APPROVED

FEDERAL PURCHASE 

PROGRAM SPECIFICATION 

(FPPS) FOR FRESH 

CHILLED, BONELESS BEEF 

FOR FURTHER 

PROCESSING INTO FULLY 

COOKED ITEMS

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 BB 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 – Boneless Beef (BB) – 2016 is for use by a contractor of the 

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

Staff to deliver fresh-chilled (never previously frozen) boneless beef for 

further processing into fully cooked items.

200 APPLICABLE DOCUMENTS

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

FPPS-BB-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 

301 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. 

302 Substitution Programs - Contractors that may produce boneless beef for 

processing into fully cooked items for direct sales to further processors 

that hold QA Division substitution plans shall declare this in their technical 

proposal. It is the contractor’s responsibility to ensure that substitutable 

boneless beef raw materials sold to further processors for use as 

substitutable product are produced and managed according to provisions 

outlined in Section 301.
Approved by CMS

Date Issued: 04/26/04

Date Revised: 04/18/16 2

310 MATERIAL REQUIREMENTS FOR FRESH-CHILLED BONELESS BEEF

311 Domestic Origin and Harvest (Slaughter) Requirements – The contractor’s 

quality control program shall be documented and have received a 

satisfactory onsite capability assessment by QA Division prior to supplying 

materials for the program. Additionally, each establishment shall be

subjected to verification audits conducted by QA Division during 

production activities that demonstrate its adherence to the documented 

program. Boneless beef shall be derived from cattle harvested at 

establishments that comply with the following origin and harvest 

requirements.

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

defined within the Master Solicitation and Supplement.

313 Humane Handling - All cattle shall be humanely handled in accordance 

with all applicable FSIS regulations and AMS requirements.

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

harvesting process.

315 Pathogen Intervention – 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 establishment’s FSIS recognized harvest 

process Hazard Analysis Critical Control Point (HACCP) plan. The CCP 

intervention(s) shall be scientifically validated to achieve a three-log 

reduction of enteric pathogens.

316 Grass Fed – When specified in the invitation, boneless beef destined to be 

labeled as grass fed shall be supported by documentation and the FSIS 

approved label which substantiates such a claim.

317 Residue Prevention – Harvest and production establishments shall have a 

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.

318 Boneless Beef Requirements 

318.1 Traceability – Boneless beef shall be traceable to sources that comply with 

the above domestic origin and harvest requirements. 

318.2 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.
Approved by CMS

Date Issued: 04/26/04

Date Revised: 04/18/16 3

318.3 Boneless beef commonly referred to by the industry as XF trimmings (e.g., 

Beef Fat with Visible Lean) shall not be allowed as a standalone raw 

material source.

318.4 Objectionable materials - The following objectionable materials shall be 

excluded:

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

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

internal fat (kidney, pelvic, and heart fat). 

318.4.2 All bone, cartilage, shoulder tendon, elbow tendon, silver skin from the 

outside round, sacrosciatic ligament, opaque periosteum, serous 

membrane (peritoneum), tendinous ends of shanks, patellar ligament 

(stifle joint), gracilis membrane (from the inside round), achilles tendon, 

back strap and abdominal tunic.

318.5 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.

318.6 Lot - A lot shall consist of a single combo sized bin of approximately 2,000 

pounds of boneless beef produced within a day, between “cleanup to 

cleanup” (see APPENDIX C) and that is from a single harvester or from a 

single processor. 

318.7 Microbial Testing – All lots of fresh chilled boneless beef shall be tested for 

all indicator microorganisms listed in APPENDIX B. All samples shall be 

sent to the AMS designated laboratory (ADL). 

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

supplying procedures for sample preparation, and submission. The ADL

shall require contractors to submit this form as an official record with each 

sample. Samples submitted for boneless beef produced under a 

substitution plan 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 

contractor. Contractor’s technical proposal shall include and describe 

sample collection and preparation procedures provided by the ADL. 

318.7.2 Sample Selection 

318.7.2.1 For Beef Manufacturing Trimmings – The composite sample shall be 

selected as described within FSIS Directive 10,010.1 Revision 4 (N-60 

Sections 8, 9 and NOTE).

318.7.2.2 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 weigh 25 grams ± 10 percent.
Approved by CMS

Date Issued: 04/26/04

Date Revised: 04/18/16 4

318.7.2.3 Alternative sample collection methods may be used provided they are 

approved by AMS as equivalent to the manual excision protocols 

referenced in Section 319.7.2.1. The supplier’s technical proposal shall

include and describe any proposed alternative sample collection and 

preparation methods and procedures.

318.7.2.4 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.

318.7.2.5 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.

318.7.3 Testing and Results 

318.7.3.1 The microbiological testing for all indicator microorganisms shall be in 

accordance with the applicable AMS-approved testing methodologies.

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

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

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

318.7.3.3 The ADL shall record results of all indicator microorganisms’ analysis in a 

format that can be easily captured and analyzed.

318.7.3.4 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 319.7.4.

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

delivered to USDA.

318.7.4 Statistical Process Capability – The statistical process capability of a 

boneless beef contractor to comply with microbial requirements shall be 

based on the assessment of calculated process capability (CPU) 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 
Approved by CMS

Date Issued: 04/26/04

Date Revised: 04/18/16 5

boneless beef offered for testing for AMS purchase programs shall be 

monitored by AMS and the contractor, to determine individual lot 

acceptance and/or capability of the contractor’s process according to 

APPENDIX B. Ineligible boneless beef 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 boneless 

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

318.7.5 Contractor’s Responsibility - The contractor shall provide results and 

process capability status (as applicable) involving each lot of boneless 

beef to be delivered to the 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 contractor has 

been deemed ineligible, and wants to continue in the program, the 

ineligible boneless beef contractor 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 contractor may re-enter the program under conditional status.

318.7.6 Supplier requests to remove samples from AMS testing shall be submitted 

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

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

described in Section 318.7) shall not be diverted for use in ground beef 

products for delivery to USDA under FPPS-GB or for Type II under FPPSCGB. 

320 STATE OF REFRIGERATION

321 Fresh-chilled boneless beef shall be maintained and delivered at a 

temperature not to exceed 40oF.

330 FAT LIMITATIONS 

331 Requirements - The contractor shall establish a target average of 15 

percent fat of all boneless beef destined for USDA. The upper and lower 

specifications limits shall be 18.0 and 12.0 percent fat respectively. 

Production lots with average fat results that are not within the upper and 

lower specification limits shall not be shipped to USDA. 

332 Process Capability -The processor’s capability (Cpk) value shall be one (1) 

or higher when the average results from 20 consecutive production lots 

(which always shall include the last production lot) are calculated. 
Approved by CMS

Date Issued: 04/26/04

Date Revised: 04/18/16 6

333 Documentation - The contractor shall declare within its technical proposal:

333.1 Lot size, number of samples, selection and preparation procedures,

333.2 The laboratory and a test method, 

333.3 Data management and storage of fat results,

333.4 Statistical Process Control (SPC) charting methods which shall include a 

process capability report (histogram) that is capable of calculating a Cpk 

value (see Exhibit A).

334 Assessment by AMS - AMS reserves the right to:

334.1 Check production records of the recipient where the contractor’s boneless 

beef is further processed; 

334.2 Select and analyze samples at the further processor. The results may be 

used by the contracting officer as a “check” to determine if fat content is in 

compliance with the fat limitation requirements; and/or

334.3 Deem a contractor unreliable for failure to comply with the above 

requirements. 

340 PACKAGING AND PACKING

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

packaging, packing, closure, marking, and palletizing 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. 

342 Packaging and Packing – The contractor shall bulk package the boneless 

beef within lined “combo bins” in such a manner to maintain the product in 

excellent condition. The combo bins of boneless beef shall be covered so

that the container arrives at the destination intact. 

343 Net Weight – The contractor shall have procedures that accurately 

determine the net weight of the boneless beef. Each filled combo bin shall 

weigh from 1850 to 2250 pounds. AMS reserves the right to perform net 

weight examinations at destination. 

344 Marking of Containers – All shipping container markings shall include all 

information required by FSIS regulations and the following information: 

344.1 The following statement: “Complies with FPPS-BB-2016 - Boneless Beef

for Further Processing into Fully Cooked Items”:

344.2 A code number that shall indicate traceability to production lot and date. 
Approved by CMS

Date Issued: 04/26/04

Date Revised: 04/18/16 7

344.3 USDA Shield (at least 2 inches high).

344.4 Purchase Order Number.

344.5 Fat Declaration. 

344.6 The appropriate material number listed in the table below for each of the 

items:

Item Material Number

Boneless Beef Combo, Fresh 100155

Boneless Beef Combo, Grass Fed, Fresh 110091

Note: All labeling shall be illustrated in the Contractor’s technical 

proposal. 

345 Total net weights per delivery unit - The delivery unit shall be 40,000 

pounds. 

346 Sealing - 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) F 1157-04 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.

400 CONTROL OF NON-CONFORMING PRODUCT

401 The contractor shall include a plan and supporting documentation to 

assure that non-conforming product is not delivered under USDA 

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

of non-conforming product, including documentation of final disposition 

(e.g., diverted to cooked product or destroyed).

500 QUALITY ASSURANCE 

510 Warranty and Complaint Resolution

511 Warranty – The contractor shall guarantee that the product complies with 

all specification requirements, technical proposal declarations, and 

provisions set forth in the Master Solicitation.
Approved by CMS

Date Issued: 04/26/04

Date Revised: 04/18/16 8

512 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.

520 Contractor Checkloading - Contractor shall perform checkloading 

examinations at the time of shipment and issue a contractor’s certificate to 

accompany each shipment that includes all of the following information:

520.1 Purchase Order Number/Purchase Order Line Item Number;

520.2 Sales Order Number/Sales Order Line Item Number;

520.3 Destination of shipment;

520.4 Name of Product and applicable Material Number;

520.5 Shipping Date;

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

shipping container code(s) and the code used that provides traceability to 

production lot and date;

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

production lot;

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

as applicable;

520.9 Contractor certification that product conforms with the applicable 

specification (FPPS-BB-2016);

520.10 Count and projected net weight verified and;

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

Date Issued: 04/26/04

Date Revised: 04/18/16 9

APPENDIX A

DATA ENTRY AND PROCESS CAPABILITY VALUE

Data Entry

The ADL shall record microbiological test results on spreadsheets and make 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). 

The ADL shall provide the calculated process capability values (CPU, 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) shall be calculated by the ADL. CPU shall be used 

for microbiological tests, given 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 332). The upper specification limits (USL) for 

microbiological requirements are 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 

Z-values (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
Approved by CMS

Date Issued: 04/26/04

Date Revised: 04/18/16 10

APPENDIX B

AMS BONELESS BEEF PROCESS REQUIREMENTS FLOW CHART

Quality Control Program – Prior to bidding on 

boneless beef contracts with the USDA, the 

documented quality control program as 

described within the approved technical 

proposal 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 (which shall include the last 

recorded result as defined within APPENDIX 

C) of boneless beef (see Section 319.7.4) 

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 lots (which shall include the last 

recorded result) recorded in spreadsheets, 

where the process capability (CPU) 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;

 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.

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

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 

contractor may also declare itself ineligible at any time.

Quality Control Program 

Approved by AMS

Process Assessment Status

Process 

Capable?

Conditional Status

Not to exceed 60 calendar days

Process 

Capable

Ineligible Status

Satisfactory 

AMS 

Assessment 

Audit?

Yes

No

No

Yes

Yes

AMS PROCESS

REQUIREMENTS FLOW CHART

No
Approved by CMS

Date Issued: 04/26/04

Date Revised: 04/18/16 11

Ineligible Supplier/Contractor – An ineligible boneless beef contractor shall not be 

allowed to supply boneless beef to USDA 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 

contractor ineligible at any time.

AMS MICROBIAL REQUIREMENTS FOR BONELESS 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
Approved by CMS

Date Issued: 04/26/04

Date Revised: 04/18/16 12

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. 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 13

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 14

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 15

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 Boneless 

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 Boneless Beef Purchase Program is to 

procure from boneless beef processors that are statistically capable of meeting the 

upper specification limits specified within the FPPS-BB. The specification limits reflect 

customer needs (See Figure 3). 

Table 1