Service area
Food Manufacturing Food Safety Programs
Prerequisite programs, sanitation, environmental monitoring and CAPA that hold up.
- Service lines
- 11 listed
- Delivery
- Onsite and remote
- Coverage
- United States
Overview
What this covers
Facilities rarely fail on the food safety plan document. They fail on the programs the plan depends on: a sanitation procedure with no validated contact time, an environmental monitoring program that samples the same easy sites every week, an allergen matrix that does not reflect the current changeover sequence, or a corrective action log where every entry says 'retrained operator'.
We work at that operational layer. GMP audits against the standard you are held to, sanitation and environmental monitoring programs designed around your actual zone map and pathogen risk, allergen programs with real changeover validation, and root cause analysis discipline that distinguishes a training failure from a process design failure.
Who this is for
- Food and beverage manufacturers and co-manufacturers of any size
- Ready-to-eat and refrigerated processors carrying environmental pathogen risk
- Facilities handling major food allergens alongside allergen-free product runs
- Plants with repeat audit findings, a rising complaint trend, or a recent hold or withdrawal event
- Operations standing up a quality system for the first time or scaling from a single line to multiple shifts
Manufacturing services
- GMP / cGMP audits
- Sanitation programs
- Environmental monitoring
- Allergen programs
- Food defense
- Food fraud
- Recall programs
- Supplier approval
- CAPA
- Root cause analysis
- SOP development
Engagements are scoped to what applies to your operation. Where a listed service is not relevant to your products, processes or jurisdiction, we will say so.
How an engagement runs
Sequenced so each step earns the next.
Nothing gets written before the operation is verified, and nothing is declared complete before it has been tested against the standard it will be judged by.
Baseline GMP audit
A documented walkthrough against the applicable requirement set — Part 117 Subpart B, your certification scheme, or a customer standard — with findings ranked by food safety significance rather than by how easy they are to fix.
Sanitation and environmental monitoring design
Zone mapping, master sanitation scheduling, chemical concentration and contact time verification, and a sampling plan that deliberately looks in the places you would rather not find something. Including what to do when a result comes back positive.
Allergen, food defense and food fraud programs
Allergen risk assessment and changeover validation with label control, intentional adulteration vulnerability assessment and mitigation strategies where applicable, and a food fraud vulnerability assessment across your ingredient base.
CAPA and root cause discipline
A corrective and preventive action process with real root cause methodology, effectiveness verification, and trending — so the same finding does not reappear at the next audit under a slightly different heading.
SOPs and recall readiness
SOPs written for the operator who has to follow them at 2 a.m., plus a recall program with a mock recall exercise that tests traceability speed and accuracy end to end.
Regulatory basis
The requirements behind the work.
Applicability depends on your products, processes, size and jurisdiction. Exemptions and modified requirements exist throughout these rules, and part of the engagement is establishing which apply to you.
Summaries below are educational and simplified. They are not legal advice and do not replace the text of the regulation or guidance from your regulatory authority or counsel.
- 21 CFR Part 117 Subpart B
- Current Good Manufacturing Practice: personnel, plant and grounds, sanitary operations, sanitary facilities and controls, equipment and utensils, processes and controls, warehousing and distribution, and defect action levels.
- 21 CFR Part 117 Subpart C
- Food safety plan requirements including sanitation preventive controls, allergen preventive controls, supply-chain program, and the recall plan that must accompany a hazard requiring a preventive control.
- 21 CFR Part 121
- Mitigation Strategies to Protect Food Against Intentional Adulteration. Applies to certain covered facilities and drives the vulnerability assessment and food defense plan; exemptions exist, including for many small businesses.
- 21 CFR Part 117 Subpart G
- Supply-chain program requirements where a hazard requiring a preventive control is controlled before receipt, including approval of suppliers and supplier verification activities.
Applied by industry
How this looks in practice.
The same regulatory framework produces very different programs depending on the operation it lands in.
- Food ManufacturersFDA inspection, customer audits and GFSI certification all test the same underlying system. We build it once, properly, so each of those reviews draws on the same evidence.
- Dietary Supplement ManufacturersPart 111 is built on written specifications and a quality unit with real authority. Most findings trace to a specification that was never established or data that never reached the batch record.
- Private Label BrandsYour name is on the package and someone else's plant made it. Oversight of the co-manufacturer is the whole job, and a certificate on file is not oversight.
- WarehousesStorage facilities are judged on pest control, temperature integrity, segregation and traceability. Third-party warehouses are increasingly audited as hard as manufacturers.
- DistributorsDistributors rarely create hazards, but they decide whether one spreads or stops. Receiving discipline and lot-level traceability are the two controls that matter most.
Questions we get asked
Manufacturing — common questions
How is a GMP audit from SURU different from our certification audit?
A certification audit produces a decision; ours produces a work plan. We are not a certification body and cannot certify anything. We audit to find what your certification body or an FDA investigator would find, and we tell you about it while you still have time to fix it — including the uncomfortable findings a supplier auditor might soften.
Our environmental monitoring program never finds anything. Is that good?
It usually means the sampling plan is looking in the wrong places. A program that never detects an indicator organism in a wet, complex, ready-to-eat environment is more often evidence of weak site selection than of a sterile plant. We redesign around zone definitions, harbourage points and event-based sampling, and we make sure a documented response plan exists before a positive result forces an improvised one.
Can you write our SOPs, or does that have to come from us?
We draft them with your team, on your floor, using your equipment names and your terminology. SOPs written entirely off-site read as generic and get ignored. We also keep them shorter than most consultants do — a procedure nobody can finish reading is not a control.
Related
Other practice areas
FDA & FSMA Compliance
The FDA Food Safety Modernization Act moved the regulatory burden from reacting to contamination to proving you prevented it. We build the hazard analysis, preventive controls, supplier verification and records systems that carry that burden — and we prepare your team for the inspection that tests them.
Read moreHACCP
A HACCP plan is only worth what its critical limits can be defended with. We develop, rebuild and independently review plans across seafood, juice, retail and specialized processes — including the variance and validation documentation that regulators ask for first.
Read moreDietary Supplements
Part 111 is a specification-driven rule. Most observations we see trace back to a specification that was never established, an identity test that was never performed, or a batch record that a quality unit signed without the supporting data attached.
Read more
Manufacturing
Tell us what you need to be ready for.
Send the operation, the products and the deadline. We will tell you which parts of manufacturing apply to you and what it takes to be ready — in writing, before you commit.
Direct contact
- info@surucompliance.com
- 651-329-4787
- Serving food businesses nationwide, onsite and remotely.
SURU Compliance is a regulatory consulting practice. We are not a government agency, a certification body, or a law firm, and we do not provide legal advice or guarantee regulatory outcomes.