HACCP/GMP/SSOP AUDIT

1. OBJECTIVE
Deliver to client/audited a resume of the HACCP, SSOP and GMP audit execution resume aiming to make them understand in what consists an audit process.

2. SCOPE
Covers all HACCP audits that are required by clients for aquatic and fishing products processors, except in those circumstances when the client requires specific needs that differ with the aforementioned in this procedure.

3. RESPONSIBILITY
Responsibility for following correct procedures belongs to the HACCP auditor.

4. PROCEDURE
HACCP audit system consists in the verification of three main parts following detailed:
a. Good Manufacturing practices (GMP)
The GMP are minimum requirements for food processors that allow to develop food products. Those requirements include items such as hygiene control, product’s temperature control, dejects handling, employee training, plant design, etc.,
The food processor needs GMP as base to produce safe food, and as a tool to protect consumer form health risks.
If a food processor doesn’t fulfill with GMP requirements, it must be considered that the product represents great risk to consumer’s health.
b. Sanitary standard operational procedures
They are specific points taken by GMP’s requirements, that must be developed as formal procedures that oblige processors to keep higher control than those demanded in fulfilling GMP.
These formal procedures for sea and aquatic products include eight mandatory main points:
Security of the water that enters in contact with food (including ice);
Condition of cleaning surfaces in contact with food;
Crossed contamination prevention;
Maintenance of sanitary facilities, hands cleaning and disinfecting;
Protection of food, labeling materials and food contact surfaces from adulteration;
Proper labeling, storing and adequate use of toxic compounds;
Employee’s health control in those conditions that could cause food’s microbiological contamination;
Pests exclusion from the plant.
Those procedures will include, as a legal requirement, archives and records which can confirm their control.
c. HACCP system’s requirements
USA’s Federal Regulation Code, Title 21 part 123, requires that any sea and aquatic’s product processor, whose final destination is the USA, must have a formal HACCP in the plant, in order to avoid any risks related to the processed product and can protect final consumer’s health.
This is a formal system which requires that processor follows a defined structure to design a correct control for all identified risks in all food process’ steps. Like all formalized system, requires documentation that support all control activities that must be performed in the processor’s facilities.

4.1. HACCP’s audit procedures
Depending on the size of processor’s facilities and the quantity of products processed in it, HACCP’s audit system consists in four and a half – or more – days of work, usually divided this way:

FIRST DAY
First day includes a general revision of all documented system, including manuals, formats, procedures, etc., that are previously given by processor in order to confirm that these documents follow legal requirements established by USA’s Federal Regulation Code, title 21 parts 123 and 110.
In this day auditor compares the provided documents with regulation’s specific requirements. If any non-conformity is found, the auditor will take note and will indicate processor to the beginning (second day) of plant’s audit. In this moment, the auditor develops checklist to the plant’s audit, and that will be used as a tool to review specific points under auditor’s perception (under his experience) that are low performing or must be put into revision in order to be confirmed.

SECOND TO THIRD DAY
During these two days, auditor overhauls GMP’s requirements fulfillments as well the following of all SSOP’s procedures, including such controls as (or other additional points based in documents provided by processor):
GMP’s requirements
Auditor will proceed its revision according to audit procedures standards stipulated in the USFDA 21 CFR Par 110, Directive 93/43/CEE and Hygiene texts, paying attention to the following items:
Staff’s control
Staff’s health control
Cleaning and hygiene norms followed by staff
Training programs applied to the staff
Supervision’s activity control
Installations and buildings
Control and handling of plant’s sites
Plant’s construction and design
Sanitary operations
General maintenance
Utilized substances in the cleaning and maintenance
Chemical compounds storage
Sanitary facilities and controls
Water supply control
Tubing system controls
Sewer system control
Sanitary services control and facilities for washing hands
Generated dejects control
Equipment
Production and process’ controls
Control of raw material, packaging and other utilized ingredients
Manufacture’s operations control
Temperature and time controllers
Applied controls in food security related themes
Storing and provision’s control
SSOP’s requirements
The auditor verifies that the processor has designed, developed and implemented SSOP’s procedures according to the 08 minimal conditions required by the American Code of Federal Regulations, Title 21 Part 123.11.b1 a b8.
Security of water that makes contact with food (including ice)
Audit, at this point, includes records revision, installations verifications, water treatment verification, water storage verification, analysis record revision, Ice handling and storage and established quality control procedures.
Food contact surfaces’ cleaning conditions
At this point, audit includes revision of cleaning & disinfecting procedures of all surfaces in contact with food, approval of these procedures, verification of used chemical’s security, archive revision and other related themes.
Crossed contamination prevention
The auditor verifies that all process’ flux, used materials, chemical handlings and facilities don’t offer any circumstance of risk to the product in a situation of crossed contamination.
Keeping of hands washing, disinfecting and toilets
All washrooms are verified, disinfecting measures and toilets in order to confirm that they are in good and clean condition, and staff’s usage is according GMP’s requirements, and also confirms that all personal hygiene related procedures are being followed.
Food protection, packing materials and surfaces in contact with food from adulteration
The auditor confirms that food handling procedures, packing material and chemical handling don’t allow any situation that could contaminate the product.
Properly labeling, storing and use of chemical compounds
During audit, it is confirmed that processor has established - and is following - clear and safe procedures for handling toxic compounds.
Control of employee’s health condition that could produce food’s microbiological contamination
Processor is audited in order to verify what kind of control is being performed in order to avoid any kind of contamination produced by employees (education, medical guidance, etc.), that could put the product in risk.
Plant’s plague extermination
All procedures regarding plant’s plague control are checked, in order to confirm that they are fulfilling GMP’s requirements, and that used chemicals don’t represent any additional risks to the food process, and also intervene to confirm that established controls are efficient in plague controlling.

FOURTH DAY
In the fourth day, the auditor checks all archives related to HACCP’s system fulfillment, especially those mandatory regulation requirements established in the American Code of Federal Regulation, Title 21 Part 123.
Auditor revision of all system generated archives as well all archives used as support to control confirmation purposes & established critical limits. In case of any doubts related with the processor’s system fulfillment, they are presented in order to clarify or confirm any non-conformities.
Also during this day, the auditor will interview all people related to the HACCP’s system to confirm what is their level of knowledge as well to investigate how deep is the company’s commitment regarding food security and consumer’s protection.
In this day auditor confirms that all designed HACCP controls are being performed according written procedures, and also confirms that such procedures are adequate in order to control all identified risks during audit.

FIFTH DAY
During this day auditor develops written report of the performed audit of the previous days with all non-conformities.
The report is given to the processor with the objective of informing system’s fulfillment state, covering GMP, SSOP and HACCP’ requirements separately.
Each non-conformity (Critic, bigger, smaller) will be explained in a detailed manner, soliciting its correction in a defined time. Its explanation aims to make processor understand what could be the possible consequences of non-correcting the observed situation.
Observations have as finality the improvement of the applied system in processor’s facilities, due to this they only will be mentioned when processor solicits them. Observations mustn’t be considered as non-conformities.

4.2. FOLLOWING PROCEDURES (ONCE FINISHED AUDIT PROCESS)
In each founded non-conformity (disrespecting specific point of the aforementioned regulations) and sustained in objective evidence, the processor will receive some time to correct the problematic situation. In a general way the time given to correct these situations will be as follows (the criteria to establish the kind of non conformity is taken from U.S. NOAA HACCP-QMP, Codex Alimentarius, USFDA, EU Food Safety Council and other food security founts):
Found non-conformities types definitions
Critical non-conformities (any which could put consumer’s health in danger)
Time for resolution: Immediately
Bigger non-conformities (they don’t necessarily affect consumer’s health, but are legal “must” requirements of the aforementioned regulations)
Time for resolution: Three Months
Smaller non-conformities (they are failures related to the established system structure, but non health related)
Time for solution: Six months
Observations (these are all situations that are not considered as failures, only auditor feels that they could be improved in order to obtain a better performance, but processor could take notice or not)
Time for resolution: No time limit

4.3. FINAL CONSIDERATIONS
After audit, SUDAMAR will keep the client informed of all improvements developed by processor in order to correct the non-conformities situations detected during audit.
Also after audit a re-audit must be done after six months, if company doesn’t present critical or bigger non-conformities.
In situations where company presents critical and bigger non-conformities, the client shouldn’t buy the product (but this depends of client’s considerations) from processor until necessary correction are made in order to avoid any problems to consumer’s health or non fulfillment of USA’s HACCP system legal requirements, regarding sea and aqua culture products.
NOTE: All audit derived information is strictly confidential, and only processor and client will have access to it, unless both parts indicate something different.