Whether it is your first inspection or your tenth, onsite inspections can be a little intimidating and overwhelming. Read on to take out some of the guesswork. Discover what the regulations require during inspections, what a typical inspection may include, and how you can prepare.
Regulatory Requirements for Inspection
Inspections are primarily covered in the organic regulations under §205.403, but the term also shows up in definitions, recordkeeping, and many other parts of the regulations. The most pertinent points are:
- In §205.403(a), the regulations require that certifying agents conduct on-site inspections at least annually for each certified operation that produces or handles organic products. [§205.403(a)] The recently finalized Strengthening Organic Enforcement (SOE) rule goes further to specify that this means once per calendar year.
- Inspections must be scheduled and conducted when an authorized representative is present and when the land, facilities, and activities that demonstrate compliance can be observed. There is an exception to this requirement for Unannounced inspections. [§205.403(b)]
- The purpose of inspections is to verify compliance with the regulations, that the organic system plan is accurate, and that prohibited substances have not been and are not being applied. [§205.403(c)].
- An Exit Interview must be conducted with an authorized representative to confirm the accuracy and completeness of observations and information gathered during inspections. The inspector must also address the need for any additional information as well as issues of concern. [§205.403(d)] The SOE rule also included an update to explicitly require for mass-balance and traceability audits as a part of the on-site inspections.
- The recordkeeping section of the regulations states that “records must be maintained for no less than 3 years beyond their creation and the operations must allow … access to these records for inspection and copying during normal business hours to determine compliance with the applicable regulations set forth in this part.” [§205.103(c)]
Common Parts of an Inspection
A typical inspection will include the following parts, but keep in mind certain sections may sometimes combined or done in a different order:
- Initial contact – The inspector will reach out to you, usually via phone and/or email with a proposed date and time. We ask inspectors to give clients at least two weeks notice whenever possible.
- Opening meeting – On the appointed day, the inspection often starts with an opening meeting to discuss what the inspector needs to accomplish while on-site. This usually includes introductions and any logistical items such as relevant staff availability or time restraints, as well as an overview of the inspection process.
- OSP Review – The inspector goes over your Organic System Plan, Annual Update or Initial Application and related documents to verify accuracy. If you previously received a Notice of Noncompliance or Minor Issue, the inspector is also expected check to see if those corrective actions are still in place.
- Facility or Farm Tour – During this walkthrough the inspector verifies maps, equipment lists, product flows, etc.
- For producers, the inspector will need to see all of your organic fields you are requesting for certification, as well as equipment and areas used for storage. This is often accomplished by driving or walking to each field and walking out into at least some of the fields.
- Operations with organic livestock will of course also include visiting animal housing and grazing areas and viewing the livestock requested for certification.
- For handling operations, you can expect the inspector to walk the entire facility, including areas that are not used for organic handling. The inspector will need to see all equipment and storage areas used for organic handling.
- Records Audit – The inspector will request records to conduct applicable audits to verify organic recordkeeping practices. The audits may include:
- Traceability Audits – These are now explicitly required by the regulations for all applicants and certified operations. The inspector will be checking your recordkeeping system to determine if it is possible to trace an organic product (or ingredient) back one step in the supply chain. So, for example, the inspector may select a specific organic product sold and trace that item through your system back to the certified organic supplier.
- Mass Balance (or In/Out Audits) – Also explicitly required by the regulations, this audit verifies that the quantities of organic product and ingredients coming in accounts for the quantity of organic products and ingredients going out. This is typically done for one product or component over a period of time. In its most simple form, the formula is: Total incoming organic = Total outgoing organic + Total organic inventory.
- Feed Audits
- Recipe Verification – Applicable to handling operations that make products using multiple ingredients. The inspector will review batch records and compare to the approved formulation on file with OneCert to determine if the composition matches what is approved by OneCert and to ensure the organic percentage is calculated correctly.
- Exit Interview – Required by the regulations and summarizes the issues found during the inspection. OneCert provides inspectors with a form to document this event, and a copy of this form must be left with you at the end of the inspection. Once the Exit Interview is signed, you shouldn’t submit any further information to the inspector. If you have questions or want to address a concern from the inspection, please submit that directly to OneCert.
Preparing for an Inspection
To help the inspection go smoothly, you can make sure to have all relevant records available and ready to go. If any records can only be accessed digitally, be sure to have that device with you and the appropriate personnel present to access the information the inspector will need.
Common Records (All scopes, as applicable):
- Receipts and label information for all inputs (e.g. those used for fertility, pest, weed, disease, or facility pest control, cleaners and sanitizers, etc.)
- Records of input use including the material, date, location and rate of application
- Composting records
- Reciepts and tags for seeds, non-GMO and untreated statements, seed search documentation
- Field activity records
- Harvest records (including buffer harvests)
- Sales documentation (Invoices, bills of lading, settlement sheets, etc.)
- Equipment cleanout logs, clean transport records
- Storage and inventory records
- Livestock grazing records, feed fed records, DMI and/or synthetic methionine calculations
- Product labels
- SOP’s and SSOP’s
- Receiving and purchase documentation of all products/ingredients
- Supplier certificates for all products/ingredients
- Production records (batch sheets, packing records, sanitation logs, etc.)
- Sales and shipping records
- Transportation records
- State Organic Registration (if required in your state)
- Reports from recent state, county or municipal health inspections
Unannounced Inspections
The NOP requires that all certifiers conduct Unannounced Inspections on at least 5% of their certified operations each year. OneCert selects these operations at random, due to risk (e.g., complexity, history of issues), or as the result of a complaint or investigation.
In these cases, the inspection will be scheduled during regular business hours. The inspector will not notify the client before his/her arrival, unless it is absolutely necessary to ensure that appropriate representatives are present. This notification can be no more than 4 hours before the inspection.
The inspector must review a portion of the operation as outlined by OneCert. The inspector may be prepared to do a full inspection of the operation at that time. The full inspection could count as the annual inspection barring any noncompliance issues or major changes in the operation.
If the inspector is not authorized to do a full inspection or cannot do a full inspection or the unannounced inspection reveals a major issue, OneCert will conduct a second inspection so we can determine full compliance with the Regulations.
The annual update and fee will still be due on the operation’s due date regardless of when the unannounced inspection occurs.
Still have questions about your inspection? Reach out to us at inspect@onecert.com!