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1.Audit Summary
BRC Site
Company name AGROINDUSTRIAS AIB S.A. 1577726
Code
Exclusions from
None
scope
Justification for
No
exclusion
2. Audit Results
Audit result Certificated Audit grade AA Audit type Announced
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Fundamental 0
Number of non-conformities Critical 0
Major 0
Minor 3
3.Company Details
Address Av. Ricardo Bentín Mujica 901 - 903 - Motupe - Lambayeque.
4.Company Profile
Plant size 10-25K sq.m No. of 501-1500 No. of HACCP 4-8
(metres square) employees plans
Subcontracted processes No
Major changes since last The company has built a new warehouse for the IQF frozen fruit processing
BRC audit and fresh lemon packaging. Two new machines have been introduced to
the processes, an automatic sorter for lemons and a HPP (high pressure
pulp) for the process of avocado pulp.
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4.Company Profile
Company Description
Agroindustrias AIB S.A. It was founded in December 2005 as a result of the purchase of Agroindustrias
Backus S.A. by a society formed by four business groups, three of them were national companies and
the other was American; all of them related to the agro-export sector Agroindustrias AIB SA has two
industrial plants, one of them located in Motupe (North Plant) and the other in Chincha (South Plant), in
addition to own fields of lemon, peppers. , pomegranate, asparagus. The northern plant has the capacity
to process canned fruits and vegetables, juices and derivatives, fresh and frozen products. All the
production of Agroindustrias AIB S.A. It is exported to the whole world. The site has 3 work shifts, with
640 employees in high season, products produced in a production area of 17 800 m2. the company
indicates that they have 21 HACCP plans, but these are grouped into 5 manuals (plans) because they
have similar flows and hazards. Part of the raw material is supplied by our own Globalgap certified
fields..
5.Product Characteristics
Product categories 05 - Fruits, vegetables and nuts
06 - Prepared fruit, vegetables and nuts
07 - Dairy, liquid egg
11 - Low/high acid in cans/glass
15 - Dried food and ingredients
18 - Oils and fats
Finished product safety rationale Canned: for fruits pH < 3.5, acidification and pasteurization; for
peppers: pH < 4.6, acidification, and pasteurization. Pulps simple/
sugary: pH 2.7 – 6.0, sanitation with min 30 – 200 ppm peracetic
acid or 100 to 250 ppm chlorine, pasteurization (90 - 96°C, 2000 -
3000 kg/h), acidification. Juices simple / concentrate: pH 1.5 – 3.2,
pH >13 (simple), pH>5.0 (concentrates), pasteurization (96- 100°C),
and frozen (from 1 to 2 years stored ambient or < -18°C, could have
addition of sodium metabisulphite, acidification; depending on the
product). Distilled and cold pressed key type “A” lime/lemon oil,
shelf life 18 months, frozen storage. Dried lime peel: humidity 8 –
12%, 12 months in frozen storage. Fresh: whole fruit, shelf life 10 –
50 days, stored in cold 6 – 8 °C
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5.Product Characteristics
Allergens handled on site Sulphur dioxide and Sulphites
Choose an allergen
Choose an allergen
Choose an allergen
Choose an allergen
Choose an allergen
Choose an allergen
Choose an allergen
Choose an allergen
Choose an allergen
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Choose an allergen
Choose an allergen
Choose an allergen
Choose an allergen
Products in production at the time Canned pepper. IQF frozen mango cubes. Lemon juice. Fresh
of the audit lemon Dehydrated lemon peel.
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6.Audit Duration Details
On-site duration 28 man hours Duration of production 14 man hours
facility inspection
Reasons for deviation It is considered 28 hours of audit, because although they have 21 HACCP
from typical or expected plans, they are grouped only in 5, as detailed in the report.The total number
audit duration of people taken into account for the calculation is over 501, because at the
time of the audit it was possible to verify that more than 80% of the personnel
declared in the FCOM01 were working on the day.
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Present at audit
Note: the most senior operations manager on site should be
listed first and be present at both opening & closing meetings
(ref: clause 1.1.9)
Opening Site Closing
Name / Job Title Meeting Inspection Procedure Meeting
Review
Victor Guzman / Site Manager X X X
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Non-Conformity Summary Sheet
Critical or Major Non Conformities Against Fundamental Requirements
No. Clause Details of non-conformity Critical or Major? Anticipated re-audit date
Critical
No. Clause Details of non-conformity Anticipated re-audit date
Major
Evidence
Proposed preventive provided
Date
No. Clause Details of non-conformity Correction action plan (based on root document, Reviewed by
reviewed
cause analysis) photograph,
visit/other
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Minor
Evidence
provided
Proposed preventive action plan (based Date Reviewed
No. Clause Details of non-conformity Correction document,
on root cause analysis) reviewed by
photograph,
visit/other
Root cause:
During the inspection of the Shortage in the area.
production process in the Lack of awareness in the Adequate Use
exit area of the frozen fruit Change the white plastic of materials that are in direct contact
IQF freezer, plastic baskets baskets, by black baskets. with the product.
were shown in white Plan of actions: Photographs of
1 2.2.1 colour, arranged directly on Wash and disinfect the white Maintain a stock of black plastic baskets black baskets. 2018-12-14 Luis Borda
the platform where the baskets that were the base in or independent structures that serve as Training record
staff stands to work, and process. a base to supply when necessary to the
which do not differ from process.
those used to contain Reinforce the staff about the proper use
product. of materials that are in direct contact
with the product.
Root cause:
Discoordination with internal auditors
The company has
on the drafting of internal audit reports
established that two audits
and registration of findings in the
must be performed on each
Hold a meeting with the checklists. Training records
process per year, which
internal audit team of the for internal
have been executed but in
North Plant, in order to Plan of actions: auditors.
the checklists of the
2 3.4.2 internal audits, the two
coordinate the drafting of - Review the procedure of internal Modified 2018-12-14 Luis Borda
internal audit reports and audits. checklist.
audits have been
issuance of checklists. - Coordinate improvements of the audit Check list
documented in a single
process with the team of internal communication.
checklist, the comments
auditors through a meeting.
can´t be differentiated of
- Use of checklists in electronic file,
the first and second audit.
uploaded to google drive, so that each
internal auditor records their findings.
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- Lead auditor will check that the
checklist is complete for each audit cycle
performed.
Root cause:
Lack of awareness in the storage of
During the inspection of the consumables and products ready for
kitchen of the dining room consumption according to the GMP
BPM cookbook
service, it was possible to regulations.
Dining room.
verify that in the freezer
Training record.
used to store fresh Remove all food directly from Plan of actions:
Photographs of
3 4.8.10 vegetables, ready-to-eat the meat and vegetable - Reinforcement in good manufacturing
identification of
2018-12-14 Luis Borda
foods were kept (jellies) freezers. practices to the staff of the dining room
freezers with type
and in the case of raw meat service.
of product to
there was a container with - Label the freezers and refrigerators
contain.
boiled water ready to indicating the types of products that
prepare soft drinks. should be stored.
- Publish basic BPM rules applicable to
dining room service personnel.
Comments on non-conformities
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Voluntary Modules Non-Conformity Summary Sheet
Critical
No. Clause Details of non-conformity Anticipated re-audit date
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Major
Evidence provided
Proposed preventive action
document, Date Reviewed
No. Clause Details of non-conformity Correction plan (based on root cause
photograph, reviewed by
analysis)
visit/other
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Minor
Evidence
Proposed preventive action provided
Reviewed
No. Clause Details of non-conformity Correction plan (based on root cause document, Date reviewed
by
analysis) photograph,
visit/other
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FSMA Module Non-Conformity Summary Sheet
Critical
No. Clause Details of non-conformity Anticipated re-audit date
Major
Evidence provided
Proposed preventive action
document, Date Reviewed
No. Clause Details of non-conformity Correction plan (based on root cause
photograph, reviewed by
analysis)
visit/other
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Minor
Evidence
Proposed preventive action provided
Reviewed
No. Clause Details of non-conformity Correction plan (based on root cause document, Date reviewed
by
analysis) photograph,
visit/other
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Detailed Audit Report
1. Senior management commitment
The company has an integrated system policy signed by Roberto Falcone M. - General Manager of last
revision date of 05/28/2018 documented in "AIB-G00-001-CT: Integrated Management System Policy".
The policy is sent through the intranet of the company, to all the head offices. Plant personnel are
informed on the first day of their hiring, following the induction procedure, where they are informed of the
vision, mission, policies, objectives, food safety. This is replicated every year in their contract renewal in
training.
Registration is verified "F11-045-09. Training Record "of last date of 10/29/2018 where the policy has
been communicated to all personnel working in the plant.
The company has raised "AIB-G00-002-CT: Objectives of the Integrated Management System" dated
05/28/2018 and verified Excel box "Indicator BRC 2018" where it verifies "Deployment of Quality Indicators
and Food Safety 2018 - North Floor "
It verifies objectives by department or area, in these are defined: indicators, formula, goal, frequency of
measurement, average and measurement results.
Example of the objective of operations management, "Compliance with quality and food safety indicators"
with a target greater than 90% and formula of # of indicators that are met between the total number of
indicators expressed in percentage. Monthly monitoring is verified with results of August at 100%,
September at 92% and October at 85%, in this last indicator that has not been reached, it is verified that a
report has been delivered "Analysis of Collection Indicator - September - October 2018 "and it has been
agreed to address the issue with top management in the coming week, since it is a strategic objective and
not only depends on field management.
The company has reviewed its system based on the BRC standard, annually, verifying the final report of
November 5, 2018, verifying meeting minutes with the signature of E. Falcone - GG; E, Santa Maraí - GOI;
J. puertas - GAF and F. Elguera - Coordinator of integrated systems.
Topics covered in the meeting, including, review of the integrated management policy, the results of
audits, corrective actions, complaints, non-conforming products, performance of the HACCP system,
changes in the system, resource needs, revision of the status of the last revision.
The company has meeting schedules that are established that must be carried out monthly by the plant
committee. The minutes of the committee of last date of 10/26/2018 are verified, where they have dealt
with issues of the beginning of the mango campaign, review of the mango HACCP plan and verification of
the flow, samples of the Taití lemon peel, preparation for the ISO audit, preparation for the Chepen pepper
campaign, update of the new ship PAMA (plant 2). The heads of the plant and the heads of the different
areas participate in the meetings.
The management demonstrates its commitment, with the allocation of human resources necessary for the
process and the allocation of financial resources to properly carry out the manufacture of the declared
products, the good state of the facilities and equipment and adequate assigned personnel is verified in
quantity and competence.
To keep the information updated, the company has a folder with an internal network system "LEGAL
REGULATIONS" where the Supervisor of Quality Management Systems, updates the information and all
personnel have access to information.
The company has the current standard in digital, and certification and audit times are within time and in
force.
The company has passed within the window of certification audit dates.
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The opening and closing meetings were attended by the Plant Manager, who is the main responsible for
the activities in the plant.
Clause Justification
reference
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During the inspection, an adequate implementation of the pre-requisite programs for the production of safe
foods is verified.
It is verified that they have specific procedures that comply with the requirements of BPM and hygiene
programs (POES), ejm.
"AIB-G10-BP-001- NP: BPM Plant Guidelines" which refers to the behavior of personnel within the plant,
procedures for sanitation of personnel.
"AIB-G10-BP-009-NP: Pest Control" that describes the procedures for pest control and frequency of
actions, etc.
"AIB-N11-MP-003-NP: Standard Operating Procedure for Sanitization - Juices" for the hygiene of the
plant and equipment of juices.
It verifies records of controls of the programs, such as "N11-014-04: Record Sanitization Line Juices -
Infrastructure"; registration "N11-015-04: Verification of Juice Cleaning - Lemon Processes" and the record
"N11-016-04: Verification of Cleaning of Filled Cabin"
The company has five HACCP manuals, in which the processes have been grouped to:
1.- HACCP Manual for preserves, which groups the processes:
AIB-G10-MH-002-NP: HACCP Plan for Canned Pepper Processing - V.11
AIB-G10-MH-004-NP: HACCP Plan for Canned Jalapeño Processing - V.10
AIB-G10-MH-005-NP: HACCP Plan for the Processing of Coverage of Passion Fruit - V.11
AIB-G10-MH-014-NP: HACCP Plan for the Processing of Preserved Pepper- V.9
AIB-G10-MH-032-NP: HACCP Plan for Mango Coverage Processing - Maracuango - V.7
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5.- HACCP Manual for oils, juices and dehydrated skin:
AIB-G10-MH-012-NP: HACCP Plan for the Processing of Distilled Lemon Oil - V.10
AIB-G10-MH-013-NP: HACCP Plan for the Processing of Dehydrated Lemon Peel - V.10
AIB-G10-MH-015-NP: HACCP Plan for the Processing of Lemon Juice - V.11
The plans describe the products and the scope of the plan. Each plan includes a description of the
product, which includes the name of the product, ingredients, physical-chemical aspects, micro and
sensory characteristics, conservation method, packaging, storage and distribution conditions, shelf life,
labeling, the intended use, the steps of the process.
Example: Canned jalapeños, products made with jalapeños Sayula variety, Mitla, Compadre, Perfecto and
Tam Mild (Capsicum annuum). Packed in 15 or 28 oz tinplate primary packaging, A5, A10 formats or glass
containers of 233, 248 and 393 ml. Secondary packaging corrugated cardboard boxes or heat shrinkable
bags. Useful life of 3 years in natural environmental conditions.
For each product, there is a process flow, which can be grouped by product types:
In simple or concentrated juices and pulps, the most important stages in common are the reception of the
raw material, the washing of the fruit, the extraction of the pulp, the storage in patching tanks, the thermal
treatments (pasteurized or sterilized) , concentration (for concentrated products), packed in cylinders of
200 kg, frozen (for pasteurized), stored in frozen or environment and dispatch.
The canned products, the relevant stages are reception of raw material, blanching (peppers) removal of
seeds, packaging, addition of government liquid, exhausting, closed packaging, heat treatment
(pasteurized or sterilized), cooled, palletized, stored, labeling and dispatch.
The IQF frozen product, has the stages in common, reception, washing and / or sanitizing, peeling, cubed-
halves, frozen IQF, packaging, labeling, storage and dispatch.
There are records of verification of the flow chart and evaluation of the HACCP plan dated 02/19/2018 for
the flow of fresh pomegranate, 26/02/2018 for flow of mango and mango pulp in frozen cubes, 3/04 / 2018
for frozen sliced lemon, 5/3/2018 for frozen avocado pulp, dehydrated lemon peel and flow of distilled
lemon oil, 06/15/2018 for simple concentrated juice sterilized, turbid concentrate, clarified lemon juice, and
simple lemon juice, on 07/01/2018 frozen avocado pulp and fresh lemon flow, 07/25/2018 simple and
concentrated passion fruit juice with and without seeds, 3/08/2018 Piquillo peppers preserves, 08/20/20
2018 mango juice sweetened and the 10/30/2018 mango frozen. It verifies flows with the dates and the
signatures of the HACCP team that carried out the verifications of the flows.
To elaborate the HACCP plans, the company has resorted to the following information:
Regulation on health surveillance and control of food and beverages. DS N ° 007-98-SA. September 25,
1998
Food hygiene - Basic texts. Codex Alimentarius Commission. Joint FAO / WHO Program on Food
Standards. Rome 2002. CAC / RPC 1-1969, Rev 4-2003
RM 449-2006 / MINSA Sanitary Regulation for the Application of the HACCP System in the Manufacture
of Foods and Beverages.
RM 591-2008 MINSA Sanitary Standard Microbiological Criteria
RM 495-2008-MINSA / NTS 069-2008-MINSA Sanitary Standard
During the inspection it was possible to verify that the diagrammed flow corresponds to the productive
stages that they carry out in their processes.
It is verified that the HACCP plans have carried out the hazard analysis at each stage of the process and
the measures for the hazards have been identified. Result of the hazard analysis, the following PCCs have
been identified for the process of:
Preserves:
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PCC1: Packaging and Heavy, the presence of foreign matter is not allowed. It is monitored with the
records "G11-037-03: Control of packaging line-attribute table", "G11-038-01: Inspection report of filters-
Preserves", "G11-030-03: Verification of points of control critical-line of preserves "and" G11-070-01:
Breaking bottles "that is recorded during the whole canning process.
The danger is also controlled in the metal detection stage, with limits of the presence of metallic material:
higher than Ferric 2.5 mm, and non-ferrous 3.0 mm stainless steel 4.0.) Monitored with the record "G11-
162-03: Control of Metal detector "with a frequency of the beginning, refreshment and end of process,
during the process every 2 hours.
PCC2: Acidified for piquillo and morron preserves. Limit is not allowed pH levels above the allowed limits
(4.5). Monitored with the record "G11-034-03: Control of Addition and Acidification Liquid" each batch
prepared.
PCC3: Closed. Limit on tinplate containers that the overlap must be ≥ 45%. Monitored with the record
"G11-035-04: Double Closing Examination", "G11-069-03: Closing Examination of Flasks" and "G11-068-
02: Visual Inspection Closing".
In glass containers, the limit is the safety of the closure, limit of 3 to 11 mm from the seam towards the lip
of the lid of the bottle. Monitored with the record "G11-069-03: Closing Examination - Flasks" every half
hour and record "G11-068-02: Visual Inspection of Closures" every half hour.
PCC4: Thermal treatment. The limit is that it must be within the parameters established for each type of
format, established in the AIB-G11-038-CT AIB-G11-039-CT. It is monitored with the record "G11-071-02:
Control of Sterilization Process" in each batch of treatment and graphic chart of the heat treatment.
Frozen:
PCC1: Disinfection. Per-acetic acid 100-250 ppm or chlorine 100-200 ppm. Monitored with "G11-163-02:
Water Control Wash, Rinse and Disinfect Frozen Process".
PCC2: metal detection, with limits of the presence of metallic material: higher than Ferric 4.0 mm, and
non-ferrous 3.0 mm stainless steel 4.0.) Monitored with the record "G11-193-01: Control of Metal Detector
- Frozen Plant" with a frequency of at the beginning, refreshment and end of process, during the process
every two hours.
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PCC - Closed studies have been conducted from 18 to 09/23/2015
PCC - Disinfection, validated on 11/16/2017
PCC - Heat treatment by heat exchanger, study dated 13 to 18/02/2016
The company has a record preservation procedure, these are conserved 12 months longer than the
product's useful life.
It is verified that the HACCP plans have been verified in late dates of October 30, 2018 for frozen mango,
on August 3 of the canning line. Records of meetings of the HACCP team are verified for the evaluation
and verification of the plans in the "Meeting Minutes" notebook. HACCP plans are verified with revisions in
the current year.
The personnel responsible for monitoring the CCPs, evidence specific knowledge to perform the assigned
controls, are food engineering professionals, and evidence of training, in control of critical points of
preserves and frozen, taught in the facilities of the plant, by the Head of Quality Assurance.
Monitoring records of the CCPs are verified and it is evidenced that the records of the HACCP system are
kept.
Clause Justification
reference
It is verified that the company has a quality manual "AIB-G00-MC-001-NP: QUALITY AND FOOD SAFETY
MANUAL FOR AGROINDUSTRIES AIB S.A". The manual describes the quality system and refers to
procedures, records, primers, etc. that comply with the requirements of the standard. The manual is
distributed with a record "G10-004-02: DISTRIBUTION SHEET".
The instructions and procedures are placed at each work point, which is considered relevant to ensure the
quality, safety and legality of the product. They are legible and adequate to control the defined processes.
The company has the procedure "AIB-G10-MN-001-NI: Guidelines for the Elaboration of Standards",
which describes the control of documents, responsibilities to approve them and substitutions.
They have a master list where all the documents of the integrated quality system have been consigned.
The company keeps records in digital formats and physical records (formats), these are archived 12
months longer than the product's useful life.
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The magnetic records are archived in the server of the company and the systems area makes safeguards
in different media (external hard drives, and copies in backup computers)
The company has three network systems (north, south and Lima) these are protected with the same
procedure.
The physical records (formats, are filed by the quality management area, these are stored in boxes,
labeled with indexes and stored in document stores.
They have "G10-041-02: Annual Audit Program" prepared in January for 2018 and published in the
electronic network, where it is verified that audits have been scheduled throughout the certification period.
The frequency was determined by a risk assessment "G10-052-01: Evaluation of Risk Associated with the
Processes".
Compliance with scheduled audits is verified, for example, two audits are scheduled to the agronomic
area, verifying audits on April 25 and August 29, 2018 where the management of suppliers and risks
associated with raw materials were audited.
All scheduled audits have been executed and audit reports are verified "G10-014-05: Internal Audit
Report"
Internal audits have been carried out by internal auditors with training and competence in audits, verifying
"G10-067-01: List of Internal Auditors".
The auditors are competent, evidencing knowledge of the BRC standard and training in two intern auditors
", each auditor has a record of their history where their competence and evaluation is verified.
Competency evidence is requested from internal auditor Rossilyn Fiestas Chávez, who took the
Interpretation course of the BRC Standard V7 dictated by the company ENRED LATAM GROUP SAC, on
April 29, 2015 and "Training of Internal Auditors ISO 9001: 2015 "On May 28, 2018 dictated by the
company" GTC - Change Managers "
The reports of the audits, comment on both the conformities and the non-conformities.
The company has established that the inspections will be monthly for all areas if they have production.
They have a checklist, for equipment and infrastructure, to ensure that they do not represent a risk to the
product, it verifies records "N12-015-03: Checking List Lemon Peel Drying Plant" executed on 11/13/2018,
registration "N12-037-09: Checking List Frozen Line N1" with which the frozen plant is inspected.
Hygiene monitoring records of the facilities "Inspection Report BPM, Equipment and Infrastructure" to
verify the status of the facilities, compliance with BPM, cleaning, etc. of date 11/09/2018. These
inspections are carried out monthly.
It is verified that they have risk assessment for packaging material and supplies in "F14-012-01: Risk
Assessment in Suppliers of Inputs, Containers and Packaging". It is verified that in the risk analysis, the
hazards to be controlled and the measures to be taken have been identified. It is verified, for example, that
for the supplier of tin containers, it has been evaluated with the record "Re-Evaluation of Suppliers" of last
date on 08/24/2018 with result of qualification of 94.65%
It is also verified that suppliers provide quality certification of the materials used (varnish) made by "Institut
Nehring".
To manage the purchases of raw materials, the company has "N13-033-01: Risk Assessment - Raw
Material" where the risk assessment has been carried out for each type of raw material (peppers,
avocado, mango, pomegranate, in this it is verified chemical-pesticide risks, biological-pathogenic risks
and physical risks of presence of foreign bodies).
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It is verified that they have procedure "AIB-N13.NP.004-NP: Selection Evaluation and Reevaluation of
Suppliers"
The "Agronomic Department" has a list of suppliers of raw materials, in which all the suppliers that have
been evaluated and approved have been listed, following the procedure "AIB-N13-MP-004-NP: Evaluation
of Selection and Re-evaluation of Suppliers "for the evaluation of raw material suppliers.
It verifies records of visits to the field of the producer with the format "N13-018-05: Questionnaire of Good
Agricultural Practice" dated 05/27/2016 with a score of 97.77% with a minimum of 72% and "N13-014- 02:
Revaluation Sheet of Permanent / Annual Crops Suppliers ".
Application tracking records are verified in the format "N13-010-003: Application Report of Chemical
Products" which is reported in the income of the harvested fruit and the lack of time for the supplier is
verified "Martín Saavedra / José Alcarazo "verified as of last 09/09/2018.
The company does not buy raw materials from intermediaries, all raw materials come from fields that have
been inspected by the agronomic department, which ensure that the hazards identified in the risk analysis
have been controlled.
The raw material and packaging are evaluated at each reception, there is a procedure for the reception of
raw materials and packaging material, "AIB-N13-MP-005-NP: Collection and Reception of Raw Material"
and "AIB-N15 -NP-001-NP: Reception, Storage and Delivery of Supplies, Containers and Packages "
In the reception of raw materials is inspected in the plant, for it has the record "N11-087-01: Quality
Evaluation of Raw Material - Jalapeño" for the reception of 12/11/2018 of the supplier Fundo las Rosas
and the registration "N11-083-01: Quality Evaluation of Raw Material - Industrial Lemon" for the reception
of lemon for the process of distilled oil dated 12/11/2018 from supplier Henry Zapata.
The inspection in reception of packaging material is done in the format "G11-002-03: Quality Control of
Materials of Inputs, Packaging and Packaging".
The approved raw material and revenues are approved by QA and released in the SAP system.
3.6 Specifications
The company has technical specifications for supplies, raw materials and packaging material. These are
described in the HACCP manuals and in process booklets.
There are technical specifications sheets of supplies and materials in the specifications booklets. It was
possible to verify product process booklets, where the final product is described.
AIB-N11-014-CT: Process Description Piquillo Pepper
AIB-N11-015-CT: Description of Process Pepper Morrón
AIB-N11-011-CT: Process Description Coverage of Passion Fruit.
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AIB-N11-008-CT: Description of Mango Pulp Process.
It is also verified that they have specifications for raw materials:
"AIB-G10-ME-001-FT-003: Piquillo pepper"
"AIB-G10-ME-001-FT-004: Lemon for Juices"
"AIB-G10-ME-001-FT-005: Passion fruit"
"AIB-G10-ME-001-FT-014: Mango for Frozen"
"AIB-G10-ME-001-FT-017: Pepper Morrón"
and packaging materials:
"ETO.CAD.405: tall stackable white - for piquillo peppers"
"Twist Off Caps - nominal diameter 63mm"
The specifications of the finished product, they agree with the client for it is sent by mail the specifications.
3.9 Traceability
The company has defined that all the raw material that enters in the same day, is considered a lot, for that
reason all the product elaborated the same day, is lotizada with the same code. It is verified that the inputs
and materials used in the production can be traced to the corresponding batch, it records the output of
these inputs and materials, which allow traceability.
The company has carried out a traceability test of:
Dehydrated shell, made on 11/07/2018 for lot 29536, processed on October 21, 2018. Time used 1 hour
30 minutes.
Turbid concentrated lemon juice, made on 10/30/2018 for lot 25836, processed on 10/25/2018. Time used
1 hour 40 minutes.
Fresh lemon Taiti, made on 03/09/2018 for lot 27/02/2018, processed on 02/28/2018. Time used 1 hour 05
minutes.
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Whole bell pepper canned, made on 11/07/2018 for 24 oz bottle of lot 267, processed on 09/23/2018.
Time used 3 hours 5 minutes.
Frozen Taiti sliced lemon, made on 08/16/2018, batch 08/08 that was processed on August 11 and 13,
obtaining presentation in bulk boxes x 10 kg. Time spent 55 minutes.
In all the tests carried out, it was verified that it was possible to identify the origin and quantities of the raw
materials used for each of them, the supplies and packing material used, the products obtained and the
location of the lots at the time of the test.
The traceability system of canned red pepper was tested A10 lot 355 of production date 20/12/2017 that
was in the warehouse of finished products - preserves.
It was verified that the raw material came from the suppliers NAJSA and CHEPEN, with incomes of dates
16, 18 and 19 of December 2017 and a total of 113, 916 Kg. It verifies the used supplies, citric acid,
calcium chloride, table salt, cylindrical cans formats A-10 and 3 Kg, each consumption reported in the
consumption parts that indicate the batches of the same. Production report is verified that indicates that a
total of 45,504.55 Kg of final product can be produced in the presentations of LC.A-10 integers (31683.1
Kg), LC.A-10 strips (12,587.25 Kg) and LC.3 Kg strips (1234.2 Kg) being the yield of 51.58%.
The test report shows that to date all the products of the entire A-10 formats and all the product of the 3Kg
formats have been shipped, leaving 6,394 cans in the A-10 cans. The list of customers to whom they have
been dispatched is shown. The test could be carried out in 3 hours and 15 minutes.
Likewise, traceability was requested for halves of frozen avocado lot 244 dated from production
31/08/2018 that was in the frozen storage chamber. It was possible to identify that the raw material came
from AIB Chincha and the PROSERLA supplier with income from August 12, 17 and 18, 2018 with a total
of 64,486.75 kg of raw material of which were consumed at the production date for the batch in question of
14.102 kg. Verification of quantities and products obtained is verified being 121 avocado boxes in halves x
10 kg (1210 kg) and 560 boxes pulp of avocado x 24 lb (6096.28 kg), yield 51.8%. The materials and
batches of the same used are verified. At the time of the trial all the products were in storage chamber.
The time required for traceability was 3 hours 30 minutes.
The company has "AIB-G10-MG-013-NP: Attention to Complaints and Claims of Clients". The complaint
response format is verified, where the complaints are registered and reported in meetings with the
management and decision making.
Claims records are verified "G1O-063-01: Customer Claims Attention" where the claims are documented,
the causes are analyzed, and actions are proposed.
Verification of trend analysis "Indicator of Attention to Complaints / Complaints" updated on 11/7/2018.
Claims are part of the indicators, measurement and reports are taken.
It has the procedure "AIB-N10-MP-001-NP: Incident Management Plan - North Plant" to deal with incident
situations, where possible emergency events have been identified and the measures that must be taken to
prevent products affected by the incident, are released accidentally.
They also have the "AIB-C10-MC-001-NP: Product Withdrawal Procedure" and a test performed on
03/05/2018 for the fresh pomegranate product is verified, for pesticide values above the allowed residual.
Communication with the AGRIFOOD customer from the Netherlands is verified, the recovery report of the
affected lot is verified (harvest of 01/02/2018), quantity, 30, 593 kg. The product was in transit at the time
of the test and will be communicated to the client when the product reaches its destination. It is verified
that the company indicates to eliminate the product for being with possible contamination.
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3.12 Customer focus and communication
The production specifications are sent to the production headquarters by means of the production orders,
and also emails of the characteristics requested for the product to be processed are sent.
These are coordinated between the commercial area and the client (if necessary), usually products are
manufactured with specifications already defined and standardized.
Clause Justification
reference
4. Site standards
4.2 Security
Risk analysis is verified for each process line (Food defense plan for canned jalapeños, lemon juice,
passion fruit juice, canned pepper, frozen avocado pulp and frozen mango). A vulnerability analysis chart
is verified with the measures applied. The measures were evaluated in the month of March 2018.
The plant has security personnel, trained in security measures and identification of sabotage risks, 24
hours a day.
Training in Food Defense was carried out on the heads and area supervisors on June 18, 2018
(awareness BASC), on August 8, 2018 (report of suspicious shipments) and on August 29, 2018 (Food
defense and food fraud).
Security - PLAN INVEST surveillance are BAS certified.
The plant has an operating license for the district of Motupe, # 0065 dated 1/16/2007. The factory has
registration No. 003- MINAGRI-SENASA Lambayeque for food with primary process, dated January 17,
2013, and RD # 546-2015 / Dhaz / DIGESA / SA dated 23.02.2015 for processed products.
The company is BASC certified.
The site has a risk zoning map "AIB-G11-043-CT-05: Zones According to Levels of Risk of Pollution of
Products" dated 06/25/2018, this map where routes of personnel circulation have been defined, location of
personnel facilities, process flow, waste disposal routes and 3 types of zones have been identified:
1.- Low risk: Juice line, distillation room and conserve warehouse.
2.- Special care: Frozen line.
3.- Closed products: warehouses.
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The ship of frozen (special care), is a ship separated from the other processes, exclusive for the products
that are processed, with equipment, personnel and own materials and exclusive of the line.
The visits are informed with the booklets "G11-021-08: Control of Visits" with which they control health and
"F11-026-01: Control of Visits" with which it is informed the security measures and provisions of BPM.
The facilities are large, suitable for the processes and storage of products and is kept in good condition.
4.4 Building fabric, raw material handling, preparation, processing, packing and storage areas
The factory is built with modern construction materials. The company makes continuous investments in
buildings, equipment and facilities. The process and packaging equipment are of a high level. The walls
are of noble material, smooth and kept in good condition.
The floors are constructed of coated concrete, which are maintained through the maintenance program
and are generally in good repair condition.
The drains, are suitable, allow the continuous flow of process wastewater, protected with metal grids.
The plans of the special care areas show that the water flow is adequate (they do not represent a risk for
the product). It is evident that in the gutters the waters flow easily.
The access doors to the ships are hermetically sealed and have curtains as protective barriers.
They have automatic closing devices.
The lighting is artificial and adequate in the canning and frozen process rooms. The illumination in the
juices ship is natural in the day and artificial in the night. The lamps are protected by plastic sheets.
The water used in the plant is supplied from the own wells. The water is made potable with the addition of
chlorine (chlorination). Water analysis certificate is verified by laboratory SAG N ° 122658-2018 dated
06/06/2018 with results of physical chemical analysis (heavy metals, total metals, sensory, odor color)
microbiological, parasites, helminths, protozoa. The company performs monthly monitoring in its
microbiology laboratory verifying reports of last date of 10/31/2018 "G11-87-01: Microbiological Control of
Waters" with counts of viable mesophilic aerobes, total coliforms, fecal coliforms and chlorine control.
The company has "AIB-G11-043-CT" Plano where indicate the water lines.
The company uses Azetil (a mixture of ethylene - nitrogen) colorless, odorless gas from the INDURA
supplier, declaring in a safety sheet (DA-PE-AZETIL-00 of March 2013) that it is harmless by skin contact,
inhalation and ingestion.
Ice is not used in processes.
4.6 Equipment
The equipment is built in stainless, smooth material. Built by companies specialized in equipment for the
food industry.
It has a design suitable for sanitization. They are placed in linear form, so that it has a flow without
crosses.
It verifies equipment, in the process of pulps and juices, stainless steel tanks, pumps, stainless steel
pipes, heat exchangers, pulp machines.
In the line of IQF, tubs and strips for the selection and washing of the fruit, strips of food-grade plastic or
Teflon.
Continuous freezer and static freezer.
Automatic selection equipment for fresh lemon.
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Packing machines for lemon juice lines.
4.7 Maintenance
The company has a maintenance program for equipment "N12-028-05: Critical Equipment Maintenance
Planning", and Excel sheet "Preventive Plan 2018" for the maintenance and control of non-critical
equipment is also verified.
They have a checklist, for equipment and infrastructure, to ensure that they do not represent a risk to the
product, it verifies records "N12-015-03: Checking List Lemon Peel Drying Plant" executed on 11/13/2018,
registration "N12-037-09: Checkin Listt Frozen Line N1" with which the frozen plant is inspected.
The maintenance program of the dehydrated shell hydraulic press was requested, verifying that it was
programmed in the list of critical equipment, with an annual frequency of change of oil and monthly
inspection of bolts, compliance is verified, with the registration of 30/07 / 2018 oil change and registration
of monthly bolt inspections.
The company has records of line inspections.
"N11-065-02: Control Of Materials With Risk To Discard - Line Pepper" daily inspections.
"N12-007: Jalapeno Line Inspection Sheet"
"N12-014-03: Checking Lits Line of Lemon"
"N12-037-03: Checking Lits Frozen Line Mango - Avocado"
The company uses FG food grade greases, which are stored separately from regular lubricants, checked
the file Interlube HTP and Berulub FG-H 2 EP.
When maintenance is carried out in the process areas, personnel makes sure to remove all maintenance
material and clean the work area. The maintenance workshops are far from the production areas, clean
and tidy.
There is an internal maintenance team in all work shifts.
The company has appropriate changing rooms for men and women, suitable. The staff has lots of lockers
in the locker room to store their personal belongings. It is not allowed to keep the uniform in locker rooms.
The area of special care, has an exclusive area to clean and with exclusive uniforms for the place.
They have areas suitable for sanitation, conditioned with pedal-operated pipes, liquid soap, hand dryers
and instructions for washing boots and hands. They also have pipes for hand washing inside the process
rooms.
The bathrooms are far from the process rooms and adequate. Smoking is not allowed in all the facilities of
the plant.
The company provides food to the staff, for this they have a dining room and kitchen service within the
facilities of the plant. The dining room service is routinely inspected by quality staff.
The company has a warehouse for chemical products, exclusive for toxic products, separated from other
warehouses, with restricted access and with padlocks.
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Chemical products have safety sheets of:
Klerat blocks / Bradiofanouna at 0.005% / issued by TQC
Knock Down EC / Cypermethrin + tratramethrin / issued by SyP Ingenieros
Divosan / 15% peracetic acid / issued by Diversey.
No products that emit excessive strong odors are used.
4.9.5 Wood
Wood materials are not used in the process lines where the product is exposed to contamination by these
materials. Wooden pallets are used for packaged, final products, in areas of finished product warehouses.
In the line for the preparation of government liquid for preserves, there is a filter (metal screen 0.5 mm
opening) for the retention of foreign bodies and solids that may come from the preparation of government
liquids. Also, the lines of juices, pulps and concentrates, have sieves where the foreign bodies are
retained. These are inspected each time a batch is changed. Records "G11-038-01: Inspection Report
Filters - Preserves" and "G11-025-02: Inspection Report Filters - Juices" are evidenced.
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metal detector is continuously verified with the controls. They have patterns Fe 4.0 mm (214638), for not
Fe 3.0 mm (214606) and SS 4.0 mm (214667), a control at the beginning of a turn, then every 2 hours and
at the end of the turn, by the production controller. It is registered in the format "G11-162-03: Control of
metal detection".
4.10.4 Magnets
No magnets are used.
4.10.6 Container cleanliness – glass jars, cans and other rigid containers
The containers of glass and can are washed before entering the packaging process. The containers are
placed face down in a belt that transports them to the pressure washing equipment.
The staff is aware of the glass breakage procedure. The cleaning of the containers is verified once a
month with the microbiological test in the laboratory of the company, 4 samples are taken after cleaning.
The results of the tests dated 09/10/2017 are shown, with results of counting of yeasts and molds, coliform
bacteria and E. coli.
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4.11.7 Cleaning in place (CIP)
They have CIP hygiene instruction "AIB-N11-MP-003-NP: Juice SSOP" and verification records "G11-026-
02: Verification of Online Juice Sanitization"
The CIP washing procedure describes that the entire system is first washed with water, then hot soda
solution is passed, and rinsed with hot water. The system has pump systems for recirculation, which is
schematized in one plane.
They have records of verification of rinse with phenolphthalein and records "N11-013-04: Inspection of
juice line" where the status of the butterflies (spray balls) is verified.
The company has a procedure of "AIB-F11-MP-033-NP: Segregation, handling and storage of solid
waste". They also have a sketch of the location of garbage containers, the elimination of waste is carried
out through a company marketing solid waste for animal feed.
The waste is disposed directly to the vehicles that transport it directly, without accumulation in containers.
The plant does not produce surplus products, it does not sell products to the staff. The residual product of
the process is ready for animal feed.
During the inspection, there is no evidence of infestation by pests or traces of their presence.
Pest control is carried out in conjunction with the company SANEAMIENTO AMBIENTAL EMSA SERVICE
SRLTda. With authorization N ° 022-2001-SA and Ministerial Resolution No. 449-2001-SA / DM.
They have a certificate N ° 1008 of 01/31/2018 for rat extermination, disinfection and disinfection. The
activities are carried out twice a year as stated in the pest control program. The company has a report
dated May 31, 2018 on the situational status of pest control, carried out by the company EMSA Service
SRLtda.
It is verified that the company carries out monitoring of the bait stations and of the insectocutores,
evidencing itself registry "G11-116-04: Monitoring of Rodent Stations and Application of Baits" of 07 and
11/11/2018; "G11-167-02: Monitoring of Internal Mechanical Traps of Rodents" dated last November 06
and 08 of 2018 and "G11-114-03: Control of Plant Fumigation" dated last 10/30/2018. The monitoring is
evaluated by the head of quality assurance.
The company has a tendency in Excel charts of the monitoring of the registers "G12-067: Monitoring of
Internal Mechanical Traps of Rodents" and "G12-066: External Traps" updated to November of 2018.
Checks of trends from year to year are verified 2013 to the present.
They have plans "AIB-G11-018-CT: Sketch of Location of Rodent Stations in the Perimeter of the Plant".
The personnel in charge of carrying out these activities, has certificates of training by the company EMSA
Service SRLtda of date 22/01/2018 topic "Pest Control", which demonstrates competence for these
activities.
The raw materials, supplies and finished products are stored in separate, adequate warehouses. The
frozen products are stored in storage chambers at temperatures of -18C maximum. The warehouses are
adequate, clean and tidy, the products well identified.
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There are warehouses for raw materials, for packaging and packing material and warehouses for finished
products, all independent and staffed by each warehouse.
Warehouses that require temperature control are monitored by automated and verified continuous
systems with manual controls. These temperatures are recorded at least every 4 hours by quality
personnel, records are verified "G11-194-01: Temperature Control - Frozen plant"
It verifies an adequate rotation of the stock, the boss of finished products, registers in the computer
system, the income and outputs of the products, ensuring the rotation of the products.
The product is transported by contracted container service (containers with cold-frozen system or dry
containers).
The loads of the finished products are described in the procedure "AIB-N14-MG-017-NP: Preparation of
Packing List and Identification of Pallet". The vehicles are inspected with the registration "N14-003-03:
Check List Inspection of Units", ensuring that they are in a good state of hygiene and maintenance.
The units that transport preserves do not require temperature control.
The units that transport frozen, are checked by monitoring systems in the containers these are set at the
temperatures required by the product.
Clause Justification
reference
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5. Product control
The company has the procedure "AIB-D10-MG-001-NP: Product Design and Development".
The procedure refers to the steps for the development of the product and indicators to define if the new
product is viable or not.
Project of "new product - soasado pepper and blanch pepper" is verified, for which the compliance of the
procedure is verified, with a meeting of the people of the company involved, documented in the notebook
"Agreements of Meetings - Idi" of date 05/09/2018, with topics of proposal of the flow diagram and discuss
each stage of the process for the new product, where the availability of technology and equipment has
been evaluated.
It is verified that prototype tests have been carried out, evidencing photos of the final product, to which a
series of physical organoleptic and microbiological evaluations have been planned. Excel sheet "Useful
Life Schedule" is verified where the dates and types of analysis to be performed have been scheduled to
validate the useful life of the product.
It is defined that a HACCPCP plan will have to be carried out, or included in a similar one, where the risk
of the new product must be evaluated.
To date it is verified "Report JID / 01.08: Elaboration of sweet peppers in the process of frozen"
The design of labels and the information they contain is managed according to the procedure "AIB.N11-
051-CT: Flow Diagram of Label Approval", consisting of the client sending the initial design (information
and art). This is revised , approved and prepared to print a preliminary, this is returned to the client to give
its approval of the same and just proceed to print the complete batch of labels.
In the hazard analysis of the HACCP plan, the assessment is made for possible cross-contamination by
allergens, which is identified with the use of sodium metabilsulfite, in the line of lemon juice and lemon
juice from clarified and preserved concentrated lemon juice. The measure implemented is that the line of
lemon juice, where the allergen cone ingredient is handled, is exclusive for that product, which has
eliminated the risk of contamination to other products and for the other line of concentrated lemon juice
clarified preserved, validated sanitation procedures have been implemented, which are monitored with the
record "G11-026-02: Verification of Online Sanitizing of Juices" with test strips for metabisulfite detection.
They also have supplier risk assessment.
The company trains the staff on their BPM issues, aspects of contamination by allergens, which can be
introduced by the personnel and the policies on these foods. Training record "F11-045-090: Training
record" dated 19/07/2018 with the subject "Management of Allergens" is verified.
Analysis "N13-033-01: Evaluation of Risks - Raw Material" is verified where it has been determined that
the risk of fraud or substitution is very low, due to the nature of the raw materials and because the
company has personnel in The entire supply chain, from harvest to arrival at the plant, which monitors the
load of the raw material, including personnel from the agronomic area, follows up the crop fields from well
before the harvest, with which it is estimated the amounts to be harvested by third-party fields. You do not
work with raw materials of preserved identity.
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The site has the SGF certification that includes safety, authenticity, hygiene, sustainability, traceability and
labeling.
The site has a current Kosher certificate.
The packaging material is suitable for the products that are processed. It has certificates of analysis
delivered by the provider RESINPLAST supplier of polyethylene bags, certificate N ° 003395-2018 dated
3/26/2018 issued by laboratory "La Molina Total Quality" for microbiological analysis and certificate N °
391501-1309581 date of May 11, 2018 issued by SGS laboratories for monomer migration analysis (vinyl
chloride, residual acrylonitrile, styrene monomer).
The supplier of boxes of cardboard TRUPAL, delivers certificates of conformity of the material - technical
sheet for packing box of avocado in halves of date 02/04/2018.
The bucket supplier "Industrias de Envase" delivers certificates of quantification of heavy metals from
19/12/2017 made by the CERPER laboratory.
With these certificates, the company controls the identified risks to packaging and packaging materials.
The company has a product analysis program. Example for Juices and frozen, all batch are analyzed. For
preserves physicochemical evaluations are carried out on all batches and microbiological once per week
per format (commercial stability) and once a month (commercial sterility). The results are recorded and
reported in the computer system (Excel spreadsheet of the network, which is managed by quality)
The evaluation of the finished product is carried out in an accredited external laboratory 17025, which is
verified in the certificates issued by the laboratories.
The company has a microbiological analysis laboratory, which is separated from the process vessels and
has BPM measures to avoid contaminating the products and processes. They have an independent
drainage system to the process vessels.
The methods used are those described in the ICMSF standards. The personnel that execute the analyzes
are professionals of Biology / Microbiology. They have inter-laboratory tests to validate their methods.
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Clause Justification
reference
5.2.3 No products are produced with special attributes or designed to satisfy a specific group
of consumers.
6. Process control
6.1 Control of operations
The company has specific work instructions for all the steps of the production process, and the steps to
follow in case of proceeding with the change of packaging material or ingredients, the performance of
quality evaluations of the raw material (for example, physical and organoleptic), evaluations of products
during the process (for example, pH, Brix), evaluations of finished product (control packaging according to
customer requirements, laboratory analysis of release before finished product), dispatch control, the
evaluation of equipment and materials.
Verify procedures:
AIB-N11-017-CT: Process Description Chunk Mango
AIB-N11-014-CT: Process Description Piquillo Pepper
AIB-N11-015-CT: Description of Process Pepper Morrón
AIB-N11-011-CT: Process Description Coverage of Passion Fruit.
AIB-N11-008-CT: Description of Mango Pulp Process.
AIB-N11-018-CT: Process Description Frozen Avocado Pulp
The parameters of the process and characteristics of the product are controlled with the records Example.
G11-071: Sterilized control
G11-099: Contrast Tape Control
G11-130: Productive Process Control - Jalapeño
G11-131: Quality Control of Jalapeño in Process
G11-164: pH control in Immersion
G11-163: Control of Wash Water, Rinsing and Disinfection - Frozen Process
The equipment that monitors the thermal processes, has sound and light alarms, to alert that the
parameters are not under control. Example: the horizontal waterfall autoclave - FERLO N ° 11, has an
alarm device.
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6.3 Quantity, weight, volume and number control
The company controls the weights of the packaged products, for it every hour verifies that the weight of
the packaged product complies with the agreements with the client or those established by law. Checks
records "G11-036: Weight Control"
Verify balance control records, each time the process starts. The scales are verified with calibrated
standard weights.
The company has a program of calibrations and verification of devices "General Program of Calibrations
and Verification of Equipment and Devices of Measurement". They also have "N12-029-03: Calibration
Program 2018 - Pasteurizer and autoclaves" updated on 11/07/2018
Calibration certificates are evidenced, made by the company ADVANCED METROLOGY:
N ° 59930-18848- CLF-2018 - dated 05/31/2018 - Manovacuometer CRIM-027
N ° 59944-13056- CLT-2018 - dated 05/30/2018 - Liquid glass thermometer CRIT-064
N ° 59937-13049- CLT-2018 - dated 05/30/2018 - Analogue thermometer TERD-003
Certificate issued by the company TEST & Control:
N ° LTH-1182-2018 - dated 06/23/2018 - Analog thermometer T-335003
They have a booklet "G11-026-CT: Program of Calibrations 2018 - Patterns Laboratory", this indicates
codes, status and locations of plant measurement patterns. Calibration certificates issued by the company
CADENT are verified:
N ° 0402-LM-2018 dated 05/15/2018 for weighing 500 g code G11-5-PES-04
N ° 0403-LM-2018 dated 05/15/2018 for weight of 1 Kg code G11-5-PES-05
N ° 0404-LM-2018 dated 05/15/2018 for weighing 2 kg code S / C
N ° 0069-CLM-2018 dated 05/15/2018 for weighing 4 kg code S / C
N ° 0305-CLT-2018 dated 06/05/2018 for glass liquid thermometer code G11-5-TER-01
N ° 0309-CLT-2018 dated 05/06/2018 for glass liquid thermometer code G11-5-TER-05
No. 0005-CLW-2018 dated 05/06/2018 for stopwatch code G11-S-CRO-01
N ° 0024-CLL-2018 dated 06/02/2018 for micrometer code G11-5-MIC-01
N ° 0025-CLL-2018 dated 24/01/2018 for vernier code G11-5-VER-01
These calibrated instruments are used to verify the accuracy of the devices with which the processes are
monitored. It is evidenced verification records "G11-094-02: Verification Record" for the monitoring of dial
thermometer, manovacuometer, PVC vernier, potentiometer, with a daily frequency. They have a list of the
instruments used in the plant.
Clause Justification
reference
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7. Personnel
7.1 Training: raw material handling, preparation, processing, packing and storage areas
The company has an annual training program "TRAINING PLAN 2018", prepared by the Human
Resources area and supervised by the SIG Coordinator.
All personnel that enter to work, go through an induction program, where they are indicated the quality
policy, work policies, basic aspects of BPM, SSOP, and tasks to be performed in their work.
"F11-006-04: PERSONAL INDUCTION OF OPERATING PROOF". Induction training records of last date
of 10/26/2018.
The staff that monitors the CCPs, has competence, verifying training in "HACCP and PCC" for each of the
three lines that have PCC (Frozen, juices and preserves), verification of training records dated 3 of April
(juices - topping), April 20 (PCC frozen avocado), July 3 (PCC preserves) and October 29 (frozen mango
PCC). TAC's training records are verified Franklin Córdova Castillo (trained in PCC metal detection on
11/12/18), Manual Chuzón Fosen (trained on 06/02/2018) and Marcos Raymundo and Facundo Ramos
(trained on 3 and 4/09/2018.
The "F11-045-090: Training record" shows the people who attend the trainings, the person who dictates
the trainings, the date and time, the subject of training, the hours dictated and signatures of the assistants
and the speaker. This register is also used for personnel competency evaluations.
7.2 Personal hygiene: raw material handling, preparation, processing, packing and storage areas
The hygiene requirements are contemplated in the manual "" AIB-G10-BP-007-NP: Good Manufacturing
Practices ". It has cabinets for sanitation before entering the process ships. It has been arranged that the
staff with wounds and bandages do not work online.
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7.4 Protective clothing: employees or visitors to production areas
The rules for the use of uniforms are established in the manual "AIB-G10-BP-007-NP: Good
Manufacturing Practices".
The company provides complete and appropriate uniform for staff and visits. The company has its own
clothes laundry where the uniforms of the staff are washed daily. The laundry of clothes of the company
assures the hygiene of the protection rapa with procedures of washing and disinfection with chlorine in the
processes of rinsing. The clothes are separated by work areas.
For the area of special care (frozen area and IQF packaging) there is an environment where the staff
changes their uniform and a clean and exclusive use is given to that room. A sanitation area is checked
before entering the room with a washing and disinfecting system for hands and boots.
The uniforms that are used in the freezing plant (special care area) have commercial washing and
sterilization procedures and is verified with microbiological analysis "Uniform Control" verifying reports of
last dates 08/11/2018 with total aerobic count, molds, yeasts, E. coli and fecal coliforms, made in the
laboratory of the plant, with a monthly frequency.
The company has only used gloves in areas that do not imply a risk to the product (such as worker
protection and integrity are controlled).
Clause Justification
reference
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Module 8 - Traded Goods
Scope
8.2 Specifications
8.5 Traceability
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Module 9: Management of Food Materials for Animal Feed
Scope
9.1 Management Commitment
9.2 HACCP
9.4 Specifications
9.5 Traceability
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9.7 Labelling
9.8 Training
Scope
11.1 Traceability
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11.4 Management of cross-contamination between species
11.6 Training
Scope
12.1 Senior management
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12.3 Outsourced production
12.4 Specifications
12.7 Labelling
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LSQA, Av Italia 6201, Montevideo, Uruguay.
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Module 15 FSMA Preventive Controls Preparedness Module
(Y/N) or
Not
Applicable
(NA)
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6 15.1.6 The hazard analysis must
additionally identify and evaluate
the following known or reasonably
foreseeable hazards, which are
associated with the food or facility:
Economic adulterants
which affect food safety
Environmental pathogens
where ready-to-eat (RTE)
food is exposed to the
environment prior to
packaging and the
packaged food does not
receive a kill step
Radiological hazards
Unintentional adulterants
which affect food safety
7 15.1.7 All identified known or reasonably
foreseeable hazards must be
evaluated to determine “hazards
requiring a preventive control” (i.e.,
significant hazards).
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Appropriate disposal (i.e.,
destroy, divert, repurpose)
of recalled product
10 15.1.10 Establish monitoring activities and
a written procedure for each
preventive control consistent with
the requirements of BRC section
2.10.
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Sampling procedure to
include method, quantity,
frequency, and number of
samples
Analytical method
Laboratory conducting
analysis
Corrective action
procedure where pathogen
is detected
15 15.1.15 Where environmental monitoring
for a pathogen (or indicator
organism) is used as a verification
activity, a scientifically valid and
written testing procedure must
identify the following:
Adequate number and
location of sample sites
Timing and frequency of
sampling
Analytical method
Laboratory conducting
analysis
Corrective action
procedure where pathogen
is detected
16 15.1.16 Devices used to verify preventive
controls must be calibrated.
17 15.1.17 Identify a Preventive Controls
Qualified Individual (PCQI)
responsible for developing the food
safety plan, validating preventing
controls, review of records, and
reanalysis of the plan.
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Identity of the product and
lot code where applicable
19 15.1.19 The owner, operator or agent in
charge of facility must sign and
date the written food safety plan
initially and then upon any
changes following reanalysis.
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24 15.2.1 Human food by-products held for
distribution as animal food must be
held under conditions that will
protect against contamination,
including the following:
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vulnerabilities and
actionable process steps
Mitigation strategies
appropriate to reduce the
vulnerability
Procedures for food
defense monitoring,
corrective action and
verification
27 15.3.3 A written vulnerability assessment
shall be prepared for each food
type manufactured, processed,
packed, or held, which evaluates
the following key criteria (at a
minimum):
Scale and severity of
threat if a contaminant is
added to product
Degree of physical access
to the product
Ability of an attacker to
successfully contaminate
product—including
consideration of an inside
attacker
A vulnerability assessment shall be
documented for each food type
regardless of the outcome and
provide justification as to why each
point, step or procedure in the
operation was or was not identified
as an actionable process step.
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Procedures shall include
recordkeeping requirements for all
monitoring activities.
30 15.3.6 Written corrective action
procedures shall be established
and implemented when mitigation
strategies are not properly
implemented. The procedure shall
include the following criteria:
Method for identifying and
correcting a lack of
implementation
Method for reducing the
likelihood of recurrence
Recordkeeping
requirements for corrective
actions
31 15.3.7 Written verification procedures
shall be established and
implemented to ensure that food
defense monitoring and corrective
action are performed according to
procedures. Verification
procedures shall describe activities
to verify implementation of
mitigation strategies.
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A change in facility
operations which creates a
new significant
vulnerability
Knowledge about a new
threat applicable to the
food or facility becomes
known
Mitigation strategies are
not implemented as
intended
FDA requires reanalysis
based on new threats or
scientific evidence
33 15.3.9 All records required by 21 CFR §
121 must include:
Date and time of activity
being documented
Signature/ initials of
individual performing
activity or conducting
record review
Information to identify the
facility (e.g., name and
location)
Identity of the product and
lot code where applicable
34 15.3.10 The owner, operator or agent in
charge of facility must sign and
date the written food defense plan
initially and then upon any
changes following reanalysis.
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clean condition, they shall not be
used.
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40 15.4.5 Where the site receives
temperature controlled product
immediately following
transportation, it shall conduct an
assessment to determine whether
the food was subject to
temperature abuse.
41 15.4.6 Contracts with carriers shall
specify that the carrier is
responsible for the following
sanitary activities where agreed to
in writing with shipper.
Sanitary condition of
vehicles and transportation
equipment
Following shipper’s
sanitary specifications
(including pre-cooling
requirements where
applicable)
Recording compliance with
operating temperature
where critical to food
safety
Procedures for the use of
bulk vehicles, which
includes recording the
previous cargo and most
recent cleaning for the
shipper
42 15.4.7 Contracts with carriers shall
specify that the carrier implements
a training program for all personnel
engaged in transportation
activities, which covers
Awareness of potential
food safety problems that
may occur during food
transportation
Basic sanitary
transportation practices to
address those potential
problems
Responsibilities of the
carrier
43 15.4.8 The site shall keep all records
related to U.S. transportation
operations and transportation
service contracts as original or
electronic records for a minimum
of 12 months beyond termination
of the activity or contract. Offsite
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records shall be retrievable within
24 hours.
44 15.4.9 The recordkeeping policy shall
ensure all sanitary design
requirements and cleaning
procedures for vehicles are
maintained onsite and all offsite
records are retrievable within 24
hours.
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animals or take measures such as
hand washing and protective
clothing to prevent contamination
of produce and food contact
surfaces following contact with
worker animals.
50 15.5.6 The water distribution system
supplying agricultural water used
for harvest, packing, holding—and
associated equipment—shall be
maintained, regularly inspected
and equipment properly stored to
prevent the system from being a
source of contamination to
produce and food contact
surfaces. The system shall be
inspected for conditions, which
could introduce known or
foreseeable hazards into or onto
produce.
Where testing of the water source
or system inspection reveals
contamination, deficiencies shall
be corrected such as the repair of
well caps or sanitary seals.
51 15.5.7 Agricultural water treatment must
be delivered and monitored at a
frequency that ensures water is
safe, of adequate sanitary quality,
and meets the microbial quality
criteria of no detectable generic
Escherichia coli (E. coli) in 100mL.
52 15.5.8 Potable water quality standards
used shall ensure the microbial
quality criterion is met, which is no
detectable generic E. coli in 100
mL.
53 15.5.9 Where agricultural water does not
meet microbial quality criteria or is
determined to be unsafe and not of
adequate sanitary quality, water
use must be discontinued along
with treatment or other correction
that reestablishes sanitary quality
and microbial criteria.
Where water treatment is not
performed, re-inspection of the
entire affected agricultural water
system shall be conducted
followed by the identification of
conditions leading to the
introduction of hazards into or onto
produce or food contact surfaces,
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correction, and verification of
correction to ensure water meets
microbial quality criteria.
54 15.5.10 Agricultural water testing may be
performed by the site (or site
representative) or by a third party
provided representative samples of
the site's water source is secured.
Aseptic water sampling must be
performed. The method of analysis
for water testing is U.S.
Environmental Protection Agency
(EPA), ‘‘Method 1603: Escherichia
coli (E. coli) in Water by Membrane
Filtration Using Modified
membrane-Thermotolerant
Escherichia coli Agar (Modified
mTEC), EPA–821–R–09–007),’’
December, 2009 or equivalent
method.
55 15.5.11 During harvest, packing and
holding operations (e.g.,
hydrocooling, washing), manage
water to maintain its safety and
sanitary quality and prevent
contamination of produce to
include establishing and following
a water-change schedule for
recirculated water.
Visually monitor the water quality
of water used for harvest, packing,
and holding activities for organic
build-up (e.g., soil, plant debris).
Maintain and monitor the
temperature of water used for
harvest, packing, and holding
activities as appropriate to the
commodity and operation to
minimize infiltration of pathogens
into produce.
56 15.5.12 Dropped produce (i.e., produce
that comes in contact with the
ground prior to harvest) where the
produce would not normally touch
the ground as a part of growing
and harvest (e.g., cantaloupe,
almonds, etc.) shall not be
distributed.
57 15.5.13 Sewage disposal and septic
systems shall be controlled and
appropriate for the site to prevent
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the contamination of produce and
food contact surfaces.
58 15.5.14 Plumbing shall not allow backflow
or cross-connection between
waste and potable water lines.
59 15.5.15 All produce safety related records
must be reviewed, dated, and
signed within a reasonable
timeframe after being made by the
supervisor or responsible party.
60 15.5.16 All produce safety documents and
records must be retained at the
site for 2 years after the record is
created.
Where records are stored offsite,
they must be retrievable within 24
hours.
Records related to equipment or
processes used by the site for
analyses, sampling, or action
plans—including the results of
scientific studies, tests, and
evaluations—shall be retained at
the site for at least 2 years after
their use is discontinued.
61 15.5.17 Specific additional requirements
for the harvesting, packing, and
holding of sprouts.
Establish and implement a written
Environmental Monitoring plan for
the testing of Listeria spp or
Listeria monocytogenes.
The environmental monitoring plan
shall include the following criteria:
Target test (i.e., Listeria
spp. or L. mono)
Sample frequency (no less
monthly)
Sample timing (i.e., when
in the process are samples
collected)
Sample sites where the
number of samples and
location are sufficient to
determine the efficacy of
controls (includes food
contact and non-food
contact surfaces)
The plan shall describe aseptic
methods for sample collection and
LSQA, Av Italia 6201, Montevideo, Uruguay.
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testing according to FDA's
‘‘Testing Methodology for Listeria
species or L. monocytogenes in
Environmental Samples,’’ Version
1, October 2015 (or equivalent).
62 15.5.18 Specific additional requirements
for the harvesting, packing, and
holding of sprouts.
The environmental monitoring plan
shall include a corrective action
plan if any samples are positive for
Listeria spp. or L. mono.
If Listeria spp. or L mono are
identified in the harvesting,
packing, holding area, the
following activities shall occur as a
part of the corrective action
process:
Resample positive
surfaces and the
surrounding area to
determine the extent of
contamination
Clean and sanitize the
affected and surrounding
areas
Resample and re-test to
confirm the elimination of
Listeria spp. or L. mono
Conduct finished product
testing as appropriate
Take additional action to
prevent recurrence and to
prevent adulterated food
from entering commerce
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