An Equal Opportunity Provider and Employer 1

April 2014

AMENDMENT NO. 2

SUPPLEMENT 212 TO THE AMS MASTER SOLICITATION

FOR THE PURCHASE OF FRESH CHILLED BONELESS BEEF PRODUCTS 

FOR FURTHER PROCESSING INTO FULLY COOKED ITEMS FOR 

DISTRIBUTION TO FEDERAL FOOD AND NUTRITION ASSISTANCE 

PROGRAMS

This Amendment is issued to make the following changes to Supplement 212 to 

the AMS Master Solicitation, dated May 2012:

1) The document is renamed: 

“Supplement 212 to the AMS Master Solicitation for the Purchase of Fresh 

Chilled Boneless Beef Products for Further Processing into Fully Cooked 

Items for Distribution to Federal Food and Nutrition Assistance Programs.”

2) Section III. Instructions For Submission of Technical Proposal, is revised in 

its entirety to read as follows:

A. Submission

The format in Exhibit B shall be used in preparing the technical proposal. 

The supplier shall submit the technical proposal as an email file attachment 

to the COTR (darin.doerscher@ams.usda.gov and 

steve.whisenant@ams.usda.gov). The technical proposal must be submitted 

in its entirety. If the file size of the technical proposal is too large to send in a 

single email, it may be divided and sent in multiple emails (i.e. Part 1, Part 2, 

Part 3, etc.). The collection of attachments and appendices may be 

submitted as a separate document, as well.

B. Technical Proposal Revisions

Changes to a supplier’s technical proposal may be submitted to the COTR in 

response to the USDA program amendments, clarification requests, preaward and post-award assessments, monitoring program, or at the request 

of the supplier. Maintenance of the integrity and clarity of each technical 

proposal is critical. All technical proposal revisions must meet the following 

criteria:

1. Any changes to a technical proposal made by the supplier after its 

initial submittal shall be accomplished by submitting replacement pages 

or an entire technical proposal. A cover letter must be submitted with the 

changes identified and an explanation of the need for the change. The 

supplier shall include the revision date and the appropriate page 

Agricultural Marketing 

Service

Commodity 

Procurement Staff

1400 Independence 

Ave., SW, 

Room 3522-S, 

STOP 0239

Washington, DC 

20250-0239

Voice 202.720.4517 

Fax 202.720.5871
 An Equal Opportunity Provider and Employer 2

number(s).

2. Changes from the original technical proposal shall be highlighted and 

deletions in strikeouts.

3) Replace Exhibit A, Checklist and References to Applicable Bid and Contract 

Provisions, dated May 2013, with the attached version, dated April 2014. Changes 

are indicated in blue font.

4) Remove Exhibit C. The external portal site and this request form are no longer 

utilized for technical proposal submission.

5) Replace Attachment I, Technical Requirements Schedule for USDA Purchases of 

Fresh Chilled, Boneless Beef for Further Processing (TRS-BB-2013), dated May 

2013, with the attached Federal Purchase Program Specification (FPPS) for Fresh 

Chilled, Boneless Beef for Further Processing Into Fully Cooked Items, dated April 

2014.

All other terms and conditions remain unchanged. 

The U.S. Department of Agriculture (USDA) prohibits discrimination against its customers, employees, and applicants for employment on

the bases of race, color, national origin, age, disability, sex, gender identity, religion, reprisal, and where applicable, political beliefs, marital 

status, familial or parental status, sexual orientation, or all or part of an individual's income is derived from any public assistance program, 

or protected genetic information in employment or in any program or activity conducted or funded by the Department. (Not all prohibited 

bases will apply to all programs and/or employment activities.)

If you wish to file a Civil Rights program complaint of discrimination, complete the USDA Program Discrimination Complaint Form (PDF), found

online at http://www.ascr.usda.gov/complaint_filing_cust.html, or at any USDA office, or call (866) 632-9992 to request the form. You may also 

write a letter containing all of the information requested in the form. Send your completed complaint form or letter to us by mail at U.S. 

Department of Agriculture, Director, Office of Adjudication, 1400 Independence Avenue, S.W., Washington, D.C. 20250-9410, by fax (202) 690-

7442 or email at program.intake@usda.gov.
Agricultural Marketing Service

Commodity Procurement Staff

SUPPLEMENT 212 TO THE AMS MASTER SOLICITATION EXHIBIT A

Dated April 2014

Page 1 of 1

CHECKLIST AND REFERENCES TO APPLICABLE BID AND CONTRACT PROVISIONS

FRESH CHILLED BONELESS BEEF PRODUCTS FOR FURTHER PROCESSING INTO FULLY COOKED ITEMS

PRODUCT DESCRIPTION OFFER/CONTRACT PROVISIONS

WBSCM 

Material 

Description

Specifications 

Listed in Priority 

Order

WBSCM 

Material 

Number

Packaging and 

Packing

Minimum Offer 

Unit 

Size/Shipping 

Unit

Tolerance 

Section

Delivery 

Period 

Federal/State 

Plants Section 

I.D.

BEEF FRESH

CHILLED

BNLS COMBO20/2000 LB 

Federal Purchase 

Program 

Specification 

(FPPS) for Fresh 

Chilled, Boneless 

Beef for Further 

Processing Into 

Fully Cooked 

Items, dated April 

2014.

100155 20 lined combo 

bins packed to 

approximately 

1,850 to 2,250 lbs. 

in each combo bin 

40,000 lbs.

20 combo bins

NONE 3-day 

delivery 

period

Federal & State

BEEF FRESH

CHILLED

BNLS GRASS 

FED CMB20/2000 LB 

110091 20 lined combo 

bins packed to 

approximately 

1,850 to 2,250 lbs. 

in each combo bin

40,000 lbs.

20 combo bins

NONE 3-day 

delivery 

period

Federal & State
APPROVED

FEDERAL PURCHASE 

PROGRAM SPECIFICATION 

(FPPS) FOR FRESH CHILLED, 

BONELESS BEEF FOR 

FURTHER PROCESSING

INTO FULLY COOKED ITEMS

Contracting Officer Technical Representative (COTR)

Agricultural Marketing Service (AMS)

Livestock, Poultry and Seed (LPS) Program 

Food Safety and Commodity Specification (FSCS) Division

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

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

previous requirements in blue

Effective: APRIL 2014

Approved by CMS 

Date Issued: 04/26/04

Date Revised: 04/21/14

100 SCOPE

101 This FPPS – Boneless Beef (BB) – 2014 is for use by a contractor of the 

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

(CPS) 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-2014: 

210.1 Quality Assessment Division (QAD) Procedures Manual.

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

210.3 Applicable Supplement to AMS Master Solicitation.

300 CHECKLIST OF REQUIREMENTS 

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

documented quality control program that includes procedures, records, 

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

Requirements. The COTR may request changes to the technical proposal 

at any time.

310 MATERIAL REQUIREMENTS FOR FRESH-CHILLED BONELESS BEEF 

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

quality control program must be documented and have received a 

satisfactory onsite capability assessment by QAD prior to supplying 

materials for the program. Additionally, each plant is subjected to 

verification audits conducted by QAD during production activities that 

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demonstrate their adherence to the documented program. Boneless beef 

shall be derived from cattle harvested at facilities that comply with the 

following origin and harvest requirements.

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

defined within the 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 must be removed during the 

harvesting process.

315 Pathogen Intervention – The harvest process must include at least two 

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

critical control point (CCP) in their FSIS recognized harvest process 

Hazard Analysis Critical Control Point (HACCP) plan and the CCP 

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

reduction of enteric pathogens.

316 Carcass Testing - Routinely test carcasses for Shiga-toxigenic Escherichia 

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

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

interventions.

317 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.

318 Residue Prevention – Harvest and production establishments must have a 

Hazard Analysis Critical Control Point (HACCP) system to control 

veterinary drug, pesticide, and environmental contaminant residues per 

FSIS regulations. Helpful information is available in the FSIS Compliance 

Guide for Residue Prevention 2013

319 Boneless Beef Requirements 

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

with the above domestic origin and harvest requirements. 

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

The contractor’s technical proposal shall include detailed production 

scheduling that addresses time and temperature controls necessary to 

maintain excellent condition of the boneless beef.

319.3 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.

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319.4 Objectionable materials - The following objectionable materials shall be 

excluded:

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

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

fat (kidney, pelvic, and heart fat). 

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

outside round, sacrociatic 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. 

319.5 Mechanical Separation - Boneless beef that is mechanically separated 

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

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

319.6 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. 

319.7 Microbial Testing – All lots of fresh chilled boneless beef must be tested 

for all indicator organisms listed in APPENDIX B. All samples will be sent 

to the AMS designated laboratory (ADL). 

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

supplying procedures for sample preparation, and submission. The 

laboratory shall require contractors to submit this form as an official record 

with each sample. The laboratory will also be responsible for supplying 

shipping supplies (including sampling bags and shipping materials), to 

each contractor. Contractor’s technical proposal will include and describe 

sample collection and preparation procedures provided by the ADL. 

319.7.2 Sample Selection 

319.7.2.1 For Beef Manufacturing Trimmings – The composite sample will be 

selected as described within FSIS Directive 10,010.1 Revision 3 (N-60 

Sections 8, 9 and NOTE).

319.7.2.2 For every lot of beef Manufacturing Trim, one sample will be prepared 

from five (5) pieces of trim from five (5) different pieces of beef product. 

The sample for indicator organisms (aerobic plate count, total coliform and 

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

319.7.2.3 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) 

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administered during production and post-production shall be described in 

the supplier’s technical proposal.

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

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

testing, including location of sample collection, frequency of sample 

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

determination of whether such additional sampling and testing constitutes 

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

319.7.3 Testing and Results 

319.7.3.1 The microbiological testing for all indicator organisms will be in 

accordance with the applicable AMS-approved testing methodologies.

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

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

lot.

319.7.3.3 The ADL will record results of all indicator organisms’ analysis in a format 

that can be easily captured and analyzed.

319.7.3.4 The ADL will 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.

319.7.3.5 Any lot that exceeds the critical limit criteria of APPENDIX B cannot be 

delivered to the USDA.

319.7.4 Statistical Process Capability – The statistical process capability of a 

boneless beef contractor to comply with microbial requirements will be 

based on the assessment of calculated process capability (CPU) derived 

from the individual combo test results representing one (1) 2,000 pound 

combo lot randomly selected by the ADL from every five (5) consecutive 

individual 2,000 pound combo lots produced each production day. In the 

event that a production day concludes with less than five (5) consecutive 

individual 2,000 pound combo lots, a randomly selected test result will be 

utilized from one of the remaining lots. The spreadsheets will be 

maintained so that process capability assessment on the twenty (20) lots 

can be determined as described within APPENDIX B. Test results 

involving all boneless beef offered for testing for AMS purchase programs 

will be monitored by AMS and the contractor, to determine individual lot 

acceptance and/or capability of their process according to APPENDIX B. 

Ineligible boneless beef contractor may re-enter the program under 

conditional status provided corrective actions have been submitted for 

review and approved, implemented and a satisfactory onsite corrective 

action audit by QAD has been conducted. Upon notification by the COTR 

that the plan has adequately addressed the issues that resulted in the 

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ineligible status determination, the boneless beef contractor may re-enter 

the program under conditional status.

319.7.5 Contractor’s Responsibility - The contractor will 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 QAD

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 QAD has been conducted. Upon notification by 

the COTR that the plan has adequately addressed the issues that resulted 

in the ineligible status determination the boneless beef contractor may reenter the program under conditional status. 

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

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

319.8 Lots of boneless beef tested for indicator organisms only (as described in 

319.7) cannot be diverted for use in ground beef products for delivery to 

USDA under FPPS-GB. 

320 STATE OF REFRIGERATION

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

temperature not to exceed 40o

F.

330 FAT LIMITATIONS 

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

percent fat of all boneless beef destined for all USDA destinations. The 

upper and lower specifications limits will 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 will not be shipped to USDA. 

332 Process Capability -The processors capability (Cpk) value shall be one (1) 

or higher when the average results from twenty (20) consecutive 

production lots (which always will include the last production lot) are 

calculated. 

333 Documentation - The contractor shall declare within their technical 

proposal:

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

333.2 The laboratory and a test method, 

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333.3 Data management and storage of fat results,

333.4 Statistical Process Control (SPC) charting methods which will 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 as unreliable for failure to comply with the above 

requirements. 

340 PACKAGING AND PACKING

341 The contractor’s technical proposal and process will 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 must 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-2014 - Boneless Beef 

for Further Processing Into Fully Cooked Items”: 

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

344.3 USDA Shield (at least 2 inches high).

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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 will be 40,000 

pounds. 

346 Sealing - All products must be delivered to AMS assigned destinations 

under seal with tamper proof, tamper resistant, serially numbered, high 

security seals that meet the American Society for Testing and Materials 

Standard (ASTM) F 1157-04 and/or the International Organization for 

Standards (ISO) 17712-2010 as required under this Supplement. Seals 

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

400 CONTROL OF NON-CONFORMING PRODUCT

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

is not delivered under USDA contracts. The plan must address 1) control 

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

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

notification in writing to the COTR of final disposition (e.g., diverted to 

cooked product or destroyed).

500 QUALITY ASSURANCE 

510 Warranty and Complaint Resolution

511 Warranty – The contractor will guarantee that the product complies with all 

specification requirements, technical proposal declarations, and provisions 

set forth in the program Supplement.

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512 Complaint Resolution – Customer complaint resolution procedures will be 

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

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

replacement or monetary compensation. The procedures will be used to 

resolve product complaints from recipient agencies or AMS.

520 Checkloading – Invoice for payment must be supported by:

521 Recipient's signature on the bill of lading; 

522 Consignee's receipt evidencing date shipped and received; or

523 Other commercial receipt evidencing delivery of the product. 

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APPENDIX A

DATA ENTRY AND PROCESS CAPABILITY VALUE

Data Entry

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

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

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

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

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

The ADL will 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) is calculated by the ADL. CPU will be used for 

microbiological tests since these requirements only have an upper specification limit. 

Cpk will be used for fat testing requirements that have an upper and lower specification 

limit (see Section 332). The upper specification limits (USL) for microbiological 

requirements will be found in APPENDIX B. The calculations for CPU and Cpk are as 

follows:

Calculation of process capability (CPU) with an 

upper specification limit only

Step 1. The first calculation will determine the Zvalue (upper):

 

Z-value (upper) = (USL – Process Average) / 

Standard Deviation

Step 2. The Z-value divided by 3 will calculate the 

CPU:

 

CPU = Z-value (upper) / 3

Calculation of process capability (Cpk) with an 

upper and lower specification limit

Step 1. The first set of calculations will determine 

the smaller value of the two 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 will calculate the Cpk.

CPU = Z-value (smaller value of the upper or 

lower) / 3

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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 must have received a satisfactory 

onsite capability assessment by QAD. AMS 

will audit and monitor the program. The quality 

control program must specifically address 

management of microbial data to comply with 

the AMS Process Requirements Flow Chart 

and the following descriptions. 

Process Assessment Status - A process 

assessment involves sampling and testing of 

20 consecutive lots (which will include the last 

recorded result as defined within APPENDIX 

C) of boneless beef (see Section 319.7.4) 

destined for USDA contracts for the microbes 

listed within the table below. 

Process Capable? – Flow chart decision step 

that involves test results for up to 20 

consecutive lots (which will include the last 

recorded result) recorded in spreadsheets, 

where the process capability (CPU or Cl) value 

is calculated (See APPENDIX A) for 

evaluation. A process that is not capable shall 

be declared to the COTR immediately when 

results are known and will result in switching 

from process assessment status to conditional 

status or switching from conditional status to 

ineligible status when:

 The CPU values do not meet the levels 

specified in the table below;

 Two results exceed any of the critical limits 

in the table below; * or

 After 2 or more results, the CPU value is 

negative.*

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

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

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

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

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

Change in status begins after a cause and effect analysis has been performed and 

corrective actions have been implemented. The boneless beef 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

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Ineligible Supplier/Contractor – An ineligible boneless beef contractor will 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 will be under Conditional 

Status. The AMS COTR 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 

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Figure 2

AMS Microbial and fat Results 12-7/20

Total Coliform Count

COMPANY = Noname's Packing

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

O

O O

O

O

O

O O O O O O

O

O

O

O O O

O

O

O

O

O

O

O

O

O

O

Individ.

cl

lcl

ucl

-100

-50

0

50

100

150

200

5 10 15 20 25 30 35 40

 

APPENDIX 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 will assist in 

evaluating a process and assigning the 

appropriate control point (see Figure 1).

"Cleanup to cleanup" - Part of a HACCP 

program that the establishment has in place to 

support statistically distinguishing one portion of 

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

on clean equipment. However, "cleanup to cleanup" without other supporting 

documentation may not be adequate to statistically distinguish one portion of production 

from another. If a sample analysis yields a positive result, any product produced in the 

same time frame with the same process or equipment is suspect, unless an intervention 

occurred that would indicate a change in the status of the process/equipment.

Control Charts – A control chart is a 

run chart with statistically derived 

upper and lower control limits (ucl 

and lcl). The control chart 

demonstrates if a process is in 

statistical control. When properly 

designed, control charts provide an 

early warning of problems allowing 

for adjustments to be made before 

production of non-conforming 

products. Microbial test results may 

be plotted on control charts for 

individual measurements and fat test 

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

results (See Figure 2). 

Effect

Cause Cause

Cause Cause

Cause

Cause

Cause

Cause

Cause

Cause

Cause

Cause

Cause

Cause

Cause

Cause

Cause

Cause

Cause

Figure 1

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AMS Fat Data

Average Fat

Company = B

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

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

Mean

-3sp +3sp

LSL USL

Target

0

2

4

6

8

10

12 13 14 15 16 17 18

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

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

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

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

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

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

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

involve relating the process average with a lower 

specification limit. 

CPU - Process Capability Value (CPU) is the 

same as Cpk except that there is no lower 

specification limit. The process performance 

index is correctly known as a Centered Process 

Capability Upper Specification Limit only (CPU) 

(See Figure 3).

Excellent Condition - All product must be in 

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

surfaces shall be of a color and bloom normally 

associated with the class, grade, and cut of meat 

and typical of meat which has been properly 

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

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

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

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

and odors characteristically associated with vacuum 

packaged meat in excellent condition shall be acceptable. 

Also, product shall show no evidence of mishandling. 

Beef must be maintained in excellent condition through 

processing, storage, and transit. 

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

process. Standard symbols are used to identify the start, 

finish, processing steps and decision steps. It can be 

used to simplify a complex process so that it can be 

analyzed (Figure 4). 

Histograms – The histogram shows a pictorial 

representation of the frequency of distribution of microbial 

test results over time. Sometimes referred to as process 

capability charts, histograms compare the distribution of 

the test results with AMS specification requirements. Use 

histograms along with control charts to better understand 

process capability (See Figure 3). 

Start

Process Step

Decision

Finish

No

Yes

Figure 4

Figure 3

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Figure 5

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

occurrence. The Pareto analysis is helpful 

in identifying and justifying which problems 

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

Process – For the purpose of this 

specification, a single process involves the 

input of a raw material on a production line 

with a value added activity resulting in a 

output that can is be further processed or 

meet a customer’s need. A complex 

process involves output being another 

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

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

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

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

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

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

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

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

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

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

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

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

production.

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

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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. 

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

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