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DNV GL © 2016
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15 March 2016 SAFER, SMARTER, GREENER DNV GL © 2016
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15 March 2016 Kathleen Wybourn & John Kukoly
Food Safety Modernization Act
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Webinar # 3 BRC and FSMA
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15 March 2016
Meet the Speakers
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Kathleen Wybourn
Director Food & Beverage
DNV GL US & Canada
John Kukoly
Director
BRC Americas
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Questions are Welcome
Enter your questions in the Chat Box at the bottom right hand corner of your screen. Questions will be answered at the end of the presentations.
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The FSMA BRC Connection
A DNV.GL webinar John Kukoly BRC Global Standards
2809 United States
684 South
America
3922 UK
5616 Rest of Europe
543 Africa
3801 Asia
540 Oceania
2489 Italy
1651 Spain
890 France
603 Germany
543 Canada
19,000 food sites 24,000 total sites Food issue 7 released July 2015
Internationally recognised & GFSI compliant
Single Standard and protocol governing an accredited audit
Independent assessment of a company’s quality & hygiene systems
Certificated companies can be viewed on the BRC Global Standards Directory
Comprehensive scope – quality, legality & product safety
Benefits of using the BRC Global Standards
Addresses part of legislative requirements
Prevention
Inspections, Compliance, and Response
Import Safety
Enhanced Partnerships
Regulation Final
(consent decree)
Preventive Controls (Human Food) 30-Aug-15
Preventive Controls (Animal Food) 30-Aug-15
Produce Safety 31-Oct-15
Foreign Supplier Verification Program 31-Oct-15
Third Party Accreditation 31-Oct-15
Sanitary Transport 31-Mar-16
Intentional Adulteration 31-May-16
Business Type Compliance Timeline
Very small (< $1 million) 3 years
Subject to PMO 3 years
Small (< 500 FTE) 2 years
Everyone else 1 year Exemptions???
Mostly – except your suppliers
What’s new?
• HACCP to HARPC Preventative controls
• 21 CFR 117 (formerly 21 CFR 110)
cGMP update
Preventative Controls
• Qualified Individual • Supplier approval • Broader scope when assessing risks
Preventative Controls
Written food safety plan + HACCP plus PRP’s
= HARPC
“Identification of risk (potential hazard)
and proactive prevention”
“Validated”
Hazard Analysis
Hazards: biological, physical,
chemical (radiological and allergenic)
Occurrence: natural, unintentional
introduction, intentional introduction
Consider: likelihood and severity,
environmental pathogens
HARPC Considerations
Formulation Facility
Full process • Transport, manufacturing,
packaging labeling, storage, distribution
Reasonably foreseeable use
Sanitation • Product, process, people
HARPC Controls
Define “actionable level” of risks
Controls may include: • CCP’s • CP’s • PRP’s • Control activities
• Hand washing • Supplier approvals
Preventative Controls Qualified Individual (PCQI)
Someone who has successfully completed certain training in the development and application of risk-based preventive controls or is otherwise qualified through job experience to develop and apply a food safety system.
The written food safety plan required of food facilities must be prepared, or its preparation overseen, by one or more preventive controls qualified individuals
PCQI is charged with overseeing the validation that preventive controls are capable of controlling identified hazards…
cGMP’s Updated
21 CFR part 110 replaced by 21 CFR
part 117
Added: prevention of
allergen cross contact
Enhanced: supplier
approvals
Customer Controlled Hazards (117.136)
Documented explanation of
expected controls at customer /
consumer due to nature of product
(cocoa beans, coffee beans)
Documented expectations for
commercial customers regarding
controls (with verification)
Corrective Actions (117.150)
Corrective action plans, and actions, must include
assessment for and disposition
of product at risk
Supplier Approval
Verification of controls at supplier to ensure risk
management
Includes activities
undertaken on behalf of site (i.e. brokers, importers)
117.410 allows a fairly broad
range of supplier approval
mechanisms
Supplier Approvals
117.430 requires supplier audits
unless documented explanation determining otherwise
117.435 requires supplier auditors to be qualified for
task
117.420 allows alternate approval
mechanisms if verified and
effective
117.415 supplier self declarations
not accepted
BRC leads to FSMA?
FSMA
• The law is 89 pages • 21 CFR 117 is 100 pages • Federal Register Commentary
(regulations.gov) is 262 pages
BRC • Food 7 is 40 pages
Coming Soon
TAG has just completed a full analysis of BRC Food 7 vs PCHF
BRC will be releasing guidance, the comparison matrix, and an additional module for PCHF (end March)
HARPC for BRC training
FSA recognized PCQI training
Action Plan
Stay informed
Consider PCQI training
Re-assess hazard identification and management of external controls
Re-assess supplier approval mechanisms
Build PCQI qualification proof
Get certified
More?
•http://www.regulations.gov/#!documentDetail;D=FDA-2011-N-0920-1979 cGMP
commentary
•http://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm FDA FSMA
website
•https://www.federalregister.gov/articles/2015/09/17/2015-21920/current-good-manufacturing-practice-hazard-analysis-and-risk-based-preventive-controls-for-human
Federal Register Commentary
•http://www.ecfr.gov/cgi-bin/text-idx?SID=e9ca025764f8adff02bc93a2655d8450&mc=true&node=pt21.2.117&rgn=div5 21 CFR 117
Back to DNV.GL
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FDA FSMA – Accredited Third-Party Certification
The FDA FSMA rule on the Accredited Third-Party Certification is now final. This rule, proposed in July 2013, and published November 2015,
establishes a voluntary program for the accreditation of third-party certification bodies, also known as auditors, to conduct food safety audits and issue certifications of foreign facilities and the foods for humans and animals they produce. These requirements will help ensure the competence and
independence of the accreditation bodies and third-party certification bodies participating in the program. Certification audits under GFSI should not be confused with
Accredited Third-Party Certification under FSMA- THESE ARE COMPLETELY DIFFERENT
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Foreign entities may use certifications under FSMA for 2 purposes:
Certifications may be used by importers to establish eligibility for participation in the Voluntary Qualified Importer Program (VQIP), which offers expedited review and entry of food into the U.S. To prevent potentially harmful food from reaching U.S., the FDA
can also require in specific circumstances that a food offered for import be accompanied by a certification from an accredited third-party certification body. In either case domestic facilities will not be audited under
this program. This program only applies to foreign facilities and only
under very limited cases.
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Accredited Third-party certification bodies
Are required to perform unannounced facility audits and to notify the FDA upon discovering a condition that could cause or contribute to a serious risk to public health. Accredited third-party certification bodies must:
– Ensure their audit agents are competent and objective – Verify the effectiveness of corrective actions to address
identified deficiencies in audited facilities – Assess and correct any problems in their own performance – Maintain and provide the FDA access to records required to be
kept under the program
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Two Kinds of Audits that can be performed
Accredited third-party certification bodies can perform as part of the program, consultative and regulatory. In both kinds, auditors will examine compliance with applicable federal food safety requirements. – A consultative audit is conducted in preparation for a
regulatory audit and is for internal use. In addition to compliance with federal standards, a consultative audit also considers how the facility meets industry standards and practices. Only a regulatory audit can be the basis for certification.
An accredited third-party certification body could be a foreign government or other third-party entity or individual.
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DNV GL A global business assurance partner
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10,400 Food and beverage companies partner with us to ensure safety and sustainability
Position One of the world’s leading certification bodies
People 2,000 highly skilled specialized employees
2,400 Healthcare organizations trust us to help them improve quality and patient safety
Partnership with more than 70,000 customers in over 180 countries
80,000 Management system (ISO 9001, 14001, 18001, etc.) certificates issued under more than 80 accreditations
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Experience and expertise
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DNV GL has extensive competence and experience in auditing, and solid track record in tailoring assessment programs based on customer needs
We are flexible … and we work with a project management approach
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Question & Answers
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DNV GL © 2016
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Thank you for Attending
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Kathleen Wybourn
Director Food & Beverage
DNV GL US & Canada
John Kukoly
Director
BRC Americas
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What’s next
BRC and FSMA Webinars: March 15 & March 31
FSSC and FSMA Webinars: April 15 & April 29
SQF and FSMA Webinars: May 5 and May 26th
IFS and FSMA Webinars: Dates TBD
Preventive Control Trainings: Dates TBD
Contact April Lefebvre, BDR Food & Beverage, DNV GL [email protected] 678- 425-8168
SAVE THE DATE
DNV GL Food Safety Symposium
Rosemont, IL
September 21 & 22
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DNV GL © 2016
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15 March 2016
John Kukoly, BRC Americas Director [email protected] 905-892-9469 Kathleen Wybourn, Director Food & Beverage, DNV GL [email protected] April Lefebvre, BDR Food & Beverage, DNV GL [email protected] 678-425-8168
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CONTACT US:
