Many small—and all large—buyers have certain standards or requirements, which they enforce via “Quality Audits”. These audits will include sections on inspection and traceability, the most stringent example of which is the Costco audit. The applicable sections are detailed below in a truncated list for your reference, but these sections are all fulfilled when an x-ray system is bought from ABM Equipment with DSO because of the following clause:
“Companies with corporate generated recall systems in place need only provide the auditor with a copy of their program and evidence they have tested the system on a finished product, an ingredient, and primary packaging since their last annual audit. A test shall not be required during the audit if the evidence provided shows that the system was able to recover 100% of the test subject in under 2 hours in all three exercises.” (DSO is real-time)
Costco Audit Overview
(Our comments in italics)
Incoming foreign material control (X-ray optional)
- Specifications that include physical hazard parameters for all raw materials including primary packaging.
- Incoming raw material (including primary packaging) inspection procedure that includes documented verification against specifications at a defined frequency. Corrective actions shall be documented when variances are identified. Trends should be monitored and documented.
- Storage, handling, and transport procedures that include necessary controls to prevent foreign material contamination, and the corrective actions should incidents occur.
- A glass and brittle plastic policy which maintains a map of glass and brittle plastic in product zones and areas, verified at a defined frequency.
- A policy that restricts the use of materials in product zones and areas that are not easily cleanable or prone to creating foreign material contamination. These materials include – but are not limited to – foam rubber, any type of carpet, wood, non-food grade plastic, cardboard, tape, etc. Clothes, towels, and other cleaning materials that pose a risk of contamination or adulteration shall not be used to remove dirt or debris from product.
- A mechanism for employees to report concerns that includes specific language for foreign material contamination
- Annual training on foreign material hazards for all employees at the facility, including instruction on the mechanism employees can use to report concerns.
- Procedure for visitor and contractor awareness and acknowledgement of the operation’s requirements.
- Documented inspections at a defined frequency of equipment, glass and brittle plastic, and other reasonably likely sources of foreign material. Corrective actions shall be documented where deficiencies are identified and trend analysis shall be conducted at a defined frequency and any trends should be documented.
- Customer complaint procedures that address foreign material investigation and the documentation of corrective and preventive actions. Trend analysis shall be conducted at a defined frequency and preventive actions shall be documented when trends are identified.
Finished product inspection (X-ray mandatory)
All manufacturing operations must have a proper X-ray detection device with appropriate reject mechanism, except in the following circumstances:
- Composition is such that it limits the performance of the X-ray technology to an unacceptable level. (Metal detection as well as a letter from a subject matter expert confirming that X-ray is not applicable are required. (Both can be supplied by ABM Equipment.))
- Shell Eggs, whole raw agricultural commodities, whole roasted coffee beans, whole muscle meats, and packaging product. The operation will need to maintain current good manufacturing practices for foreign material.
- Operations that utilize physical barriers (e.g. screens, filters, sieves) that are appropriately sized and placed. The operation will need to conduct integrity checks at a defined frequency and maintain current good manufacturing practices and prerequisite programs to catch foreign material.
- System which can tie inputs and outputs (including packaging and processing aids) to their corresponding lots
- Within two hours.
- Trace 1 step forward, 1 back
- Mark products with use-by/sell-by/best-before date which can be used for recalls (produce items should include packed-on date or QR code which can be scanned in event of recalls)
- Julian dating not allowed
- Perform 2 mock recalls/years simulating different issues (with ingredients vs packaging vs finished goods, etc.)
- Verify Contact Info Yearly – Verify your own contacts are still valid for recalls, and call/email the appropriate parties for both supplier and buyer to verify their info has not changed, and be able to prove you verified it.
Again, all requirements for these sections are met or advised upon when an x-ray machine is purchased from ABM with a DSO installation.