Proper Recordkeeping and Documentation: The Key to Reducing Risk and Liabilities

Melanie Neumann, The Acheson GroupJames P. Reynolds, Lineage LogisticsHolly Mockus, Alchemy Systems

Melanie Neumann, J. D., M.S.

EVP & CFOThe Acheson Group, LLC

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OverviewWhat do the rules require for record keeping

How do you approach record keeping and documentation for compliance

Other legal considerations

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FSMA Status Summary - “The 7 Pillars”

Proposed Rule Final DeadlinePC- Human Food-Final September 17, 2015PC- Animal Food-Final September 17, 2015Produce Safety October 31, 2015FSVP October 31, 2015Third Party Accreditation October 31, 2015Sanitary Transport March 31, 2016Food Defense May 31, 2016

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Rules Enacted Upon Signing

• Inspection of records• Suspension of registration • Expanded administrative detention• Authority to require import certificates• Mandatory recall

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The Food Safety Plan-A Key Required Document • You must prepare, or have prepared, and implement a written food

safety plan.

• The food safety plan must be prepared, or its preparation overseen, by one or more preventive controls qualified individuals.

• Preventive controls qualified individual means a qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety system.

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The Food Safety Plan

Hazard Analysis

Preventive Controls

Monitoring

Corrective Actions

Verification

Reanalysis

Documentation

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Implementation Records (§ 117.190)Records needed for:• Documentation for hazard analysis• Documentation for not establishing a

preventive control • Monitoring of preventive controls• Corrective actions• Verification, including

− Validation− Verification of monitoring− Verification of corrective actions;− Calibration of process monitoring and verification instruments;− Product testing− Environmental monitoring− Records review− Reanalysis

• Document the supply chain program• Document training for the preventive controls qualified individual and the qualified

auditor. 9

Records for Supply Chain (§ 117.475)• Must have a written plan• If importer must have documentation showing to be in compliance

with FSVP• Documentation of the approval of a supplier• Procedures for receiving raw materials• Documentation demonstrating use of the written procedures for

receiving raw materials• Documentation of the determination of the appropriate supplier

verification• Documentation of the conduct of the onsite audit (lots of details)• Sampling and testing (lots of details)• Review of the suppliers food safety records• Verification activities other than onsite audit• Actions taken with regard to non-compliance

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Required Records• All records can be stored off site, with exception of the written

food safety plan, as long as they are accessible within 24 hours of a request for official review– Food Safety Plan records do not need to be stored in one

location or in “one binder”• Record retention begins after the applicable compliance date• Records must also document

– Training– Reanalysis

• Electronic records exempt from 21 CFR Part 11, however must be equivalent to paper records and handwritten signatures

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Legal Considerations • Admissions Against Interest • Speculation• Strict Liability

– The Park Doctrine: • The Park Doctrine is based on a 1975 U.S. Supreme Court case

affirming FDA’s right to bring a criminal misdemeanor case against corporate executives based on a strict liability theory.

• A corporate official can be held criminally liable for violations of the FD&C Act even if the official did not intend for the violations to occur.

• NO ACTUAL KNOWLEDGE OR NEGLIGENCE REQUIRED• Complaint Management People, Process & Systems are Key!

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Thank Youmelanie@achesongroup.com

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James P. Reynolds

Director of Food Safety & Compliance

Lineage

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Lineage Logistics

• Refrigerated warehousing

• 100+ locations / 12 certifications

• Food product storage and handling

• Wide array of services

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Background

• Joined Lineage Logistics in 2012• 20+ year career in Naval Aviation• Documentation– Operational status– Lessons learned– Compliance

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Overview

1. Objectives & relationships2. Role of management3. Common pitfalls

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Recordkeeping Objectives

1. Operations/communication2. Demonstrate effective food safety3. Audit & regulatory compliance

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Recordkeeping Relationships

Audits & Regulations

Food SafetyOperations

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Operations

1. Incoming & outbound inspections2. Storage temperatures3. Inventory control4. Value-added services– Effectiveness– Capturing of costs

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Food Safety1. Chemical Control2. Personal Hygiene3. Product Equipment4. Cleaning and Sanitation5. Training6. Receiving, Storage and

Shipping7. Traceability and Withdrawal

(Recall)8. Pest Control9. Allergen Control

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Audits & Regulations

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SQF requirements

“Records…shall be maintained”

• 2.1.4 Management Review• 2.1.5 Complaint Management • 2.1.6 Business Continuity Planning• 2.2.2 Records• 2.3.1 Product Development and Realization• 2.3.2 Raw and Packaging Materials• 2.4.6 Non-conforming Product or Equipment• 2.4.7 Product Rework• 2.4.8 Product Release• 2.5.1 Responsibility, Frequency and Methods• 2.5.2 Validation & Effectiveness• 2.5.4 Verification of Monitoring Activities• 2.5.5 Corrective and Preventative Action

• 2.5.6 Product Sampling, Inspection and Analysis

• 2.5.7 Internal Audits• 2.6.1 Product Identification• 2.6.2 Product Trace• 2.6.3 Product Withdrawal and Recall• 2.9 Training• 12.2.7 Premises and Equipment Maintenance• 12.2.8 Calibration• 12.2.9 Management of Pests and Vermin• 12.2.11 Cleaning and Sanitation• 12.6.8 Transport• 12.6.9 Unloading

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FSMA: Preventive Controls

1. Hazard Analysis• Develop controls• Justify decision to not include

2. Associated steps• Monitoring• Corrective actions / Corrections• Verification

3. CGMPs (GDPs for Lineage)

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FSMA: Sanitary Transportation

• Trailer inspection– Sanitation– Structure– Temperature

• All captured on inspection form

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HACCP

1. CCP management2. Temperature control3. Corrective actions

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Role of Management

1. Prioritization– Corrective action

processing– Root cause investigations– Trend analyses

2. Personnel accountability

3. Support / Resources

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Common pitfalls1. “Check in the block”

record format

2. Overly complex documentation

3. Poor system of verification

4. Inadequate management commitment

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Summary

1. Commitment to consistency2. Pay attention to the details3. Organizational discipline

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Holly Mockus

Product Manager Alchemy

Record Description

• An account of something, preserved in a lasting form.

• Typically made as the activity occurs

• Functions as evidence of activities performed

• Proves you did what you said you were going to do

• Required by regulation(s)

• Paints a picture of the product, process, plant, and culture

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Preparation

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• New form development– Involve the end user– Train– Test– Learn– Pivot

• KISS

• Set your team up for success!

Customize

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• Create forms that meet the exact need

• Reassess – Changes– High level of errors– Feedback– Procedure updates

• Track and Trend– Don’t collect data to collect data

Include:

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• Date

• Product

• Facility name and location

• Initials / Signature

• Time

• Work Instructions

• Critical limits / Action limits

Uniformity

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Require consistency in all documentation

• AM / PM or military time

• Date format

• Signatures or initials

• Product name or product code

• Header info

• Footer info

• Logo

Demand Perfection

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Do Don’t

Use ink Fill out in real time

Fill out initials, date and time

ABCDEF

Review document

before submitting

Use exact time

Fill in all information as required

Write clearly – use best

penmanship

Use pencil – can be erased

Fill out in advance

Use hash marks, lines,

ditto

Use cheat sheets

Estimate time

Leave blank spaces – use N/A or other

Use markers or pastel ink – can

run or fade

Mock Exercises

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• Pull records from several months ago for review with management team– Can you find the document?– How long did it take to retrieve?– Is it complete?– Does it paint an accurate picture?– Are you following your procedure?– Is record review a part of mock exercises?

• Providing records to a regulator– Notify your legal counsel – Provide copy / keep original– Verify marked Confidential

Questions?