Professional Documents
Culture Documents
Report 349240 en
Report 349240 en
OCTOBER 2020
Name and address of the company (or head office): Name and address of the assessed site:
Cooperativa Agroindustrial de Palmito APROPAL
Ltda
Av. La Marginal No. 177 - Barrio San Martin - CPM.
Alianza, Caynarachi, Lamas
15020 San Martin
Peru
COID: 44742
Contact person in case of emergency (e.g. recall):
Name: Sheila Barrera
E-Mail: gerencia@apropal.pe
Phone: 51964974119
Phone: Fax: Phone: Fax:
51964974119
Website: E-Mail: Website: E-Mail:
www.apropal.pe gerencia@apropal.pe
Technology scope(s): A, C, F
Additional information
Exclusions: No
Decentralised structure(s): No
Number of buildings: 1
Number of floors: 1
Decentralised structure(s): No
Maximum number of employees at peak season within a calendar year and explanation: 45
Process is scheduled according to raw material (heart of palm) reception income, that enters the site. Normally
production is carried out in one production shift, unless raw material income requires a second production shift to
be enabled.
Detailed description of product groups and products per scope produced in the company. Full view of
the company’s on-site processes:
Does the assessed site have fully outsourced products in addition to the main No
processes/products?
Does the assessed site have traded products in addition to main processes/products? No
Description about key investments made by the company related to the production and product safety
and quality in the last 12 months (construction changes, machinery, etc.)
Investment on site's infrastructure, exterior fences. Change of 2 machines, product cutting (whole heart of palm
in 2 formats), slices. Heat tunnel for packing. Change of process ceilings. Walls at peeling area were changed to
ceramic (2 m high). Construction of warehouse for agricultural materials (chemicals, fertilizers).
Does the company fulfil the requirements about the use of the IFS (Food) Logo, as defined in Yes
the IFS Food Certification protocol (Part 1)?
Working language of the site and language in which the food safety and quality management system is
written:
Spanish
If the site is certified for other standards, specify the name(s) of the standard(s):
Additional information:
Assessment data
Language in which the IFS Food Assessment was conducted: Spanish
Assessment duration (only for IFS Food Assessment): 16h (calculated Assessment time:
16h)
Which products were produced and which processes have been running during the on-site evaluation?
Additional information:
This is a registration assessment, the certificate was suspended and recall during 2021 by last CB.
A 12 25 24 101 32 3
B 0 0 0 0 1 0
C 0 1 0 11 1 0
D 0 0 1 3 1 0
N/A 0 0 0 19 1 1
Major non-
0 0 0 0 0 0
conformities
KO non-
0 0 0 0 0 0
conformities
Result per
100 97.12 92 87.61 91.43 100
chapter (%)
Policy 1.1.1 Food safety policy is detailed in MNL-PC v.5 dated 10/01/2022, associated with
the policy, a series of objectives and indicators have been defined that cover
the requirements of the standard. The objectives and indicators are reviewed in
meetings between the Site Manager and responsible personnel of each area of
the site. Monthly meetings are held. The dashboard of indicators, process
performance were reviewed. Examples:- Customer complaints received 13%,
not achieved (5%) due to hardness of product.- 0% complaints related to food
safety, achieved. - Certification maintenance, not achieved for HACCP and
IFS. - Reduction of NC of external audits, not achieved.Objectives stablished
for 2022 on 1/1/2022, perfonce is discussed and documented monthly through
emails by area.A Food Safety Culture Development Program is been
established, and it is based on the development of corporate values. Activities
have been carried out related to personnel training, communication media
(WhatsApp group), reporting of food safety or any issue through confidential
media.
Corporate 1.2.1 The objectives/indicators are reviewed in meetings between the Site Manager
structure and responsible personnel (QA, production chief, maintenance, warehouse).
Monthly meetings are held where the indicators, process performance, process
needs, etc., are reviewed. An organizational chart MNL-OCAPA dated
11/10/2021 is available, Job descriptions and profiles were defined for all
positions, it includes: position, sector, responsibilities, required knowledge and
experience, training. Under the senior management are the QA, Logistic,
agriculture, and Production chiefs. All workers know their job description, a
signed copy is kept under the employee file. Verified examples MNL-PPT job
profile manual:- EC/QA chief; MV/production supervisor; LC/maintenance
responsible; JC/agriculture chief.
1.2.5 Working instructions and procedures are available in hard copy for all
personnel and areas and digital copy are managed only by QA and senior
manager, it was evidenced during the site walk that most recent version of
documents were available in each area.Legal requirements are managed
according to procedure "revision de normas nacionales e internacionales" PRC
-RNNI dated 06/09/2021, quarterly reviews are carried out, some information
sources are: IFS portal, DIGESA (Peru regulatory body), Codex Alimentarius,
EU, Diario El Peruano, Indecopi (fraud), myGFSI, USDA.
1.2.6 The regulatory Agency that rules food manufacturing sites is "DIGESA", the
site's license is R1902314NUEAODE. Last regulatory visit for HACCP
validation, was carried out on 11/02/2022, a formal resolution that details
compliance with local regulation is available and valid for 2 years.Notification to
CB is included in procedure "comunicación a casa certificadora" PRC-CCC
dated 17/01/2022.
Management 1.4.1 Management review is carried out annually, last was dated 03/12/2021
review (General manager with associates) and 12/2021 (General manager with site's
team), these were documented in minutes and physical report.
Records and 2.1.2.2 There is procedure for record management PRC-CDM v.7 dated 01/07/2021,
documented where retention time is product shelf life + 12 months (5 years).
information
HACCP analysis 2.2.3.7 Specified CCPs: Sterilisation Holding time pH value Packaging
controlsSeam / seal controlsFurther explanation:CCP1: acidification, risk of
Clostridium b., critical limit pH 1.9 - 2.5.CCP2: brine adition, critical limit
temperature 90 - 100°CCCP3: seams according to each presentation (cans 15
and 28 oz: superposition 45 - 61%; compactness 81 - 95% / galon cans A-10:
superposition 46 - 60%; compactness 81 - 96% / glass jars: 5 mm)CCP4:
sterilization, Clostridium b., and thermophiles, critical limit: holding time (15 - 20
min) and temperature (100 - 110°C).
Establish a 2.2.3.8.1 CCP1: acidification, pH is controlled on each brine batch, record RGS-PLG-
monitoring 040 and brine preparation specification SPC-LGA v.6 dated 26/01/2022.CCP2:
system for each temperature control every 30 min, record RGS-CP-001.CCP3: seam control at
CCP the beginning, middle and at the end of production (destructive control - record
RGS-CVCL-008-A) and visual control every 30 min, record RGS-CVCL-008-
B.CCP4: sterilization (Tx=93.3 °C; Z=8.89 °C Po=10 minutos), time and
temperature control by PLC each batch.
HACCP analysis 2.2.3.10 Verification is carried out annually and as required, last verification was carried
out 09/06/2022.
Personal 3.2.1 There is an internal GMP rules document MNL-BPM v.2 dated 05/02/2020, this
hygiene GMP manual includes personnel behaviour, practices, culture, cross-
contamination prevention, allergen cross-contact prevention.For health
requirements and medical services operation there is the procedure
"Operación del consultorio medico" PRC-CHSP v.6 dated 13/07/2021.
3.2.2 During the site walk, good conditions and practices were observed regarding
the use of protective clothing. Inspections and evaluations of the personal
hygiene conditions are carried out daily, by QA and responsible of the process
area. Record RGS-CHPP-018 (production), RGS-CHPA-022 (warehouse) is
completed, this includes uniform use, absence of jewelry, use of protective
elements, hand washing, etc. Personnel hygiene requirements also apply to all
visitors to production areas.
3.2.8 The site provides to their employees white pants and shirts (3), aprons, boots,
gloves, face mask, hairnet. Aprons are desinfected on a daily basis and are left
at the sanitary filter.VIsitors and external are provided with protective cloths
(coat, hairnet).
Training and 3.3.1 A training program is in place "Plan Anual de Capacitación" PLN-ACP v.7 dated
instruction 30/12/2021.
3.4.5 Based on risk the site has determined that hand washing station shall be
located at the entrance of the production area. These facilities are counted in
sufficient number, they are equipped with activation devices without manual
contact, with water at appropriate temperature, neutral soap, paper towels for
hand drying and alcohol dispensers.
Specifications 4.2.1.1 Specifications are available for all raw materials and finished product reviewed
during this assessment, and are updated according to procedure "Control de
documentos y sus modificaciones" PRC-CDM v. 7 dated 01/07/2021, every 3
years.The specification includes product name, brine composition, chemical,
physical, organoleptic and microbiological parameters, shelf life, coding,
labeling, and packing.Specifications reviewed:- Finished product SPC-CPFSC
v.5 dated 9/10/2021Clients agreements:- CMEX whole heart of palm CDP44
ALE dated 14/10/2021, labeling approval dated 19/11/2021.- RFTN contract
agreement (labeling, specification) dated 11/03/2022 per product.
4.2.1.3 For raw material and packaging are available, reviewed during the
assessment:- Heart of palm SPC-MP v. 3 dated 04/01/2022- Salt PT-SAL-07
dated 26/05/2021- Citric acid EEQ-005 77-92-9 dated 15/08/2011- Tin cans
and lids FT-99119-A-B-03 dated 18/02/2019
4.2.1.5 Declaration "free from" or other related to production methods, are not made or
required by customers.
Formulas/Recip 4.2.2.1 Customer agreements are available, there is a file with client specifications
es and requirements for product, labels, printed labels/carton box, coding,
etc.During the assessment client's specification were available at process area,
brine preparation, and laboratory. Agreements reviewed during the
assessment:- CMEX whole heart of palm CDP44 ALE dated 14/10/2021,
labeling approval dated 19/11/2021.- RFTN contract agreement (labeling,
specification) dated 11/03/2022 per product.
Product 4.3.2 A procedure for product development is in place PLN-CP "diseño de producto y
development/ proceso" v. 2 dated 4/02/2021, however the site does not carried out product
Product development.
modification/
Modification of
production
processes
4.4.2 A procedure is in place for approval and monitoring of suppliers PRC-HP v.4
dated 17/09/2021.
Product 4.5.1 Packaging used are metal rigid containers and lids, glass jars, labels, carton
packaging boxes. Specifications are available FT-99119-A-B-03 dated 18/02/2019,
accordingly to suppliers and the facility requirements. Supplier of cans and lids
is certified to BRCGS valid until 30/08/2022 and 31/01/2023.Migration test
check were report 2019L30181/1 dated 04/10/2019 (cans) and report
FCM2060782 dated 20/03/2020 (lids); compliance letter was available for cans
and lids dated 05/02/2021 and 10/08/2021.
Factory location 4.6.1 The facility is located in a rural area, it is surranded by fields and main road.
During the site walk it was observed that there are not negative environmental
conditions impact. Grassed areas were observed in good maintenance
conditons, there is no water standing. Perimeter is protected by metal and
concrete fence with CCTV monitoring and security guards.
Constructional 4.9.1.1 The facilities are adequate for the production processes carried out in each
requirements one. The buildings are of solid construction and of suitable materials. The
product is not exposed and no risks derived from the design and construction
were observed in any area. There are extractors and injectors, so the risks of
condensation is minimized.
Water 4.9.9.1 Water supply comes from site's wells, it is chlorinated accordingly to procedure
PRC-DACH "desinfección de agua para consumo humano", to meet legal
requirements. Water is monitored for free chlorine on a daily basis and is
recorded on format RGS-CCA-020. Well water is only chlorinated to comply
with local regulation from 0.3 to 3 ppm.There is an actual schematic layout of
water distribution CRQ-TDA dated 04/02/2021. Water potability is tested
externally, on a annual basis accordingly parameters detailed in Peruvian
regulation, records reviewed: report# 1-06329/22 dated 20/05/2022 (physical,
chemical and microbiological parameters).
Cleaning and 4.10.1 Cleaning instructions are available and documented in procedure PRC-
disinfection LDSCIA v.8 dated 27/07/2021, this included all equipment and utensils p.e.
tables, dicers, trays, retorts, tanks, conveyor belts, scales, etc., there is a
cleaning program/schedule PRG-PLD dated 07/07/2021 where tasks,
frequency and responsible are detailed according to areas.Daily cleaning is
carried out in product contact surfaces: conveyor belts, cutting equipment,
tables, knives; weekly: retort, walls, dust mesh, sealing machines; biweekly:
extractors, doors, windows, cealings, pipes and lamps; monthly: curtains and
ceilings.Cleaning activities were observed on day 2, and cleaning release with
visual inspections, records reviewed during the assessment:- RGS-IDS-081
"Inspeccion diaria de sanidad" daily cleaning inspection- RGS-LDSCDA-066
contac surfaces cleaning- PRC-ACP-068 no direct contact surfaces cleaning-
RGS-CLU-071 utensils cleaning- RGS-LDSPIEU-091 weekly cleaning
4.10.8 Safety data sheets and instructions of chemicals are available at the general
warehouse and at the cleaning chemicals warehouse for production areas,
there is also a table with approved chemicals and dosification NST-TDILD
dated 27/07/2021.Examples reviwed during the assessment:- clean soap, TDS
dated 21/08/2020- acideter, TDS dated 07/10/2021- DDC-10, TDS dated
02/07/2020- food machinery grease, TDS dated 12/07/2010
4.10.9 Chemicals storage is carried out in a warehouse outside production area, all
chemicals are stored accordingly compatibility and characteristics, these have
the label of manufacturer, for those that are dispensed in small containers,
labels are printed and attached for identification, SDS were available.
Foreign material 4.12.2 The risk of product contamination has been reduced by visual inspection and
risk mitigation by different washing process steps. The HACCP hazard analysis has identified
the need of filters at brine dosing (exhauster) to assure absense of foreign
material, these are inspected in a daily basis.Documented procedure PRC-
CRV v.3 dated 16/09/2020 for handling glass and brittle materials that includes
the list of all glass, brittle and similar materials detailing location, number and
type. Checks of glass, brittle, and similar materials are conducted monthly.
Records “control de vidrio, ceramica y plastico duro en ambientes” code RGS-
CVCPDA-072 of the glass and hard plastic last updated 31/05/2022, were
reviewed during the assessment.Glass breakage procedure requieres that
production stops, product and area is isolated, cleaned and
inspected.Authorization is required before production can recommence, work
wear is changed, and records completed.
4.12.10 Visual inspections are carried out for foreign material detection, personnel is
trained by areas and rotation to maximise effectiveness are carried out every 2
hours. Training records reviewed dated 05/13/2021.
Pest monitoring 4.13.2 There is a pest management program PRC-CP v.3 dated 09/05/2022, there is
and control a PCO FEIRL that performs quarterly visits, the site is responsible of
monitoring the pest program and devices weekly. QA team have designated
CC/pest operator, under the guidance of QA chief, last training dated
02/12/2021. All records reviewed were found complete and signed. Results of
controls are analyzed for trends monthly, information reviewed during the
assessment showed that there have not been infestation. A site map with all
pest devices is available as part of program PLN-UTCR dated 03/03/2021.Pest
control chemicals used have a sanitary registration and are suitable for
use.Deviation: It is not assured that all bait stations are identified, e.g. 7, 15
and 17 identification was not available//No se asegura que todas las
estaciones de cebadero se encuentran identificadas, ej. estaciones 7, 15 y 17
no se encontraron identificadas.
Receipt and 4.14.1 Controls on the acceptance of raw materials do not compromise the safety,
storage of legality or quality of products.The documented procedure for the acceptance of
goods raw materials are according to inspection plan v.1 dated 01/2021. Raw material
acceptance and its release are based on one or a combination of:• product
sampling and testing• visual inspection on reception
4.14.2 Good storage conditions were observed during the assessment, heart of palm
is received in the afternoon, conditions of reception area are well maintained.
Warehouse for packing material and finished goods have a rack system and a
rotation system based in FIFO.
4.14.5 Products are identified by coding, product is packed in box and the pallets are
labeled with a card that includes lot, production date, quantity, client PO,
destiny. After stability analysis are done, QA gives a release notification so the
product can be labeled, final packing according client's specification and
dispatch. The site produces based on orders posted by client's, stock of
products is not kept. Reviewed during the assessment, whole heart of palm 28
oz cans, batch ALE 06/22/040, internal code ALE251040Y, produced
09/02/2022, exp. dated 30/06/2025.
Transport 4.15.1 Conditions of transport (cleaning and security) are reviewed before each
loading, these are recorded in format RGS-ISLVC-090, this includes cleaning
conditions, foreing materials and substances, absence of pests, security points
in walls, ceiling and floor. Loading area is observed in good cleaning and
maintenance conditions. Example 1 reviewed through documentation
(traceability exercise) batch ALE251040Y destiny EU. All found to be in order.
Equipment 4.17.1 Process equipment is designed and built for the activities carried out, contact
surfaces are suitable for this purpose, e.g. tables, cutting blades are built in
stainless steel, conveyor belts are plastic, trays are plastic and have food
contact compliance statement.
4.18.2 Traceability system is tested at least annually, tests are carried out for finished
products and raw materials, reviewed during the assessment: E.g. 1: test dated
25/06/2022, product heart of palm slices 1 kg, batch ALM3321/228, mass
balance 100% (418 envases), time < 4 hours.Deviation: It is not assured that
test records are available for traceability exercises from raw materials to
finished goods//No se asegura que los registros de prueba estén disponibles
para los ejercicios de trazabilidad desde las materias primas hasta los
productos terminados.
Allergen risk 4.19.2 The company has carried out a risk assessment of its raw materials,
mitigation ingredients and packaging MTR-FAI dated 14/09/2021. The results of the risk
analysis indicated that there are no allergens involved in the operations.
Food Fraud 4.20.2 The company conducted a vulnerability assessment: YesRaw material groups/
product groups identified:14 NoneDescription why the identified raw materials
are vulnerable to food fraud:No high/medium risk materials
identified.Explanation which criteria were selected:Fraud vulnerability
assessment included historical fraud in the sector and probability of detection.
Rawmaterials and packaging are visually identifiable, there is a supplier
approval and follow up program, and annually raw material analysis are carried
out as control.Details of the assessment:Vulnerability assessment was last
reviewed on 09/2021.Members of the food fraud team, food defense and
HACCP are the same as the company has a small structure (Senior manager,
QA, production and warehouse responsible and the accountant acts as
secretary for all the teams)
Internal audits 5.1.1 Internal audit procedure PCDT-AU v. 7 dated 18/01/2022, the scope is related
to all management systems implement on the site. There is a risk analysis to
determine frequency 14/9/2021; there are 4 trained internal auditors, that have
received the following training IFS v.7 dated 12/02/2022.Records reviewed
during the assessment:- chapter 1 audit dated 21/02/2022- chapter 2, 3, 4 and
5 audit dated 19/03/2022- chapter 4 and 6 audit dated 31/03/2022Audit reports
stated conformance and non conformance.
Site factory 5.2.1 There is a site inspection program with a frequency based on risk determined
inspections in MTR-HGPR dated 29/03/2022: daily inspections to internal areas, reception,
boilers, chemical warehouse, maintenance workshop and personnel facilities;
weekly inspections (pest program) to internal and external areas structures
(walls, doors, floor, windows, nets). Annually as required by legal requirement
with DIGESA checklist. These inspections are carried out by QA staff. Results
of inspections are recorded in format RGS-IISIET-055, examples reviewed
during the assessment dated 31//05/2022.
Process and 5.3.1 Verification of CCPs is carried out by the site, annually to establish operation
working limits, e.g. CCP1 pH < 4,2 in finished product, salt% related to clients
environment specification, CCP2 heat treatment validation was carried out by TechniCAL
validation and dated 02/02/2017, product validation reviewed: carried pout by Grupo FS tall
control 15 oz 06/01/2017; where time, temperatures, pressure accordingly to type of
product and packaging have been carried out, no cold points have been
identified. Cleaning processes are verified through visual inspection and
microbiology, surveillance are carried out daily, internal process (conveyors,
utensils), packing (cans/jars, filters), heat treatment area (brine, water tanks).
Microbiology swabs are taken annually accordingly to testing plan, analysis
carried out to contact surfaces - hands, aprons and gloves (S. aureus,
Salmonella), contact surfaces and utensils (coliforms, Salmonella),
environment (TVC, yeast and molds). All records found in order with no
deviations on results.Reviwed during the assessment:- report N° 012-UMAA-
P/2022 dated 11/01/2022 (environment) - report N° 011-UMAA-P/2022 dated
11/01/2022, results for coliforms, S. aureus and Salmonella (hands)- report N°
010-UMAA-P/2022 dated 11/01/2022, results for coliforms and Salmonella
(filling tables, classification conveyor, cutting table, peeling conveyor)- lighting
report 0168-2021 dated 25/11/2021No deviations reported.
Calibration, 5.4.1 There is a calibration program CRN-CEIM, that includes a master list of
adjustment and equipment with identification code, date of last calibration and date for next
checking of calibration and frequency.
measuring and
monitoring
devices
Quantity control 5.5.1 The plant operates a quantity control system, which conforms to legal
monitoring requirements in the country where the product is sold and customer
requirements.Products are packed to minimum weight and individual jar/can is
weighed.Weight control reviewed during the site walk and the traceability test,
were found to be satisfactory. Records are in place, every batch 2 or 3 samples
are taken for drained weight, records available RGS-CPD-028.
Product and 5.6.1 Product is tested every production batch at the site's laboratory for pH, salt,
process acidity, sensory parameters, defects, net and drained weight, also stability is
analysis carried out at ambient, 37°C, 55°C for 8 days according to product testing plan
MNL-CCPT v. 4 dated 12/07/2021. All records reviewed for traceability test and
products processed during the assessment were found to be in order.External
analysis reviewed:Finished product:- analysis report 1-06731/22 dated
20/05/2022 for acidity, salt, fiber, pH, heavy metals, commercial stability
(thermophiles).- nutritional report INF-VVNCP dated 14/02/2020, external
anlysis report 1-11117/19 dated 22/11/2019Raw materials:- citric acid report 1-
05546/22 dated 21/05/2022 for ash, citrate, moisture, purity, sulphates, Pb- salt
report 1-06426/22 dated 20/05/2022 for heavy metals, purity, moisture,
sulphates, coliforms- heart of palm report 1-06337/22 dated 21/05/2022 for
heavy metals, pesticides
5.6.2 Laboratories used for external analysis and to evaluate reliability of results are
ISO/IEC 17025 accredited:- CERPER S.A. accreditation N° LE-003 valid until
06/2023; - TEST&CONTROL (calibration) accreditation N° LC-416 valid until
07/2022
Product release 5.7.1 Procedure for product release is in place PRC-CLPT v.6 dated 16/07/2021 "
Cuarentena y Liberación de Producto Terminado". Release process is based
on stability analysis of the product at ambient, 37°C and 55°C for 7 days
accordingly to legal and client's requirements, to confirm pH and sensory
parameters, these are recorded in format RGS-IPF-002. All records were in
order.
Management of 5.8.1 A procedure is in place for the management of customer and regulatory
complaints from complaints PRC-NC v. 6 dated 16/07/2021, the site has received 1 complaint
authorities and during 2022 due to product hardness. None related with foreign material.
customers
Management of 5.10.1 A procedure for non-conforming product management is in place PRC-NCP v.6
non- dated 16/07/2021, when a product does not meet the specifications or the
conformities results of the analyzes are not satisfactory, a non-conforming product report is
and non- generated and product is blocked and placed at the non conforming area at the
conforming warehouse. Deviation: It is not assured that all non conforming products are
products identified, during the site walk it was observed at finished product warehouse
that all products including non conforming product are identified by a white
label; however non conforming product is in the designated area.//No se
asegura que todos los productos no conformes estén identificados, durante la
visita al sitio se observó en el almacén de productos terminados que todos los
productos, incluido el producto no conforme, están identificados con una
etiqueta blanca; sin embargo, el producto no conforme se encuentra en el área
designada.
Corrective 5.11.1 A procedure for corrective actions is in place PRC-ACP v.3 dated 19/97/2021.
actions A CAPA matrix is in place for the root cause analysis, corrections, preventive
measures, and follow up for closure.Reviewed during the assessment:- 4.4.3
corrective action closed with the format for supplier evaluation closed 03/2022-
4.11.2 waste management considering legal requirements will be implemented
until July 2022- 4.9.4.2.1 peeling paint of walls at heart of palm peeling area,
ceramic was put in walls closed in 05/2022.- 4.3.4 labeling information review
according legal requirements, procedure implemented in 06/2022
5.11.2 Corrective actions are developed and track through CAPA matrix RGS-ACPM-
057, managed by QA chief and senior manager, a full description of non-
conformance, with a root cause analysis (5Ws), inmediate action taken and
responsible of the process to address the correction within timescale,
corrective/preventive action plan. Verification of corrections are carried out by
QA personnel. The cause analysis and corrective actions defined for the
deviations of the internal audit, autoinspections and customer complaints were
reviewed.
Food defence 6.2 The site has a Food Defence procedure PRC-FD v. 4 dated 04/01/2022
plan implemented, annual review of Food Defense plan DAFA carried out in
21/02/2022. The procedure has considered all production and warehouse
areas, and found to be critical, mitigation strategies include access restriction
to authorized personnel and monitored by identification, secured with padlocks,
biqeekly security inspections (last dated 30/06/2022), and CCTV monitoring.
Last food defense test was carried out in 02/2022.
5 4.4.5 The purchased services shall be C Purchased services checked during the
checked in accordance with the assessment:- transport: contract HE
existing specifications. The S.A.C dated 30/11/2021 and TAC S.A.C.
schedule of these checks shall dated 01/03/2022, cleanliness, security
take into account, at a minimum: and sabotage, transport hygiene
- the defined service guide.Deviation: It is not assured that
requirements purchased services supplier's have been
- the supplier’s status (according evaluated, during the documentary review
to its assessment) it was evidenced that a supplier
- the impact of the service on the assessment was not available for external
finished product. laboratory and calibration services//No se
asegura que los proveedores de los
servicios adquiridos hayan sido
evaluados, durante la revisión documental
se evidenció que no se contaba con una
evaluación de proveedores para los
servicios de laboratorio y calibración
externos.
9 4.8.2 The process flow, from receipt of C There are site layouts PLN-FPCA v.2
goods to dispatch, shall be dated 06/2021, PLN-FMP dated 09/2020
established, reviewed and where layout of personnel and material flow, PLN
necessary, modified to ensure -UEM equipment. Process is straight from
that the microbiological, chemical reception to heat treatment and coding.
and physical contamination risks Reception and product peeling are carried
of raw materials, packaging out in a separate room, product go to next
material, semi-finished and steps trough conveyors to void cross-
finished products are avoided. contamination due to personnel flow,
The cross-contamination risks cutting, packing and sterilization are
shall be minimised through carried out in another room with air flow
effective measures. control and dedicated
personnel.Deviation: The cross-
contamination risk is not minimised
through effective measures, during the
site walk it was observed at acidification
preparing step that the plastic container
was in direct contact with floor, with no
identification an open during the
process//El riesgo de contaminación
cruzada no se minimiza a través de
medidas efectivas, durante la visita al sitio
se observó en el paso de preparación de
acidificación que el contenedor de plástico
estaba en contacto directo con el piso, sin
identificación y abierto durante el proceso.
19 4.10.11 Where a company hires a third- NA Cleaning and disinfection are carried out
party service provider for by site's personnel.
cleaning and disinfection
activities, all requirements
specified above shall be clearly
defined in the service contract.
1 1.1.1 The senior management shall A Food safety policy is detailed in MNL-PC
develop, implement and v.5 dated 10/01/2022, associated with the
maintain a corporate policy, policy, a series of objectives and indicators
which shall include, at a have been defined that cover the
minimum: requirements of the standard. The
- food safety and product objectives and indicators are reviewed in
quality meetings between the Site Manager and
- customer focus responsible personnel of each area of the
- food safety culture. site. Monthly meetings are held. The
This corporate policy shall be dashboard of indicators, process
communicated to all employees performance were reviewed. Examples:-
and shall be broken down into Customer complaints received 13%, not
specific objectives for the achieved (5%) due to hardness of product.
relevant departments. - 0% complaints related to food safety,
achieved. - Certification maintenance, not
achieved for HACCP and IFS. - Reduction
of NC of external audits, not
achieved.Objectives stablished for 2022
on 1/1/2022, perfonce is discussed and
documented monthly through emails by
area.A Food Safety Culture Development
Program is been established, and it is
based on the development of corporate
values. Activities have been carried out
related to personnel training,
communication media (WhatsApp group),
reporting of food safety or any issue
through confidential media.
7 1.2.5 The senior management shall A Working instructions and procedures are
have a system in place to available in hard copy for all personnel
ensure that the company is kept and areas and digital copy are managed
informed of all relevant only by QA and senior manager, it was
legislation, scientific and evidenced during the site walk that most
technical developments, recent version of documents were
industry codes of practice, food available in each area.Legal requirements
safety and product quality are managed according to procedure
issues, and that they are aware "revision de normas nacionales e
of factors that can influence internacionales" PRC-RNNI dated
food defence and food fraud 06/09/2021, quarterly reviews are carried
risks. out, some information sources are: IFS
portal, DIGESA (Peru regulatory body),
Codex Alimentarius, EU, Diario El
Peruano, Indecopi (fraud), myGFSI,
USDA.
8 1.2.6 The senior management shall A The regulatory Agency that rules food
ensure that the certification manufacturing sites is "DIGESA", the site's
body is informed of any license is R1902314NUEAODE. Last
changes that may affect the regulatory visit for HACCP validation, was
company’s ability to conform to carried out on 11/02/2022, a formal
the certification requirements. resolution that details compliance with
This shall include, at a local regulation is available and valid for 2
minimum: years.Notification to CB is included in
- any legal entity name change procedure "comunicación a casa
- any production site location certificadora" PRC-CCC dated
change. 17/01/2022.
For the following specific
situations:
- any product recall
- any product recall and / or
withdrawal by official order for
food safety and / or food fraud
reasons
- any visit from health
authorities which results in
notifications and / or penalties
issued by authorities the
certification body shall be
informed within three (3)
working days.
31 2.2.3.7 Establish critical limits for each A Specified CCPs: Sterilisation Holding
CCP: time pH value Packaging controlsSeam /
For each CCP, the appropriate seal controlsFurther explanation:CCP1:
critical limits shall be defined acidification, risk of Clostridium b., critical
and validated to clearly identify limit pH 1.9 - 2.5.CCP2: brine adition,
when a process is out of critical limit temperature 90 - 100°CCCP3:
control. seams according to each presentation
(cans 15 and 28 oz: superposition 45 -
61%; compactness 81 - 95% / galon cans
A-10: superposition 46 - 60%;
compactness 81 - 96% / glass jars: 5 mm)
CCP4: sterilization, Clostridium b., and
thermophiles, critical limit: holding time (15
- 20 min) and temperature (100 - 110°C).
42 3.2.2 KO N° 3: The requirements for A During the site walk, good conditions and
personal hygiene shall be in practices were observed regarding the use
place and applied by all of protective clothing. Inspections and
relevant personnel, contractors evaluations of the personal hygiene
and visitors. conditions are carried out daily, by QA and
responsible of the process area. Record
RGS-CHPP-018 (production), RGS-CHPA
-022 (warehouse) is completed, this
includes uniform use, absence of jewelry,
use of protective elements, hand washing,
etc. Personnel hygiene requirements also
apply to all visitors to production areas.
48 3.2.8 Suitable protective clothing A The site provides to their employees white
shall be available and in pants and shirts (3), aprons, boots, gloves,
sufficient quantity for each face mask, hairnet. Aprons are
employee. desinfected on a daily basis and are left at
the sanitary filter.VIsitors and external are
provided with protective cloths (coat,
hairnet).
51 3.3.1 The company shall implement A A training program is in place "Plan Anual
documented training and/or de Capacitación" PLN-ACP v.7 dated
instruction programs with 30/12/2021.
respect to the product and
process requirements and the
training needs of the
employees, based on their job,
and shall include:
- training contents
- training frequency
- employee’s task
- languages
- qualified trainer/tutor.
52 3.3.2 The documented training and/or A Training is provided to all employees prior
instruction shall apply to all to commencing work and on an annual
personnel, including seasonal basis, training records are available,
and temporary workers and reviewed during the assessment:- Internal
employees from external policies, GMPs, uniforms, cleaning
companies, employed in the requirements, health and safety rules,
respective work area. Upon activities to be done (hiring) example
employment, and before reviewed dated 20/06/2022.- Food
commencing work, they shall Defense dated 11/12/2021 - Uniform
be trained/instructed in wasing and hygiene dated 9/9/2021-
accordance with the PPRs dated 4/1/2022- GMPs, foreign
documented training/instruction material and allergen dated 20/7/2021-
programs. Traceability (labeling and product
identification) dated 23/5/2022- Cleaning
and disinfection dated 6/6/2022- IFS
standard dated 11/4/2022- Pest control
and identification dated 2/12/2021- CCP
(heat treatment) dated 10/1/2022- CCPs
monitoring dated 12/10/2021
55 3.4.1 The company shall provide A Staff facilities are observed in good
suitable staff facilities, which cleaning and repair conditions. There is
shall be proportional in size, sufficient space for changing rooms and
equipped for the number of bathrooms, external clothes are left in
personnel, designed and lockers and there are separate areas for
controlled so to minimise food shoes and process boots, hand washing
safety risks. Such facilities shall stations are supplied with neutral soap,
be kept in a clean and good hand sanitizer, and paper towels. There
condition. are also hand washing and sanitizing
facilities at the main entrance to the
process.
59 3.4.5 Hand hygiene facilities shall be A Based on risk the site has determined that
provided and shall adress, at a hand washing station shall be located at
minimum: the entrance of the production area. These
- adequate number of wash facilities are counted in sufficient number,
basins they are equipped with activation devices
- suitably located at access without manual contact, with water at
points to and/or within appropriate temperature, neutral soap,
production areas paper towels for hand drying and alcohol
- sole use for cleaning hands dispensers.
only.
The necessity of similar
equipment in further areas (e.g.
packing area) shall be based on
hazard analysis and
assessment of associated risks.
66 4.2.1.1 Specifications shall be available A Specifications are available for all raw
and in place for all finished materials and finished product reviewed
products. They shall be up to during this assessment, and are updated
date, unambiguous and in according to procedure "Control de
compliance with legal and documentos y sus modificaciones" PRC-
customer requirements. CDM v. 7 dated 01/07/2021, every 3
years.The specification includes product
name, brine composition, chemical,
physical, organoleptic and microbiological
parameters, shelf life, coding, labeling,
and packing.Specifications reviewed:-
Finished product SPC-CPFSC v.5 dated
9/10/2021Clients agreements:- CMEX
whole heart of palm CDP44 ALE dated
14/10/2021, labeling approval dated
19/11/2021.- RFTN contract agreement
(labeling, specification) dated 11/03/2022
per product.
79 4.4.1 The company shall control A Periodical visits are carried out by
purchasing processes to ensure agriculture department to all heart of palm
that all externally sourced raw supplier's field to verify performance,
materials, semi-finished product application (fertilization and
products, packaging materials pesticides). Packaging and ingredients
and services, which have an suppliers are a GFSI recognized scheme
impact on food safety and or HACCP certified.Records reviewed
product quality, conform to during this assessment:- Heart of palm
defined requirements. supplier evaluation is carried out
according to supplier crop visit schedule,
last evaluation was carried out 06/2021.
Suppliers: CHMA; JGL; PLP; THW- Citric
acid E&M SRL, BRCGS certified valid until
16/01/2023, laboratory analysis are
carried out every 3 years for ash, citrate,
moisture, purity, sulphates, Pb; last
analysis report 1-05546/22 dated
21/05/2022.- Salt QPC, HACCP
certification valid until 13/01/2023,
laboratory analysis are carried out every 3
years for heavy metals, purity, moisture,
sulphates, coliforms; last anlysis report 1-
06426/22 dated 20/05/2022.- Tin cans and
lids FDS/MTPR, BRCGS certified valid
until 30/08/2022 and 31/01/2023;
migration analysis report 2019L30181/1
dated 04/10/2019 and report
FCM2060782 dated 20/03/2020; also
compliance letters are available for each
supplier.
80 4.4.2 A procedure for the approval A A procedure is in place for approval and
and monitoring of suppliers monitoring of suppliers PRC-HP v.4 dated
(internal and external) shall be 17/09/2021.
in place. The approval and
monitoring procedure shall
contain clear assessment
criteria, such as:
- audits performed by an
experienced and competent
person
- certificates of analyses
- supplier reliability
- complaints
- required performance
standards.
81 4.4.3 The results from the supplier A Approved supplier list "Lista de
assessments shall be reviewed proveedores y resumen de evaluación"
regularly and this review shall RGS-EDPH-056 dated 15/08/2021; "lista
be justified by risk assessment. de proveedores de palmito homologados
Records of the reviews and the 2022" for heart of palm.Records reviewed
consequential actions of during this assessment:- Heart of palm
assessment shall be supplier evaluation is carried out
documented. according to supplier crop visit schedule,
last evaluation was carried out 06/2021.
suppliers: CHMA; JGL; PLP; THW- Citric
acid E&M SRL, BRCGS certified valid until
16/01/2023, laboratory analysis are
carried out every 3 years for ash, citrate,
moisture, purity, sulphates, Pb; last
analysis report 1-05546/22 dated
21/05/2022.- Salt QPC, HACCP
certification valid until 13/01/2023,
laboratory analysis are carried out every 3
years for heavy metals, purity, moisture,
sulphates, coliforms; last anlysis report 1-
06426/22 dated 20/05/2022.- Tin cans and
lids FDS/MTPR, BRCGS certified valid
until 30/08/2022 and 31/01/2023;
migration analysis report 2019L30181/1
dated 04/10/2019 and report
FCM2060782 dated 20/03/2020; also
compliance letters are available for each
supplier.
83 4.4.5 The purchased services shall C Purchased services checked during the
be checked in accordance with assessment:- transport: contract HE S.A.C
the existing specifications. The dated 30/11/2021 and TAC S.A.C. dated
schedule of these checks shall 01/03/2022, cleanliness, security and
take into account, at a sabotage, transport hygiene
minimum: guide.Deviation: It is not assured that
- the defined service purchased services supplier's have been
requirements evaluated, during the documentary review
- the supplier’s status it was evidenced that a supplier
(according to its assessment) assessment was not available for external
- the impact of the service on laboratory and calibration services//No se
the finished product. asegura que los proveedores de los
servicios adquiridos hayan sido
evaluados, durante la revisión documental
se evidenció que no se contaba con una
evaluación de proveedores para los
servicios de laboratorio y calibración
externos.
87 4.5.1 Based on hazard analysis, A Packaging used are metal rigid containers
assessment of associated risks and lids, glass jars, labels, carton boxes.
and intended use, the company Specifications are available FT-99119-A-B-
shall define the key parameters 03 dated 18/02/2019, accordingly to
for the packaging materials in suppliers and the facility requirements.
detailed specifications Supplier of cans and lids is certified to
complying with the current BRCGS valid until 30/08/2022 and
relevant legislation and other 31/01/2023.Migration test check were
relevant hazards or risks. The report 2019L30181/1 dated 04/10/2019
company shall check and verify (cans) and report FCM2060782 dated
the suitability and existance of 20/03/2020 (lids); compliance letter was
functional barrier(s) of the available for cans and lids dated
consumer unit packaging 05/02/2021 and 10/08/2021.
material for each relevant
product tests/analysis such as:
- organoleptic tests
- storage tests
- chemical analyses
- migration test results.
90 4.6.1 The company shall investigate A The facility is located in a rural area, it is
the extent to which the factory surranded by fields and main road. During
environment (e.g. ground, air) the site walk it was observed that there
may have an adverse impact on are not negative environmental conditions
food safety and product quality. impact. Grassed areas were observed in
Where it is established that good maintenance conditons, there is no
product safety and/or quality water standing. Perimeter is protected by
could be compromised, metal and concrete fence with CCTV
appropriate control measures monitoring and security guards.
shall be implemented. The
effectiveness of the
implemented measures shall be
periodically reviewed (e.g.
extremely dusty air, strong
smells).
94 4.8.2 The process flow, from receipt C There are site layouts PLN-FPCA v.2
of goods to dispatch, shall be dated 06/2021, PLN-FMP dated 09/2020
established, reviewed and layout of personnel and material flow, PLN
where necessary, modified to -UEM equipment. Process is straight from
ensure that the microbiological, reception to heat treatment and coding.
chemical and physical Reception and product peeling are carried
contamination risks of raw out in a separate room, product go to next
materials, packaging material, steps trough conveyors to void cross-
semi-finished and finished contamination due to personnel flow,
products are avoided. The cutting, packing and sterilization are
cross-contamination risks shall carried out in another room with air flow
be minimised through effective control and dedicated
measures. personnel.Deviation: The cross-
contamination risk is not minimised
through effective measures, during the site
walk it was observed at acidification
preparing step that the plastic container
was in direct contact with floor, with no
identification an open during the
process//El riesgo de contaminación
cruzada no se minimiza a través de
medidas efectivas, durante la visita al sitio
se observó en el paso de preparación de
acidificación que el contenedor de plástico
estaba en contacto directo con el piso, sin
identificación y abierto durante el proceso.
97 4.9.1.1 Premises where food products A The facilities are adequate for the
are prepared, treated, production processes carried out in each
processed and stored shall be one. The buildings are of solid
designed and constructed to construction and of suitable materials. The
ensure food safety. product is not exposed and no risks
derived from the design and construction
were observed in any area. There are
extractors and injectors, so the risks of
condensation is minimized.
119 4.9.9.1 Water which is used as an A Water supply comes from site's wells, it is
ingredient in the production chlorinated accordingly to procedure PRC-
process, or for cleaning, shall DACH "desinfección de agua para
be of potable quality at the point consumo humano", to meet legal
of use and supplied in sufficient requirements. Water is monitored for free
quantity; this also applies to chlorine on a daily basis and is recorded
steam and ice used within the on format RGS-CCA-020. Well water is
production area. only chlorinated to comply with local
regulation from 0.3 to 3 ppm.There is an
actual schematic layout of water
distribution CRQ-TDA dated 04/02/2021.
Water potability is tested externally, on a
annual basis accordingly parameters
detailed in Peruvian regulation, records
reviewed: report# 1-06329/22 dated
20/05/2022 (physical, chemical and
microbiological parameters).
123 4.9.10.1 The quality of compressed air NA Compressed air is not used.
that comes in direct contact
with food or primary packaging
material shall be monitored
based on hazard analysis and
assessment of associated risks.
If gases are used, they shall
demonstrate adequate safety
and quality through a
declaration of compliance and
shall be suitable for the
intended use.
125 4.10.1 Based on hazard analysis and A Cleaning instructions are available and
assessment of associated risks, documented in procedure PRC-LDSCIA
cleaning and disinfection v.8 dated 27/07/2021, this included all
schedules shall be available equipment and utensils p.e. tables, dicers,
and implemented. These shall trays, retorts, tanks, conveyor belts,
specify: scales, etc., there is a cleaning
- objectives program/schedule PRG-PLD dated
- responsibilities 07/07/2021 where tasks, frequency and
- the products used and their responsible are detailed according to
instructions for use areas.Daily cleaning is carried out in
- dosage of cleaning and product contact surfaces: conveyor belts,
disinfection chemicals cutting equipment, tables, knives; weekly:
- the areas to be cleaned and/ retort, walls, dust mesh, sealing machines;
or disinfected biweekly: extractors, doors, windows,
- cleaning and disinfection cealings, pipes and lamps; monthly:
frequency curtains and ceilings.Cleaning activities
- documentation requirements were observed on day 2, and cleaning
- hazard symbols (if necessary). release with visual inspections, records
reviewed during the assessment:- RGS-
IDS-081 "Inspeccion diaria de sanidad"
daily cleaning inspection- RGS-LDSCDA-
066 contac surfaces cleaning- PRC-ACP-
068 no direct contact surfaces cleaning-
RGS-CLU-071 utensils cleaning- RGS-
LDSPIEU-091 weekly cleaning
132 4.10.8 Safety Data Sheets and A Safety data sheets and instructions of
instructions for use shall be chemicals are available at the general
available for chemicals and warehouse and at the cleaning chemicals
cleaning and disinfection warehouse for production areas, there is
agents. Personnel responsible also a table with approved chemicals and
for cleaning and disinfection dosification NST-TDILD dated
shall be able to demonstrate 27/07/2021.Examples reviwed during the
their knowledge of such assessment:- clean soap, TDS dated
instructions, which shall always 21/08/2020- acideter, TDS dated
be available on site. 07/10/2021- DDC-10, TDS dated
02/07/2020- food machinery grease, TDS
dated 12/07/2010
135 4.10.11 Where a company hires a third- NA Cleaning and disinfection are carried out
party service provider for by site's personnel.
cleaning and disinfection
activities, all requirements
specified above shall be clearly
defined in the service contract.
151 4.12.10 Where visual inspection is used A Visual inspections are carried out for
to detect foreign materials, the foreign material detection, personnel is
employees shall be trained and trained by areas and rotation to maximise
operative changes shall be effectiveness are carried out every 2
performed at an appropriate hours. Training records reviewed dated
frequency to maximise the 05/13/2021.
effectiveness of the process.
154 4.13.2 The company shall have C There is a pest management program
adequate pest control PRC-CP v.3 dated 09/05/2022, there is a
measures in place which shall PCO FEIRL that performs quarterly visits,
be in compliance with local the site is responsible of monitoring the
legal requirements and shall pest program and devices weekly. QA
take into account, at a team have designated CC/pest operator,
minimum: under the guidance of QA chief, last
- factory environment (potential training dated 02/12/2021. All records
pests) reviewed were found complete and
- type of raw material/finished signed. Results of controls are analyzed
products for trends monthly, information reviewed
- site plan with area for during the assessment showed that there
application (bait map) have not been infestation. A site map with
- constructional designs all pest devices is available as part of
susceptible for pest activity, program PLN-UTCR dated
such as ceilings, cellars, pipes, 03/03/2021.Pest control chemicals used
corners have a sanitary registration and are
- identification of the baits on suitable for use.Deviation: It is not assured
site that all bait stations are identified, e.g. 7,
- responsibilities, in-house/ 15 and 17 identification was not
external available//No se asegura que todas las
- agents used and their estaciones de cebadero se encuentran
instructions for use and safety identificadas, ej. estaciones 7, 15 y 17 no
- frequency of inspections se encontraron identificadas.
- rented storage if applicable.
The pest control measures shall
be based on hazard analysis
and assessment of associated
risks.
160 4.14.1 All incoming goods, including A Controls on the acceptance of raw
packaging materials and labels, materials do not compromise the safety,
shall be checked for conformity legality or quality of products.The
against specifications and a documented procedure for the acceptance
determined inspection plan. of raw materials are according to
The inspection plan shall be inspection plan v.1 dated 01/2021. Raw
justified by risk assessment. material acceptance and its release are
Records of those inspections based on one or a combination of:•
shall be available. product sampling and testing• visual
inspection on reception
161 4.14.2 The storage conditions of raw A Good storage conditions were observed
materials, semi-finished, during the assessment, heart of palm is
finished products and received in the afternoon, conditions of
packaging materials shall reception area are well maintained.
correspond to product Warehouse for packing material and
specification and shall not have finished goods have a rack system and a
any negative impact on other rotation system based in FIFO.
products.This shall be defined
in an implemented and
maintained system.
164 4.14.5 All products shall be clearly A Products are identified by coding, product
identified. Use of products shall is packed in box and the pallets are
be undertaken in accordance labeled with a card that includes lot,
with the principles of First In/ production date, quantity, client PO,
First Out and/ or First Expired/ destiny. After stability analysis are done,
First Out. QA gives a release notification so the
product can be labeled, final packing
according client's specification and
dispatch. The site produces based on
orders posted by client's, stock of products
is not kept. Reviewed during the
assessment, whole heart of palm 28 oz
cans, batch ALE 06/22/040, internal code
ALE251040Y, produced 09/02/2022, exp.
dated 30/06/2025.
166 4.15.1 The conditions inside the A Conditions of transport (cleaning and
vehicles, such as: security) are reviewed before each
- absence of strange smells loading, these are recorded in format RGS
- high dust load -ISLVC-090, this includes cleaning
- adverse humidity conditions, foreing materials and
- pests substances, absence of pests, security
- mould points in walls, ceiling and floor. Loading
shall be checked before loading area is observed in good cleaning and
and documented to ensure maintenance conditions. Example 1
compliance with the specified reviewed through documentation
conditions. (traceability exercise) batch ALE251040Y
destiny EU. All found to be in order.
179 4.17.1 Equipment shall be suitably A Process equipment is designed and built
designed and specified for the for the activities carried out, contact
intended use. Before surfaces are suitable for this purpose, e.g.
commissioning, it shall be tables, cutting blades are built in stainless
verified that the product steel, conveyor belts are plastic, trays are
requirements are complied with. plastic and have food contact compliance
statement.
185 4.18.2 The traceability system shall be C Traceability system is tested at least
tested on a periodic basis, at annually, tests are carried out for finished
least annually and each time products and raw materials, reviewed
the traceability system during the assessment: E.g. 1: test dated
changes. The test samples 25/06/2022, product heart of palm slices 1
shall represent the complexity kg, batch ALM3321/228, mass balance
of the company´s product 100% (418 envases), time < 4
range. The test records shall hours.Deviation: It is not assured that test
verify upstream and records are available for traceability
downstream traceability (from exercises from raw materials to finished
delivered products to raw goods//No se asegura que los registros de
materials, and vice versa). The prueba estén disponibles para los
traceability of the finished ejercicios de trazabilidad desde las
product shall be performed materias primas hasta los productos
within four (4) hours maximum. terminados.
192 4.19.2 Based on hazard analysis and A The company has carried out a risk
assessment of associated risk, assessment of its raw materials,
preventive and control ingredients and packaging MTR-FAI dated
measures shall be in place from 14/09/2021. The results of the risk
receipt to dispatch, to ensure analysis indicated that there are no
that potential cross allergens involved in the operations.
contamination of products by
allergens is minimised. The
potential cross contamination
risks related to:
- environment
- transport
- storage
- raw materials
shall be considered. Control
measures shall be verified.
197 4.20.4 The food fraud vulnerability A Last review dated 21/02/2022.
assessment shall be regularly
reviewed, at least annually,
and/or in the event of increased
risks. If necessary, the food
fraud mitigation plan shall be
revised/updated accordingly.
202 5.2.1 Site and factory inspections A There is a site inspection program with a
shall be planned and carried frequency based on risk determined in
out for topics such as: MTR-HGPR dated 29/03/2022: daily
- constructional status of inspections to internal areas, reception,
production and storage boilers, chemical warehouse, maintenance
premises workshop and personnel facilities; weekly
- external areas inspections (pest program) to internal and
- product control during external areas structures (walls, doors,
processing floor, windows, nets). Annually as required
- hygiene during processing by legal requirement with DIGESA
and within the infrastructure checklist. These inspections are carried
- foreign material hazards out by QA staff. Results of inspections are
- personnel hygiene. recorded in format RGS-IISIET-055,
The frequency of inspections examples reviewed during the assessment
shall be justified by risk dated 31//05/2022.
assessment and be based on
the history of previous
experience.
203 5.3.1 The criteria for process and A Verification of CCPs is carried out by the
working environment validation site, annually to establish operation limits,
and control shall be clearly e.g. CCP1 pH < 4,2 in finished product,
defined. Where the control of salt% related to clients specification,
process and working CCP2 heat treatment validation was
environment parameters carried out by TechniCAL dated
(temperature, time, pressure, 02/02/2017, product validation reviewed:
chemical properties, etc.) are carried pout by Grupo FS tall 15 oz
essential to ensure the food 06/01/2017; where time, temperatures,
safety and product quality pressure accordingly to type of product
requirements, such parameters and packaging have been carried out, no
shall be monitored and cold points have been identified. Cleaning
recorded continuously and/ or processes are verified through visual
at appropriate intervals. inspection and microbiology, surveillance
are carried out daily, internal process
(conveyors, utensils), packing (cans/jars,
filters), heat treatment area (brine, water
tanks). Microbiology swabs are taken
annually accordingly to testing plan,
analysis carried out to contact surfaces -
hands, aprons and gloves (S. aureus,
Salmonella), contact surfaces and utensils
(coliforms, Salmonella), environment
(TVC, yeast and molds). All records found
in order with no deviations on
results.Reviwed during the assessment:-
report N° 012-UMAA-P/2022 dated
11/01/2022 (environment) - report N° 011-
UMAA-P/2022 dated 11/01/2022, results
for coliforms, S. aureus and Salmonella
(hands)- report N° 010-UMAA-P/2022
dated 11/01/2022, results for coliforms and
Salmonella (filling tables, classification
conveyor, cutting table, peeling conveyor)-
lighting report 0168-2021 dated
25/11/2021No deviations reported.
204 5.3.2 All rework operations shall be NA Rework is not carried out.
validated, monitored and
documented. These operations
shall not affect the food safety
and product quality
requirements.
207 5.4.1 The company shall identify and A There is a calibration program CRN-CEIM,
record the measuring and that includes a master list of equipment
monitoring devices required to with identification code, date of last
ensure compliance with food calibration and date for next calibration
safety and product quality and frequency.
requirements. Their calibration
status shall be recorded.
Measuring and monitoring
devices shall be legally
approved if required by
legisltation.
208 5.4.2 All measuring devices shall be A Records reviewed during the assessment:
checked, adjusted and - micrometer certificate TC-02285/2022
calibrated at specified intervals, dated 1/02/2022- vacuummeter certificate
with a monitoring system. This TC-01317-2022 dated 27/01/2022-
system shall be in accordance thermometer (blanching) certificate TC-
with defined, recognised 01290-2022 dated 29/01/2022- incubator
standard/ methods and within (37°C) certificate TC-01319-2022 dated
relevant limits of the process 07/02/2022- incubator (55°C) certificate
parameters values. The results TC-01320-2022 dated 07/02/2022-
of the checks, adjustments and thermometer (brine) certificate TC-01289-
calibrations shall be 2022 dated 29/01/2022- weight pattern
documented. certificate TC-01608-2022 dated
29/01/2022- ph meter certificate TC-01318
-2022 dated 28/01/2022
210 5.5.1 The company shall define A The plant operates a quantity control
compliance criteria to control lot system, which conforms to legal
quantity. A frequent and requirements in the country where the
methodological strategy for product is sold and customer
quantity control shall be in requirements.Products are packed to
place to meet legal minimum weight and individual jar/can is
requirements of the destination weighed.Weight control reviewed during
country/ies and customer the site walk and the traceability test, were
specifications. found to be satisfactory. Records are in
place, every batch 2 or 3 samples are
taken for drained weight, records available
RGS-CPD-028.
212 5.6.1 Testing plans, for internal and A Product is tested every production batch
external analysis shall be at the site's laboratory for pH, salt, acidity,
justified by risk assessment to sensory parameters, defects, net and
ensure that product safety, drained weight, also stability is carried out
quality, safety, legal and specific at ambient, 37°C, 55°C for 8 days
customer requirements are met. according to product testing plan MNL-
The plans shall cover topics, CCPT v. 4 dated 12/07/2021. All records
such as: reviewed for traceability test and products
- raw materials processed during the assessment were
- semi-finished products, found to be in order.External analysis
- finished products reviewed:Finished product:- analysis
- packaging materials report 1-06731/22 dated 20/05/2022 for
- contact surfaces of processing acidity, salt, fiber, pH, heavy metals,
equipment commercial stability (thermophiles).-
- relevant parameters for nutritional report INF-VVNCP dated
environmental monitoring. 14/02/2020, external anlysis report 1-
All test results shall be 11117/19 dated 22/11/2019Raw materials:-
recorded. citric acid report 1-05546/22 dated
21/05/2022 for ash, citrate, moisture,
purity, sulphates, Pb- salt report 1-
06426/22 dated 20/05/2022 for heavy
metals, purity, moisture, sulphates,
coliforms- heart of palm report 1-06337/22
dated 21/05/2022 for heavy metals,
pesticides
213 5.6.2 Analyses, which are relevant for A Laboratories used for external analysis
food safety, shall preferably be and to evaluate reliability of results are
performed by laboratories with ISO/IEC 17025 accredited:- CERPER S.A.
appropriate accredited accreditation N° LE-003 valid until
programs/ methods (ISO/IEC 06/2023; - TEST&CONTROL (calibration)
17025). If the analyses are accreditation N° LC-416 valid until
performed internally or by a 07/2022
laboratory without the
appropriate accredited
programs/ methods, the results
shall be verified on a regular
basis by laboratories accredited
to these programs/ methods
(ISO/IEC 17025).
219 5.7.1 A procedure for quarantine A Procedure for product release is in place
(blocking/hold) shall be in place PRC-CLPT v.6 dated 16/07/2021 "
that is justified by risk Cuarentena y Liberación de Producto
assessment. The procedure Terminado". Release process is based on
shall ensure that only raw stability analysis of the product at ambient,
materials, semi-finished and 37°C and 55°C for 7 days accordingly to
finished products and legal and client's requirements, to confirm
packaging materials conforming pH and sensory parameters, these are
to product requirements, are recorded in format RGS-IPF-002. All
processed and dispatched. records were in order.
232 5.11.2 KO N° 10: Corrective actions A Corrective actions are developed and
shall be clearly formulated, track through CAPA matrix RGS-ACPM-
documented and undertaken as 057, managed by QA chief and senior
soon as possible to avoid the manager, a full description of non-
further occurrence of non- conformance, with a root cause analysis
conformities. The (5Ws), inmediate action taken and
responsibilities and the responsible of the process to address the
timescales for corrective correction within timescale,
actions shall be clearly defined. corrective/preventive action plan.
Verification of corrections are carried out
by QA personnel. The cause analysis and
corrective actions defined for the
deviations of the internal audit,
autoinspections and customer complaints
were reviewed.
235 6.2 A food defence plan and A The site has a Food Defence procedure
procedure shall be developed PRC-FD v. 4 dated 04/01/2022
based on probability and be implemented, annual review of Food
implemented in relation to Defense plan DAFA carried out in
assessed threats. This shall 21/02/2022. The procedure has
include: considered all production and warehouse
- legal requirements areas, and found to be critical, mitigation
- identification of critical areas strategies include access restriction to
and/or practices and policy of authorized personnel and monitored by
access by employees identification, secured with padlocks,
- visitors and contractors biqeekly security inspections (last dated
- all other appropriate control 30/06/2022), and CCTV monitoring. Last
measures. food defense test was carried out in
The food defence plan shall be 02/2022.
reviewed at least annually, and
updated when appropriate.
Assessment participants
Name Position Opening On-site Documenta- Closing
meeting assessment tion review meeting
Agriculture
JC
Department
LR Logistics
LC Maintenance