APPROVED

FEDERAL PURCHASE 

PROGRAM SPECIFICATION 

(FPPS) FOR GROUND BEEF 

ITEMS, FROZEN

Contracting Officer Technical Representative (COTR)

Agricultural Marketing Service (AMS)

Livestock, Poultry and Seed (LPS) Program 

Food Safety and Commodity Specification (FSCS) Division

Room 2628 S-Bldg, Phone: (202) 692-0342

Supersedes: TRS-GB-2013 May 2013 – Changes from 

previous requirements in blue

Effective: APRIL 2014

Approved by CMS 

Date Issued: 04/26/04

Date Revised: 04/21/14

100 SCOPE

101 This FPPS – Ground Beef (GB) – 2014 is for use by the Department of 

Agriculture (USDA), AMS, Commodity Procurement Staff (CPS) to 

procure frozen ground beef products.

200 APPLICABLE DOCUMENTS

210 The following documents are incorporated as part of this USDA, AMS, 

FSCS Division FPPS-GB-2014: 

210.1 Quality Assessment Division (QAD) Procedures Manual.

210.2 Food Safety and Inspection Service (FSIS) Directive 10,010.1, Revision 3.

210.3 Applicable Supplement to AMS Master Solicitation.

300 CHECKLIST OF REQUIREMENTS

310 ITEMS

311 The contractor’s technical proposal will declare which items will be offered 

to USDA. Bulk or patties will be specified within USDA procurement 

documents.

312 Bulk

Item Material Number

Ground Beef (10-pound bulk packaged) 100158

Ground Beef-Irradiated 

(10-pound bulk packaged) 110085

Ground Beef, 1-pound packages 100159

Coarse Ground Beef 100154
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Date Issued: 04/26/04

Date Revised: 04/21/14 2 

Ground Beef (10-pound bulk packaged) 

(LFTB Optional) 110261

Ground Beef, 1-pound packages 

(LFTB Optional) 110260

313 Patties

Item Material Number

Ground Beef Patties-85/15 – 2.8 oz. 

(Meat / Meat Alternate (MMA) 2.0 oz.) 110349

Ground Beef Patties-85/15 – 2.1 oz. 

(MMA 1.5 oz.) 110350

Ground Beef Patties-Irradiated-85/15 – 2.8 oz. 

(MMA 2.0 oz.) 110082

Beef Patties with Soy Protein Product-85/15 –

2.8 oz. (MMA 2.0 oz.) 110348

Beef Patties with Soy Protein Product-85/15 –

2.1 oz. (MMA 1.5 oz.) 110347

Ground Beef Patties-90/10 – 2.8 oz. 

(MMA 2.0 oz.) (Not to Exceed 10% Fat) 110346

Lean Beef Patties-5% Fat 100163

Lean Beef Patties-5% Fat (LFTB Optional) 110270

320 MATERIAL

321 The contractor’s technical proposal must describe a process plan with a 

documented quality control program that includes procedures, records, 

forms, etc., that demonstrate conformance with the following Checklist of 

Requirements. The Contracting Officer’s Technical Representative 

(COTR) may request changes to the technical proposal at any time.

322 Domestic Origin and Harvest (Slaughter) Requirements

322.1 Quality Control Program - The harvester’s quality control program must be 

documented in each contractor’s technical proposal and have received a 

satisfactory onsite capability assessment by QAD. 

322.2 Boneless beef shall be derived from cattle harvested at facilities that 

comply with the following origin and harvest requirements. 

322.2.1 Domestic Origin - All beef will originate from U.S. produced livestock as 

defined in the Supplement, as amended. 

322.2.2 Humane Handling – All cattle shall be humanely handled in accordance 

with all applicable FSIS regulations and AMS requirements.

322.2.3 Residue Prevention – Harvest and production establishments must have a 

Hazard Analysis Critical Control Point (HACCP) system to control 

veterinary drug, pesticide, and environmental contaminant residues per 
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Date Issued: 04/26/04

Date Revised: 04/21/14 3 

FSIS regulations. Helpful information is available in the FSIS Compliance 

Guide for Residue Prevention 2013. 

322.2.4 Spinal Cord Removal – All spinal cord tissue shall be removed during the 

harvesting process. 

322.2.5 Pathogen Intervention Steps – The harvest process must include at least 

two pathogen intervention steps. One of the intervention steps must be a 

critical control point (CCP) in the supplier’s FSIS recognized harvest 

process HACCP plan and the CCP intervention(s) must be scientifically 

validated to achieve a three-log reduction of enteric pathogens. 

322.2.6 Carcass Testing - Routinely test carcasses for Shiga-toxigenic 

Escherichia coli O157 (including O157:H7 and O157:Non-Motile (NM); 

herein referred to as E. coli O157:H7) at CCP to verify effectiveness of 

interventions.

323 Boneless Beef Requirements

323.1 Quality Control Program - The boneless beef supplier’s quality control

program must be documented within each contractor’s technical proposal 

and have received a satisfactory onsite capability assessment by QAD

prior to supplying materials for the program. Additionally, each plant is 

subjected to verification audits conducted by the QAD during production 

activities that demonstrate their adherence to the documented quality 

control program. 

323.2 Traceability – Boneless beef shall be traceable to sources that comply 

with the above domestic origin and harvest requirements. 

323.3 Boneless beef commonly referred to by the industry as XF trimmings 

(e.g., Beef Fat with Visible Lean) is not allowed as a standalone raw 

material source for grinding. 

323.4 Meat Recovery Systems

323.4.1 Mechanical Separation - Boneless beef that is mechanically separated 

from bone with automatic deboning systems, advanced lean (meat) 

recovery (AMR) systems or powered knives, will not be allowed.

323.4.2 Lean Finely Textured Beef (LFTB) – When specified, LFTB, or meat 

components produced using similar methods may be used as a raw 

material provided a scientifically validated intervention is applied during 

the LFTB manufacturing process that reduces enteric pathogens by at 

least a three log basis. When LFTB is used, the following criteria must be 

met: 
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Date Issued: 04/26/04

Date Revised: 04/21/14 4 

323.4.2.1 Red Color – The producer of LFTB shall assure that the product has a 

discernible redness in color. The LFTB shall maintain the same redness 

in color until time of processing to minimize the effect of the color to the 

finished ground beef. 

323.4.2.2 Fat Content - Does not exceed 10 percent fat. 

323.5 Handling - All boneless beef must be maintained in excellent condition. 

The contractor’s technical proposal shall include detailed production 

scheduling that addresses time and temperature controls necessary to 

maintain excellent condition of the boneless beef.

323.5.1 Except for boneless beef destined for Ground Beef Products to be 

irradiated, frozen boneless beef may be used provided it is ground into the 

final product within 60 days from the date of pack. Boneless beef 

destined for irradiated ground beef shall never be frozen before grinding 

and shall be ground within five (5) days from harvest. 

323.5.2 The contractor shall document all procedures for handling of LFTB and 

must use it within 60 days of the date of production. 

323.6 Objectionable Materials – The following objectionable materials shall be 

excluded: 

323.6.1 Major lymph glands (prefemoral, popliteal, and prescapular), thymus 

gland, and the sciatic (ischiatic) nerve (lies medial to the outside round). 

All bone, cartilage, and the following heavy connective tissues:

323.6.1.1 White fibrous – Shoulder tendon, elbow tendon, silver skin (from the 

outside round), sacrociatic ligament, opaque periosteum, serous 

membrane (peritoneum), tendinous ends of shanks, gracilis membrane, 

patellar ligament (associated with the stifle joint), and achilles tendon. 

323.6.1.2 Yellow elastin – Back strap and abdominal tunic. 

323.7 Lot – A lot shall consist of approximately 2,000 pounds of boneless beef 

(including LFTB) produced within a day, between “cleanup to cleanup” 

(see APPENDIX D) and that is from a single harvester or processor.

323.8 Microbial Testing – Samples from all lots of fresh chilled boneless beef, 

including LFTB, must be sent to an AMS designated laboratory (ADL). 

Samples from each lot will be tested for E. coli O157:H7, Salmonella, and 

indicator microorganisms. One sample from every 10 lots of fresh chilled 

boneless beef (excluding LFTB), selected at random by the ADL, will be 

tested for non-O157 STECs (O26, O45, O103, O111, O121, O145). 

323.8.1 Sample Preparation and Handling - The ADL will be responsible for 

supplying procedures for sample preparation, and submission. The 

laboratory shall require suppliers to submit a sample submission form as 
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Date Issued: 04/26/04

Date Revised: 04/21/14 5 

an official record with each sample. The ADL will also be responsible for 

supplying shipping supplies (including sampling bags and shipping 

materials) to each supplier. Suppliers’ technical proposal will include and 

describe sample collection and preparation procedures provided by the 

ADL.

323.8.2 Sample Selection

323.8.2.1 For Beef Manufacturing Trimmings – The sample will be selected as 

described within FSIS Directive 10,010.1 Revision 3 (N-60 Sections 8, 9 

and NOTE).

323.8.2.2 For every lot of beef Manufacturing Trim, three (3) samples will be 

prepared from seventy (70) pieces of trim from seventy (70) different 

pieces of beef product. The sample for E. coli O157:H7 and non-O157 

STECs will be sixty (60) pieces and weigh 325 grams ± 10 percent; the 

sample for Salmonella will be five (5) pieces and weigh 25 grams ± 10 

percent; the sample for indicator organisms (aerobic plate count, total 

coliform and generic E. coli) will be five (5) pieces and weigh 25 grams ±

10 percent.

323.8.2.3 For LFTB – The random sample will be selected as described within FSIS 

Directive 10,010.1 Revision 3. The sample for E. coli O157:H7 will weigh 

325 grams ± 10 percent; the sample for Salmonella will weigh 25 grams ± 

10 percent; the sample for indicator organisms (aerobic plate count, total 

coliform and generic E. coli) will weigh 25 grams ± 10 percent.

323.8.2.4 When boneless beef has been exposed to any anti-microbial treatment, 

no sample units shall be selected for at least 15 minutes after such 

treatment. All anti-microbial treatments (e.g. techniques and procedures) 

administered during production and post-production shall be described in 

the supplier’s technical proposal.

323.8.2.5 If the contractor plans to do microbiological testing in addition to that 

required by AMS, the technical proposal must identify in detail such 

testing, including location of sample collection, frequency of sample 

collection, and intended use of testing results. AMS will make a 

determination of whether such additional sampling and testing constitutes 

“prescreening,” in which case it will not be allowed. 

323.8.3 Testing and Results

323.8.3.1 The microbiological testing for all microbes will be in accordance with the 

applicable AMS-approved testing methodologies.

323.8.3.2 Notification for presence of pathogens and exceeding critical limit criteria - 

When presence of E. coli O157:H7, non-O157 STECs, or Salmonella is 

confirmed positive or any critical limit is exceeded for indicator microbes:
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Date Issued: 04/26/04

Date Revised: 04/21/14 6 

323.8.3.2.1 The ADL will immediately notify FSIS and the COTR of all confirmed 

pathogens.

323.8.3.2.2 When pathogen results are positive, FSIS and the COTR will be notified 

by the boneless beef supplier of the final disposition of the affected lot.

323.8.3.2.3 When the critical limit is exceeded for indicator organisms, the boneless 

beef supplier will notify the COTR of the final disposition of the affected 

lot.

323.8.3.3 The ADL will record all results on spreadsheets and calculate the process 

capability (CPU, Cl) for microbial tests performed on production lots as 

outlined in Section 323.8.4.

323.8.3.4 Any lot that tests positive for E. coli O157:H7, non-O157 STECs, or

Salmonella, or exceeds the critical limit criteria of APPENDIX B cannot be 

used to produce ground beef or any other product purchased by USDA.

323.8.4 Statistical Process Capability – Boneless beef supplier compliance with 

microbial requirements will be based on the assessment of the calculated 

process capability (CPU, Cl) values derived from the individual combo test 

results representing one (1) 2,000 pound combo lot randomly selected by 

the ADL from every five (5) consecutive individual 2,000 pound combo 

lots produced each production day. In the event that a production day 

concludes with less than five (5) consecutive individual 2,000 pound 

combo lots, a randomly selected test result will be utilized from one of the 

remaining lots. The spreadsheets will be maintained so that process 

capability assessment on the twenty (20) lots can be determined as 

described within APPENDIX B. Test results involving all boneless beef 

offered for testing for AMS ground beef purchase programs will be 

monitored by AMS, the contractor, and the boneless beef supplier to 

determine individual lot acceptance and/or capability of their process 

according to APPENDIX B. Ineligible boneless beef suppliers may reenter the program under conditional status provided corrective actions 

have been submitted for review and approved, implemented and a 

satisfactory onsite corrective action audit by QAD has been conducted. 

Upon notification by the COTR that the plan has adequately addressed 

the issues that resulted in the ineligible status determination, the boneless 

beef supplier may re-enter the program under conditional status. 

323.8.5 Contractor’s Responsibility - The contractor will require its boneless beef 

supplier(s) to provide results and process capability status (as applicable) 

involving each lot of boneless beef to be processed into ground beef for 

USDA. Test results and process capability status (as applicable) for 

individual lots shall be provided to the QAD agent upon request. In the 

event a boneless beef supplier has been deemed ineligible, and wants to 

continue in the program, the ineligible boneless beef supplier may re-enter 

the program under conditional status provided corrective actions have 

been submitted for review and have been deemed approved, 
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Date Issued: 04/26/04

Date Revised: 04/21/14 7 

implemented and a satisfactory onsite corrective action audit by QAD has 

been conducted. Upon notification by the COTR that the plan has 

adequately addressed the issues that resulted in the ineligible status 

determination the boneless beef supplier may re-enter the program under 

conditional status.

323.8.6 Supplier request to remove samples from AMS testing must be submitted 

and approved by COTR prior to sample removal from ADL testing.

324 Ground Beef Requirements

324.1 Quality Control Program - The ground beef quality control program must 

be documented within the contractor’s technical proposal and have 

received a satisfactory onsite capability assessment audit by QAD. 

324.2 Traceability – All ground beef production must be traceable to the 

boneless beef lots (including LFTB) and their associated microbial test 

results. 

324.3 Handling - The contractor’s technical proposal shall include detailed 

production scheduling that addresses time and temperature controls 

necessary to maintain excellent condition of the ground beef. Except for 

ground beef, 1-pound packages, all other ground beef items shall be 

delivered within 60 days from date of pack. Ground Beef 1-pound 

packages shall be delivered within 30 days from date of pack. 

324.4 Lot - For the purpose of microbiological testing, a lot is defined as the 

amount of finished ground beef product, for each material number, 

produced within a day, between “cleanup to cleanup” (see APPENDIX D) 

which must be further divided into sub-lots not to exceed 10,000 pounds.

324.5 Microbiological Testing – All sub-lots of ground beef will be tested for all 

microbes listed in APPENDIX B after final grinding and before freezing, 

except for ground beef products that are irradiated. The irradiated 

products will be tested for Salmonella and E. coli O157:H7 after the 

irradiation process, and the other microbes listed in APPENDIX B prior to 

irradiation. All samples will be sent to the ADL.

324.5.1 Sample Preparation and Handling - The ADL will be responsible for 

supplying procedures for sample preparation, and submission. The 

laboratory shall require contractors to submit a sample submission form 

as an official record with each sample. The ADL will also be responsible 

for supplying shipping supplies (including sampling bags and shipping 

materials) to each contractor. Contractor’s technical proposal will include 

and describe sample collection and preparation procedures provided by 

the ADL.

324.5.2 Sample Selection – Production processes of ground beef will be subject to 

the following sampling strategy:
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Date Issued: 04/26/04

Date Revised: 04/21/14 8 

324.5.2.1 Sub-lot Microbial Testing – For every sub-lot, three (3) original and 

reserve samples will be prepared from four (4) individual sample units for 

each microbial test. The sub-lot samples will be 325 grams ± 10 percent, 

25 grams ± 10 percent, and 25 grams ± 10 percent each for E. coli

O157:H7, Salmonella, and indicator organism tests, respectively of 

finished ground beef, randomly selected throughout each 10,000 pounds 

of production. The four (4) individual sample units shall be composited to 

produce a sample that represents each microbial test for each sub-lot. 

The contractor will describe in their technical proposal the procedure in 

which the four (4) sample units will be selected throughout the sub-lot to 

be composited for each microbial test. These samples shall be submitted 

to the ADL for analysis. The reserve samples will be held for testing in 

case the COTR deems it necessary. The contractor will describe, in their 

technical proposal the method to be used to maintain the identity and 

traceability of each sub-lot. No more than 10,000 pounds shall be 

produced during each sub-lot, except for the last sub-lot produced in the 

lot may exceed the 10,000 pound limitation by five (5) percent. 

324.5.3 Testing and Results - The samples from each sub-lot will be analyzed by 

the ADL for all microbes listed in APPENDIX B. 

324.5.3.1 The microbiological testing for all microbes will be in accordance with the 

applicable AMS-approved testing methodologies.

324.5.3.2 Any sub-lot that tests positive for E. coli O157:H7 or Salmonella, or any 

critical limit criteria noted in APPENDIX B that is exceeded will result in 

that sub-lot and adjoining sub-lots (one preceding and one following within 

a day, between “clean up to clean up”) being ineligible for this program or 

any other USDA purchase program. Other sub-lots produced within the 

lot unit will be deemed ineligible for this program unless the contractor can 

demonstrate a scientific or other data-supported basis for defining the 

sub-lot(s) relative to test results and why ground beef produced from 

same source material that resulted in the ineligible determination should 

not be considered affected by the test results.

324.5.3.3 Notification for presence of pathogens or when critical limit is exceeded – 

When presence of E. coli O157:H7 or Salmonella is presumptive positive 

or confirmed positive; or any critical limit is exceeded for indicator 

microbes: 

324.5.3.3.1 The ADL will immediately notify FSIS and the COTR of all confirmed 

pathogens.

324.5.3.3.2 When pathogens results are positive, FSIS and the COTR will be notified 

by the contractor of the final disposition of the product.
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Date Issued: 04/26/04

Date Revised: 04/21/14 9 

324.5.3.3.3 When the critical limit is exceeded for indicator organisms, FSIS and the 

COTR will be notified by the contractor of the final disposition of the 

product.

324.5.3.3.4 Ground beef associated with the positive pathogen test results or critical 

limit exceeded results will be ineligible for any USDA purchase program.

324.5.3.4 The ADL will record all results on spreadsheets and calculate the process 

capability (CPU, Cl) for microbial tests performed on sub-lots as outlined 

in Section 324.5.3.5.

324.5.3.5 Statistical Process Capability - The ADL will record the results on 

spreadsheets and calculate the process capability (CPU or Cl) value for all

sub-lot microbial tests performed. The spreadsheets will be maintained 

so that process capability may be determined according to the 

requirements within APPENDIX B. The spreadsheets will be maintained 

so that process capability assessment on each twenty (20) sub-lot 

grouping can be determined as described within APPENDIX B. Test 

results will be monitored by the contractor and COTR to determine 

acceptability of the process according to APPENDIX B. Ineligible 

contractors may re-enter the program under conditional status provided 

corrective actions have been submitted for review and approved, 

implemented and a satisfactory onsite corrective action audit by QAD has 

been conducted. Upon notification by the COTR that the plan has 

adequately addressed the issues that resulted in the ineligible status 

determination, the contractor may re-enter the program under conditional 

status. 

324.5.3.6 Contractor request to remove samples from AMS testing must be 

submitted and approved by COTR prior to sample removal from ADL 

testing.

330 PROCESSING

331 The contractor’s technical proposal and process shall assure compliance 

with the following requirements:

331.1 Grinding and Blending

331.1.1 Ground Beef - Boneless beef shall be ground twice, with the final grind 

passing through a 1⁄8-inch grinding plate. Blending after final grinding is 

allowed only to the extent that it doesn’t affect the appearance of the 

finished ground beef. 

331.1.2 Coarse Ground Beef - Boneless beef shall pass at least once through a 

grinding plate that is no smaller than 3⁄4-inch or no larger than a 1.0-inch. 

Blending after final grinding is allowed only to the extent that it doesn’t 

affect the appearance of the finished ground beef.
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Date Revised: 04/21/14 10

331.1.3 Fat Break-Outs - The grinding, blending, and packaging process shall be 

conducted in a manner that precludes large fat “break outs” (solid chunks 

of fat greater than 1.0 cubic inch) or objectionable fat “smears” in the 

finished product. 

331.2 LFTB – When specified as an option, LFTB will not exceed 15 percent by 

weight of each batch of combined fine ground finished products (Material 

Numbers 110261, 110260, 110270).

331.3 Bone Collector/Extruder Systems - Except for Coarse Ground Beef, a 

bone collector/extruder system must be in operation to remove remaining 

bone, cartilage, and heavy connective tissue during the final grind. For 

those collector/extruder systems that have a secondary lean recovery 

system, the product from the secondary recovery system shall be allowed 

provided it does not exceed more than 2.0 percent of finished product 

weight (on a batch weight basis). 

331.4 Shape and Waffling of Patties - All patties must be round or oval in shape 

and waffled or scored on both sides. 

331.5 Metal Detection - All product shall be free of metal contaminates. 

Detection of stainless steel, ferrous, and non-ferrous (e.g., lead, copper, 

and aluminum) metals is required. The contractor's technical proposal 

must identify and describe the equipment, location, detection procedure, 

sensitivity levels, frequency of equipment validation, and corrective action 

procedures. 

331.6 Equipment – All equipment used to produce ground beef products for 

USDA shall be maintained and routinely checked for optimal performance. 

 

331.7 Irradiated Ground Beef - When specified by the purchaser, ground beef 

products to be irradiated shall comply with the additional requirements 

specified in APPENDIX C.

331.8 Beef Patties with Soy Protein Product (SPP) - The SPP will be hydrated to 

yield no less than 18% protein (as-is basis).

[(Percent Protein of SPP on “as-is” Basis / 18) – 1] = x

x = maximum pounds of water to be added to each pound of dry 

SPP.

331.8.1 Texture - The physical characteristics of SPP, in the dry form, must be 

either granular or textured.

331.8.2 Type and Combination Rate - The types of soy that may be used and 

combination rates shall be as set forth below.
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Date Revised: 04/21/14 11

Type of Soy (% Protein “As is 

Basis”)

Maximum % of Hydrated SPP in 

each batch of Combined 

Finished Product

Granular Concentrate (65%) 20.0

Flaked Textured Concentrate 

(65%) 25.0

Textured Isolate (85%) 25.0

Note: SPP (of any texture) that has been hydrated by the SPP 

manufacturer may be used provided that: The product is frozen and the 

protein content (as is basis) of the hydrated SPP is stated on the 

manufacturer's label.

331.8.3 Domestic Origin – SPP ingredients shall be derived from U.S. produced 

products.

331.9 Ground Beef Patties-90/10 (110346) - The patties shall not have any nonmeat ingredients added.

331.10 Lean Beef Patties (100163, 110270) – Non-meat components may be 

used to enhance the palatability of the patties comprising no more than 15 

percent of the raw formula. The contractor’s technical proposal must list 

all ingredients (i.e., water, processing aids, binders, seasonings, etc.) 

within their formula. Significant ingredients (more than 1 percent) shall be 

derived from U.S. produced products.

340 STATE OF REFRIGERATION

341 Bulk Packaged Ground Beef Items - Shall be frozen to 00

F within 72 hours 

after completion of the final grinding of the involved lot. 

342 Patties - will be individually quick frozen (IQF) to 100

F or below prior to 

packaging and then frozen to 0oF or lower within 24 hours after 

completion of packaging and packing of the lot. Patties will not stick 

together after they are packaged and packed.

343 All USDA ground beef products will be stored, shipped, and delivered at 

temperatures that do not exceed 0oF.

350 FAT LIMITATIONS

351 The contractors will establish a target average of 15 percent fat for all 

ground beef products except for the ground beef patties-90/10 and lean 

beef patties (100163, 110270). The upper and lower specifications limits 

will be 18 and 12 percent fat respectively. The target fat content will be 

declared on the shipping container label and the nutrition facts panel. For 

ground beef patties-90/10, the upper specification limit will be 10 percent 

and the contractor will declare their target. For lean beef patties (100163, 
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Date Issued: 04/26/04

Date Revised: 04/21/14 12

110270), the average fat target shall be 5 percent with upper and lower 

specification limits being 6 and 4 percent fat respectively. Separate 

Statistical Process Control (SPC) assessments will be conducted on 

ground beef products with a targeted average of 15 percent fat, the 

ground beef patties-90/10, and the lean beef patties (100163, 110270).

352 Contractor Process Assessment - The contractor shall declare the 

production lot size, laboratory, test method, and SPC methodologies in 

their technical proposal.

352.1 Sampling and testing - The contractor will randomly select four individual 

sample units (selected after initial grinding or blending) to be analyzed for 

fat content from each production lot destined for USDA. The sample unit 

size will be determined by the testing method used by the contractor’s 

laboratory.

352.2 Recording results - The contractor will record the results on spreadsheets. 

The calculated process capability (Cpk/CPU) value (as discussed in 

APPENDIX A) will be used to determine if the process is in statistical 

control. Under contractor process assessment, no production lots shall be 

allowed delivery to USDA with average test results that are outside the 

upper or lower specification limits. 

352.3 Process Capability Assessment - Twenty (20) consecutive production lot 

results (that include the last production lot) will be recorded on 

spreadsheets for capability assessment by the contractor and the AMS 

agent. The processor’s capability (Cpk/CPU) shall be one or higher. 

353 AMS Process Assessment – For the first 20 production lots, the AMS 

agent will direct the contractor to randomly select samples, each 

consisting of four sample units. For finely ground beef, each initial sample 

unit shall not exceed two pounds. For coarse ground beef, each initial 

sample unit shall not exceed 10 pounds. Initial sample units may be 

blended and/or further reduced in size. From each initial sample unit a 

final sample unit will consist of 200 – 300 grams each. Each sample unit 

shall be independent from those samples selected for contractor process 

assessment and sent to the ADL for fat analysis. The ADL will be 

responsible for supplying sampling protocol, all sample handling 

materials, and sampling methods (including sample unit size to be 

submitted to the ADL, preparation, handling of reserve samples, etc.) for 

sample preparation and submission. The ADL will record the results on 

spreadsheets and submit them to the contractor and AMS for comparison 

to the contractor’s process assessment. After 20 consecutive results, the 

contractor shall notify the COTR immediately and declare what immediate 

corrective and preventative actions will be taken when:

353.1 The ADL calculated process average fat results (mean) varies more than 

one (1) percent from the contractor’s calculated process average results, 

or; 
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Date Revised: 04/21/14 13

353.2 The calculated process capability (Cpk/CPU) is less than one for results 

from either the contractor’s designated laboratory or the ADL. 

353.3 The contractor must notify the COTR that the process is not capable for 

fat and then sample and test an additional 20 consecutive results that 

must meet the criteria for AMS Process Assessment. Change in status 

begins after a cause and effect analysis has been performed and 

corrective actions have been implemented. If the contractor remains in 

Unreliable Status after the additional 20 consecutive lots, a cause and 

effect analysis must be performed and corrective actions submitted within 

5 business days to AMS for review and approval. If the contractor still 

remains in Unreliable Status after the second round of 20 consecutive lots 

a cause and effect analysis must be performed and corrective actions 

submitted within 5 business days to AMS for review and approval, 

implemented and a satisfactory AMS assessment audit has been 

completed. The COTR reserves the right to deem a contractor as 

Unreliable for consideration on future contract awards when corrective or 

preventative actions are not adequate or effective or the contractor is 

unresponsive in declaring status or submitting corrective actions.

354 Continuous AMS Assessment – If AMS process assessment is 

satisfactory, the AMS agent will direct the contractor when to randomly 

select samples (each consisting of four sample units) from a production 

lot. No more than two production lot samples are sent to the ADL on a 

weekly basis. The ADL will continually record 20 consecutive results 

(always including the last recorded result as defined within APPENDIX D) 

on spreadsheets and submit the calculated process capability (Cpk/CPU) 

value to the contractor and AMS. The ADL’s calculated process capability 

(Cpk/CPU) value will continually be compared to the contractor’s 

calculated process capability (Cpk, CPU) value as each contractor’s test 

result is recorded to conduct the AMS Process Assessment as described 

above (using 20 consecutive results).

360 PATTY WEIGHT, THICKNESS, SHAPE, AND COLOR

361 The contractor’s technical proposal and process will assure, using SPC 

tools, that the following requirements are met:

362 Patty Weight

362.1 Material Numbers 110349, 110348, 110082, 110346 - Target weight will 

be 2.8 ounces. Acceptable weight tolerance range will be 2.7 to 2.9 

ounces.

362.2 Material Numbers 110350, 110347 - Target weight will be 2.1 ounces. 

Acceptable weight tolerance range will be 2.0 to 2.2 ounces.

362.3 Material Number 100163, 110270 - Target weight will be 3.1 ounces. 

Acceptable weight tolerance range will be 3.0 to 3.2 ounces.
Approved by CMS 

Date Issued: 04/26/04

Date Revised: 04/21/14 14

363 Patty Thickness – 5/16 inch (+/- 1/16).

364 Shape - Patties shall be round or oval in shape and waffled or scored on 

both sides.

365 Color – Color of patties shall be monitored for normal appearance and 

color. When cooked to an internal temperature of 160o

F by the end user, 

patties with internal or external pink appearance will not be allowed. 

370 MEAT / MEAT ALTERNATES

371 Patties must comply with the following MMA designations:

Material Number Portion Weight (oz.) MMA (oz.)

110349 2.8 2.0

110082 2.8 2.0

110348 2.8 2.0

110346 2.8 2.0

110350 2.1 1.5

110347 2.1 1.5

380 PREPARATION FOR DELIVERY

381 The contractor’s technical proposal and process will assure that all 

packaging, packing, closure, marking, and palletization comply with the 

National Motor Freight Regulations and FSIS regulations and the 

requirements listed below. The contractor also must have procedures for 

verifying the net weight of shipping containers. 

382 Packaging and Packing

382.1 All immediate containers (casings or packages) shall function as a tamper 

evidence indicator to provide added assure of product integrity through 

the method of sealing or closure. 

382.2 Fine Ground Beef (Material Number 100158, 110261) – Fine ground beef 

must be vacuum packaged or packaged in casings and sealed. All 

packages will weigh 10 pounds. The casings or packages shall be closed 

by metal clips or by a heat-sealing method. Four (4) packages will be 

placed into each shipping container.

382.3 Fine Ground Beef (Material Number 100159, 110260) – Fine ground beef 

must be vacuum packaged or packaged in casings and sealed. All 
Approved by CMS 

Date Issued: 04/26/04

Date Revised: 04/21/14 15

packages will weigh 1 pound. Forty (40) packages will be placed into 

each shipping container. 

382.4 Fine Ground Beef-Irradiated (Material Number 110085) – Fine ground 

beef must be vacuum packaged in a thermo formed plastic container. 

Each package shall weigh 10 pounds. The package shall be rectangular 

in shape and shall be made from materials that have been approved by 

FDA for irradiation application. Packages shall be packed into shipping 

containers with net weights of 40 pounds. The depth, width, and length of 

the containers shall be considered depending on the type of ionizing 

radiation used.

382.5 Coarse Ground Beef (Material Number 100154) - Coarse ground beef 

must be bulk packaged (with no packaging materials) directly into leakproof shipping containers with fiberboard that is wax impregnated, has a 

moisture barrier coating, or have plastic laminated interior panels. 

382.6 Patties (Material Numbers 110347, 110348, 110349, 110350, 110346, 

100163, 110270, 110082) –Separation material between patties is not 

required provided the IQF patties do not stick together at the time of 

shipment. Patties must be placed into immediate containers following 

either of the following methods:

382.6.1 Flexible Containers - Either four 10-pound, five 8-pound, or eight 5-pound 

flexible (plastic) vacuum packaged or sealed containers will be placed into 

each shipping container. Hand twisting or hand tying is not acceptable.

382.6.2 Fiberboard Containers – When fiberboard is used for immediate 

containers, either four 10-pound or two 20-pound fiberboard containers 

will be placed into each shipping container. Patties may either be vacuum 

packaged or within sealed flexible containers (hand twisting or hand tying 

is not acceptable) when placed into the fiberboard immediate container or, 

placed into the fiberboard immediate container that is lined with a plastic 

bag to completely cover the product. For this option, fiberboard 

immediate containers will then have to be sealed with tape or glue.

382.7 Ground Beef Patties-Irradiated (Material Number 110082) – Patties must 

be packaged into sealed flexible (plastic) immediate containers. They 

may weigh either 20 pounds or 10 pounds. Packaging materials shall be 

approved by FDA for irradiation application. Separation material between 

patties is not required provided the IQF patties do not stick together at the 

time of shipment. Packages will be packed into shipping containers with 

net weights of 40 pounds. Consideration of the depth, width, and length 

of the containers shall be considered depending on the type of ionizing 

radiation is used. 

382.8 Style and Size of Shipping Containers - Only one style and size of 

immediate and shipping container may be used in any one delivery unit.
Approved by CMS 

Date Issued: 04/26/04

Date Revised: 04/21/14 16

383 Shipping Container Net Weight

383.1 Using SPC tools, the contractor shall assure the following net weights:

383.1.1 Ground Beef (fine ground bulk and patties) - will be packed to a net weight 

of 40 pounds.

383.1.2 Coarse Ground Beef - will be packed to a net weight of 60 pounds.

384 Closure

384.1 Shipping containers will be closed by strapping, taping or gluing. When 

strapping is used, the initial closure (usually the bottom of container) shall 

be secured by the gluing or taping method. 

385 Marking of Containers*

385.1 Both immediate and shipping containers will have a printed code that 

includes the establishment number and is traceable to the production lot 

and date. All container markings shall include all information required by

FSIS along with the additional information listed below: 

385.2 Ground Beef, 1-pound package labels (100159, 110260) will have the 

following information included on commercially labeled packages: 

385.2.1 Safe handling instructions.

385.2.2 Nutrition Facts panel (to include fat declaration of 15 grams of fat per 100 

gram serving). 

385.2.3 The “best if used by” date (180 calendar days from the date of 

production).

385.2.4 The FSIS establishment number. 

385.2.5 A code number that will indicate traceability to production lot and date. 

385.3 Shipping Containers - Commercially marked shipping containers will 

include the information as follows:

385.3.1 USDA Shield (at least 2 inches high and appearing on the top of the 

container or on the principle display panel). 

 

*All labeling shall be illustrated in the Contractor’s technical proposal.
Approved by CMS 

Date Issued: 04/26/04

Date Revised: 04/21/14 17

385.3.2 Applicable Purchase Order Number.

385.3.3 The product name shall include no additional disclaimers and qualifiers to 

the name and material numbers listed below.

Product Name That Shall Appear on the 

Label Material Number

Ground Beef 1/ 100158

Ground Beef (LFTB Opt)1/ 110261

Ground Beef, 1 pound packages 100159

Ground Beef, 1 pound packages (LFTB Opt) 110260

Ground Beef – Irradiated1/ 110085

Coarse Ground Beef 100154

Ground Beef Patties-85/151/ 110350

Ground Beef Patties-85/151/ 110349

Beef Patties with SPP-85/151/,2/ 110348

Beef Patties with SPP-85/151/,2/ 110347

Ground Beef Patties-Irradiated-85/151/ 110082

Ground Beef Patties-90/101/ 110346

Lean Beef Patties1/ 100163

Lean Beef Patties (LFTB Opt)1/ 110270

1/ Shall include the statement “For Institutional Use Only” on the 

principle display panel. 2/ The ingredient statement must include the identification of the added 

hydrated SPP. 

385.3.4 Fat Declaration.

385.3.5 Shipping containers containing irradiated ground beef shall bear the 

required FSIS markings for irradiated products and a “best if used by 

date” (180 calendar days from date of production). 

385.3.6 Nutrition Facts panel to include fat declaration of:

385.3.6.1 15 grams of fat per 100 grams serving size for bulk items (100158, 

110261, 100159, 110260, 110085, 100154),

385.3.6.2 12 grams of fat per 80 grams serving size for patty items -15% fat 

(110349, 110350, 110348, 110347, 110082),

385.3.6.3 8 grams of fat per 80 grams serving size for patty item - NTE 10% fat 

(110346), and

385.3.6.4 4.5 grams of fat per 88 grams serving size for patty items – 5% fat 

(100163, 110270).
Approved by CMS 

Date Issued: 04/26/04

Date Revised: 04/21/14 18

385.3.7 Ingredient declaration (including single ingredient products).

385.3.8 An allergen statement in a format which complies with the Food Allergen 

Labeling and Consumer Protection Act (FALCPA) for any product which 

contains milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, soy or 

wheat; e.g. Allergen: This product contains ______.

386 Palletized Unit Loads

386.1 All products shall be stacked on new or well-maintained pallets and 

palletized with shrink wrap plastic. 

387 Total Net Weights Per Delivery Unit

387.1 The delivery units for each of the respective material numbers are as 

follows:

Material Number Pounds Per 

Delivery Unit

100158, 100159, 110085, 110261, 110260 40,000

110349, 110350, 110348, 110347, 110346, 

110082, 100163, 110270 38,000

100154 42,000

Note: No tolerances will be allowed.

388 Sealing

388.1 All products must be delivered to AMS assigned destinations under seal 

with tamper proof, tamper resistant, serially numbered, high security seals 

that meet the American Society for Testing and Materials Standard

(ASTM) F1157-04 and/or the International Organization for Standards 

(ISO) 17712-2010 as required under this Supplement. Seals shall be 1⁄8thinch diameter cable, high-security bolt, or equivalent.

390 USDA QUALITY ASSURANCE

391 Warranty and Complaint Resolution

391.1 Warranty - The contractor will guarantee that the product complies with all 

specification requirements, technical proposal declarations, and 

provisions set forth in the program supplement. 

391.2 Complaint Resolution - Customer complaint resolution procedures will be 

included in the technical proposal. These procedures will include: a point 

of contact, investigation steps, intent to cooperate with AMS, and product 

replacement or monetary compensation. The procedures will be used to 

resolve product complaints from recipient agencies or AMS.
Approved by CMS 

Date Issued: 04/26/04

Date Revised: 04/21/14 19

392 AMS Monitoring and Production Assessment

392.1 A QAD agent must be present during the production of the finished 

product for all USDA ground beef contracts. The QAD agent will monitor 

and verify the processing steps, quality assurance activities, and any 

corrective actions to assure that all requirements outlined in the approved 

technical proposal are complied with. The QAD agent will be conducting 

the monitoring and production verification in accordance with applicable 

QAD procedures. Any deviations to contractual requirements will be 

reported to the contractor and COTR. The COTR will make all 

determinations as to the acceptability of the product relative to findings 

documented by the QAD agent.

393 Control of Non-Conforming Product

393.1 The contractor must include a plan to assure that non-conforming product 

(i.e., boneless beef, LFTB, ground beef) is not delivered under USDA 

contracts. The plan must address 1) control and segregation of nonconforming product, 2) removal of any USDA markings, and 3) disposition 

of non-conforming product, including vendor notification in writing to the 

COTR of final disposition (e.g., diverted to cooked product or destroyed).

394 Contractor Checkloading

394.1 Contractor will perform checkloading examinations at the time of shipment 

and issue contractor’s certificate to accompany each shipment that 

includes all of the following information:

394.1.1 Purchase Order Number/Purchase Order Line Item Number;

394.1.2 Sales Order Number/Sales Order Line Item Number;

394.1.3 Destination of shipment;

394.1.4 Name of Product and applicable Material Number;

394.1.5 Shipping Date;

394.1.6 Production lot number(s) and date each lot was produced along with 

shipping container and immediate container code(s) and the code used 

that provides traceability to establishment number, production lot and

date;

394.1.7 Count of shipping containers and total projected net weight in each 

production lot;
Approved by CMS 

Date Issued: 04/26/04

Date Revised: 04/21/14 20

394.1.8 Identity of car or truck (car numbers and letters, seals, truck license, etc.) 

as applicable;

394.1.9 Contractor certification that product conforms with the applicable 

specification (FPPS-GB-2014);

394.1.10 Count and projected net weight verified and;

394.1.11 Signature of company official responsible for checkloading.
Approved by CMS 

Date Issued: 04/26/04

Date Revised: 04/21/14 21

APPENDIX A

DATA ENTRY AND PROCESS CAPABILITY VALUES

Data Entry

The ADL will record microbiological and fat test results on spreadsheets and to have 

those spreadsheets readily available to AMS and its contractors/suppliers. Quantitative 

(plate count) results will be expressed as colony forming units (CFU) per gram or per ml 

reflecting the original sample measurement. Test results will be entered as a whole 

number (i.e., no decimal places, no preceding < (less than) symbol). Qualitative results 

for E. coli O157:H7, each of the non-O157 STEC serotypes, and Salmonella will be 

recorded as a 1 for a positive results and as a 0 for negative results. 

The ADL will provide the calculated process capability values (CPU, Cpk and Cl) in the 

spreadsheets so that the supplier’s process capability assessment can be determined, 

as described in APPENDIX B. 

Process Capability Values – CPU or Cpk 

The process capability value (CPU or Cpk) 

is calculated by the ADL. CPU will be used 

for microbiological tests and for Beef 

Patties – 90/10 fat tests since these 

requirements only have an upper 

specification limit. Cpk will be used for fat 

testing requirements that have an upper 

and lower specification limit (see section 

3.5). The upper specification limits (USL) 

for microbiological requirements will be 

found in APPENDIX B. The calculations 

for CPU and Cpk are as 

follows:Calculation of process capability 

(CPU) with an upper specification limit 

only

Step 1. The first calculation will determine 

the Z-value (upper):

Z-value (upper) = (USL – Process 

Average) / Standard Deviation

Step 2. The Z-value divided by 3 will 

calculate the CPU:

CPU = Z-value (upper) / 3

Calculation of process capability (Cpk) 

with an upper and lower specification 

limit

Step 1. The first set of calculations will 

determine the smaller value of the two Zvalues (upper or lower):

Z-value (upper) = (USL – Process 

Average) / Standard Deviation

Z-value (lower) = (Process Average – 

LSL) / Standard Deviation

Step 2. The smaller of the two Z-values 

(upper or lower) divided by 3 will calculate 

the Cpk.

CPU = Z-value (smaller value of the 

upper or lower) / 3

Process Capability Value – Cl

The central line (Cl; x-bar) is the process average or arithmetic mean that indicates the 

incidence of positive E. coli O157:H7 and Salmonella results. Results from non-O157 

STECs are not used to calculate process capability.
Approved by CMS 

Date Issued: 04/26/04

Date Revised: 04/21/14 22

APPENDIX B

AMS BONELESS & GROUND BEEF PROCESS REQUIREMENTS FLOW CHART

Quality Control Program – Prior to bidding on 

ground beef contracts with the USDA, the 

documented quality control program as 

described within the approved technical 

proposal (raw material suppliers and grinders) 

must have received a satisfactory onsite 

capability assessment by QAD. AMS will audit 

and monitor the program. The quality control 

program must specifically address 

management of microbial data to comply with 

the AMS Process Requirements Flow Chart 

and the following descriptions.

Process Assessment Status - A process 

assessment involves sampling and testing of 

20 consecutive lots or sub-lots (which will 

include the last recorded result as defined 

within APPENDIX D) of boneless beef (see 

Section 323.8.4) or ground beef (see Section

324.5.3.5) destined for USDA contracts for the 

microbes listed within the table below. 

Process Capable? – Flow chart decision step 

that involves test results for up to 20 

consecutive SPC only lots or sub-lots (which 

will include the last recorded result) recorded in 

spreadsheets, where the process capability 

(CPU or Cl) value is calculated (See 

APPENDIX A) for evaluation. A process that is 

not capable shall be declared to the COTR 

immediately when results are known and will 

result in switching from process assessment 

status to conditional status or switching from 

conditional status to ineligible status when:

 The CPU values do not meet the levels 

specified in the table below;

 The Cl values do not meet the levels 

specified in the table below for 

Salmonella or E. coli O157:H7;

 Two results exceed any of the critical limits in the table below; * or

 After 2 or more results, the CPU value is negative.*

*Immediate action will be taken prior to completion of 20 lots or sub-lots.

Quality Control Program 

Approved by AMS

Process Assessment 

Status

Process 

Capable? 

Conditional Status

Not to exceed 60 calendar days

Process 

Capable? 

Ineligible Status

Satisfactory 

AMS 

Assessment 

Audit?

Yes

No

No

Yes

Yes

AMS PROCESS 

REQUIREMENTS FLOW CHART

No
Approved by CMS 

Date Issued: 04/26/04

Date Revised: 04/21/14 23

Conditional Status –To regain process capable status, the boneless beef supplier or 

contractor must notify the COTR that the process is not capable, and then have 20 

consecutive results that meet the ‘Process Capable’ criteria within 60 calendar days or 

in accordance with a production schedule pre-approved by the COTR. Change in 

status begins after a cause and effect analysis has been performed and corrective 

actions have been implemented. The boneless beef supplier or contractor may also 

declare itself ineligible at any time.

Ineligible Supplier/Contractor – An ineligible Boneless Beef Supplier or Ground Beef 

Contractor will not be allowed to supply boneless or ground beef products under USDA 

contracts until a cause and effect analysis has been performed and corrective actions 

have been submitted to AMS for review and approved, implemented and a satisfactory 

AMS assessment audit has been completed. Once satisfactorily becoming eligible, 

subsequent production will be under Conditional Status. The AMS COTR reserves 

the right to declare a boneless beef supplier or ground beef contractor ineligible at any 

time.

AMS MICROBIAL REQUIREMENTS FOR BONELESS & GROUND BEEF

Microbial Test USL (cfu) Critical Limits (cfu) CPU or Cl Value

Standard Plate Count 50,000 / gram 100,000 / gram CPU > 1 

Total Coliforms 100 / gram 1,000 / gram CPU > 1 

E. coli 100 / gram 500 / gram CPU > 1 

Salmonella Positive (+) result / 25 

grams

Cl < 0.05

E. coli O157:H7 Positive (+) result / 325 

grams

Cl < 0.05
Approved by CMS 

Date Issued: 04/26/04

Date Revised: 04/21/14 24

APPENDIX C

REQUIREMENTS FOR GROUND BEEF-IRRADIATED PRODUCTS

Ground Beef-Irradiated products shall be subjected to ionizing radiation from gamma 

ray, electron beam, or x-ray sources. The following requirements are in addition to all 

requirements specified within this FPPS. 

Handling 

Products shall be packaged and placed into shipping containers and frozen to 0°F 

within 72 hours from time of completion of the production lot prior to irradiation. 

Products must be maintained in a frozen state from the time of leaving the shipping 

freezer and throughout the irradiation process. After irradiation, the products must be 

palletized, reloaded, and dispatched to the final destination. 

Dosimetry 

Ground beef shall be subjected to ionizing radiation to receive a dosage that is no less 

than 1.35 kilograys (kGy) and no more than 3.00 kGy. Irradiation facilities shall: 

• Submit the initial dosimeter data verifying minimum and maximum dosages 

received within the technical proposal, and 

• Maintain and provide confirmation dosimeter data to AMS upon request for each 

unit of ground beef irradiated.

Microbial Testing 

Irradiated Ground Beef Products (patties and bulk) - shall be tested for Standard Plate 

Count, Total Coliforms, and E. coli after final grinding and before freezing and tested for 

E. coli O157:H7, non-O157 STECs, and Salmonella after completion of the irradiation 

process. 
Approved by CMS 

Date Issued: 04/26/04

Date Revised: 04/21/14 25

Figure 2

AMS Microbial and fat Results 12-7/20

Total Coliform Count

COMPANY = Noname's Packing

Individ.: cl: 47.7419 ucl: 179.465 lcl: -83.9811 * Rule violation Subgrp Size 1

O

O O

O

O

O

O O O O O O

O

O

O

O O O

O

O

O

O

O

O

O

O

O

O

Individ.

cl

lcl

ucl

-100

-50

0

50

100

150

200

5 10 15 20 25 30 35 40

 

APPENDIX D

GLOSSARY OF TERMS

Cause and Effect Diagrams – A cause and 

effect analysis is used to identify the cause or 

source of non-conformities. It categorizes the 

source as derived from impact on a process 

presented by Human, Machinery, Material, 

Methods, Environment, and Measurement (Test). 

The Cause and Effect Diagram will assist in 

evaluating a process and assigning the 

appropriate control point (see Figure 1).

"Cleanup to cleanup" - Part of a HACCP 

program that the establishment has in place to 

support statistically distinguishing one portion of 

production from another. Production destined for USDA contracts is to be commenced 

on clean equipment. "Cleanup to cleanup" may be an effective means of preventing 

cross contamination of one part of production to another with E. coli O157:H7. 

However, "cleanup to cleanup" without other supporting documentation may not be 

adequate to statistically distinguish one portion of production from another. If a sample 

analysis yields a positive result, any product produced in the same time frame with the 

same process or equipment is suspect, unless an intervention occurred that would 

indicate a change in the status of the process/equipment.

Control Charts – A control chart is a 

run chart with statistically derived 

upper and lower control limits (ucl 

and lcl). The control chart 

demonstrates if a process is in 

statistical control. When properly 

designed, control charts provide an 

early warning of problems allowing 

for adjustments to be made before 

production of non-conforming 

products. Microbial test results may 

be plotted on control charts for 

individual measurements and fat test 

results may be plotted on control charts featuring average and range of the fat test 

results (See Figure 2). 

Effect

Cause Cause

Cause Cause

Cause

Cause

Cause

Cause

Cause

Cause

Cause

Cause

Cause

Cause

Cause

Cause

Cause

Cause

Cause

Figure 1
Approved by CMS 

Date Issued: 04/26/04

Date Revised: 04/21/14 26

AMS Fat Data

Average Fat

Company = B

Samples: 20 Mean: 15.3664 Std Dev: .8421Cpk: 1.042 Spec Lim: ( 12, 18)

Est % out: ( .0032012, .088179) Act % out: ( .0000, .0000)

Mean

-3sp +3sp

LSL USL

Target

0

2

4

6

8

10

12 13 14 15 16 17 18

Cpk – Process Capability Value (Cpk) is a capability analysis index used to determine if 

a process can meet specification limits. A Cpk value of 1 indicates that the process is 

producing at least 99.73% within the specification limit. Cpk values of 1 for many 

organizations have become the minimum requirement. However, the larger the Cpk 

values the better. Cpk differs from other process capability analyses since it considers 

the process average along with the distribution of test results. Since there is no lower 

specification limit for USDA microbial requirements, the calculation for Cpk will not 

involve relating the process average with a lower 

specification limit. 

CPU - Process Capability Value (CPU) is the 

same as Cpk except that there is no lower 

specification limit. The process performance 

index is correctly known as a Centered Process 

Capability Upper Specification Limit only (CPU) 

(See Figure 3).

Excellent Condition - All product must be in 

excellent condition (e.g., exposed lean and fat 

surfaces shall be of a color and bloom normally 

associated with the class, grade, and cut of meat 

and typical of meat which has been properly 

stored and handled). Cut surfaces and naturally exposed lean surfaces shall show no 

more than slight darkening or discoloration due to dehydration, aging, and/or microbial 

activity. The fat shall show no more than very slight discoloration due to oxidation or 

microbial activity. No odors foreign to fresh meat shall be present. Changes in color 

and odors characteristically associated with vacuum 

packaged meat in excellent condition shall be acceptable. 

Also, product shall show no evidence of mishandling. 

Beef must be maintained in excellent condition through 

processing, storage, and transit. 

Flow Charts – Flow charts depict all of the steps of a 

process. Standard symbols are used to identify the start, 

finish, processing steps and decision steps. It can be 

used to simplify a complex process so that it can be 

analyzed (Figure 4). 

Histograms – The histogram shows a pictorial 

representation of the frequency of distribution of microbial 

test results over time. Sometimes referred to as process 

capability charts, histograms compare the distribution of 

the test results with AMS specification requirements. Use 

histograms along with control charts to better understand 

process capability (See Figure 3). 

Start

Process Step

Decision

Finish

No

Yes

Figure 4

Figure 3
Approved by CMS 

Date Issued: 04/26/04

Date Revised: 04/21/14 27

Figure 5

Pareto Diagrams – The Pareto diagram ranks the importance of different nonconformities. Typically, non-conformities are measured against frequency of 

occurrence. The Pareto analysis is helpful 

in identifying and justifying which problems 

will need to be solved first (see Figure 5).

Process – For the purpose of this 

specification, a single process involves the 

input of a raw material on a production line 

with a value added activity resulting in a 

output that can is be further processed or 

meet a customer’s need. A complex 

process involves output being another 

processes input. The production of ground beef is a complex process.

Process Capability Assessment on 20 consecutive lots – For the purpose of this 

specification, process capability assessments are conducted on data results from each 

lot for fat and microbial requirements. A process assessment involves sampling and 

testing of 20 consecutive lots (which always includes the last recorded result). 

Information from each lot will be evaluated with information from the preceding 19 lots 

(i.e., while in process assessment of the first 20 lots, the process was found to be 

capable, then assessment will continue on lot numbers 2-21). This has often been 

referred to as a ‘Rolling 20’. This assessment takes into account process variations 

that may be attributed to product, management, sources, and time (see Figure 6). 

Random Sampling – A process of selecting a sample from a lot whereby each unit in 

the lot has an equal chance of being selected and is representative of the lot’s 

production.

Statistical Process Control (SPC) – SPC is the primary analysis tool of quality 

improvement. The objective of any quality improvement strategy is to identify and 

reduce the amount of variation. SPC analyzes the variation in a process and is the 

applied science that assists suppliers to collect, organize and interpret microbial and fat 

test results on processing of ground beef destined for USDA. 

Figure 6

Boneless defects

Frequency (%) - Samples 1 to 9

CONN TIS

LYMPH

BONE

FATINT

BLOOD CL

Category

35

21

20

10

4

Count

0 5 10 15 20 25 30 35 40
Approved by CMS 

Date Issued: 04/26/04

Date Revised: 04/21/14 28

SPC provides tools to help measure, identify, and eliminate variation from customer 

requirements (see Table 1). 

Tools for Statistical Process Control

Flow Charts Scatter Diagrams

Pareto Diagrams Run Charts

Cause and Effect Diagrams Control Charts

Histograms Capability Assessment

Upper and lower control limits (UCL and LCL) – Control limits are statistical 

calculations of the distribution of test results. Upper and lower control limits represent 

+/- 3 standard deviations of the process results. Data plotted outside the limits 

represent special causes of variation. A process may be considered “out of statistical 

control” when results are outside these limits. Upper and lower control limits are not to 

be confused with specification limits. A supplier wishing to be an eligible participant in 

the Ground Beef Program shall have a process that is capable of producing within the 

specification limits (See figure 2). 

Upper and lower specification limits (USL and LSL) – Normally, the customer sets 

the specification limits. The objective of the Ground Beef Purchase Program is to 

procure from ground beef processors that are statistically capable of meeting the upper 

specification limits specified within the FPPS-GB. The specification limits reflect 

customer needs (See Figure 3). 

Table 1