3-A Tpvmanual 2007

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3-A Sanitary Standards, Inc.

Manual for Third PartyVerification (TPV)

and

3-A Symbol Authorization

3-A Sanitary Standards, Inc. Manual Issuance Date: Jan. 2003 Revision Date: June 2007

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Table of ContentsTABLE OF CONTENTS ..............................................................................................................2

DISCLAIMER................................................................................................................................5

INTRODUCTION..........................................................................................................................6

B1 How to Use this Manual ....................................................................................................6

B2 3-A Sanitary Standards, Inc..............................................................................................6

B3 3-A Sanitary Standards .....................................................................................................7

B4 3-A Symbol .........................................................................................................................7

B5 3-Symbol Authorization List.............................................................................................8

B6 Policies of the TPV Program.............................................................................................8

B6.1 Integration of Existing Authorization Holders to the TPV Program ..............................8B6.2 Random Audits Following TPV Integration.................................................................11B6.3 New 3-A Symbol Authorizations..................................................................................12B6.4 3-A Symbol Authorization Renewals ...........................................................................12B6.5 3-A Symbol Authorization Amendments......................................................................13B6.6 Reports of Alleged Nonconformance (RAN) ...............................................................13B6.7 Used and Remanufactured Equipment..........................................................................17B6.8 Ownership of Certified Conformance Evaluator (CCE) Certificates ...........................17B6.9 Code of Ethics ...............................................................................................................18

TPV EQUIPMENT AND MACHINERY CERTIFICATION................................................19

C1 Notice to Applicants.........................................................................................................19

C2 Verification Report Format ............................................................................................19

C2.1 Report Language ...........................................................................................................19C2.2 Cover Page ....................................................................................................................20C2.3 Verification Checklist Pages .........................................................................................22

C3 TPV Certification Procedures ........................................................................................23

C4 TPV Report Submission Procedures..............................................................................26

C4.1 CCE Report ...................................................................................................................26C4.2 TPV Reports of Conformance.......................................................................................26


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C4.3 TPV Reports of Nonconformance................................................................................ 26

C5 TPV Report Review and CCE Monitoring Procedures ...............................................30

C6 3-A Interpretations Committee (IC) ..............................................................................30

C7 Dispute Review and Determination Procedures ...........................................................31

C7.1 Applicant Rights and Procedures ..................................................................................31C7.2 TPV Dispute Resolution ...............................................................................................31

C8 TPV Certificate of Conformance....................................................................................34

C9 TPV Certificate of Nonconformance..............................................................................34

C10 3-A Symbol Authorization Forms and Documents.......................................................35

CERTIFICATION.......................................................................................................................36

D1 Basic Qualifications for Education and Experience .....................................................36

(See Appendix 3, Exhibits 2 and 3)

D2 Required Knowledge, Skills, and Abilities ....................................................................36

D3 CCE Candidate Application Package Requirements ...................................................37

D4 Submission of Applications .............................................................................................38

D5 Application Evaluation....................................................................................................38

D6 CCE Certification ............................................................................................................38

D6.1 Initial CCE Certification ...............................................................................................38D6.2 Annual Maintenance .....................................................................................................38D6.3 Renewal of CCE Certification ......................................................................................39D6.4 Denial or Withdrawal of CCE Certification..................................................................39D6.5 Appeal of Denial or Withdrawal of CCE Certification.................................................39

D7 Maintenance of CCE Competence .................................................................................40

D8 CCE Certification Documentation and Listing.............................................................40

ADMINISTRATION...................................................................................................................41

E1 File Retention ...................................................................................................................41

E1.1 CCE Certification Files.................................................................................................41

E2 3-A Symbol Authorization Files .....................................................................................42


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E3 Announcements and Listings..........................................................................................42

E4 Service Mark ....................................................................................................................43

E5 Fees....................................................................................................................................44E5.1 3-A Symbol Authorization............................................................................................44E5.2 Certification of CCEs....................................................................................................44

E6 TPV Operations Manual Maintenance..........................................................................44

APPENDIX 1: Glossary of Terms .............................................................................................45

APPENDIX 2: 3-A Symbol Application Materials ..................................................................49

APPENDIX 3: TPV Forms ........................................................................................................70

APPENDIX 4: Engineering Design and Technical Construction File ...................................85

APPENDIX 5: 3-A Sanitary Standards, Inc.............................................................................90


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DISCLAIMERA1 The authorized appearance of the 3-A Symbol on equipment indicates verification by

a third party that the equipment conforms to the applicable 3-A Sanitary Standards.Appearance of the 3-A Symbol does not represent an endorsement of the equipmentby 3-A Sanitary Standards, Inc. as to quality, sanitation, or safety. 3-A SanitaryStandards, Inc. disclaims all warranties, expressed or implied, with respect to suchequipment, including warranties of marketability and fitness for use. 3-A SanitaryStandards, Inc. also disclaims any and all liability for injury to persons or property, orother damages of any nature, including special, indirect, consequential,

compensatory, and punitive damages, directly or indirectly resulting from theperformance operation, or the failure to operate, of any equipment.

Certified Conformance Evaluator (CCE) status is achieved by satisfying acombination of defined education, experience, and/or examination requirements.Certification is not an assurance of competence or ability. 3-A Sanitary Standards,Inc. disclaims liability for any injury to persons or to property, or other damages ofany nature whatsoever, including special, indirect, consequential, compensatory, andpunitive damages, directly or indirectly resulting from negligent conduct or other actsor omissions of any individual certified as a CCE.

By issuing the 3-A Symbol, and by providing for certification of individuals as CCEs,3-A Sanitary Standards, Inc. is not undertaking to render professional or otherservices for or, on behalf of, any person or entity. 3-A Sanitary Standards, Inc. doesnot undertake to perform any duty owed by any person or entity to someone else.3-A Sanitary Standards are developed through a consensus standards developmentprocess that brings together individuals representing varied viewpoints and intereststo achieve consensus. While 3-A Sanitary Standards, Inc. administers the process andestablishes rules to promote fairness in the development of consensus, it does notindependently test, evaluate, or verify the accuracy of any information or thesoundness of any judgments contained in the standards.


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INTRODUCTIONB1 How to Use This Manual

B1.1 All timeframes, limits, response times, etc., referenced in days are to be interpreted asworking days and as target times designed for the timely completion of the variousaspects of the Third Party Verification (TPV) program.

B1.2 Any reference to the singular form may be assumed applicable to the plural form.Any reference to the masculine form shall be assumed applicable to the feminineform.

B1.3 Any reference to a responsible organization, person, or position shall be assumedapplicable to any other organization, person, or position to which authority has beenduly delegated.

B1.4 This manual establishes the policies and procedures for equipment suppliers to verifyconformance to 3-A Sanitary Standards and to obtain and maintain authorization touse the 3-A Symbol. These procedures include requirements for initial and periodicinspections to determine conformance. The manual also contains procedures forsubmitting nonconformance reports, how they are resolved, and de-listing methodsfor well-founded nonconformance reports. Reinstatement procedures are included.These policies and procedures are for new as well as used and remanufactured

equipment. The manual also includes procedures for conducting verification ofcredentials (Appendix 3, Exhibits 2 & 3) and selection and dismissal of the CertifiedConformance Evaluators (CCEs).

B2 3-A Sanitary Standards, Inc.

B2.1 3-A Sanitary Standards, Inc. (3-A SSI) (Appendix 5) is a not-for-profit 501(c)(3)organization dedicated to protecting public health. 3-A SSI executes its mission by:(a) developing standards for sanitary equipment design, fabrication and materials ofconstruction, and (b) by providing a third party verification (TPV) program tomonitor equipment conformance to individual 3-A Sanitary Standards and E-3-A

Sanitary Standards (collectively 3-A Standards). 3-A Accepted Practices arecurrently not covered by TPV and 3-A Symbol authorization. (See Appendix 5 foradditional background information concerning 3-A SSI.)


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B3 3-A Sanitary Standards

B3.1 The 3-A Standards provide sanitary (hygienic) criteria for materials, design,fabrication, cleanability and, if necessary, installation of identified equipment and

machinery. 3-A Sanitary Standards Committees develop documents with the activeparticipation of three stakeholder groups representing regulatory control officials,processors (users) and suppliers of equipment and machinery. Numerous committeesrepresent the three stakeholder groups. Proposed standards are reviewed by, and mustbe approved by, the three stakeholder groups. It is only after the tripartite acceptanceof the standards by the stakeholders that TPV can be requested and authorization for3-A Symbol use made. (More information www.3-A.org)

B3.2 The tripartite standards development is advantageous to the industry. The acceptanceof certified equipment bearing the 3-A Symbol by regulators and processors is anadvantage to equipment suppliers.

B4 3-A Symbol

B4.1 The use (display) of the 3-A Symbol is beneficial to all 3-A stakeholder groups. TheTPV prior to 3-A Symbol authorization documents the manufacturers commitment toconformance to the 3-A Standards. Use of the 3-A Symbol advises regulators andprocessors that a credible, objective, third party has verified that certified productsconform to standards and applicable regulatory requirements. The cost for the thirdparty verification is based on the contract established between a CCE and theapplicant for the TPV evaluation.

B4.2 3-A SSI oversees TPV and 3-A Symbol authorization. The Board of Directors of 3-ASSI may revise at any time the policies and procedures in this manual.

B4.3 Equipment and machinery evaluated using the 3-A TPV program and determined toconform to the applicable 3-A Standards will be authorized to use the 3-A Symbol onequipment. The companies so authorized will sign a declaration (Appendix 2, Exhibit2) agreeing that the 3-A Symbol will be placed only on equipment fully complyingwith the relevant 3-A Standard(s) and that the company will abide by all otherapplicable requirements (see Appendix 2). The 3-A Symbol must be displayed inaccordance with the provisions found in Appendix 2, Exhibit 6. Rubber and plasticmaterials meeting 3-A Standards 18-xx or 3-A 20-xx must restrict symbol use to print

materials or on a website.


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B5 3-A Symbol Authorization List

B5.1 Beginning in 2003, the Holders of 3-A Symbol Authorizations list will be availableonly on the 3-A SSI website. The list can be accessed at no charge from

www.3-A.org. The list is updated monthly.

B6 Policies of the TPV Program

B6.1 Integration of Existing Authorization Holders to the TPV Program

B6.1.1 The timeline for orderly transition to TPV is four (4) years. During the four (4)-yearintegration period, existing symbol authorization holders will be required to submit aTPV certificate with their 3-A Symbol authorization renewal application. All existingsymbol authorization holders have been assigned to a group to balance the number ofTPV verifications to be performed each year and to subject manufacturers of similar

equipment and machinery to equal requirements. The eight (8) groups and the 3-AStandards they represent are established using the 3-A Symbol Holders List (seeSection B6.1.3). Each of the groups has been designated for integration during one(1) of the specified years until full integration has been achieved. This grouping issubject to review as new 3-A Standards become effective.

B6.1.1.1 Also, during each of these four (4) integration years, new applications and Reports ofAlleged Nonconformance (RAN) certifications (Appendix 2, Exhibit 8) will beperformed as necessary. New applicants will be required to submit a TPVcertification consistent with the order of the groupings outlined in the integrationpolicy. New 3-A Symbol applications for equipment not listed in one of the eight (8)

groupings will require a TPV.

B6.1.1.2 Once integrated into the TPV certificate program, 3-A Symbol authorizations willfollow the guidance of section B6.4, 3-A Symbol Authorization Renewals, and B6.5,3-A Symbol Authorization Amendments. (See Appendix 2 for forms and relateddocuments.)


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B6.1.2 Full integration will be achieved within four (4) years. Future TPV certifications willbe required in accordance with the certification policy established in the CertificationPolicy Section C. The sequence of rotation may change due to an amendment if aRAN is substantiated.

B6.1.3 Sequence ofTPV

Integration

Standard

NumberGroup 1 - Tanks and Processors 2006

01- Storage Tanks

05- Automotive Tankers

13- Farm Bulk Tanks

22- Silos

24- Batch Pasteurizers

25- Batch Processors30- Farm Storage Tanks

32- Uninsulated Tanks

Group 2 - Fillers 2006

17- Fluid Fillers

23- Viscous Product Fillers

27- Dry Products Filler

Group 3 Valves and Fittings 2005

51- Plug Valves

52- Plastic Plug Valves53- Compression Valves

54- Diaphragm Valves

55- Boot Seal Valve

56- Leak Detect Valve

57- Tank Outlet Valve

58- Vacuum Breakers and Check Valves

59- Sample Valves

60- Rupture Disks

61- Steam Injectors

62- Hose Assemblies

63- Fittings

64- Pressure Reducing Valves

65- Sight Glasses

68- Ball Valves

78- Spray Devices


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Group 4 Pumps and Mixers 2003

04- Homogenizers

35- Continuous Blenders

36- Colloid Mills

44- Diaphragm Pumps47- CIP Pumps

73- Shear Mixers

Group 5 Heat Exchangers/

Ice Cream Freezers 2006

11- Plate Heat Exchangers

12- Tubular Heat Exchangers

19- Ice Cream Freezers

31- Scraped Surface Heat Exchangers

Group 6 Conveyors and Feeders 200639- Pneumatic Conveyors

41- Mechanical Conveyors

75- Belt Feeders

81- Auger Feeders

Group 7 - Instruments 2004

02- Pumps

18- Rubber

20- Plastics

28- Flow Meters

46- Refractometers

50- Dry Product Level Sensors

74- Sensors

Group 8 - Other 2003

10- Filters

16- Evaporators

26- Sifters

29- Air Eliminators

33- Tubing

34- Bulk Bins38- Cottage Cheese Vats

40- Bag Collectors

42- In-Line Strainers

45- Membrane Modules


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B6.2 Random Audits Following TPV Integration

B6.2.1 Every six (6) years, based on the anniversary date of the most recent TPV report, each

3-A Symbol authorization holder will be subject to random selection for submissionof materials with their renewal request to support their authorization and to determineif a new TPV certificate will be required.

B6.2.1.1 Twenty-nine (29) authorizations are to be randomly selected from the groupidentified in B6.2.1 each year after the initial six (6) years of the program. If selected,the 3-A Symbol authorization holder will be required to submit to 3-A SSI thefollowing information:

B6.2.1.1.1 3-A Symbol Authorization Renewal Application Form;

Table of Contents of the Engineering Design and Technical Construction File

(EDTCF), including reference to (Appendix 4): List of Engineering Drawing Numbers;

Materials Certifications;(Plastics, Rubbers, Adhesives, Undocumented Metal Alloys);

Certificate of Conformance; and

Certificate of Quality Control;

B6.2.1.2 The materials submitted will be compared by 3-A SSI to the supporting materials onfile with the most recent TPV certificate. If conformance discrepancies are observedwith the newly submitted information, a new TPV certificate will be required.


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B6.3 New 3-A Symbol Authorizations

B6.3.1 Requests for new 3-A Symbol authorizations are in order at any time. A copy of the

current application will be maintained on the 3-A SSI web site. Upon receipt of arequest for a new 3-A Symbol authorization, 3-A SSI shall respond with thenecessary application materials within ten (10) days if the requester is unable toaccess the on-line application. (See Section C for specific guidance and Appendix 2,Exhibit 5.)

B6.4 3-A Symbol Authorization Renewals

B6.4.1 Authorization Renewals Without TPV

B6.4.2 For the renewal of a 3-A Symbol authorization that does not require the submission ofa TPV report in a given year, applicants shall submit an annual renewal applicationform (Appendix 2, Exhibits 2, 3, & 4) and appropriate fees prior to the anniversarydate of their authorization(s) to assure uninterrupted authorization(s) to display thesymbol.

B6.4.3 Authorization Renewals With TPV

B6.4.4 For the renewal of a 3-A Symbol authorization that requires the submission of a TPVreport, applicants shall submit an annual renewal application form accompanied bythe TPV report and appropriate fees prior to the anniversary date of their

authorization(s) to assure uninterrupted authorization(s) to display the symbol.

B6.4.5 Notification letters will be sent at least ninety (90) days prior to renewal dates whenTPV certification is required, and at least forty-five (45) days prior to renewal dateswhen no TPV certification is necessary.


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B6.4.6 If the symbol holders renewal authorization notification is not received within atleast ten (10) days of the anniversary date, it is the symbol holders responsibility todetermine the status of the materials. A grace period of fifteen (15) days will beautomatically granted. Beyond fifteen (15) days, written justification for additional

time is required but in no case shall it be more than an additional fifteen (15) days. Ifthe additional fifteen (15) days is granted, a late fee of $100 will be assessed. Afterthirty days (30) of no response, the 3-A Symbol authorization shall be rescinded.

B6.4.7 For all authorizations, 3-A SSI shall respond within ten (10). If the authorization isdenied, thirty (30) days are granted to resolve any nonconformance issues. Ifnonconformance issues are unresolved, 3-A Symbol authorization will be rescinded.(See Section C7.2 for TPV dispute resolution.)

B6.4.8 The application notice and materials may be transmitted electronically or in hardcopy.

B6.5 3-A Symbol Authorization Amendments

B6.5.1 All 3-A Symbol authorization holders are encouraged to maintain their authorizationcurrent by submitting amendments for changes in design, fabrication, or materials ofconstruction (Appendix 2, Exhibits 2, 3, & 5). The 3-A Symbol authorization holdermay choose to submit a TPV certificate to verify the modifications meet the current3-A Standard criteria.

B6.5.2 When an amendment is for the addition of a size variation (serial design) of apreviously authorized design, an accompanying TPV certificate is not required.

B6.5.3 If an amendment on a TPV certificate is not submitted and a nonconformance isdetermined by a subsequent TPV evaluation, the applicant shall be required to notifypurchasers of record of the equipment, since the last recorded documentation ofconformance, of the nonconformance issue(s) and arrange for repairs or upgrades tobring the equipment into conformance.

B6.6 Reports of Alleged Nonconformance (RAN)

B6.6.1 All users of 3-A Standards (regulators, industry users, and fabricators) are encouragedto submit a RAN whenever nonconformance to a standard is suspected. Alleged

nonconformance of 3-A Symbol bearing equipment may be submitted to 3-A SSI atany time. A form for nonconformance reporting is available from www.3-A.org or inAppendix 2, Exhibit 9 of the TPV manual. The report shall contain all the necessaryinformation for 3-A SSI to support the allegation including but not limited to:


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B6.6.1.1 1. Name of equipment or machinery;

2. Model3. Serial Number (if available);4. Physical location [address, phone and fax numbers];5. Applicable 3-A Standard(s);

6. All criteria for which conformance is not met and the reasons, includingquantitative measurements, if appropriate; and7. Any other appropriate documentation.

B6.6.2 Within ten (10) days of receipt, 3-A SSI shall notify the alleged nonconformingparty(s) of the allegation, the standard criteria in question, and procedures to befollowed to obtain resolution to the allegation(s). The manufacturer and user are torespond within ten (10) days to 3-A SSIs inquiry. Following the response from themanufacturer and the user, the 3-A SSI will evaluate, with advice from the 3-AInterpretations Committee (IC, see Section C6) as appropriate, the validity of theallegation within ten (10) days. All interested parties are encouraged to maintain

files.

B6.6.3 If the allegation is not substantiated, the alleged parties involved in the complaint willbe notified within ten (10) days the reasons for rejection of the RAN.

B6.6.4 If the allegation is substantiated, 3-A SSI will conduct an investigation sufficient todetermine the party responsible for the condition(s) that initiated the RAN. Theresponsible party may be the original fabricator, a distributor, or the end user of theequipment. The responsible party will be notified and allowed to respond. 3-A SSIwill conduct informal discussions with the responsible party and the individualsubmitting the RAN to resolve the nonconformance and develop a plan for correctiveactions. If a resolution is agreed upon, the responsible party will be informed that aTPV evaluation and certificate will be required in order to close the RANinvestigation.

B6.6.5 If the informal discussions are unsuccessful at resolving the RAN, the RAN will bepresented to the 3-A IC to determine the validity of the RAN. (See Section C6.)

B6.6.6 If the IC determines the RAN is unsubstantiated, 3-A SSI will notify all of theinterested parties in writing that the RAN has been resolved and the reason for thedecision.

B6.6.7 If the IC determines the RAN is substantiated, the responsible party shall develop aplan of corrective action.

B6.6.7.1 If the manufacturer is the responsible party, they shall notify all purchasers of recordof the in-service equipment sold since the last documented TPV report ofnonconformance that manufacturer corrections need to be made.


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B6.6.7.2 If the user is the responsible party, they shall complete all corrective actions as soon

as possible to bring the equipment into conformance.

B6.6.8 If the responsible party is the manufacturer and chooses not to make corrections, 3-ASSI will immediately revoke the authorization, notify all interested parties, and whenappropriate, publish a notice of the revocation.

B6.6.9 If the responsible party is the user and chooses not to make corrections, 3-A SSI willnotify all interested parties that the Symbol on that piece of equipment is no longersanctioned.

B6.6.10 Resolution of the RAN must be completed within ninety (90) days of its receipt by 3-A SSI or the 3-A Symbol authorization will be rescinded. Revocation of 3-A Symbolauthorization use or a nonrenewal of an application will require a TPV certification tobe submitted with any future authorization application for the equipment.

B6.6.10.1 Resolution shall include a documented mutually agreed upon plan for corrective

action, scheduling of the corrective actions, and scheduling of the appropriate TPVevaluation. To accommodate completion of all necessary actions, the actualperformance of some activities may exceed the 90 days provided they have beenscheduled within an agreed upon timeframe.

B6.6.11 Throughout the evaluation and processing of the RAN, 3-A SSIs responsibilities andactions include:1. Thorough review of all applications, nonconformance reports and appeals with

advice from the 3-A IC when needed.2. Communication of decisions to all materially affected parties and organizations.3. If nonconformance is substantiated, a TPV evaluation is required to resolve the

nonconformance issue(s). When resolved, a new authorization anniversary date isestablished and a TPV certificate is required to be submitted with the firstanniversary renewal application. The initial (maximum) authorization fee will beassessed.

4. If a nonconformance is substantiated and the applicant chooses not to resolve theissue(s), actions shall be taken to revoke the 3-A Symbol Authorization.

5. Publish, when appropriate, nonrenewed authorizations on the 3-A SSI website andin Food Protection Trends (FPT).

6. If revocation of 3-A Symbol use is for nonconforming design or serialmanufacture quality control reason, publish as in item 5.

7. If a substantiated RAN is due to in-plant (user) modification, only the appropriate

control authorities will be notified.8. Communicate issues of public health significance to regulatory agencies andencourage them to report nonconformance issues.

9. When a 3-A Symbol authorization is revoked, the applicant will be required toreturn the 3-A Symbol Authorization certificate, and a letter confirming that theuse of the 3-A Symbol has been discontinued, including removal of the Symbolfrom existing nonconforming equipment.

10.Engage legal counsel when necessary.


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PROCEDURE FOR REPORTING OF

ALLEGED NONCONFORMANCE

RAN DisputeReceived

Letter Of NotificationTo Manufacturer

Letter OfNotification To

User (Plant)

3-A SSI ReviewsResponses To

Determine If DisputeIs Substantiated

3-A SSI DeterminesResponsible Party

With Help From IC

Substantiated RANUnsubstantiated

RAN

InformalDiscussions WithResponsible Party

To ObtainResolution

Formal Review IfMeeting Of Minds

Not Achieved

Review By IC

ManufacturerResponsible

ProcessorResponsible

Notice That A TPVWill Be Required

To ResolveNonconformance

Issue(s)

Chooses Not ToCorrect

NonconformanceIssue(s)

Notice toPurchaser

Of Record ofNonconformance

Responsible PartyContracts For TPV

CompletesCorrective

Actions

Chooses NotTo Make

CorrectiveActions

ManufacturerNotifies All InService Users

MakesCorrections

Letter To InterestedParties DetailingThe Resolution

3-A SSINotifies

InterestedParties

3-A SSI RevokesAuthorization AndGives Notification

Letter To InterestedParties ResolvingAnd Ending The

RAN Process


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B6.7 Used and Remanufactured Equipment

B6.7.1 These policies establish procedures for monitoring the continued conformance ofused or remanufactured equipment and machines bearing the 3-A Symbol.

B6.7.2 As new or revised 3-A Sanitary Standards become effective, in-service equipmentmay continue to display the 3-A Symbol as authorized using the 3-A Standards ineffect at the time of the original authorization and installation; provided that theequipment is not in violation of any policy of the authorized inspection or regulatoryagency having jurisdiction.

B6.7.3 3-A Symbol authorization is initially granted to original equipment manufacturers.Remanufacturers may apply for 3-A Symbol authorization for a specific piece ofequipment prior to sale.

B6.7.3.1 Used equipment and machinery remanufacturers may submit to 3-A SSI a proposal tobe granted the authority to assign a 3-A authorization for specific models and type ofequipment. The authority will include periodic evaluation.

B6.7.4 The 3-A Symbol authorization shall be deemed void upon any modification to theequipment bearing a 3-A Symbol which renders or may cause the item to no longermeet the criteria of the 3-A Standards.

B6.7.5 All parties engaged in the purchase of used equipment or replacement parts areencouraged to determine that the equipment or parts intended for purchase conformsto the criteria of the current, appropriate 3-A Sanitary Standards. When discrepancies

are observed with the standards criteria, a RAN is to be completed and sent to 3-ASSI.

B6.7.6 When 3-A SSI receives a RAN for a piece of used, remanufactured, or transferredequipment or machinery, 3-A SSI shall follow the procedures in B6.6.

B6.8 Ownership of Certified Conformance Evaluator (CCE) Certificates

B6.8.1 3-A SSI shall retain control of all CCE certificates issued. The 3-A SSI Board ofDirectors shall retain all rights to determine which activities and displays shall be

authorized for use of the CCE certificate or the initials CCE or any otherrepresentations of the intent or purpose of the certificate, title or initials.


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B6.9 Code of Ethics

B6.9.1 To ensure that every user of a 3-A Symbol can have confidence in the integrity of the3-A Symbol authorization, CCEs shall respect and adhere to the principles of ethical

conduct set forth in this section (Form Appendix 3, Exhibit 3). The followinggeneral principles apply to every CCE. Where a situation is not specifically coveredby these principles, a CCE shall apply the intent of the principles in determiningwhether their conduct is proper.

1. CCEs shall not hold financial interests that conflict with the conscientiousperformance of duties.

2. CCEs shall not engage in financial transactions using audit-derived information orallow the improper use of such information to further any private interests.

3. CCEs shall not solicit or accept any gift or other items of monetary value beyondreasonable compensation for their duties from any person or entity seeking audit

activities from, doing business with, or whose interests may be substantiallyaffected by the performance or nonperformance of their duties.4. CCEs shall perform only the TPV activities within the scope of their knowledge.5. CCEs shall maintain strict confidentiality of proprietary information learned

through their TPV activities.6. CCEs shall act impartially and they shall not give preferential treatment to any

organization(s) or individual(s).7. CCEs shall adhere to all laws and regulations that provide for equal opportunity

for all regardless of race, color, religion, gender, national origin, age, or disability.8. CCEs shall endeavor to avoid any actions creating the appearance that they are

violating the ethical tenets set forth in this section. Whether particular

circumstances create an appearance that these tenets have been violated shall bedetermined from the perspective of a reasonable person with knowledge of therelevant facts.

B6.9.2 Violators of any of the Code of Ethics tenets shall be subject to removal from theTPV program.


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TPV EQUIPMENT

AND MACHINERYCERTIFICATION

C1 Notice To Applicants

C1.1 3-A SSI shall notify authorized 3-A Symbol holders prior to their authorizationrenewal dates with appropriate notification materials. Notification letters will be sentat least ninety (90) days prior to renewal date when TPV certification is required, andat least forty-five (45) days prior to renewal date when no TPV certification isnecessary. The notification packet will contain materials and information necessaryto obtain the renewal. New applicants for 3-A Symbol authorization will be providedwith similar packets of necessary information. The packet will include:

C1.1.1 Sample notification letter (See Appendix 2, Exhibit 1);Website where 3-A Standards and listing of CCEs can be found.

C2 Verification Report Format

TPV reports shall follow a standard format to assure uniformity and provide for easeof monitoring. The report shall consist of a cover page identifying the applicant,equipment evaluated, type of verification, declaration of findings, and the CCEssignature, and the completed checklist used to document the verification. (SeeAppendix 3, Exhibit 1.) As appropriate, additional pages can be included forrecording necessary observations.

C2.1 Report Language

C2.1.1 TPV reports shall be prepared using standard English and typed.


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C2.2 Cover Page

Each cover page and support page(s) shall refer to one evaluation. If a TPVassignment is for multiple equipment or machinery type(s), a separate TPV reportshall be prepared for each equipment and machinery type.

C2.2.1 The CCE shall complete all of the information blocks on the Verification Reportcover page (Appendix 3, Exhibit 1). If information is not available, such as theapplicant has not assigned a serial number to the equipment, use the phrase NotApplicable.

C2.2.2 Applicant: Record the applicants complete name and mailing address.

C2.2.3 Verification Location: Record the location address where the verification wasperformed. If the verification is performed at the same location as the applicantsaddress, use the phrase Same as Applicant.

C2.2.4 Date: Record the date(s) that the verification was performed.

C2.2.5 CCE: The CCE shall record his/her name.

C2.2.6 Equipment or Machinery Type: Record a generic description of the equipmentverified such as, Compression Valve or Fluid Milk Filler.

C2.2.7 Model Number: Record the model number(s) of the equipment verified.

C2.2.8 Serial Number: Record the serial number(s), if applicable, of the equipment verified.

C2.2.9 3-A Standard: Record the number and effective date of the covering 3-A Standardused for the verification.

C2.2.10 Applicant/Verification Contact: Record the name and telephone number of theapplicant contact who can respond to inquiries pertaining to the verification or whoshould be provided a copy of the completed report. A fax number or e-mail addressmay also be included.

C2.2.11 3-A Authorization Number: Record the authorization number from the applicantscurrent authorization certificate.

C2.2.12 Type of Verification: Place an X in the appropriate box.

C2.2.13 Declaration of Findings: Upon completion of the verification, indicate whether theequipment verified was in conformance or nonconformance by placing an X in theappropriate box.


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C2.2.13.1 To mark the In Conformance box, there shall be no marks on the checklist

(Appendix 3, Exhibit 1) in the No column. If any No items are checked, theNonconformance box shall be marked.

C2.2.13.2 When the Nonconformance box is marked, additional statements specifically

describing which criteria from the base 3-A Sanitary Standards were not inconformance must be included in the Observations and Findings column or on anattached page.

C2.2.14 Observations and Findings: Refer to the guidance below in the Verification Checklistpages section for the proper format to document nonconformanceissues in the bodyof the report. The following are examples only of statements of nonconformanceusing the 3-A Sanitary Standards For Compression-Type Valves for Milk and MilkProducts, Number 53-01 as the base standard.

C2.2 Certification of the rubber gasket material could not be documented.

D2.1 Valve body not readily disassembled; held in place by 6 bolts.

D4.1 No radius at the juncture of the valve stem to the gasket plate.

D7.7 Power actuator bolted flush with the valve body with no clearance.

D7.8 Power actuator cannot be removed from the valve stem.

C2.2.15 CCE Signature: The CCE must sign the report for it to be official.

C2.2.16 When the typed report is received by 3-A SSI, the following information shall beadded to the form.

C2.2.16.1 Date Received: Record the date received by 3-A SSI.

C2.2.16.2 Received By: Record the name of the individual who received the TPV Report.

C2.2.16.3 Verification Number: 3-A SSI shall assign a unique verification number to facilitatetracking and filing of verification reports.


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C2.3 Verification Checklist Pages

C2.3.1 The Verification Checklist Pages (See Appendix 3, Exhibit 1) are designed to begeneric. The numbering sequence on the checklist is not intended to match the

number sequence in the 3-A Sanitary Standards used as the basis of the verification.A number of 3-A Sanitary Standards include specialized criteria sections, which maynot be included in the generic format. In those cases, use the blank page to identifythe additional specialized criteria sections covered by the verification (See page 75,lines 102 to 131). The CCE should not attempt to include the specialized criteria inthe generic format sections.

C2.3.2 Each line item shall be marked with an X in the appropriate column to indicate thatthe line item has been evaluated.

C2.3.3 As appropriate, any comments or explanatory notes shall be listed in the

Observations and Findings column. The comment or note shall be identified as towhich Checklist line number the comment refers to and also the appropriate 3-ASanitary Standards criteria that has been observed to be in nonconformance. The firstreference number should always be the Checklist line number. The following areexamples of statements of nonconformance using the 3-A Sanitary Standards ForCompression-Type Valves for Milk and Milk Products, Number 53-01 as the basestandard.

Line No.13 C2.2 Certification of the rubber gasket material could not be

documented.

44 D2.1 Valve body not readily disassembled.

65 D4.1 No radius at the juncture of the valve stem to the gasket plate.

102 D7.7 Power actuator bolted flush with the valve body with no clearance.

103 D7.8 The power actuator cannot be removed from the valve stem.


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C3 TPV Certification Procedures

C3.1 The TPV certification is performed under an agreement (verbal or written) betweenthe CCE and the applicant. All fees and expenses for the verification are to be

established between these two parties. Upon accepting a contract to conduct a TPVevaluation, the CCE shall report the following in writing (fax, mail, or e-mail) to 3-ASSI on or before initiating the TPV evaluation:

1. Name, address, phone, fax, e-mail of the CCE conducting the TPV examination;2. Same as above for the company;3. 3-A Standard(s) applied for the authorization.

C3.2 The CCE shall use his/her knowledge and experience to conduct a detailed physicalevaluation of the equipment, drawings, and documentation. The CCE shall conductthe verification at a pace to assure all components are carefully evaluated against the

standards criteria. If the equipment offered for evaluation can be configured usingmultiple optional components or accessories, all of the optional features must bepresented for evaluation. The CCE shall be diligent in asking sufficient questions todetermine such items as identification of all materials of construction, options, or add-on features offered with the equipment, methods of fabrication, etc. Throughout theevaluation the CCE shall exercise critical observation/critical analysis (as in carefuljudgment and scholarly recommendations) at all times.

C3.3 The verification is to be conducted on the basis of a detailed physical evaluation ofthe equipment and a review of all engineering drawings and documentationassociated with the equipment to be verified. This may include general assembly

drawings and drawings of individual equipment components and subassemblies. TheCCE shall request and review all certifications for components fabricated from rubberor rubber-like materials, plastic materials, adhesives, or metal alloys not identified bythe applicable 3-A Standards.

C3.3.1 When the verification is to evaluate a series of equipment, which is of an identicaldesign except for scaling up or down in size, only one set of drawings representativeof the basic design need be evaluated.

C3.4 The CCE is to verify that the applicant has a written quality control procedure withdocumentation to assure conformance to 3-A Standards.

C3.5 The CCE shall perform an on-site evaluation at the applicantsmanufacturing/fabrication or assembly location where the complete, assembled itemidentified for 3-A Symbol authorization is available.

C3.5.1 When deemed necessary by the CCE, an additional on-site evaluation shall beperformed at the installation location of the applicants choosing to evaluate a fully


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assembled installation for items being evaluated for conformance to the followingstandards. 16- Evaporators 22- Silo Tanks 39- Pneumatic conveyors 40- Bag Collectors

C3.6 To assure uniformity of verification presentation and to assist 3-A SSI evaluate theTPV report, all checklist items in which an X has been placed in the No columnmust have a detailed explanatory note describing the nonconforming observation.(See Appendix 3, Exhibit 1) for sample TPV report forms. Additionally, thefollowing checklist items also require an explanatory comment when the line item isapplicable. Mark the columns as appropriate. As necessary, additional pages are tobe added in order to clearly describe the observations.

C3.6.1 A. Scope

C3.6.2 Metals

C3.6.2.1 Line 5: Cast CF-16F, CF-8 or CF-8m. If used, record the component and the castgrade.

C3.6.2.2 Line 6: Other recognized 3-A Alloy. If used, record the component and the alloy.

C3.6.2.3 Line 7: Alloy equivalent to above. If a nonlisted alloy is used, record the alloy used,the component(s) fabricated from the alloy, and the certification of equivalencydocumentation.

C3.6.2.4 Line 10: Gold or Silver Solder. If used, record the type of solder, and that thecertification of conformance (silver solder only) is available.

C3.6.3 Nonmetals

C3.6.3.1 Line 13: Rubber 3-A 18- compliant. If rubber or rubber-like materials are used,record the materials used, and that the certification documentation is available.

C3.6.3.2 Line 15: Plastic 3-A 20- compliant. If plastics are used, record the plastics used andthat the certification documentation is available.

C3.6.3.3 Line 16: Adhesives meets 21 CFR 175. If adhesives are used, record the adhesive(s)used, and that the documentation of 21 CFR 175 conformance is available.

C3.6.4 Fabrication

C3.6.4.1 Line 39: Adhesives meets 21 CFR 175. If an adhesive is used, add the statementSee Line 16.


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C3.6.4.2 Line 84: Agitators (meets criteria). Record the type of agitator(s) provided, e.g., topmounted, side mounted, bottom mounted, etc.

C3.6.4.3 Line 85: Type. Record the type(s) of support(s) provided, e.g., legs, slab mounted,

wall mounted, hanging mount, etc. See line 88.

C3.6.4.4 Lines 89-92: Appurtenances meet referenced 3-A Standards. Record eachnonconforming appurtenance on a separate line. Identify the specific appurtenanceand the corresponding covering 3-A Sanitary Standard. If there are anynonconforming observations, they are to be clearly documented that theappurtenances do not conform to 3-A Sanitary Standards.

C3.6.4.5 Line 100: Engineering Design and Technical Construction File (EDTCF) (SeeAppendix 4). This information, which may be assembled from multiple sources, is tobe used by the CCE as a primary source of verification details. Since each EDTCF is

unique to the equipment type manufactured, the amount and types of informationpresent will vary widely. The CCE shall review the EDTCF carefully, and utilizinghis/her expertise, determines if the file is complete. In order to mark this item with anX in the Yes column at least the following sections, as listed in the 3-A SanitaryStandards Form and Style Manual Document, shall be present in the EDTCF:

C3.6.4.5.1 Other documentation:a. an overall drawing of the subject equipment;b. full detailed drawings, accompanied by any calculations, notes, test

results, etc. required to check the conformity of the equipment to the 3-AStandards or 3-A Practices;

e. if essential, any technical report or certificate obtained from a competenttesting body or laboratory (The following examples are not intended to bean all-inclusive list, plastic certification, rubber certification, adhesivecertification, air filter certification, etc.);

i. a copy of the instructions for the product (Instruction Manuals/InstructionBooks);

j. for serial manufacturing, the internal measures that will be implemented toensure that the equipment will continue to be manufactured in conformityto the provisions of the 3-A Sanitary Standards;

m. bills of material;o. sales order engineering files documenting modifications to design; andq. change records.

C3.6.4.6 See page 75, Lines 102 to 131 List Other Criteria


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C4 TPV Report Submission Procedures

C4.1 CCE shall provide the applicant with one signed original report for inclusion with theapplication package. Send one copy with signature to 3-A SSI, CCE to retain onecopy and any notes taken during the audit.

C4.2 TPV Reports of Conformance

C4.2.1 When the final verification report reveals that no nonconformance issues have beenobserved (that is, no X marks in the No column of the report) a copy of the reportis provided to the applicant for inclusion in the 3-A Symbol authorization package.Additionally, an information copy is to be sent to 3-A SSI.

C4.3 TPV Reports of Nonconformance

C4.3.1 When a verification report (See Appendix 3, Exhibit 1) reveals observations of

nonconformance issues, the applicant may choose to either correct or not correct thenonconforming element(s) of the equipment.

C4.3.1.1 New Authorization Applications (See Appendix 2, Exhibit 5)

If the applicant chooses to correct the nonconforming element(s), they may contractwith the CCE to conduct a follow-up verification to verify that the corrections havebeen completed and conform to the applicable 3-A Standard(s). In such case, theinterim nonconformance verification report is to be considered a draft document andshould not be submitted as a final report. Upon completion of the follow-upverification, the CCE will issue a final Conformance report and follow the

procedures described above.

If the applicant chooses not to correct the nonconforming element(s), a copy of thereport is to be provided to the applicant. Additionally, a copy is to be sent to 3-A SSIfor information purposes only.

C4.3.1.2 Renewal Applications (See Appendix 2, Exhibit 4)

The CCE shall complete a verification report documenting the nonconformanceissues. If the applicant chooses to correct the nonconforming element(s), they maycontract with the CCE (it is recommended that the same CCE conduct the follow-up

verification) to conduct a follow-up verification to verify that the corrections havebeen completed. The follow-up verification shall be conducted within a reasonabletimeframe in order to accomplish the corrections and comply with the timeframe ofthe authorization renewal anniversary date. The follow-up report shall includespecific provisions on how correction of any nonconforming units in use will beaccomplished. Resolution of the nonconforming issues shall be within ninety (90)days or the 3-A Symbol authorization will be rescinded. Upon completion of the


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follow-up verification, the CCE will issue a final Conformance report within thirty(30) days.

Both the initial Verification Report of nonconformance and the final Verification

Report of conformance are to be provided to the applicant and sent by the CCE to 3-ASSI. It is recommended that the CCE maintain a file copy for his/her records.

C4.3.1.3 For RAN follow-up reports, the CCE conducting the follow-up shall provide the:

Applicant the signed, original, follow-up report;

3-A SSI a copy of the follow-up report;

CCE retains a copy of the follow-up report.


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TPV Certification Procedures Flowchart

For New Applicants

New Applicant Sends Requestto 3-A Sanitary Standards, Inc.

3-A SendsNotice to Applicant Letter

& Package Materials

TPV CertificateRequired

Applicant Contracts

With CCE to Perform TheTPV

The TPV EvaluationIs Made

When TPV ShowsNon-Conformance

When TPV ShowsConformance

Applicant Chooses Not

to Make Corrections

Applicant Chooses to

Make Corrections

Applicant Sends

Application Package to3-A SSI for Review andAuthorization

CCE Sends TPV Reportto 3-A and Applicant.

No Further Action

TPV Report is HeldUp. When ready,

Applicant Arranges forFollow-up TPV

Applicant SendsCompliant TPV and

Application Package to3-A SSI for Reviewand Authorization


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TPV Certification Procedures Flowchart

For Renewal Applications

3-A Sanitary Standards, Inc.Database Identifies Need for

Renewal

3-A SendsNotice to Applicant Letter

& Package Materials

When TPV CertificateIs Not Required

When TPV CertificateIs Required

Applicant SendsApplication Package to3-A SSI forReview and

Authorization

Applicant ContractsWith CCE to PerformThe TPV

The TPV EvaluationIs Made

When TPV ShowsNon-Conformance

When TPV ShowsConformance

Applicant Chooses Notto Make Corrections

Applicant Chooses toMake Corrections in

Reasonable Timeframe

Applicant SendsApplication Package to3-A Symbol for Review

and Authorization

CCE sends TPV Reportto 3-A SSI

and Applicant

Applicant ArrangesTPV by same CCE

Applicant SendsCompliant TPV and

Application Package to3-A SSI for Reviewand Authorization


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C5 TPV Report Review and CCE Monitoring Procedures

C5.1 Each TPV report received by 3-A SSI shall be evaluated for completeness,

professional preparation, grammar, spelling, and adherence to the report formatguidelines.

C5.2 Once each year, 3-A SSI shall randomly select a TPV report for each CCE andconduct an in-depth review of all supporting documentation submitted with the 3-ASymbol authorization package. The review shall verify that all of the information onthe report is properly documented.

C5.3 Any discrepancies noted in the reviews conducted under the provisions of sectionsC5.1 and C5.2 shall be reported to the CCE; the CCE shall have the opportunity torespond. The report and response shall be placed in a CCE performance file.

Reviews without discrepancies shall also be recorded in the CCE performance file.

C5.3.1 CCE performance files are restricted to use by 3-A SSI and the CCE.

C6 3-A Interpretations Committee (IC)

C6.1 The 3-A SSI shall establish a 3-A IC comprised of eight (8) members. The membersselected shall equally represent the three 3-A stakeholder groups: Fabricators, Users,and Sanitarians. In addition, the USDA shall appoint one representative and the FDAshall appoint one representative. The chair is selected from and by the members ofthe IC for a one (1)-year term. The committee members shall be knowledgeable in a

broad range of 3-A Standards and sanitary principles. In the event of an unavoidabletie vote, the issue shall be resolved by the 3-A SSI BOD.

C6.2 Any IC member who is a party to any RAN or TPV dispute shall recusehimself/herself from those IC deliberations and decisions about the dispute.

C6.3 The IC shall use the most cost-effective means to render decisions. Reviews andhearings shall be conducted electronically (e-mail, fax, conference calls, etc.) unlessan in-person meeting is specifically requested by one of the parties to the dispute. Insuch case, the requesting party shall assume all cost for the assembly of the IC andother affected parties.

C6.4 The IC will also provide, on request, binding interpretation of 3-A Sanitary Standardsand 3-A Accepted Practices criteria, which are not associated with a RANinvestigation or a TPV evaluation, except that, issues concerning legal pasteurizationwill be issued with the concurrence of FDA.


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C6.5 When appropriate, the IC may also recommend that conflicting issues be resolved by

amendment or revision of 3-A Sanitary Standards. The IC may also recommend howsuch issues should be handled until the standards change.

C7 Dispute Review and Determination Procedures

C7.1 Applicant Rights and Procedures

An applicant may challenge the results of a TPV evaluation. Any such challengeshall be submitted in writing and dated within fifteen (15) days of the completion ofthe TPV evaluation conducted by the CCE. The challenge shall be specific to theparticular criteria in the 3-A Standard that has been alleged to be improperly appliedand a concise description of the materials, design, and fabrication utilized to supportthe challenge.

C7.2 TPV Dispute Resolution

C7.2.1 Upon receipt of the challenge, 3-A SSI will review the submitted documentation andprovide written notification of the dispute to both the applicant and the CCE.

C7.2.2 3-A SSI will contact the CCE and the applicant to attempt to resolve the disputethrough an informal meeting of the minds of the affected parties. If all the partiesagree with the submitted documentation and proposed resolution of the dispute asapplicable, 3-A SSI will notify all parties in writing of the resolution of the disputeand attach the resolution to the TPV report.

C7.2.3 If the parties cannot agree during the informal discussions to resolve the dispute, 3-ASSI will submit the dispute documentation to the IC for review. All decisions of theIC are final and are not subject to further appeal.

C7.2.3.1 If the IC determines the dispute is substantiated in favor of the applicant; i.e., theapplicant is correct, 3-A SSI will notify all the parties of the resolution of the disputein writing and attach the IC determination to the TPV report in order to document theresolution.

C7.2.3.2 If the IC determines that the dispute is unsubstantiated by the applicant; that is, the

CCE is correct, 3-A SSI will notify all the parties of the resolution of the dispute inwriting and that the report will stand as initially presented.


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C7.2.3.2.1 When the dispute confirms that a nonconforming design or quality control conditionexists, the applicant shall be required to notify all owners of in-service equipment ofthe nonconformance and arrange for the nonconformance issue to be corrected. Thenotification shall include all units of equipment sold since the date of the last TPV

certificate documenting conformance

C7.3 The applicant, when determined to be in nonconformance, may choose not to makecorrections. In such case, 3-A SSI will revoke the symbol authorization, publish therevocation in the appropriate publications, and notify all interested parties.

C7.3.1 The applicant shall be required to notify all purchasers of record of thenonconformance issue, remove the 3-A Symbol from all undistributed equipment, andreturn the 3-A Symbol Authorization Certificate to 3-A SSI.


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DISPUTE REVIEW PROCEDURES

TPV DisputeReceived

Letter ofNotification toManufacturer

Letter ofNotification

to CCE

ResolutionAttempt by

3-A SSI

InformalResolution by

3-A SSI

Formal Review ofDispute by IC

SubstantiatedDispute

(ApplicantCorrect)

UnsubstantiatedDispute

(CCE Correct)

TPV Reportand IC

Resolution

TPV Report isUnchanged

Applicant MakesCorrectionsand Notifies

In-Service Users

Responsible PartyChooses

Not to CorrectNonconformance

Issue(s)

Responsible PartyNotifies All

In-service Users

3-A SSI Revokes

Authorizationand Publishes

Notificatication

3-A SSI Letter toInterested Parties

Detailing Resolution


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C8 TPV Certificate of Conformance

C8.1 3-A SSI shall review the application package to assure that all of the components are

present and properly completed (see Section B6.4). 3-A SSI will verify that the 3-ASymbol Authorization Verification Report, prepared by the CCE, certifiesconformance, is the same as the report submitted by the CCE directly to 3-A SSI,covers the equipment type and models specified on the application form, and that allappropriate fees have been submitted.

C8.2 When all components have been verified, the new or renewal application is grantedand notifications and certificates are sent to the applicant.

C9 TPV Certificate of Nonconformance

C9.1 When issues of nonconformance are observed, the CCE will submit a copy of theVerification Report (Appendix 3, Exhibit 1) of nonconformance to 3-A SSI. Theapplicant has the option to make corrections and contract with the CCE to perform afollow-up Verification Report.

C9.2 If the applicant has made corrections and successfully passed the follow-upevaluation, they may submit their application package to 3-A SSI. 3-A SSI willfollow the same procedures as stated above for conformance TPV Certificates.Additionally, 3-A SSI will verify that the corrections for potentially out ofconformance units in use will be corrected within a reasonable timeframe or the

applicants symbol authorization shall be revoked.

C9.3 When all components have been verified, the new or renewal application is grantedand notifications and certificates are sent to the applicant.

C9.4 If the applicant chooses not to make corrections, the applicant will be notified that theapplication for 3-A Symbol authorization is being withdrawn. In addition, 3-A SSIwill undertake the following actions:

C9.4.1 1. Communicate the decision to materially affected parties and organizations.2. Publish the revoked or nonrenewed authorizations on the 3-A SSI website and

in Food Protection Trends (FPT).3. Require the return of all 3-A Symbol Authorization Certificates and a letter

from the applicant stating that they will discontinue the use of the symbol andremove the symbol from existing equipment.

4. Engage legal counsel when necessary.


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C10 3-A Symbol Authorization Forms and Documents

C10.1 Throughout the evaluation and processing of the Symbol Authorization, 3-A SSIsresponsibilities and actions include:

1. Thorough review of all applications, nonconformance reports and appeals withadvice from the 3-A IC when needed.

2. Communication of decisions to all materially affected parties and organizations.3. If nonconformance is substantiated, a TPV evaluation is required to resolve the

nonconformance issue(s). When resolved, a new authorization anniversary date isestablished and a TPV certificate is required to be submitted with the firstanniversary renewal application. The initial (maximum) authorization fee will beassessed.

4. If a nonconformance is substantiated and the applicant chooses not to resolve theissue(s), actions shall be taken to revoke the 3-A Symbol Authorization.

5. Publish, when appropriate, nonrenewed authorizations on the 3-A SSI website andin Food Protection Trends (FPT).6. If revocation of 3-A Symbol use is for nonconforming design or serial

manufacture quality control reason, publish as in item 5.7. If a substantiated RAN is due to in-plant (user) modification, only the appropriate

control authorities will be notified.8. Communicate issues of public health significance to regulatory agencies and

encourage them to report nonconformance issues.9. When a 3-A Symbol authorization is revoked, the applicant will be required to

return the 3-A Symbol Authorization certificate, and a letter confirming that theuse of the 3-A Symbol has been discontinued, including removal of the Symbol

from existing nonconforming equipment.10.Engage legal counsel when necessary.

See Appendix 2 for sample forms and documents.


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CCE

CERTIFICATIOND1 Basic Qualifications For Education and Experience

(See Appendix 3, Exhibits 2 and 3)

D1.1 3-A SSI shall retain the right to waive or alter CCE qualifications as may benecessary.

D1.2 All CCE candidates shall comply with the following basic qualifications foreducation and experience:

D1.2.1 A minimum of a Bachelor of Science degree in engineering, physical or biologicalscience curriculum plus three (3) years experience in relevant food or pharmaceuticalprocessing. One (1) year of the three (3) years of general experience shall be directlyrelated to 3-A covered equipment design or sanitary processes, or

D1.2.2 Completion of at least a secondary education plus five (5) years experience inrelevant food or pharmaceutical processing. Three (3) years of the five (5) years ofgeneral experience shall be directly related to 3-A covered equipment design or

sanitary processing.

D1.3 Examples of appropriate practical workplace experience may include: dairy industry,food industry, pharmaceutical industry, or similar sanitary (hygienic) processindustry; equipment and process design, review, installation, and FoodSafety/HACCP development. This list of examples is not all-inclusive.

D2 Required Knowledge, Skills, and Abilities

D2.1 In addition to the basic qualifications, all CCE candidates shall provide evidencedemonstrating all of the following knowledge, skills and abilities:

1. The ability to review and evaluate complex processes and operations from a broadperspective, including assessment techniques of examining, questioning,evaluating, and reporting, and to understand the role of individual units within aprocess and organization in order to prepare a final evaluation report.

2. Knowledge relative to the types of processes to which 3-A Standards coveredequipment will be applied.


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3. The ability to read and to understand engineering drawings and documentationcustomarily used in machine shops engaged in manufacturing equipment andinstrumentation for the food processing industries.

4. Knowledge of machine shop quality control testing techniques and sample plans,quality documentation, sanitary weld inspection and quality assurance and theability to use the necessary inspection instruments.

5. Basic knowledge and understanding of materials science and the regulations usedin fabricating food or pharmaceutical processing equipment.

6. Knowledge of 3-A Sanitary Standards and possession of up-to-date copies of allstandards.

7. The ability to exercise good judgment, analytical skills, and thoroughness, free

from bias, to arrive at acceptable and reasonable evaluation conclusions.

8. The ability to operate independently without supervision or guidance, particularlyduring the performance of the evaluation.

9. The ability to organize evaluation steps, and the time available and humanresources to conduct and complete a TPV evaluation.

10. The ability to clearly communicate orally with management, staff, and fellowCCEs utilizing terminology familiar to the parties involved to obtain informationrelevant to the evaluation.

11. The ability to communicate effectively in writing that is legible, clear in meaning,factually correct and concise. Spelling and grammar are important and necessarycomponents of acceptable written communication abilities.

12. The ability to communicate orally and in writing in English.

D3 CCE Candidate Application Package Requirements

D3.1 CCE candidates shall provide the following:

1. An application form (See Appendix 3, Exhibit 2);2. Two (2) letters of reference from previous employers or other individuals withknowledge of the candidates work experience and integrity. (At the discretion ofthe selecting body); and

3. A copy of their secondary education or college diploma or transcript.4. Application fee specified by 3-A SSI.


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D4 Submission Of ApplicationsThe CCE candidate shall submit all appropriate documentation of conformance withapplication package (see section D3) to:

3-A Sanitary Standards, Inc.6888 Elm Street, Suite 2DMcLean, Virginia 22101-3829USA

D5 Application Evaluation

In evaluating CCE candidates, 3-A SSI may make use of:

Examinations;Candidates submitted application package;Review of educational background and professional affiliations; andInterviews with candidates(Used at the discretion of 3-A SSI)(Interviews may be in person or by telephone)Program orientation.

D6 CCE Certification

D6.1 Initial CCE Certification

D6.1.1 A CCE candidate will be granted certification by an affirmative vote of 3-A SSI uponcompletion of the evaluation of the items listed under the Application Evaluationsection of these procedures. (See Section D5.)

D6.2 Annual Maintenance

D6.2.1 3-A SSI will charge a nominal annual CCE accreditation maintenance fee to help 3-ASSI offset direct program expenses. Notice of the annual maintenance fee will besent to the CCEs on or around the anniversary date of initial accreditation.


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D6.3 Renewal of CCE Certification

D6.3.1 Renewal of all CCE certifications is required every three (3) years. Thecandidate must complete the necessary validations, attend joint meetings of the 3-ACommittees, and is not under investigation for code of ethics violations or dereliction

of duty. The 3-A SSI shall annually review records for 3-A Committees Meeting(s)attendance, completion of three (3) required validations within the first two yearsafter receiving accreditation and compliance with the code of ethics.

D6.4 Denial or Withdrawal of CCE Certification

D6.4.1 The 3-A SSI has the authority to deny an initial CCE candidate application or arenewal CCE Certification for the following causes:

1. The basic qualification, knowledge, skills, or ability criteria are not met. The

candidate shall be provided with notice of the specific criteria and reason forfailure to comply.

2. Failure to sign the certificate of the Code of Ethics or violations of the Code ofEthics.

3. Voluntary withdrawal of the application or certification by the candidate or theCCE.

4. Nonrenewal of certification.5. Failure to attend, other than excused for just cause, the 3-A Sanitary Committees

Meeting(s). Only one (1) excused absence per each CCE renewal period isacceptable.

6. Dereliction of duty.

7. Failure to submit assessed fee(s).8. Failure to perform at least three (3) TPV audits within the first two full yearsfollowing the receipt of accreditation as a CCE.

D6.5 Appeal of Denial or Withdrawal of CCE Certification

D6.5.1 The CCE or candidate shall be entitled to due process to appeal a revocation or denialof his/her certification. The principles of fairness and being considered innocent untilproven guilty are to be followed in all proceedings. The appeal procedures shall be:

1. The appellant shall be provided with written notice of all the violations andcharges.

2. The appellant shall have the opportunity to answer the charges within thirty (30)days of notification.

3. The appellant shall be provided with notice of the determination based on thewritten response within ten (10) days of receipt of the response by 3-A SSI.


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4. The appellant may request a hearing before the 3-A IC to present evidence, to

confront witnesses who are present at the hearing, and the right to counsel (notrequired to be an attorney).

5. The date of the hearing shall not be less than one (1) month nor more than three(3) months from the request.

6. The appellant may request pre-hearing discovery when requested in writing andlisting the disclosure items.7. The location of the appeal hearing is at the discretion of 3-A SSI, but must be in

the contiguous United States.8. The appellant shall be provided with written notification of the ICs ruling

including any sanctions within four (4) weeks of the appeals hearing.

D7 Maintenance of CCE Competence

D7.1 Each CCE accepted by 3-A SSI shall maintain his/her competence by:

D7.1.1 1. Ensuring that their knowledge of sanitary (hygienic) equipment design andprocessing standards remains current.

2. Ensuring that their knowledge of auditing procedures and methods is current.3. Mandatory attendance, except for just cause, at the joint meetings of the 3-A

Sanitary Standards Committees. Only one (1) excused absence per each CCErenewal period is acceptable. In the case of an organization with multiple CCEs,at least one (1) authorized individual shall attend the meetings so that current 3-ASanitary Standards modifications can be communicated to the rest of theorganization.

4. Conduct three (3) TPV audits within the first two full years following the receiptof accreditation as a CCE.

5. It is the CCEs responsibility to take appropriate action to maintain certification.3-A SSI shall provide notice of renewal ninety (90) days prior to the anniversarydate.

D8 CCE Certification Documentation and Listing

D8.1 The 3-A SSI shall issue each accepted CCE an official certificate documenting thecertification of the CCE.

D8.2 The 3-A SSI shall maintain a database of all CCEs and a current listing on theirwebsite.

D8.3 The CCE certificate shall be as shown in Appendix 3, Exhibit 4.


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ADMINISTRATION

E1 File Retention

E1.1 CCE Certification Files

E1.1.1 Successful candidates files are to be retained for the length of the certificationperiod. The file shall contain the initial application materials, yearly records requiredfor continuing the certification and re-application materials.

E1.1.2 If the candidate is unsuccessful in the certification process, files are retained for one

(1) year.

E1.1.3 For candidates who apply but never complete the process, the incomplete files areretained for six (6) months. After six (6) months, the candidate must begin the entireprocess again with a new application and application fee.

E1.1.4 The examination file shall be retained for as long as the CCE is certified or until it isreplaced by a subsequent exam.

E1.1.5 If a candidate was initially approved but has not renewed at five (5) years or has notmet the minimum requirements, the certification has technically expired. A three- (3)

month period is allowed for reinstatement without penalty. Beyond that, theprocedures and fees for new certification shall apply.

E1.1.6 When a certified person is deceased or withdraws the certification voluntarily, filesmay be immediately disposed, except for the letter of withdrawal.

E1.1.7 The documentation for all of the above may be stored as hard copy or electronically.It is, however, highly encouraged to store records electronically for easy retrieval andediting. To facilitate this, all application materials, forms, etc. should be available forelectronic distribution and completion. If signatures are required on originalapplications and on ethics statements, hard copies are required.

E1.1.8 It should be clearly established that the relationship between 3-A SSI and with thosewho take examinations (written or oral) is contractual. The terms of that contract arethe 3-A SSI right, at their sole discretion, to cancel test scores in the event ofsuspected cheating or loss of exam confidentiality.


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E2 3-A Symbol Authorization Files

E2.1 3-A SSI shall maintain sufficient files and databases for the accurate administration ofthe TPV program and timely retrieval of information.

E3 Announcements and Listings

E3.1 Certified CCEs shall be listed on the 3-A SSI website as they become certified.

E3.2 The 3-A Authorized Symbol Holders List shall be maintained on the 3-A SSI websiteand updated weekly. The electronic list shall be organized according to increasingstandard number. The list shall contain the companys name, address, phone, fax, e-mail information, certificate number and when last issued. The printed list will bediscontinued.

E3.3 A revocation and nonrenewal list shall be maintained and revised within one (1) weekof any revocation or nonrenewal action. These lists shall be separate and include thedates of action. The information shall include standard number, certificate number,company name and model numbers.

E3.4 A list of those persons certified to perform TPV evaluations shall be maintained onthe 3-A SSI website and updated when certification is granted. The list shall containindividuals name and company. With written permission, it may also includeaddress, phone, fax and e-mail information. The certified individual must renewevery five (5) years.


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E4 Service Mark

E4.1 Certification programs often use some form of trademark registration. There areseveral types of Marks that can be registered under the Trademark Act of 1946, 15

U.S.C. t seq. The one appropriate for 3A is 102 Service Marks. These servicemarks are used to identify services (activities) that are performed by a person for thebenefit of others. The term service mark includes any word, name, symbol, ordevice that is used by a person to identify and distinguish their unique services fromthose offered by others, and to indicate the source of those services. Titles, characternames and other distinctive features may be registered as service marks. (15 U.S.C.1127.)

E4.2 3-A SSI will use a registered service mark and shall make it available to all categoriesof those people who are certified to conduct TPV on equipment included in the scopeof any and all 3-A Standards.

E4.2.1 This mark may be used by a CCE as a display on business cards, paperwork, andpromotional materials with the approval of 3-A SSI.


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E5 Fees

E5.1 3-A Symbol Authorization

New Authorization: $995Authorization Renewal (Annual): $495Authorization Amendment: $350Fees listed are subject to change by 3-A SSI.

E5.2 Certification of CCEs

ApplicationRenewalExamination (written, oral and/or practical)Reinstatement

Fees to be determined by 3-A SSI.

E6 TPV Operations Manual Maintenance

E6.1 Any interested party may petition 3-A SSI for revision or amendment to this manualat any time. 3-A SSI shall consult with the 3-A SSI Board of Directors to determineif the proposal has merit and when changes may occur by revision or amendments tothe TPV Manual. The requester will be notified of the determination on the proposal.

E6.2 3-A SSI shall appoint a review committee at least every five (5) years to conduct adetailed review of these procedures and update as necessary. All changes and

revisions shall be documented, so that users of this manual can be assured of usingthe most current version. The 3-A SSI Board of Directors is required to approve anychanges to the protocols documented in this operations manual.


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APPENDIX 1GLOSSARY OF TERMS

The following terms and definitions are commonly used in reference to the evaluationand certification industries. Not all of the terms are used in this document. They arepresented here to provide a common understanding of terms that may be used inassociation with the work conducted under the 3-A SSI, Third Party Verification(TPV) and 3-A Symbol Authorization Program. Organization acronyms may befound in Standards Management.1

F1 3-A Steering Committee: Implements the policies and procedures for developing 3-A Standards and 3-A Practices. The committee reviews requests for new standardsactivity as their relevance to the industry, and for conformance to federal and stateregulations.

F2 3-A Symbol Council: Is a founding member of 3-A SSI and has granted it the rightto authorize the use of the 3-A Symbol under the Third Party Verification program.

F3 AdministrativeOfficer(AO): The person(s) that is responsible for accomplishingthe functions of 3-A Symbol authorization, renewals, nonconformance, recordkeeping and any other described in the TPV Manual.

F4 American Dairy Products Institute (ADPI): A trade association representing dairyprocessor stakeholders and is a Founding Member of 3-A SSI.

F5 Certification Body (3-A SSI): An impartial body possessing the necessarycompetence and other qualifications to sponsor and operate a certification program.A certification body is an organization under whose authority a certification programis developed, promulgated, operated, and financed, and with whose name thecertification program is identified. (ANSI)

F6 Certification System: The organizational and procedural process or the institutionalmechanism for accomplishing product certification. (EIPSC)

F7 Certification: The act of issuing a warranty, certificate, or mark or other appropriateevidence that attests that a product or service conforms to specific standards orspecifications. (ILAC)

1 Source for most is Standards Management a handbook for profits; edited by Robert B. Toth. ANSI,1430 Broadway, New York, NY 10018.


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Quality assurance programs are used to assure that the product(s) continue to complywith the specified requirements. Satisfactory tests, inspections, and quality assuranceare the basis for certification. Evidence of certification may be by labeling of theproduct. (ASTM E699)

F8 Certified Conformance Evaluator (CCE): Person(s) meeting the requirements inSection D to perform third party verification (TPV) for conformance of equipmentand machinery to 3-A Sanitary Standards criteria. The CCE must have a currentrecognition (certification) document.

F9 Conformance: The state of having satisfied the requirements of some specificstandard(s) and/or specification(s). (IEEE)

Note: Conformance is used with respect to voluntary standards and specifications,whereas compliance is used with respect to mandatory standards and regulations.(OSCI)

F10 Consensus Procedures: The rules and regulations of a recognized or duly appointedauthority that pertain to the development of standards: 1) requiring that all knowninterested and affected parties be given due notice of the initiation and developmentof a

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