
- 3rd party labs claim that in-house testing stations are biased
- All ISO 17025 testing facilities use the same standards
- No bias is possible if ISO 17025 compliant
- 3rd party auditors require ISO 17025 standards, methods, and protocols as elements of the certification
- The primary mission of ISO 17025 certification is to assure international standards of quality performance
- Quality assurance standards eliminate bias irrespective if the lab is run by in-house personnel or 3rd party pay-for-service labs
3rd party labs report issues
Bias Conflict Claim vs ISO Certification
Challenging 3rd party lab issues
- Any issues noticed will be immediately reported to government agencies (city, county, state, federal--US FDA, USDA, etc.)
- Risk of misinformation to public
- Untrained observer errors
- Factories are "shut down" by poorly-trained or inexperienced government workers
- Once on a list, the government(s) never forget about past 'events'
- Unconfirmed recalls: "In an abundance of caution"
- 3rd-party laboratories do not retain client samples--only retain computer records--difficult to run confirmatory samples
Challenging 3rd party lab issues
Challenging 3rd party lab issues
Challenging 3rd party lab issues
- Accessioning errors in 3rd party labs are an issue (mixing up samples which causes erroneous test reports)
- Inexperienced personnel running tests during unsupervised operation periods
- Destruction of client samples post testing so no retained evidence for re-testing
- No retained client samples post testing (unless specifically requested and commissioned)
- Mis-labeling of samples
- Overwhelming of sample management systems during peak production periods
Weekend & Holiday Inavailability
Challenging 3rd party lab issues
Weekend & Holiday Inavailability
- Many third-party labs are closed for weekends and holidays
- Food safety contamination "events" occur (cross-contamination, leaks, breaks, chemical failures, etc.) do not occur on a Monday through Friday, business hours basis
- An in-house team of equipped, supplied, trained, experienced, and certified technicians will solve any unplanned 'events' in short order
- Of course, when a third-party lab opens, samples can be sent for corroborative evidence regarding the 'event' samples
- The efficiency of an in-house team to conserve resources in screening raw and in-process products is invaluable in a food safety crisis, especially when processed food products have been cut, packaged, palletized, cooled, and prepared for shipment.
- Given transportation, labor, and packaging costs, late lab results puts the producer, the buyer, and the consumer at greater risk
Regulatory Compliance
Challenging 3rd party lab issues
Weekend & Holiday Inavailability
- US Governmental statutes, laws, regulations, and rulings require mandatory compliance for food products imported and sold in the United States of America
- The US Food and Drug Administration (US FDA) has jurisdiction over food products in the USA
- The US Department of Agriculture has responsibility over food production
- Food producers who import into the USA must comply with all governmental laws and regulations
- State, county, city laws, and regulations must also be complied with in order to meet all regulatory laws, rules, and suggestions or face penalties
- In-house laboratories with ISO-17025 certification and approved assays can meet all governmental regulations