HACCP Based Risk Assessment
Purpose
To carefully analyze the production process including rooms, premises, equipment and supporting utilities based on a process flow diagram (and on-site visits, if necessary) to identify and evaluate the specific risks and define measures as well as CCPs to control the risks to assure the safety of the individual product using the principles of HACCP as laid down in the “Codex Alimentarius”. When the HACCP risk assessment is done combined with GMP considerations (GMP risk assessment), the result can serve as the basis for the selection of qualification and validation items with respect to international GMP requirement.
Prerequisites
- The production process should be established and described.
- Cleaning procedures and test control procedures should be in place and SOPs available.
- Concept for personnel hygienic measures and for different hygienic requirements in different working areas (hygienic zone concept) should be in place and should work accurately.
- There should be measures in place as well as detailed working instructions to avoid cross-contamination between different kinds of products if used in the plants.
- The production plants should be well designed, installed, operated, and maintained in a way to avoid contamination by the equipment itself, by the workers and/or the environment.
- In case of a GMP process, the relevant GMP system as described within a set of SOPs should be implemented and followed.
Procedures
- Discuss with client about the scope (e.g. product(s), with / without GMP considerations, etc.) of the risk assessment and collect the required information for quotation (Signing of Secrecy Agreement recommended).
- Prepare an offer (fixed rate, depends on the scope and the complexity of the production process - especially number of process steps).
- Sign the contract and project commence.
- Collect the relevant documents and drawings such as process flow diagram and process description ~2 weeks before on-site visit and prepare a first rough draft of the basic HACCP form including the necessary SOP.
- Perform an on-site basic training in the HACCP concept and SOP and explain on “how to do”. Start to work on the HACCP risk assessment together with the client discussing the first and/or most critical process steps. Show the way on how to proceed. (~ 2-3 days)
- Proceed in execution / moderation on the whole HACCP risk assessment dependent on the clients need and on what he want to get as service.
- After completion of the HACCP risk assessment, do a final review and CCP check (plausibility check, form-check, main-risk-check, ~ 1day).
- Final on-site discussion with the client, last discussion, and finalization.
 |
|
What is GMP
Risk Assessment
