China 2013 Audit Poultry Processing Inspection System 151D
User Manual: 151D
Open the PDF directly: View PDF 
.
Page Count: 30
| Download | |
| Open PDF In Browser | View PDF |
United States
Department of
Agriculture
Food Safety
and Inspection
Service
Washington, D.C.
20250
Li Chunfeng
Deputy Director General
General Administration of Quality Supervision,
Inspection and Quarantine (AQSIQ)
Beijing, People's Republic of China
AUG 3 0 2013
Dear Dr. Li:
The Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture
(USDA) conducted an on-site verification audit ofthe People' s Republic of China (PRC)
poultry processing inspection system from March 4-19, 2013. FSIS submitted the draft audit
report on June 28, 2013 and PRC responded on August 29, 2013 with a few minor suggestions.
The draft audit report was update with your suggestions. Enclosed is a copy of the final audit
report for poultry processing inspection system. This report was published on the FSIS website
(http://wvvw.fsis.usda.gov) on August 30,2013.
As all outstanding issues have been resolved, the PRC may proceed with certifying a list of
poultry processing establishments as meeting the FSIS requirements. These certified
establishments may then begin exporting processed (heat-treated/cooked) poultry products to
the United States under the conditions established in FSIS' April 2006 final rule; i.e. only
processed poultry products produced from poultry slaughtered under FSIS inspection in the
United States or in a country eligible to export slaughtered poultry to the United States.
If you have any questions, please contact me at telephone number 202-720-6400, facsimile
number 202-720-7990, or by e-mail at internationalequivalence@fsis.usda.gov.
9;ls~:V-
Andreas Keller {:;~
Director
International Equivalence Staff
Office of Policy Program Development
Enclosure
Dr. Li Chunfeng
2
Scott SiridelaT, US Embassy, Beijing, China
Ralph Bean, Acting minister Counselor for Agriculture Affairs
Michael Riedel,- Senior Attache
Ryan R. Scott, Agricultural Attache
Morgan Perkins, F AS, North Asia Area Director
Casey Bean, OASA, FAS
Catherine Fulton, OASA, FAS
Cecilia S. Choi, EB, State Department
AI Almanza, Administrator, FSlS
Carmen Rottenberg, Acting Chief of Staff, OA
William C. Smith, Asst. Administrator, OlEA
Jane Roth, Deputy Asst. Administrator, OlEA
Vincent Fayne, Director, MCAD, OlEA
Dee Dee Fumey, FSlS, OA
Daniel Engeljolm, Asst. Administrator, OFO
Rachel Edelstein, Assistant Administrator, OPPD
Soumaya Tohamy, Deputy Asst. Administrator, OPPD
Mary Stanley, Director, IPD, OPPD
Ronald K. Jones, Deputy Asst. Administrator, OFO
Andreas Keller, Director, IES, OPPD
Rick Hanies, Director, EPS, OPPD
Rita Kishore, Deputy Director, EPS, OPPD
Linda Chittum, Acting Director, liD, OFO
Shaukat Syed, Director, lAS, OlEA
Francisco Gonzalez, lAS, OlEA
Cham1aine McGee, EPS, OPPD
Priya Kadam, IES, OPPD
FSIS:OIA:lES:PKadam: ChinaPoultryProcessingFinalAuditReportLetter08-30-2013.docx
FINAL REPORT OF AN AUDIT CONDUCTED IN
TI-IE PEOPLE'S REPUBLIC OF CHINA
March 4 through 19, 2013
FSIS AUDIT OF THE FOOD SAFETY SYSTEM GOVERNING
THE PRODUCTION OF PROCESSED POULTRY
INTENDED FOR EXPORT TO
THE UNITED STATES OF AMERICA
Food Safety and Inspection Service
United States Department of Agriculture
1
Executive Summmy
This audit report describes the outcome of an on-site corrective action verification audit
conducted by the U.S. Department of Agriculture's (USDA) Food Safety and Inspection Service
(FSIS) on March 4-19, 2013, to determine whether the People's Republic of China's (PRC) food
safety system governing poulh·y processing remains equivalent to that of the United States
(U.S.), with the ability to produce products that are safe, wholesome, unadulterated, and properly
labeled. This audit was necessary to assess the effectiveness of the corrective actions the PRC
submitted in response to the December 1-21, 2010, verification audit. The March 2013 poultry
processing audit was conducted concunetitly with an equivalence audit of the PRC's poultry
slaughter inspection system, for which the observed findings are included in a separate report.
Representatives from the Certification and Accreditation Administration (CNCA), China
Inspection and Quarantine (CIQ) Shandong province, and USDA's Foreign Agricultural Service
(FAS) accompanied the FSIS auditors during the audit.
The audit focused on the ability of the Central Competent Authority (CCA), the General
Administration for Quality and Safety Inspection and Quarantine (AQSIQ), to regulate processed
poultry production. FSIS audited four poultry processing establishments, the CCA headquarters,
and the CIQ Shandong province govenunent offices. Detenninations concerning the
effectiveness of the PRC's food safety program focused on perfom1ance within the following six
equivalence components: (1) Govenunent Oversight, (2) Statutory Authority and Food Safety
Regulations, (3) Sanitation, (4) Hazard Analysis and Critical Control Point Systems, (5)
Chemical Residue Programs, and (6) Microbiological Testing Programs.
Based on the analysis of the corrective actions submitted by the PRC in response to the 2010
audit and the results of the 2013 audit, FSIS concludes that the CCA has adequately addressed all
previously identified concems. Therefore, the PRC's processed poultry inspection system meets
the equivalence components for FSIS equivalence criteria. Because all outstanding issues have
been resolved, the PRC may proceed with certifying a list of establishments eligible to export
processed (heat-treated/cooked) poultry products to the United States, as long as the raw poultry
is sourced from countries that FSIS determined to have a poultry slaughter inspection system
equivalent to the U.S. system.
FSIS submitted the draft audit report to PRC on July 1, 2013 and PRC responded on August 29,
2013 with no substantive issues with the report.
2
TABLE OF CONTENTS
1. INTRODUCT-ION
2. AUDIT OBJECTIVE, SCOPE, AND METHODOLOGY
3. LEGAL BASIS FOR THE AUDIT
4. BACKGROUND
5. GOVERNMENT OVERSIGHT
6. STATUTORY AUTHORITY AND FOOD SAFETY REGULATIONS
7. SANITATION
8. HAZARD ANALYSIS AND CRITICAL CONTROL POINT SYSTEMS
9. CHEMICAL RESIDUE PROGRAMS
10. MICROBIOLOGICAL TESTING PROGRAMS
11. EXIT MEETING
12. CONCLUSIONS
13. ATTACHMENTS TO THE AUDIT REPORT
3
ABBREVIATIONS AND SPECIAL TERMS USED IN THE REPORT
AI-IVB
Animal Husbandry and Veterinary Bureau
AQSIQ
Administration of Quality and Supervision and Inspection Quarantine
CCA
Central Competent Authority (AQSIQ)
CFR
Code ofFederal Regulations
CIQ
China Inspection and Quarantine Authority (Branch and Provincial)
CNAS
China National Accreditation Service for Conformity Assessment
CNCA
Certification and Accreditation Administration
E. coli
Escherichia coli
FSB
Entry-Exit Food Safety Bureau
FSL
PRC Food Safety Law
FSIS
Food Safety and Inspection Service
GB
Guobiao
HACCP
Hazard Analysis and Critical Control Point
Lm
Listeria monocytogenes
MOA
Ministry of Agriculture
MOI-l
M.inish-y of Health
PPIA
Poultry Products Inspection Act
PRC
People's Republic of China
RTE
Ready-to-Eat
Salmonella spp.
Salmonella species
SSOP
Sanitation Standard Operating Procedures
u.s.c.
United States Code
4
USDA
United States Department of Agriculture
VIC
Veterinarian-in-Charge
5
1. INTRODUCTION
The Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture
(USDA) conducted an on-site corrective action verification audit of the People's Republic of
China's (PRC) poultry processing inspection system on March 4-19, 2013. This audit was
conducted simultaneously with an FSIS on-site equivalency verification audit of the PRC's
poultry slaughter inspection system, for which the observed findings are included in a separate
report.
The audit began with an entrance meeting on March 4, 2013, in Beijing with the participation of
representatives from the General Administration of Quality Supervision, Inspection and
Quarantine's (AQSIQ) Central Competent Authority (CCA); the Certification and Accreditation
Administration (CNCA); Inspection and Quarantine (CIQ) from the Shandong province;
representatives from USDA's Foreign Agriculhiral Service (FAS) at the United States EmbassyBeijing; and the FSIS audit team. The FAS provided assistance with translations and travel
logistics.
2. AUDIT OBJECTIVE, SCOPE, AND METHODOLOGY
FSIS' objective for the audit was to verify that the PRC's food safety system governing poultry
processing is equivalent to that of the United States (U.S.), with the ability to produce and export
products that are safe, wholesome, unadulterated, and properly labeled. In pursuit of this
objective and prior to the on-site verification audit, FSIS reviewed and analyzed the proffered
corrective actions and accompanying references submitted by the CCA to address findings FSIS
identified in the 2010 audit as not being equivalent for each of the components of the poultry
processing inspection system.
Representatives from the CNCA, CIQ-Shandong, and PAS-Beijing accompanied the FSIS
auditors throughout the audit. Determinations concerning program effectiveness focused on
performance within the following six equivalence components upon which system equivalence is
based: (1) Government Oversight, (2) Statutory Authority and Food Safety Regulations, (3)
Sanitation, (4) Hazard Analysis and Critical Control Point (HACCP) Systems, (5) Chemical
Residue Programs, and (6) Microbiological Testing Programs.
FSIS auditors evaluated the implementation of management control systems developed by the
PRC to ensure that poultry inspection verification and enforcement activities are standardized.
The govemment offices audited included the CCA headquarters in Beijing, and the CIQ
Shandong Provincial office along with interviews of representatives from tlu·ee CIQ local offices
in the Shandong province.
To verify the CCA's ability to provide consistent government oversight, FSIS visited four
poultry processing establislunents identified by the CCA as eligible to export poultry products to
the United States. During establislm1ent visits, FSIS placed its emphasis on the CCA's ability to
provide oversight of inspection personnel through supervisory reviews conducted in accordance
6
with Title 9 U.S. Code ofFederal Regulations (CFR), Part 381.196 and the in-plant inspectors'
ability to verify industry compliance with the associated laws and regulations.
This 2013 verification audit did not include visits to the analytical laboratories because the
auditors did not report systemic deficiencies with the teclmical support of the poultry processing
inspection system in the 2010 audit report. A copy of the 2010 report can be viewed on the
FSIS Web site at www..f~is.usda.gov/OPP DEIFA R/China!China2010_Poult1y _Processing. pdf
Audit Scope Summary
Sectors Audited
Central Authority
Competent Authority
Offices
Provincial Office
No.
1
Locations
AQSIQ, Beijing
1
Shandong Entry-Exit Inspection and
Quarantine Bureau, Qingdao
Qingdao, Weifang, Dezhou
3
Local Offices
•
•
•
Poultry Processing Establishments
4
•
Qingdao 9-Alliance Group, Ltd
Zhucheng Waimao Co., Ltd
Weifang Legang Food Co., Ltd
Zhong' AO Holdings Group Co., Ltd
3. LEGAL BASIS FOR THE AUDIT AND AUDIT STANDARDS
The audit was conducted under the specific provisions ofthe United States' and the PRC's laws
and regulations, specifically:
U.S. Poultry Products Inspection Act, Title 21 United States Code (U.S.C.) 451 , et seq.)
U.S Poultry Products Inspection Regulations regarding eligibility to import to the United States
(9 CFR 381.196)
PRC Food Safety Law (FSL), 2009
PRC Administrative Rules on Quarantine of Animal (Decree No.6), January 21,2010
While the audit standards include applicable legislation and procedures submitted to FSIS by the
PRC, this audit included a review of the proffered corrective actions submitted to FSIS by the
PRC in response to the 20 I 0 audit findings as part of the of the document review and the
equivalence determination process.
7
4. BACKGROUND .
The PRC first requested an initial equivalence determination of its poultry processing inspection
system in May 2004, for which FSIS conducted on-site audits in 2004. In 2006, FSIS
determined that the PRC's poultry processing inspection system was equivalent to that of the
U.S. The PRC was added to the list of countries eligible to export processed poultry to the
United States with the following stipulation: processed heat-treated poultry products must be
derived from flocks slaughtered under (1) the U.S. inspection system or (2) the inspection system
of another country eligible to export slaughtered poultry products to the United States. Only such
poultry would be permitted to be imported into the United States in accordance with 9 CFR §
94.6 (b), 9 CFR 381, and the Poultry Products Inspection Act (PPIA). This restriction is in place
because USDA's Animal and Plant Health Inspection Service (APHIS) does not consider the
PRC to be free of Highly Pathogenic Avian Influenza (HPAI) and Exotic Newcastle Disease
(END). As a result of this APHIS animal disease status designation, exports to the United States
ofraw poultry from AI and END affected regions of the PRC are prohibited.
After conducting a comprehensive analysis of the PRC' s Food Safety Law 2009 and all relevant
legislation supporting the PRC's poultry processing inspection system, FSIS conducted a
verification audit in 2010 to reaffirm the ongoing equivalence status of the PRC's processed
poultry inspection system, which is required to reinstate their export eligibility. However, there
were several findings that needed corrective actions, which are detailed in the 2010 audit report
(wwwfsis. usda.gov/OPP DEIFAR/China/China201 0_Poult1y_Processing.pdj).
The PRC submitted corrective actions in response to th~ 2010 findings . In July 2011, the PRC
submitted two manuals, Inspection Quarantine Manual for Poult1y Exported to America
(IQMPES) and Microorganism Monitoring Program for Export Poult1y Products (Jv!MEPP).
FSIS reviewed and analyzed the corrective actions and these manuals as a precursor to
conducting the 2013 verification audit. During the 2013 audit, tl1e PRC submitted revisions to
the manuals, changing the name, content, and version numbers of both manuals, while improving
many sections from earlier versions. The inspection manual has been changed to Inspection
Quarantine and Supervision Work for Poultry Products Exported to the US. Handboo!C'
(IQSWPPEUH version 1.1). The microbe manual has been changed to Monitoring Programfor
Microbes in Export Poult1y Products (MPMEPP version 1.0).
FSIS auditors verified the adequacy of the coiTective actions that the CCA had proff ered in
response to the 2010 audit findings and then reassessed FSIS' prior determination of equivalence
for the PRC 's poultry processing inspection system.
5. GOVERNMENT OVERSIGHT
The first of the six components that the FSIS auditors reviewed was Government Oversight. The
evaluation included a review and analysis of corrective actions the CCA submitted in response to
the 2010 audit findings. Based on the analysis of the corrective actions the PRC submitted in
response to the 2010 audit and the results ofthe verification activities conducted in the 2013
8
audit, FSIS concludes that the CCA has adequately addressed the identified concerns reported for
this equivalence component. Therefore, the PRC's poultry processing inspection system
continues to meet-FSIS equivalence criteria for this component.
In the 2010 audit, the FSIS auditors confirmed that the State Council of the PRC delegates to
AQSIQ the authority to administer the poultry processing inspection system for exports.
AQSIQ serves as the CCA responsible for the safety offood products, promulgation of
regulations on food inspection, and the sole authority to enforce the laws and regulations
governing the export system. Registration and certification of import/export food enterprises is
conducted by two major bureaus of the CCA: the Certification and Accreditation Administration
(CNCA) and the Entry-Exit Food Safety Bureau (FSB). These bureaus verify that establishments
fulfill official requirements before they grant the establishments' certification to export. Funding
for CCA operations is provided by the central government and supplemented by fees assessed by
the goverrunent on exported products.
The auditors also determined that the PRC Ministry of Agriculture (MOA) and the Ministry of
Health (MOH) interact with the CCA to maintain appropriate regulation of the production of
poultry products for export. Under tllis arrangement, the China National Accreditation Service
for Conformity Assessment (CNAS) and the CCA, have promulgated the national standard that
provides the general requirements for laboratory quality systems. FSIS auditors observed that
the CCA delegates to inspection and quarantine bureaus (CIQ) located throughout the country
the responsibility to implement inspection of animals and animal products and to regulate poultry
processing activities at establislunents producing products for export. The organizational
structure for the delegation of authority has not changed since the 2010 audit.
In the 2010 audit, tl1e auditors reported that the CCA allowed establishment-paid inspectors to
conduct regular pre-operational sanitation verification at processing establishments. The use of
establislm1ent-paid inspectors conducting inspection activities could result in biased decisions
leading to the export of unsafe poultry products to the United States. This arrangement
constituted a conflict of interest and did not meet the requirements for ultimate control and
supervision over the official activities of all employees of the system, as articulated by FSIS
import regulations (9 CFR 381.196). As a corrective action, AQSIQ proposed to employ
goverrunent officials to conduct all official sanitation verification.
During the 2013 audit, FSIS auditors verified tl1at the CCA has implemented measures to ensure
that employees of the PRC govermnent perform official enforcement of regulatory requirements
tlu-ough cross referencing the ID badges and names of the CIQ inspectors observed performing
inspection work with the following: the CIQ office employment database; an employee pay
stub; training records; and a list of nan1es of CIQ employees, including tl1ose interviewed.
The employment records demonstrated that personnel conducting inspection activities were
employees of the PRC government. The CCA hires and utilizes official employees to conduct
inspection duties, including sanitation. The CIQs hire official staff assigned to work at
establislunents producing cooked poultry products destined for the United States and retain
employee records. PRC employees are issued ID cards, with or without photos, and assigned
specific numbers that correlate to the respective CIQ Bureau database. Based on review of the
9
documentation, FSIS auditors determined that inspection personnel who are performing
governn1ent oversight are employees of CIQ.
In the 2010 audit, the auditors found that the provincial CIQs oversaw the inspection system by
designing and implementing inspection procedures as per PRC 's national standards. The PRC's
standards are in addition to those standards imposed by other importing countries. Auditors also
found that CIQ procedures were not consistently applied throughout the country. FSIS
concluded that this autonomy created significant variation in the application ofthese standards
among provinces. FSIS auditors reported that a recurring finding in the PRC ' s system was the
lack of standardized inspection procedures and thus the lack of govenm1ent oversight of its
inspection personnel.
·
In July 2011, the PRC submitted its response to this finding with two manuals, Inspection
Quarantine Manual for Poult1y Exported to America (IQMPES) and Microorganism Monitoring
Program for Export Poult1y Products (MMEPP). The purpose of the manuals is to implement
consistent inspection and verification activities of the systems across provinces that have
establishments identified as eligible to export poultry products to the United States. To maintain
consistency in the implementation of inspection procedures across all the provinces, the CCA
trained inspectors assigned to eligible establislunents on these manuals.
In the 2013 audit, the CCA identified one province (Shandong) with tiu-ee branch CIQ Offices as
having four eligible establishments to export poultry products to the United States. The auditors
noted that the CCA revised the manuals it had provided to FSIS in the 2011 response, creating
ti1e new ti1e Inspection and Quarantine and Monitoring Manual for PoultJy Exported to America
(IQMMPEA), and the Microorganism Monitoring Program for Export Pou!tJy Products
(MMEP P). The auditors confirmed that the CCA had disseminated the two newly revised
manuals, IQMMPEA and MMEPP, to the CIQ offices and establislm1ents and reviewed training
records for inspection persmmel at ti1e provincial CIQ, and local CIQ offices. FSIS auditors
confirmed consistent application of inspection procedures in all establislunents.
During the 2013 audit, the PRC submitted revisions to the previous manuals, changing the name,
content, and versions numbers of both manuals while improving many sections from earlier
versions. The inspection manual was changed to Inspection Quarantine and Supervision Work
for Poult1y products Exported to the U.S. Handbook (IQSWPPEUH version 1.1 ). The microbe
manual was changed to Monitoring Program for Microbes in Expqrted Poultty Products
(MPMEPP version 1.0). Based on analysis of the current revised manuals, the auditors
concluded that the CCA had standardized inspection procedures across ti1e CIQ offices and the
four establislunents within the Shandong province.
In the 2010 audit, the auditors observed that the CCA provided training to the newly hired
inspection personnel and developed provisions for ongoing training. However, the auditors
observed that the CIQ inspectors did not demonsh·ate an ability to verify that implementation of
Hazard Analysis and Critical Control Point (HACCP) and microbiological testing programs was
consistent with PRC requirements. In response, AQSIQ provided training on HACCP,
Sanitation Standard Operating Procedures (SSOP), Listeria monocytogenes (Lm), and sanitation
in 2012.
10
In the 2013 audit, the auditors interviewed CCA officials and CIQ supervisory and in-plant
officials on the contents of the two manuals, inspection procedures, HACCP, sanitation,
microbiological hazards for Ready-to-Eat (RTE) products, and microbiological sampling and
testing procedures and practices. The FSIS auditors confirmed that inspection personnel were
trained on the fundamentals ofthe aforementioned inspection activities. The inspection
persmmel were able to identify all components of the written HACCP progran1s maintained by
the establishments, including microbiological hazards for RTE products. To :further assess
inspection personnel ' s lrnowledge ofHACCP, RTE programs, and supervisory assessment, the
auditors developed mock scenarios seeking projected actions expected for each scenario. CIQ
personnel were able to successfully demonstrate the knowledge required to make decisions and
take actions in accordance with the regulations of the system.
Also during the verification activities, FSIS confirmed that CIQ supervisory personnel conducted
and documented periodic evaluations of employee performance. Supervisors were interviewed
and asked to describe: (1) their preparation work/method prior to conducting subordinate
evaluation; (2) the types of questions asked of an employee during the evaluation regarding
inspection duties and knowledge ofHACCP principles; (3) whether or not the evaluation
included onsite observation in the performance of inspection activities and any sample questions
that are asked during the observation; (4) whether or not establishment written programs and
testing results are reviewed with the employee; and (5) the type of feedback (oral or written)
provided to an employee. The auditors detem1ined that the supervisors were lrnowledgeable on
these five items.
Auditors reviewed and discussed with the supervisors a sample of a completed evaluation form,
Official Patrolling Supervision Record. The auditor noted that the form did not contain the
employee's nan1e, but instead contained the establishment number. The auditors asked how one
would know which employee was evaluated. CIQ supervisor explained that the employee's
nan1e appears in the body of the document.
Supervisors were asked to describe the procedures to handle employees who demonstrate an
inability to perform inspection duties at a satisfactory level. It was explained that for an
employee deemed unfit for duty, CIQ provides additional training and the employee's
weaknesses are discussed. If the employee continues to be w1able to perform inspection duties
adequately, the person is transferred to another agency. The auditors concluded that supervisors
had the ability to effectively assess a subordinate's knowledge, skills, and ability in the
performance of inspection activities and had a process to remove an employee who is not able to
satisfactorily perform inspection duties.
Based on the analysis of the conective actions the PRC. submitted in response to the 2010 audit
and the results of the current verification activities conducted in the 2013 audit, FSIS concludes
that that the CCA has adequately addressed previously identified concerns. The CCA has hired
government inspectors to conduct verification activities and trained those employees to perform
the work. The CCA has also created and disseminated two manuals that can be uniformly
implemented across all establishments exporting processed poultry to the United States. FSIS
also detem1ined that supervisory staff demonstrated the ability to effectively assess a
11
subordinate's knowledge, skills, and ability in the performance of inspection activities and had a
process to remove an employee who was not able to satisfactorily perfonn official duties.
Therefore, the PRC's poultry process inspection system meets FSIS equivalence criteria for this
component.
6. STATUTORY AUTHOIUTY AND FOOD SAFETY REGULATIONS
The second of the six equivalence components that FSIS auditors reviewed was Statutory
Authority and Food Safety Regulations. This component pertains to the legal authority and the
regulatory framework utilized by the CCA to impose requirements equivalent to those governing
the system of processed poultry inspection organized and maintained in the United States. Based
on analysis of the corrective action submitted by the PRC in response to the 2010 audit and the
results of the current verification activities conducted in the 2013 audit, FSIS concludes that the
CCA has adequately addressed previously identified concerns reported with this equivalence
component. Therefore, the PRC's poultry processing inspection system meets FSIS equivalence
criteria for this component.
In 2010, FSIS auditors reported that the PRC's inspection system of processed poultry provided
requirements for processed poultry inspection activities; establislunent construction; control over
inedible and condemned materials; and daily inspection and periodic supervisory reviews of
official establislm1ents. In the 2013 audit, FSIS auditors confirn1ed that these requirements had
not changed.
In the 2010 audit, the auditors reported that establishment-paid inspectors were conducting
official pre-operational sanitation verification at processing establislm1ents. This finding was
presented to the CCA as an issue that constituted a potential conflict of interest. As a corrective
action, AQSIQ proposed to employ government officials to conduct all official sanitation
verification activities.
In 2013, FSIS auditors verified that the CCA has implemented measures to ensure that
employees of the PRC perform official enforcement of regulatory requirements through cross
referencing the ID badges and names of the CIQ inspectors observed performing inspection work
with CIQ office employment database, an employee pay stub, training records and a list of
names of CIQ employees, including those interviewed. The employment records demonstrated
that personnel conducting inspection were PRC employees. The CCA hires and utilizes official
employees to conduct inspection duties, including sanitation. The CIQs hire official staff
assigned to work at establislunents producing cooked poultry products destined for the United
States and retain employee records. PRC employees are issued ID cards, with or without photos
and assigned specific numbers that con-elate to the respective CIQ Bureau database. This
potential conflict of interest involving establishment-paid officials conducting inspection
activities has apparently been resolved.
In the 2013 audit, FSIS auditors interviewed supervisory and in-plant CIQ persom1el to verify
their knowledge of U.S . requirements, CCA regulations, and the two manuals, as well as to
determine their ability to conduct supervisory reviews. The auditors also observed and
12
interviewed in-plant CIQ inspectors as they performed their assigned duties related to the
verification of the adequacy of the establislunents' HACCP and operational sanitation programs.
During an observation assessment of inspection activities, an auditor discussed the operational
cooking records with the CIQ inspectors and asked the inspectors to describe specific features
within the record that aid in determining compliance and accuracy of the records. Inspectors
were asked to provide the critical control point (CCP) process step, the critical limit and
frequency of monitoring for each CCP of the records reviewed, and the number of CCPs within
the HACCP plan. Upon returning to the establishment's conference room, the auditors reviewed
with the inspectors the HACCP plan for each of the CCPs against the records reviewed during
the plant tour. The inspectors were also asked to describe the components of a HACCP program
and the type of training received. FSIS auditors found that supervisory and in-plant inspectors
were knowledgeable about their responsibilities and had the competency to perform their duties.
A minor one-time observation occurred at one establishment regarding a design flaw of the
establishment's recordkeeping form; the fonn did not account for additional temperature
verification checks being conducted by the establislm1ent Quality Control personnel. These
additional temperature verification checks were not described in the HACCP plan. During the
discussions with the inspector, he articulated measures expected to be taken by both the plant and
himself regarding compliance of critical limits and product safety, which would correct the
recordkeeping form and the HACCP plan to account for the additional temperature verification
checks. He was able to demonstrate through the additional temperature verification checks that
the product had met the critical limit and was safe. However, he failed to say he would
document the noncompliance though he had earlier described as part of his training the need for
documentation of the noncompliance along with the name of the noncompliance fonn to be used.
It is unclear why he did not list tilis activity during the discussion; however, the inspector
eventually stated he would document the noncompliance. A noncompliance record was
produced for this incident.
The auditors also reviewed and discussed the revised form Pre-Operational Inspection Official
Onsite Verification ofCooked Plants, which deals with sanitation and is generated and
maintained by the CIQ officials, and verified that officials prepared detailed documentation of
observed findings, which includes preventive measures by the establishment and verification
notation for corrective actions and signatures of the CIQ inspectors. The CCA introduced this
revised official form for-completion by ti1e CIQ inspectors conducting pre-operational sanitation
inspections and verification. The establishment must complete the form Pre-Operational Record
ofCooked Plants to document pre-operational facility reviews. During an observation
assessment of sanitation activities, the inspectors were asked to describe tile specific sanitation
reviews conducted before and during operations, as well as specifics regarding the establishment
procedures. The auditors were able to observe, in one plant, scheduled hand washlng and
sanitizing via a portable cart wheeled into each room by two Quality Assurance (QA) employees.
Employees washed their hands at the cart, and the QA employee sprayed a sanitizer on their
gloved hands before they returned to work. This activity occurred every 30 minutes. The
inspector stated that poultry meat, wllich falls on the floor, is placed inside plastic lined inedible
trash cans and only designated plant employees discard.the trash into a locked chamber
compartment at the end of the day.
13
In accordance with the analysis of the cmTective action submitted by the PRC in response to the
2010 audit and the results of the verification activities conducted in the 2013 audit, FSIS
concludes that the CCA has adequately addressed previously identified concerns reported with
this equivalence component. Therefore, the PRC's poultry processing inspection system meets
FSIS equivalence criteria for this component.
7. SANITATION
The third of the six equivalence components that the FSIS auditors reviewed was sanitation.
FSIS requires that the inspection system provide requirements for sanitation, for sanitary
handling of products, and for the development and implementation of sanitation standard
operating procedures. In the 2010 audit, there were no major findings with this component and
FSIS had concluded that the CCA had effectively implemented its requirements for sanitation
and sanitary handling of poultry products intended for export to the United States. As a result,
the PRC had met the requirements for this equivalence component.
In the 2013 audit, the auditors verified this observation and concluded that there were no
concerns. Therefore, the PRC's poultry processing inspection system meets FSIS equivalence
criteria for this component.
In the 20 I 0 audit, the FSIS auditors reviewed legislation, regulations, and official instructions
and confirmed that the CCA exercised its legal authority to require establislunents to develop and
implement sanitation programs and ensure sanitary handling of products. The auditors found
that the establislunents were maintaining sanitary conditions in accordance with AQSIQ
Directive No. 20, 2002, Regulation on Administration ofSanitary Registration and Enrollment
for Establishments ofFood for Export, and GB/T 20094-2006, AQSIQ National Standard, Code
ofHygienic Practice for Registration on Abaltoir and Meat Processing Establishments.
In 20 I 0, the auditors observed that the CCA required establislunents to conduct biannual
sanitation audits, as required by the PRC regulation. During review of the biannual sanitation
audit records, FSIS suggested improvements for in-depth reviews of these audits.
During the 2013 audit, FSIS auditors found no systemic issues with this component.
Establishments identified, documented, and corrected sanitation deficiencies noted during preoperational and operational inspection. The updated versions of the inspection manual had been
distributed to the goverrunent offices and establishments. CIQ officials effectively verified the
adequacy of the implementation of the sanitation progran1, documented their findings, and
verified adequacy of the conective actions. The FSIS auditors conducted onsite observations of
the facilities and operational activities and concluded that, overall, the establislm1ent's facilities
were well maintained and in good repair, and sanitary controls were effectively implemented to
prevent the development of insanitary conditions.
FSIS concludes that the CCA effectively implements its requirements for sanitation and sanitary
handling of poultry products intended for export to the United States. As a result, the PRC meets
the requirements for this equivalence component.
14
8. HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS
The fourth of the six equivalence components reviewed by FSIS was HACCP systems. The
inspection system must require that each official establishment develop, implement, and
maintain a HACCP plan. Based on the analysis of the corrective action submitted by the PRC in
response to the 2010 audit and the results of the verification activities conducted in the 2013
audit, FSIS concludes that the CCA has adequately addressed the previously identified concerns
reported with regard to this equivalence component. Therefore, the PRC's poultry processing
inspection system meets FSIS equivalence criteria for this component.
In the 2013 audit, the FSIS verified that the CCA had issued regulations that require each official
establishment develop, implement, and maintain a HACCP system. The auditors evaluated the
design and implementation ofHACCP programs at four certified processing establishments. The
auditors observed that the CCA exerts its legal authority by requiring operators to comply with
HACCP system mles.
In the 2010 audit, FSIS conducted an onsite audit and reported to the CCA the following findings
related to this component of the system:
Establishments failed to specifically identify Listeria monocytogenes (Lm) in their hazard
analysis as a potential biological hazard reasonably likely to occur in the post-lethality
processing envirom11ent. However, establislunents did have sanitary controls in place
controlling the post-lethality environment.
The stabilization step for heat-treated products was not identified in the hazard analysis in
some establishments.
Establislunents omitted processing steps in the product flowchart, thus the hazard analysis of
the entire process was incomplete.
CIQ officials did not recognize inadequacies of the HACCP plans that included omitted
processing steps in the flow chart, identifying missing stabilization steps, and identifying Lm
as a potential biological hazard.
The national standard outlining requirements for HACCP systems (GB/T 19538-2004) does
not require preventive measures as part of the corrective actions to deviations from critical
limits.
In response, the CCA proposed that as cmTective actions, it would develop and distribute
manuals containing inspection procedures to ensure the uniform implementation of regulatory
requirements at establislunents that produce cooked poultry products for export to the United
States. The CCA also indicated that it would train CIQ persollilel on the contents of the manuals
and would require that establislunents comply with the HACCP regulations of the system.
15
In the 2013 audit, the auditor verified that the corrective actions proffered by the CCA to address
the 2010 audit findings had been adequately implemented. Specifically, the CCA had provided
to CIQ officials and establislunents a copy of the updated inspection manual requiring that
establislunents recognize Lm as a biological hazard likely to occur in the post-lethality
processing environment. The auditors verified that the establislunent's HACCP plan did include
Lm as a biological hazard. In the Inspection Quarantine and Supervision Work for Poult1y
products Exported to the US. Handbook version 1.1, (IQSWPPEUH) manual Section 3.4.2.2.2,
the CCA has referenced 9 CFR 381.150 for lethality of Salmonella and stabilization for
Clostridium perfi·ingens in cooked poultry products as well as FSIS Appendix B for additional
controls of Clostridium perfi·ingens. Furthermore, the inspection manual requires that
establishments identify, in their Sanitation Standard Operating Procedures (SSOP) or in their
pre-requisite program, Clostridium perfi'ingens as a pathogen to be controlled during
stabilization of cooked poultry product destined for the United States. FSIS auditors conducted
on-site observations and verified that recordkeeping maintained by the establislunents adequately
documented monitoring of cooking and cooling temperatures of products. The auditors reviewed
establislunents' HACCP programs and detennined that all steps were included in the flow chart
to permit analysis of each step in the process.
In addition, the CCA updated the inspection manual with a requirement for establishments to
provide preventive measures when a deviation occurs. The auditors reviewed records for
documented deficiencies and found that the establislm1ents' stated preventive measure for the
deviations was noted. These records included verification statements and the signature ofthe
CIQ inspector verifying acceptability of the corrective action. FSIS auditors also verified that
the establislunents received a copy of the inspection manual.
The auditors interviewed inspection officials and reviewed records maintained by these officials
assigned to provide inspection at the audited establislunents. FSIS auditors found that a series of
controls was in place to ensure that only raw poultry products that arrive from eligible poultry
slaughter establislunents are accepted by further processing establislm1ents. Authorized
establislunents are poultry slaughter plants that have implemented systems to ensure that
slaughtered flocks meet regulatory requirements regarding health management, husbandry
practices, and compliance with drug withdrawal protocols. CIQ officials at the slaughter
establislunents verify during ante mortem inspection that the aforementioned requirements are
met by reviewing the Record of Veterinmy Ante-lvlortem Inspection ofExport Poulfly
Processing Plant and Quarantine Certificate. The processing establislunents include a
"receiving of raw materials" step in their hazard analysis and receive the Quarantine Certificate
as proof of raw material originating from an approved source plant. Additionally, CIQ officials
conduct verification activities associated with the receipt of raw products.
Based on the above analysis, FSIS concluded that the PRC's inspection system meets the
requirement for this equivalence component.
16
9. CHEMICAL RESIDUE PROGRAMS
The fifth of the six equivalence components reviewed by FSIS was Chemical Residues. The
inspection system must have a chemical residue control program that is organized and
administered by the national government. This includes random sampling of internal organs and
fat of carcasses for chemical residues as identified by the exporting country's meat and poultry
inspection authorities or by FSIS as potential contaminants, as well as methods to deter
recmrence of chemical residue violations.
CIQ officials verify that the raw poultry received at the poultry establishments comes from an
approved source and meets the residue control program requirements. FSIS auditors verified that
raw products utilized by the poultry processing establishments are derived from authorized
poultry slaughter establishments that comply with the AQSIQ residue control progran1 for
exported poultry products.
This component will be further discussed in the draft audit report for initial equivalence for
poultry slaughter inspection.
10. MICROBIOLOGICAL TESTING PROGRAMS
The last of the six equivalence components that the FSIS auditors reviewed was Microbiological
Testing Programs. This component pertains to regulatory requirement for the inspection system
to have a microbiological testing progran1, organized and administered by the national
government. Both the CCA and the establishments certified for export to the United States are to
employ control measures to prevent adulteration of both post-lethality exposed and non-exposed
Ready-to-Eat (RTE) products by Lm and Salmonella spp. Furthennore, the CCA must conduct
verification sampling and testing for Lm, and Salmonella spp in post-lethality exposed RTE
products, product contact surfaces, and environmental surface samples, to verify that an
establishment's control measures are effective in controlling these pathogens. Based on the
analysis ofthe corrective actions submitted by the PRC in response to the 2010 audit and the
results of the current verification activities conducted in the 2013 audit, FSIS concludes that the
CCA has adequately addressed previously identified concerns reported with this equivalence
component. Therefore, the PRC's China's processed poultry inspection system meets FSIS
equivalence criteria for this equivalence component. The following analysis explains this
decision.
In 2010 audit, FSIS conducted an audit and reported to the CCA the following findings related to
this component of the system:
• The CCA needed to provide clear direction concerning the FSIS definition ofRTE
products as outlined in 9 CFR 430.1.
• Among the provinces audited, CIQ officials had not uniformly implemented sampling
protocols to assess effective establishment control measures for Lm in the post-lethality
17
processing envirmm1ent. CIQ officials did not verify that the methods used by the
establislm1ents to test the product and the environmental samples were adequate for the
intended analysis of Lm. During the audit, the PRC discussed a zero tolerance policy for Lm
and Salmonella spp. in RTE products. However, the auditors were unable to identify any
specific legislation or written procedures describing a zero tolerance policy. The auditors
observed that a 25g test portion was used for Salmonella, though FSIS requires
a minimum of 325g test portion.
In response to the 2010 audit findings, the CCA proffered corrective actions to address each of
the findings reported. The CCA indicated that it would develop a Microorganism Monitoring
Program for Export Poultry Products (MMPEPP), which would specifically describe the method
required to monitor microorganisms, including Lm in products and in the processing
environment.
The CCA also indicated that in the newly issued regulations, Listeria and Salmonella were
specifically mentioned as pathogens of concern to be controlled in the production of cooked
products. Furthermore, the CCA stated that the MMPEPP would include the requirement for
Lm and Salmonella, testing and would clearly state that there is a zero tolerance for Lm and
Salmonella in cooked poultry products and require uniforn1 monitoring of pathogen controls for
Lm in products and the processing envirmm1ent. The manual was revised to require a 325g
san1ple for detecting Salmonella in cooked poultry products for export. Finally, the CCA
indicated in its response that it would implement training of officials on each of the items
included in the proffered corrective action.
During the 2013 audit, the auditors verified that the CCA had included the FSIS definition of
RTE, as written verbatim in 9 CFR 430.1, in its Inspection, Quarantine and Supervision Work
for Poullly Products Exported to the US. Handbook (IPSWPPEH) version 1.1, and that the CIQ
inspectors were knowledgeable ofthis definition. The CCA developed the Monitoring Program
for Microbes in Export Poultry Products (MPMEPP) version 1.0 which includes provisions for
mandatory testing for Lm and Salmonella and states that there is zero tolerance for these
pathogens in RTE products in Appendices 2 and 4. The auditors also verified that the CCA has
updated the manual to include 325g test portion for Salmonella testing.
FSIS auditors, interviewed CIQ inspectors and found that they conduct product testing for Lm
and Salmonella on a monthly basis. If a positive sample is found, either by govenm1ent testing
or by establishment testing, the CCA will initiate additional testing of food contact and
environmental surfaces. The auditors verified that this is consistent with the official instructions
contained in Appendix 2, Section 3 .1.1.1 of the MPMEPP version 1.0. Product that is positive is
either destroyed or reheated to destroy the pathogens and retested in a manner consistent with the
instructions contained in Section 3.1.6 ofthe MPMEPP version 1.0. The CCA will also conduct
an in-depth verification assessment of an establishment that produced product that tested positive
for Lm or Salmonella. In addition, the establishments are required to initiate enhanced cleaning
and sanitizing of the enviromnent and food contact surfaces.
After analysis of the MPMEPP version 1.0 manual, FSIS determined that the CCA developed
requirements and responsibilities for both regulatory verification and establishment
18
implementation of microbiological controls. Specifically, in Section 3, Jvfonitoring Procedures,
of the MPMEPP version 1.0, the CCA references the 10,000 series of FSIS directives covering
RTE products, Lm testing, and intensified verification sampling, as well as 9 CFR 430.4, and
PRC's GB 16869. In MPMEPP version 1.0, Appendix 2 and Appendix 4, the CCA provides
instructions for control and verification of Lm testing of product, food contact surfaces and the
environment for the CCA and establishments.
The CCA conducts three types of sampling as described in Appendix 2: regular, enhanced, and
conventional. In the MPMEPP version 1.0, Section 3 .1.1.1, the CCA provides instructions to
inspection personnel to conduct regular product sampling on a monthly basis. When a positive
result occurs from either regular product sampling or conventional sampling, the CCA initiates
enhanced monitoring once every 2 weeks (Section 3.1.7. 1), collecting samples from 10 FCS, 5
environment, 3 product, and 1 brine sample (if needed) while citing FSIS Directive 10,300.1
(Section 3.1.7.2).
In conventional sampling, all plants are sampled once every 4 years similar to FSIS sampling
described in Directive 10,240.5. MPMEPP version 1.0, Section 3.2.3, describes the conventional
frequency at which the CCA will sample food contact surfaces and processing environn1ent.
MPMEPP, Section 3.1.7.3 provides enhanced monitoring and comprehensive testing for seasonal
facilities that have not undergone continuous regular sampling.
For the establishments, the CCA provides instructions in MPMEPP version 1.0, Appendix 4,
regarding sampling and testing for Lm. In Section 2, the CCA mandates sampling of product,
food contact surfaces, and envirorunental surfaces. Fwthermore, Sect~on 4.1 mandates that
establishments control Lm hazards through HAACP, SSOP, or prerequisite programs. The rest
of Appendix 4 provides mandates for what to do when a positive sample is detected: sampling
size, frequency, sampling method, recordkeeping, and enhanced procedures. The CCA is
responsible for evaluating the establishment's Lm control plans and verifies the adequacy of its
implementation.
Based on the above analysis, FSIS concluded that the PRC's inspection system meets the
requirement for this equivalence component.
11. EXIT MEETING
An exit meeting was held on March 19,2013, in Beijing with AQSIQ. At this meeting, the FSIS
auditors presented their observations made during the audit.
12. CONCLUSIONS
In the 2013 audit, FSIS analyzed and verified the PRC's proffered corrective actions to previous
findings of systemic impact that were identified in the 2010 audit. This audit involved the
following equivalence components: (1) Governn1ent Oversight; (2) Statutory Authority and
Food Safety Regulations; (4) Hazard Analysis and Criti.cal Control Point (HACCP) Systems; and
(6) Microbiological Testing Programs. FSIS found that the PRC adequately addressed each of
19
the findings. Component 5, Chemical Residue Progranis, is discussed in the draft audit report for
initial equivalence for poultry slaughter inspection.
Based on the analysis of the conective actions submitted by the PRC in response to the 20 I 0
audit and the results of the verification activities conducted in the 20 13 audit, FSIS concludes
that the CCA has adequately addressed all previously identified concerns reported. Therefore,
the PRC's poultry processing inspection system meets FSIS equivalence criteria for all system
components. With all outstanding issues resolved, the PRC may certify a list of establishments
eligible to export processed (heat-treated/cooked) poultry products to the United States, as long as
the raw poultry is sourced from countries that have been determined by FSIS to have an
equivalent poultry slaughter inspection system.
Audit Team:
Francisco Gonzalez, DVM
Senior Program Auditor
(On-site auditor)
Charmaine McGee, DVM
Export Program Staff
(On-site auditor)
~
~
~),) ·-{s: (l f:,/
Priya Kadam, Ph.D
Senior Microbiologist/Senior Equivalence Officer
13. ATTACHMENTS TO THE AUDIT REPORT
None at this time.
20
United States Department of Agriculture
Food Safety and Inspection Service
Foreign Establishment Audit Checklist
1. ESTABLISHMENT NAME AND LOCATION
Zhucheng Waimao Co., LTD/Shandong Delicate Food
Co., Ltd.
East end of Mizhou Road
Zhucheng, Shandong, PRC
2. AUDIT DATE
March 8, 2013
3. ESTABLISHMENT NO.
4. NAME OF COUNTRY
People’s Republic of China
3700/03409
5. NAME OF AUDITOR(S)
6. TYPE OF AUDIT
Drs. Gonzalez and McGee
X ON-SITE AUDIT
DOCUMENT AUDIT
Place an X in the Audit Results block to indicate noncompliance with req uirements. Use O if not applicable.
Part A - Sanitation Standard Operating Procedures (SSOP)
Basic Requirements
Part D - Continued
Economic Sampling
Audit
Results
7. Written SSOP
33. Scheduled Sample
8. Records documenting implementation.
34. Species Testing
9. Signed and dated SSOP, by on-site or overall authority.
35. Residue
Sanitation Standard Operating Procedures (SSOP)
Ongoing Requirements
Part E - Other Requirements
10. Implementation of SSOP's, including monitoring of implementation.
36. Export
11. Maintenance and evaluation of the effectiveness of SSOP's.
37. Import
12. Corrective action when the SSOP's have failed to prevent direct
product contamination or adulteration.
38. Establishment Grounds and Pest Control
13. Daily records document item 10, 11 and 12 above.
39. Establishment Construction/Maintenance
Part B - Hazard Analysis and Critical Control
Point (HACCP) Systems - Basic Requirements
40. Light
41. Ventilation
14. Developed and implemented a written HACCP plan .
15. Contents of the HACCP list the food safety hazards,
critical control points, critical limits, procedures, corrective actions.
42. Plumbing and Sewage
16. Records documenting implementation and monitoring of the
HACCP plan.
43. Water Supply
44. Dressing Rooms/Lavatories
17. The HACCP plan is signed and dated by the responsible
establishment individual.
Hazard Analysis and Critical Control Point
(HACCP) Systems - Ongoing Requirements
18. Monitoring of HACCP plan.
19. Verification and validation of HACCP plan.
45. Equipment and Utensils
46. Sanitary Operations
47. Employee Hygiene
48. Condemned Product Control
20. Corrective action written in HACCP plan.
Part F - Inspection Requirements
21. Reassessed adequacy of the HACCP plan.
22. Records documenting: the written HACCP plan, monitoring of the
critical control points, dates and times of specific event occurrences.
Part C - Economic / Wholesomeness
49. Government Staffing
50. Daily Inspection Coverage
23. Labeling - Product Standards
51. Enforcement
24. Labeling - Net Weights
25. General Labeling
26. Fin. Prod. Standards/Boneless (Defects/AQL/Pork Skins/Moisture)
Part D - Sampling
Generic E. coli Testing
27. Written Procedures
52. Humane Handling
53. Animal Identification
54. Ante Mortem Inspection
55. Post Mortem Inspection
28. Sample Collection/Analysis
Part G - Other Regulatory Oversight Requirements
29. Records
Salmonella Performance Standards - Basic Requirements
56. European Community Directives
30. Corrective Actions
57. Monthly Review
31. Reassessment
58.
32. Written Assurance
59.
FSIS- 5000-6 (04/04/2002)
Audit
Results
X
FSIS 5000-6 (04/04/2002)
Page 2 of 2
60. Observation of the Establishment
Processing Establishment No. 3700/03409
FSIS auditors observed electrical cords bundled on top of several workstations’ lamps, one overhead electrical outlet with
exposed wires and frayed conduit that had been rendered difficult to clean.
FSIS auditors received copies of documented corrective actions and official verification prior to the completion of the audit. The
evidence provided demonstrated an effective corrective action and adequate official verification.
61. NAME OF AUDITOR
Drs. Gonzalez and McGee
62. AUDITOR SIGNATURE AND DATE
United States Department of Agriculture
Food Safety and Inspection Service
Foreign Establishment Audit Checklist
1. ESTABLISHMENT NAME AND LOCATION
Weifang Legang Food Co., Ltd.
Honghe Town of Changle County
Shandong, PRC
2. AUDIT DATE
March/12/2013
3. ESTABLISHMENT NO.
4. NAME OF COUNTRY
People’s Republic of China
3700/03435
5. NAME OF AUDITOR(S)
6. TYPE OF AUDIT
Drs. Gonzalez and McGee
X ON-SITE AUDIT
DOCUMENT AUDIT
Place an X in the Audit Results block to indicate noncompliance with req uirements. Use O if not applicable.
Part A - Sanitation Standard Operating Procedures (SSOP)
Basic Requirements
Part D - Continued
Economic Sampling
Audit
Results
7. Written SSOP
33. Scheduled Sample
8. Records documenting implementation.
34. Species Testing
9. Signed and dated SSOP, by on-site or overall authority.
35. Residue
Sanitation Standard Operating Procedures (SSOP)
Ongoing Requirements
Part E - Other Requirements
10. Implementation of SSOP's, including monitoring of implementation.
36. Export
11. Maintenance and evaluation of the effectiveness of SSOP's.
37. Import
12. Corrective action when the SSOP's have failed to prevent direct
product contamination or adulteration.
38. Establishment Grounds and Pest Control
13. Daily records document item 10, 11 and 12 above.
39. Establishment Construction/Maintenance
Part B - Hazard Analysis and Critical Control
Point (HACCP) Systems - Basic Requirements
40. Light
41. Ventilation
14. Developed and implemented a written HACCP plan .
15. Contents of the HACCP list the food safety hazards,
critical control points, critical limits, procedures, corrective actions.
42. Plumbing and Sewage
16. Records documenting implementation and monitoring of the
HACCP plan.
43. Water Supply
44. Dressing Rooms/Lavatories
17. The HACCP plan is signed and dated by the responsible
establishment individual.
Hazard Analysis and Critical Control Point
(HACCP) Systems - Ongoing Requirements
18. Monitoring of HACCP plan.
19. Verification and validation of HACCP plan.
45. Equipment and Utensils
46. Sanitary Operations
47. Employee Hygiene
48. Condemned Product Control
20. Corrective action written in HACCP plan.
Part F - Inspection Requirements
21. Reassessed adequacy of the HACCP plan.
22. Records documenting: the written HACCP plan, monitoring of the
critical control points, dates and times of specific event occurrences.
Part C - Economic / Wholesomeness
49. Government Staffing
50. Daily Inspection Coverage
23. Labeling - Product Standards
51. Enforcement
24. Labeling - Net Weights
25. General Labeling
26. Fin. Prod. Standards/Boneless (Defects/AQL/Pork Skins/Moisture)
Part D - Sampling
Generic E. coli Testing
27. Written Procedures
52. Humane Handling
53. Animal Identification
54. Ante Mortem Inspection
55. Post Mortem Inspection
28. Sample Collection/Analysis
Part G - Other Regulatory Oversight Requirements
29. Records
Salmonella Performance Standards - Basic Requirements
56. European Community Directives
30. Corrective Actions
57. Monthly Review
31. Reassessment
58.
32. Written Assurance
59.
FSIS- 5000-6 (04/04/2002)
Audit
Results
X
FSIS 5000-6 (04/04/2002)
Page 2 of 2
60. Observation of the Establishment
Processing Establishment No. 3700/03435
39. FSIS auditors identified structural deficiencies that included accumulation of residue on the outer surfaces of a tumbler in
the raw product area and coils of electrical cords on workstation lamps in the cooked product area.
FSIS auditors received copies of documented corrective actions and official verification prior to the completion of the audit. The
evidence provided demonstrated an effective corrective action and adequate official verification.
61. NAME OF AUDITOR
Drs. Gonzalez and McGee
62. AUDITOR SIGNATURE AND DATE
United States Department of Agriculture
Food Safety and Inspection Service
Foreign Establishment Audit Checklist
1. ESTABLISHMENT NAME AND LOCATION
Zhongao Holdings Group Co., Ltd
No. 1999 Central Street
Qingyun County
Shandong, PRC
2. AUDIT DATE
March/14/2013
3. ESTABLISHMENT NO.
4. NAME OF COUNTRY
People’s Republic of China
3700/03439
5. NAME OF AUDITOR(S)
6. TYPE OF AUDIT
Drs. Gonzalez and McGee
X ON-SITE AUDIT
DOCUMENT AUDIT
Place an X in the Audit Results block to indicate noncompliance with req uirements. Use O if not applicable.
Part A - Sanitation Standard Operating Procedures (SSOP)
Basic Requirements
Part D - Continued
Economic Sampling
Audit
Results
7. Written SSOP
33. Scheduled Sample
8. Records documenting implementation.
34. Species Testing
9. Signed and dated SSOP, by on-site or overall authority.
35. Residue
Sanitation Standard Operating Procedures (SSOP)
Ongoing Requirements
Part E - Other Requirements
10. Implementation of SSOP's, including monitoring of implementation.
36. Export
11. Maintenance and evaluation of the effectiveness of SSOP's.
37. Import
12. Corrective action when the SSOP's have failed to prevent direct
product contamination or adulteration.
38. Establishment Grounds and Pest Control
13. Daily records document item 10, 11 and 12 above.
39. Establishment Construction/Maintenance
Part B - Hazard Analysis and Critical Control
Point (HACCP) Systems - Basic Requirements
40. Light
41. Ventilation
14. Developed and implemented a written HACCP plan .
15. Contents of the HACCP list the food safety hazards,
critical control points, critical limits, procedures, corrective actions.
42. Plumbing and Sewage
16. Records documenting implementation and monitoring of the
HACCP plan.
43. Water Supply
44. Dressing Rooms/Lavatories
17. The HACCP plan is signed and dated by the responsible
establishment individual.
Hazard Analysis and Critical Control Point
(HACCP) Systems - Ongoing Requirements
18. Monitoring of HACCP plan.
19. Verification and validation of HACCP plan.
45. Equipment and Utensils
46. Sanitary Operations
47. Employee Hygiene
48. Condemned Product Control
20. Corrective action written in HACCP plan.
Part F - Inspection Requirements
21. Reassessed adequacy of the HACCP plan.
22. Records documenting: the written HACCP plan, monitoring of the
critical control points, dates and times of specific event occurrences.
Part C - Economic / Wholesomeness
49. Government Staffing
50. Daily Inspection Coverage
23. Labeling - Product Standards
51. Enforcement
24. Labeling - Net Weights
25. General Labeling
26. Fin. Prod. Standards/Boneless (Defects/AQL/Pork Skins/Moisture)
Part D - Sampling
Generic E. coli Testing
27. Written Procedures
52. Humane Handling
53. Animal Identification
54. Ante Mortem Inspection
55. Post Mortem Inspection
28. Sample Collection/Analysis
Part G - Other Regulatory Oversight Requirements
29. Records
Salmonella Performance Standards - Basic Requirements
56. European Community Directives
30. Corrective Actions
57. Monthly Review
31. Reassessment
58.
32. Written Assurance
59.
FSIS- 5000-6 (04/04/2002)
Audit
Results
FSIS 5000-6 (04/04/2002)
Page 2 of 2
60. Observation of the Establishment
Processing Establishment No. 3700/03439
The sanitary conditions and general operations of the establishment currently meet FSIS’s requirements and appear to comply
with the PRC requirements.
61. NAME OF AUDITOR
Drs. Gonzalez and McGee
62. AUDITOR SIGNATURE AND DATE
United States Department of Agriculture
Food Safety and Inspection Service
Foreign Establishment Audit Checklist
1. ESTABLISHMENT NAME AND LOCATION
Qingdao Nine-Alliance Group Co., Ltd.
Weihai West Road
Laixi, Qingdao
Shandong, PRC
2. AUDIT DATE
March 7, 2013
3. ESTABLISHMENT NO.
4. NAME OF COUNTRY
People’s Republic of China
3700/03447
5. NAME OF AUDITOR(S)
6. TYPE OF AUDIT
Drs. Gonzalez and McGee
X ON-SITE AUDIT
DOCUMENT AUDIT
Place an X in the Audit Results block to indicate noncompliance with req uirements. Use O if not applicable.
Part A - Sanitation Standard Operating Procedures (SSOP)
Basic Requirements
Part D - Continued
Economic Sampling
Audit
Results
7. Written SSOP
33. Scheduled Sample
8. Records documenting implementation.
34. Species Testing
9. Signed and dated SSOP, by on-site or overall authority.
35. Residue
Sanitation Standard Operating Procedures (SSOP)
Ongoing Requirements
Part E - Other Requirements
10. Implementation of SSOP's, including monitoring of implementation.
36. Export
11. Maintenance and evaluation of the effectiveness of SSOP's.
37. Import
12. Corrective action when the SSOP's have failed to prevent direct
product contamination or adulteration.
38. Establishment Grounds and Pest Control
13. Daily records document item 10, 11 and 12 above.
39. Establishment Construction/Maintenance
Part B - Hazard Analysis and Critical Control
Point (HACCP) Systems - Basic Requirements
40. Light
41. Ventilation
14. Developed and implemented a written HACCP plan .
15. Contents of the HACCP list the food safety hazards,
critical control points, critical limits, procedures, corrective actions.
42. Plumbing and Sewage
16. Records documenting implementation and monitoring of the
HACCP plan.
43. Water Supply
44. Dressing Rooms/Lavatories
17. The HACCP plan is signed and dated by the responsible
establishment individual.
Hazard Analysis and Critical Control Point
(HACCP) Systems - Ongoing Requirements
18. Monitoring of HACCP plan.
19. Verification and validation of HACCP plan.
45. Equipment and Utensils
46. Sanitary Operations
47. Employee Hygiene
48. Condemned Product Control
20. Corrective action written in HACCP plan.
Part F - Inspection Requirements
21. Reassessed adequacy of the HACCP plan.
22. Records documenting: the written HACCP plan, monitoring of the
critical control points, dates and times of specific event occurrences.
Part C - Economic / Wholesomeness
49. Government Staffing
50. Daily Inspection Coverage
23. Labeling - Product Standards
51. Enforcement
24. Labeling - Net Weights
25. General Labeling
26. Fin. Prod. Standards/Boneless (Defects/AQL/Pork Skins/Moisture)
Part D - Sampling
Generic E. coli Testing
27. Written Procedures
52. Humane Handling
53. Animal Identification
54. Ante Mortem Inspection
55. Post Mortem Inspection
28. Sample Collection/Analysis
Part G - Other Regulatory Oversight Requirements
29. Records
Salmonella Performance Standards - Basic Requirements
56. European Community Directives
30. Corrective Actions
57. Monthly Review
31. Reassessment
58.
32. Written Assurance
59.
FSIS- 5000-6 (04/04/2002)
Audit
Results
x
FSIS 5000-6 (04/04/2002)
Page 2 of 2
60. Observation of the Establishment
Processing Establishment No. 3700/03447
39. Establishment Construction/Maintenance
FSIS auditors observed several long electrical cords bundled with pieces of wire and repaired with
electrical tape that rendered them difficult to clean. There was also one frayed electrical cord near exposed
frozen RTE products. CIQ officials documented these structural deficiencies and ensured implementation
of adequate corrective action within 48 hours.
An air-line water trap was not adequately closed and sealed causing its contents to spray in the
surrounding area.
FSIS auditors received copies of documented corrective actions and official verification prior to the
completion of the audit. The evidence provided demonstrated an effective corrective action and adequate
official verification.
61. NAME OF AUDITOR
Drs. Gonzalez and McGee
62. AUDITOR SIGNATURE AND DATE
Source Exif Data:
File Type : PDF File Type Extension : pdf MIME Type : application/pdf PDF Version : 1.6 Linearized : No Author : USDA FSIS Create Date : 2013:08:30 11:58:58-05:00 Keywords : Foreign, Audit, Reports, -, China, 2013;, FAR Modify Date : 2013:09:04 12:39:43-04:00 Language : en XMP Toolkit : Adobe XMP Core 5.2-c001 63.139439, 2010/09/27-13:37:26 Creator Tool : KMBT_C450 Metadata Date : 2013:09:04 12:39:43-04:00 Producer : Adobe Acrobat 10.11 Paper Capture Plug-in Document ID : uuid:5a80bd76-8880-49e8-bb75-5aabd80a5733 Instance ID : uuid:38079f68-2f88-431e-912c-6fbfb1c07de9 Format : application/pdf Title : China 2013 Audit - Poultry Processing Inspection System Description : Foreign Audit Reports - China 2013 Creator : USDA FSIS Subject : Foreign Audit Reports - China 2013, FAR Page Mode : UseOutlines Page Count : 30EXIF Metadata provided by EXIF.tools