APPROVED

FEDERAL PURCHASE 

PROGRAM SPECIFICATION 

(FPPS) FOR GROUND 

BEEF ITEMS, FROZEN

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: FPPS GB March 2015 – Changes from previous 

requirements in blue

Effective: April 2016

Approved by CMS

Date Issued: 04/26/04

Date Revised: 04/18/16

100 SCOPE

101 This FPPS – Ground Beef (GB) – 2016 is for use by the Department of 

Agriculture (USDA), AMS, Commodity Procurement (CP) Staff to procure 

frozen ground beef products.

200 APPLICABLE DOCUMENTS

210 The following documents are incorporated as part of this USDA FPPS-GB2016:

210.1 Quality Assessment (QA) Division Procedures Manual.

210.2 Food Safety and Inspection Service (FSIS) Directive 10,010.1, Revision 4.

210.3 Applicable Supplement to AMS Master Solicitation.

300 CHECKLIST OF REQUIREMENTS

310 ITEMS

311 The contractor’s technical proposal shall declare which items shall be 

offered to USDA. Bulk or patties shall be specified within USDA 

procurement documents.
Approved by CMS

Date Issued: 04/26/04

Date Revised: 04/18/16 2

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

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 shall describe a process plan with a 

documented quality control program that includes procedures, records, 

forms, etc., that demonstrate conformance with the following AMS 

Checklist of Requirements. 

322 Domestic Origin and Harvest (Slaughter) Requirements

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

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

satisfactory onsite capability assessment by QA Division.

322.2 Boneless beef shall be derived from cattle harvested at establishments

that comply with the following origin and harvest requirements. 

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

defined in the Master Solicitation and Supplement. 
Approved by CMS

Date Issued: 04/26/04

Date Revised: 04/18/16 3

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 shall have a 

Hazard Analysis Critical Control Point (HACCP) system to control 

veterinary drug, pesticide, and environmental contaminant residues per 

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 shall include at least 

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

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

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

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

323 Boneless Beef Requirements

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

program shall be documented within each contractor’s technical proposal 

and have received a satisfactory onsite capability assessment by QA 

Division prior to supplying materials for the program. Additionally, each 

establishment is subjected to verification audits conducted by the QA 

Division 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, shall 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 shall be 

met: 
Approved by CMS

Date Issued: 04/26/04

Date Revised: 04/18/16 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 shall 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 days from harvest. 

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

shall 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), sacrosciatic 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, shall be sent to an AMS designated laboratory (ADL). 

Samples from each lot shall 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, 

shall be tested for non-O157 STECs (O26, O45, O103, O111, O121, 

O145).
Approved by CMS

Date Issued: 04/26/04

Date Revised: 04/18/16 5

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

supplying procedures for sample preparation, and submission. The ADL

shall require suppliers to submit a sample submission form as an official 

record with each sample. The ADL shall also be responsible for supplying 

shipping supplies (including sampling bags and shipping materials) to 

each supplier. Suppliers’ technical proposal shall 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 shall be selected as 

described within FSIS Directive 10,010.1 Revision 4 (N-60 Sections 8, 9 

and NOTE).

323.8.2.2 For every lot of beef Manufacturing Trimmings, two samples shall be 

prepared from 65 pieces of trim from 65 different pieces of beef product. 

The sample for co-enrichment of E. coli O157:H7, non-O157 STECs and 

Salmonella shall be 60 pieces and weigh 325 grams ± 10 percent; the 

sample for indicator microorganisms (aerobic plate count, total coliform 

and generic E. coli) shall be five pieces and weigh 25 grams ± 10 percent.

323.8.2.3 Alternative sampling methods may be used provided they are approved by 

AMS as equivalent to the manual excision protocols referenced in Section 

323.8.2.1. The suppliers’ technical proposal shall include and describe any 

proposed alternative sample collection and preparation methods and 

procedures.

323.8.2.4 For LFTB – The random sample shall be selected as described within 

FSIS Directive 10,010.1 Revision 4. The sample for co-enrichment of E. 

coli O157:H7 and Salmonella shall weigh 325 grams ± 10 percent; the 

sample for indicator microorganisms (aerobic plate count, total coliform 

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

323.8.2.5 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.

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

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

testing, including location of sample collection, frequency of sample 

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

determination of whether such additional sampling and testing constitutes 

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

323.8.3 Testing and Results
Approved by CMS

Date Issued: 04/26/04

Date Revised: 04/18/16 6

323.8.3.1 The microbiological testing for all microbes shall 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:

323.8.3.2.1 The ADL shall immediately notify FSIS and the FSCS Division of all 

confirmed pathogens.

323.8.3.2.2 When pathogen results are positive, FSIS shall be notified by the boneless 

beef supplier of the final disposition of the affected lot. The supplier shall

document the removal of the affected lot(s) and make such documentation 

available to an AMS Agent upon request. 

323.8.3.2.3 When the critical limit is exceeded for indicator microorganisms, the 

boneless beef supplier shall document the removal of the affected lot(s) 

and make such documentation available to an AMS Agent upon request.

323.8.3.3 The ADL shall 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 shall be based on the assessment of the 

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

combo test results representing one 2,000 pound combo lot randomly 

selected by the ADL from every five consecutive individual 2,000 pound 

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

day concludes with less than five consecutive individual 2,000 pound 

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

the remaining lots. The spreadsheets shall be maintained so that process 

capability assessment on the 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 shall 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 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 QA Division has been conducted. Upon 

notification by the FSCS Division 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. 
Approved by CMS

Date Issued: 04/26/04

Date Revised: 04/18/16 7

323.8.5 Contractor’s Responsibility - The contractor shall 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 QA Division 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 reenter the program under conditional status provided corrective actions 

have been submitted for review and have been deemed approved, 

implemented and a satisfactory onsite corrective action audit by QA 

Division has been conducted. Upon notification by the FSCS Division 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 shall be submitted 

and approved by FSCS Division prior to sample removal from ADL testing.

324 Ground Beef Requirements

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

be documented within the contractor’s technical proposal and have 

received a satisfactory onsite capability assessment audit by QA Division. 

324.2 Traceability – All ground beef production shall 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 shall be further divided into sub-lots not to exceed 10,000 pounds.

324.5 Microbiological Testing – All sub-lots of ground beef shall 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 shall 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 shall be sent to the ADL.
Approved by CMS

Date Issued: 04/26/04

Date Revised: 04/18/16 8

324.5.1 Sample Preparation and Handling - The ADL shall 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 shall also be responsible for 

supplying shipping supplies (including sampling bags and shipping 

materials) to each contractor. Contractor’s technical proposal shall

include and describe sample collection and preparation procedures 

provided by the ADL.

324.5.2 Sample Selection – Production processes of ground beef shall be subject 

to the following sampling strategy:

324.5.2.1 Sub-lot Microbial Testing – For every sub-lot, two original and reserve 

samples shall be prepared from four individual sample units for each 

microbial test. The sub-lot samples shall be 325 grams ± 10 percent for 

co-enrichment of E. coli O157:H7 and Salmonella and 25 grams ± 10 

percent for indicator organism tests, respectively of finished ground beef, 

randomly selected throughout each 10,000 pounds of production. The four 

individual sample units shall be composited to produce a sample that 

represents each microbial test for each sub-lot. The contractor shall

describe in their technical proposal the procedure in which the four sample

units shall 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 shall be held for testing in case the FSCS Division 

deems it necessary. The contractor shall 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 percent. 

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

the ADL for all microbes listed in APPENDIX B. 

324.5.3.1 The microbiological testing for all microbes shall 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 shall 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 shall 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.
Approved by CMS

Date Issued: 04/26/04

Date Revised: 04/18/16 9

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 shall immediately notify FSIS and the FSCS Division of all 

confirmed pathogens.

324.5.3.3.2 When pathogens results are positive, FSIS shall be notified by the 

contractor of the final disposition of the product and document the removal 

of the affected lot(s) and have available to an AMS Agent upon request.

324.5.3.3.3 When the critical limit is exceeded for indicator microorganisms, FSIS 

shall be notified by the contractor of the final disposition of the product and 

document the removal of the affected lot(s) and have available to an AMS 

Agent upon request.

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

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

324.5.3.4 The ADL shall 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 shall record the results on 

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

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

so that process capability may be determined according to the 

requirements within APPENDIX B. The spreadsheets shall be maintained 

so that process capability assessment on each 20 sub-lot grouping can be 

determined as described within APPENDIX B. Test results shall be 

monitored by the contractor and FSCSD 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 QA Division has been conducted. Upon 

notification by the FSCS Division 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 ADL testing shall be 

submitted and approved by FSCS Division 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
Approved by CMS

Date Issued: 04/26/04

Date Revised: 04/18/16 10

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 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 shall 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 – A bone collector/extruder system shall

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 shall 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 

shall 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 shall 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, shall be 

either granular or textured.
Approved by CMS

Date Issued: 04/26/04

Date Revised: 04/18/16 11

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

combination rates shall be as set forth below.

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 shall 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 00F within 72 hours 

after completion of the final grinding of the involved lot. 

342 Patties - Shall 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 shall not stick together after 

they are packaged and packed.

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

temperatures that do not exceed 0oF.

350 FAT LIMITATIONS

351 The contractors shall 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 

shall be 18 and 12 percent fat respectively. The target fat content shall be 
Approved by CMS

Date Issued: 04/26/04

Date Revised: 04/18/16 12

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

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

and the contractor shall declare their target. For lean beef patties 

(100163, 110270), the average fat target shall be five percent with upper 

and lower specification limits being six and four percent fat respectively. 

Separate Statistical Process Control (SPC) assessments shall 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 shall 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 shall be determined by the testing method used by the contractor’s 

laboratory.

352.2 Recording results - The contractor shall record the results on 

spreadsheets. The calculated process capability (Cpk/CPU) value (as 

discussed in APPENDIX A) shall 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) shall 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 shall direct the contractor to randomly select samples, each 

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

unit shall not exceed two pounds. Initial sample units may be blended 

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

sample unit shall 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 shall 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 shall 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 FSCS Division immediately and declare what 

immediate corrective and preventative actions shall be taken when:
Approved by CMS

Date Issued: 04/26/04

Date Revised: 04/18/16 13

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

one percent from the contractor’s calculated process average results, or;

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 shall notify the FSCS Division that the process is not 

capable for fat and then sample and test an additional 20 consecutive 

results that shall 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 shall be performed and corrective actions submitted within 

five 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 shall be performed and corrective actions 

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

implemented and a satisfactory AMS assessment audit has been 

completed. The FSCS Division 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 shall 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 shall 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 shall 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 shall assure, using SPC 

tools, that the following requirements are met:

362 Patty Weight

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

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

ounces.

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

Acceptable weight tolerance range shall be 2.0 to 2.2 ounces.
Approved by CMS

Date Issued: 04/26/04

Date Revised: 04/18/16 14

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

Acceptable weight tolerance range shall be 3.0 to 3.2 ounces.

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 160oF by the end user, 

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

370 MEAT / MEAT ALTERNATES

371 Patties shall 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 shall 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 shall 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 assurance of product integrity through 

the method of sealing or closure. 

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

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

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

closed by metal clips or by a heat-sealing method. Four packages shall

be placed into each shipping container.
Approved by CMS

Date Issued: 04/26/04

Date Revised: 04/18/16 15

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

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

packages shall weigh one pound. 40 packages shall be placed into each 

shipping container. 

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

beef shall 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 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 shall 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 shall 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 

shall 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 shall then have to be sealed with tape or 

glue.

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

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 shall 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.

383 Shipping Container Net Weight
Approved by CMS

Date Issued: 04/26/04

Date Revised: 04/18/16 16

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

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

weight of 40 pounds.

384 Closure

384.1 Shipping containers shall 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 shall 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) shall 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 shall indicate traceability to production lot and date. 

385.3 Shipping Containers - Commercially marked shipping containers shall

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 principal display panel). 

385.3.2 Applicable Purchase Order Number.

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

Date Issued: 04/26/04

Date Revised: 04/18/16 17

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

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 principal display 

panel.

2/The ingredient statement shall 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),

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).

385.3.7 Ingredient declaration (including single ingredient products).
Approved by CMS

Date Issued: 04/26/04

Date Revised: 04/18/16 18

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

Note: No tolerances shall be allowed.

388 Sealing

388.1 All products shall 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 the Master Solicitation. Seals shall 

be 1⁄8th-inch diameter cable, high-security bolt, or equivalent.

390 USDA QUALITY ASSURANCE

391 Warranty and Complaint Resolution

391.1 Warranty - The contractor shall guarantee that the product complies with 

all specification requirements, technical proposal declarations, and 

provisions set forth in the Master Solicitation. 

391.2 Complaint Resolution - Customer complaint resolution procedures shall be 

included in the technical proposal. These procedures shall include: a 

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

product replacement or monetary compensation. The procedures shall be 

used to resolve product complaints from recipient agencies or AMS.

392 AMS Monitoring and Production Assessment
Approved by CMS

Date Issued: 04/26/04

Date Revised: 04/18/16 19

392.1 A QA Division agent shall be present during the production of the finished 

product for all USDA ground beef contracts. The QA Division agent shall

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 QA Division agent 

shall be conducting the monitoring and production verification in 

accordance with applicable QA Division procedures. Any deviations to 

contractual requirements shall be reported to the contractor and FSCS

Division. The FSCS Division shall make all determinations as to the 

acceptability of the product relative to findings documented by the QA 

Division agent.

393 Control of Non-Conforming Product

393.1 The contractor shall include a plan and supporting documentation to 

assure that non-conforming product (i.e., boneless beef, LFTB, ground 

beef) is not delivered under USDA contracts. The plan shall address 1) 

control and segregation of non-conforming product, 2) removal of any 

USDA markings, and 3) disposition of non-conforming product, including 

vendor documentation of final disposition (e.g., diverted to cooked product 

or destroyed).

394 Contractor Checkloading

394.1 Contractor shall 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;

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

as applicable;
Approved by CMS

Date Issued: 04/26/04

Date Revised: 04/18/16 20

394.1.9 Contractor certification that product conforms with the applicable 

specification (FPPS-GB-2016);

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: 04/18/16 21

APPENDIX A

DATA ENTRY AND PROCESS CAPABILITY VALUES

Data Entry

The ADL shall 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 shall be expressed as colony forming units (CFU) per gram or per 

ml reflecting the original sample measurement. Test results shall 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 shall be 

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

The ADL shall 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 shall

be used for microbiological tests and for 

Beef Patties – 90/10 fat tests since these 

requirements only have an upper 

specification limit. Cpk shall 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 shall 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 shall

determine the Z-value (upper):

Z-value (upper) = (USL – Process 

Average) / Standard Deviation

Step 2. The Z-value divided by 3 shall

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 shall

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 shall

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: 04/18/16 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) 

shall have received a satisfactory onsite 

capability assessment by QA Division. AMS 

shall audit and monitor the program. The 

quality control program shall 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 shall

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 

shall 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 FSCS

Division immediately when results are known 

and shall 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 shall 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

Proces

s 

Ineligible Status

Satisfacto

ry AMS 

Assessme

nt Audit?

Yes

No

No

Yes

Yes

AMS PROCESS 

REQUIREMENTS FLOW CHART

No
Approved by CMS

Date Issued: 04/26/04

Date Revised: 04/18/16 23

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

contractor shall notify the FSCS Division 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 FSCS Division. 

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 shall 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 shall be under Conditional Status. The FSCS Division

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 / 325

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: 04/18/16 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 shall be maintained in a frozen state from the time of leaving the shipping 

freezer and throughout the irradiation process. After irradiation, the products shall 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, and Salmonella after completion of the irradiation process.
Approved by CMS

Date Issued: 04/26/04

Date Revised: 04/18/16 25

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 shall 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). 

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

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: 04/18/16 26

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 shall 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 shall 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 

shall 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

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

Figure 3
Approved by CMS

Date Issued: 04/26/04

Date Revised: 04/18/16 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 

shall 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 shall 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 shall 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: 04/18/16 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