APPROVED

FEDERAL PURCHASE 

PROGRAM SPECIFICATION 

(FPPS) FOR COARSE 

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 CGB 2015 – Changes from previous 

requirements in blue

Effective: April 2016

Approved by CMS

Date Issued: 03/05/15

Date Revised: 04/18/16

100 SCOPE

101 This FPPS – Coarse Ground Beef (CGB) – 2016 is for use by the 

Department of Agriculture (USDA), AMS, Commodity Procurement (CP) 

Staff to procure frozen Coarse Ground Beef products.

200 APPLICABLE DOCUMENTS

210 The following documents are incorporated as part of this USDA, FPPSCGB-2016:

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 MATERIAL

311 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. 

312 Domestic Origin and Harvest (Slaughter) Requirements

312.1 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.
Approved by CMS

Date Issued: 03/05/15

Date Revised: 04/18/16 2

312.2 Boneless beef shall be derived from cattle harvested at establishments

that comply with the following origin and harvest requirements. 

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

defined in the Master Solicitation and Supplement. 

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

with all applicable FSIS regulations and AMS requirements.

312.2.3 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.

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

harvesting process. 

312.2.5 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. 

320 Boneless Beef Requirements

320.1 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. 

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

with the above domestic origin and harvest requirements. 

320.3 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. 

320.4 Meat Recovery Systems

320.4.1 Mechanical Separation - Boneless beef that is mechanically separated 

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

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

320.4.2 Lean Finely Textured Beef (LFTB) – Use of LFTB is not permitted.
Approved by CMS

Date Issued: 03/05/15

Date Revised: 04/18/16 3

320.5 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.

320.5.1 Frozen boneless beef may be used provided it is ground into the final 

product within 60 days from the date of pack. 

320.6 Objectionable Materials – The following objectionable materials shall be 

excluded: 

320.6.1 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:

320.6.1.1 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. 

320.6.1.2 Yellow elastin – Back strap and abdominal tunic. 

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

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

and that is from a single harvester or processor.

320.8 Microbial Sampling and Testing – The Contracting Officer shall specify in 

the purchase solicitation and corresponding documents TYPE 1 and 

TYPE 2 Coarse Ground Beef Products, which shall determine the level of 

microbial testing required.

320.8.1 Microbial Testing for Beef Manufacturing Trimmings to be used for –

TYPE 1 - Coarse Ground Beef for Further Processing into Fully Cooked 

Items - Samples from all lots of fresh chilled boneless beef shall be tested 

for all indicator microorganisms (aerobic plate count, total coliform and 

generic E. coli). All samples shall be sent to an AMS designated 

laboratory (ADL). 

320.8.2 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. Samples of boneless beef for production of 

TYPE 1 Coarse Ground Beef for Further Processing into Fully Cooked 

Items shall be appropriately identified on the ADL sample submission

form. 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.
Approved by CMS

Date Issued: 03/05/15

Date Revised: 04/18/16 4

320.8.3 Sample Selection

320.8.3.1 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).

320.8.3.2 For every lot of beef Manufacturing Trimmings, one sample shall be 

prepared from five different pieces of trim from five different pieces of beef 

product. The sample for indicator microorganisms (aerobic plate count, 

total coliform and generic E. coli) shall be five pieces and weigh 25 grams 

± 10 percent.

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

AMS as equivalent to the manual excision protocols referenced in Section 

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

proposed alternative sample collection and preparation methods and 

procedures.

320.8.3.4 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.

320.8.3.5 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.

320.8.4 Testing and Results

320.8.4.1 The microbiological testing for all indicator microorganisms shall be in 

accordance with the applicable AMS-approved testing methodologies.

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

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

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

320.8.4.3 The ADL shall record all results on spreadsheets and calculate the 

process capability (CPU) for indicator organism tests performed on 

production lots as outlined in Section 320.8.5.

320.8.4.4 Any lot that exceeds the critical limit criteria of APPENDIX B shall not be 

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

Date Issued: 03/05/15

Date Revised: 04/18/16 5

320.8.5 Statistical Process Capability – Boneless beef supplier compliance with 

microbial requirements shall be based on the assessment of the 

calculated process capability (CPU) 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. 

320.8.6 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 Coarse 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 re-enter 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.

320.8.7 Supplier requests to remove samples from ADL testing shall be submitted 

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

320.8.8 Lots of boneless beef tested for indicator microorganisms only (as 

described above) shall not be diverted for use in Type 2 Coarse Ground 

Beef or Ground Beef products for delivery to USDA under FPPS GB. Lots 

shall be designated and labeled “FOR USE IN COARSE GROUND BEEF 

FOR FURTHER PROCESSING INTO FULLY COOKED ITEMS ONLY”.
Approved by CMS

Date Issued: 03/05/15

Date Revised: 04/18/16 6

320.9 Microbial Testing for Beef Manufacturing Trimmings to be used for –

TYPE 2 - Coarse Ground Beef - Samples from all lots of fresh chilled 

boneless beef, 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, selected at random by the ADL, shall be tested for 

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

320.9.1 Sample Preparation and Handling - The ADL shall supply 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 supply 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.

320.9.2 Sample Selection

320.9.2.1 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).

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

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

product. The sample for co-analysis 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.

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

AMS as equivalent to the manual excision protocols referenced in Section 

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

proposed alternative sample collection and preparation methods and 

procedures.

320.9.2.4 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.

320.9.2.5 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.

320.9.3 Testing and Results
Approved by CMS

Date Issued: 03/05/15

Date Revised: 04/18/16 7

320.9.3.1 The microbiological testing for all organisms shall be in accordance with 

the applicable AMS-approved testing methodologies.

320.9.3.2 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 organisms:

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

confirmed pathogens.

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

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

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

available to an AMS Agent upon request.

320.9.3.2.3 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.

320.9.3.3 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 323.9.4.

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

Salmonella, or exceeds the critical limit criteria of APPENDIX B shall not

be used to produce ground beef or any other product purchased by 

USDA.

320.9.4 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 process capability 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: 03/05/15

Date Revised: 04/18/16 8

320.9.5 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.

320.9.6 Supplier request to remove samples from ADL testing shall be submitted 

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

321 Coarse Ground Beef Item Requirements

321.1 Quality Control Program - The Coarse Ground Beef items quality control 

program shall be documented within the contractor’s technical proposal 

and have received a satisfactory onsite capability assessment audit by QA 

Division. 

321.2 Traceability – All Coarse Ground Beef items production shall be traceable 

to the boneless beef lots and their associated microbial test results.

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

production scheduling that addresses time and temperature controls 

necessary to maintain excellent condition of the Coarse Ground Beef

items. Coarse Ground Beef items shall be delivered within 60 days from 

date of pack. 

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

amount of finished Coarse Ground Beef product 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.

321.5 Microbial Sampling and Testing Options – The Contracting Officer shall

specify in the purchase solicitation and corresponding documents TYPE 1 

and TYPE 2 Coarse Ground Beef Products, which shall determine the 

level of microbial testing required. 
Approved by CMS

Date Issued: 03/05/15

Date Revised: 04/18/16 9

321.6 Microbial Testing – TYPE 1 - Coarse Ground Beef for Further Processing 

into Fully Cooked Items - All sub-lots of Coarse Ground Beef for Further 

Processing into Fully Cooked Items shall be tested for all indicator 

microorganisms (aerobic plate count, total coliform and generic E. coli)

after final grinding and before freezing. All samples shall be sent to the 

ADL.

321.6.1 Sample Preparation and Handling - The ADL shall supply procedures for 

sample preparation, and submission. The ADL shall require contractors to 

submit a sample submission form as an official record with each sample. 

Samples of TYPE 1 Coarse Ground Beef for Further Processing into Fully 

Cooked Items shall be appropriately identified on the ADL sample 

submission form. The ADL shall 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.

321.6.2 Sample Selection – Production processes of Coarse Ground Beef for 

Further Processing into Fully Cooked Items shall be subject to the 

following sampling strategy:

321.6.2.1 Sub-lot Microbial Testing – For every sub-lot, one original and reserve 

sample shall be prepared from four individual sample units for indicator 

organism (aerobic plate count, total coliform and generic E. coli) testing. 

The sub-lot samples shall be 25 grams ± 10 percent randomly selected 

throughout each 10,000 pounds of production. The four individual sample 

units shall be composited to produce a sample that represents the 

indicator organism test for each sub-lot. The contractor shall describe in 

its technical proposal the procedure in which the four sample units shall be 

selected throughout the sub-lot to be composited for the indicator 

organism 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 its 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. 

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

the ADL for all indicator organisms listed in APPENDIX B. 

321.6.3.1 The microbiological testing for indicator microorganisms shall be in 

accordance with the applicable AMS-approved testing methodologies.
Approved by CMS

Date Issued: 03/05/15

Date Revised: 04/18/16 10

321.6.3.2 Any sub-lot with 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 datasupported basis for defining the sub-lot(s) relative to test results and why 

Coarse Ground Beef produced from same source material that resulted in 

the ineligible determination should not be considered affected by the test 

results.

321.6.3.3 When any critical limit is exceeded for indicator microorganisms, FSIS 

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

The contractor shall document the removal of the affected lot(s) and make 

such documentation available to an AMS Agent upon request.

321.6.3.4 The ADL shall record all results on spreadsheets and calculate the 

process capability (CPU) for microbial tests performed on sub-lots as 

outlined in Section 324.6.3.5.

321.6.3.5 Statistical Process Capability - The ADL shall record the results on 

spreadsheets and calculate the process capability (CPU) value for all sublot 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 FSCS Division to determine acceptability 

of the process according to APPENDIX B. Ineligible contractors 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 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. 

321.6.3.6 Contractor request to remove samples from ADL testing shall be 

submitted and approved by FSCS Division prior to sample removal from 

ADL testing.

321.7 Microbial Testing – TYPE 2 - Coarse Ground Beef - All sub-lots of Coarse 

Ground Beef shall be tested for E. coli O157:H7, Salmonella, and indicator 

microorganisms as listed in APPENDIX B after final grinding and before 

freezing. All samples shall be sent to the ADL.
Approved by CMS

Date Issued: 03/05/15

Date Revised: 04/18/16 11

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

supplying procedures for sample preparation, and submission. The ADL

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

record with each sample. The ADL shall also 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.

321.7.2 Sample Selection – Production processes of Coarse Ground Beef shall be 

subject to the following sampling strategy:

321.7.2.1 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, and shall be 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 its

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 its 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. 

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

the ADL for all organisms listed in APPENDIX B. 

321.7.3.1 The microbiological testing for all organisms shall be in accordance with 

the applicable AMS-approved testing methodologies.

321.7.3.2 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 Coarse 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: 03/05/15

Date Revised: 04/18/16 12

321.7.3.3 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 

organisms: 

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

confirmed pathogens.

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

contractor of the final disposition of the product. The contractor shall

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

available to an AMS Agent upon request.

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

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

The contractor shall document the removal of the affected lot(s) and make 

such documentation available to an AMS Agent upon request.

321.7.3.3.4 Coarse Ground Beef associated with the positive pathogen test results or 

critical limit exceeded results shall be ineligible for any USDA purchase 

program.

321.7.3.4 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 324.7.3.5.

321.7.3.5 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. 

321.7.3.6 Contractor requests 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:
Approved by CMS

Date Issued: 03/05/15

Date Revised: 04/18/16 13

331.1 Grinding and Blending

331.1.1 Coarse Ground Beef items - 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 

does not affect the appearance of the finished Coarse Ground Beef items.

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 Metal Detection - All product shall be free of metal contaminants. 

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. 

331.3 Equipment – All equipment used to produce Coarse Ground Beef items for 

USDA shall be maintained and routinely checked for optimal performance. 

340 STATE OF REFRIGERATION

341 Coarse Ground Beef items shall be frozen to 00F within 72 hours after 

completion of the final grinding of the involved lot. 

342 Coarse Ground Beef items 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. The 

upper and lower specifications limits shall be 18 and 12 percent fat 

respectively. The target fat content shall be declared on the shipping 

container label and the nutrition facts panel. 

352 Contractor Process Assessment - The contractor shall declare the 

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

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.
Approved by CMS

Date Issued: 03/05/15

Date Revised: 04/18/16 14

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 - 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 Coarse Ground Beef items, 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 shall consist of 200 – 300 grams. 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:

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 

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 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 
Approved by CMS

Date Issued: 03/05/15

Date Revised: 04/18/16 15

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 PREPARATION FOR DELIVERY

361 The contractor’s technical proposal and process shall assure that all 

packaging, packing, closure, marking, and palletization complies 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. 

362 Packaging and Packing

362.1 All immediate containers shall function as a tamper evidence indicator to 

provide added assurance of product integrity through the method of 

sealing or closure. 

362.2 Coarse Ground Beef items shall be bulk packaged (with no packaging 

materials) directly into leak-proof shipping containers with fiberboard that 

is wax impregnated, has a moisture barrier coating, or have plastic 

laminated interior panels. 

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

immediate and shipping container shall be used in any one delivery unit.

363 Shipping Container Net Weight

363.1 Using SPC tools, the contractor shall assure the following net weight:

363.1.2 Coarse Ground Beef items - shall be packed to a net weight of 60 pounds.

364 Closure

364.1 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. 
Approved by CMS

Date Issued: 03/05/15

Date Revised: 04/18/16 16

365 Marking of Containers*

365.1 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: 

365.2 Shipping Containers - Commercially marked shipping containers shall

include the information as follows:

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

container or on the principal display panel). 

362.2.2 Applicable Purchase Order Number.

362.2.3 The product name and material number – Coarse Ground Beef for Further 

Processing into Fully Cooked Items and Coarse Ground Beef. Material 

Number 100154.

362.2.4 Fat Declaration – 15% Fat.

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

grams serving size.

362.2.6 Ingredient declaration (including single ingredient products).

362.2.7 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 ______.

363 Palletized Unit Loads

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

palletized with shrink wrap plastic. 

364 Total Net Weights Per Delivery Unit

364.1 The delivery unit shall be 42,000 pounds. No tolerances shall be allowed.

365 Sealing

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

Date Issued: 03/05/15

Date Revised: 04/18/16 17

365.1 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.

370 USDA QUALITY ASSURANCE

371 Warranty and Complaint Resolution

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

all specification requirements, technical proposal declarations, and 

provisions set forth in the Master Solicitation. 

371.2 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.

372 AMS Monitoring and Production Assessment

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

product for all USDA Coarse 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 conduct 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.

373 Control of Non-Conforming Product

373.1 The contractor shall include a plan and supporting documentation to 

assure that non-conforming product (i.e., boneless beef, Coarse 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).

374 Contractor Checkloading
Approved by CMS

Date Issued: 03/05/15

Date Revised: 04/18/16 18

374.1 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:

374.1.1 Purchase Order Number/Purchase Order Line Item Number;

374.1.2 Sales Order Number/Sales Order Line Item Number;

374.1.3 Destination of shipment;

374.1.4 Name of Product and applicable Material Number;

374.1.5 Shipping Date;

374.1.6 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;

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

production lot;

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

as applicable;

374.1.9 Contractor certification that product conforms with the applicable 

specification (FPPS-CGB-2016);

374.1.10 Count and projected net weight verified and;

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

Date Issued: 03/05/15

Date Revised: 04/18/16 19

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: 03/05/15

Date Revised: 04/18/16 20

APPENDIX B

AMS BONELESS & COARSE GROUND BEEF ITEMS 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 320.8.5) or Coarse Ground Beef items

(see Section 324.7.3.5) destined for USDA 

contracts for the organisms 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: 03/05/15

Date Revised: 04/18/16 21

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 AMS 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: 03/05/15

Date Revised: 04/18/16 22

APPENDIX C

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: 03/05/15

Date Revised: 04/18/16 23

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: 03/05/15

Date Revised: 04/18/16 24

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: 03/05/15

Date Revised: 04/18/16 25

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 Coarse 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-CGB. The specification limits reflect 

customer needs (See Figure 3). 

Table 1