Quality in Meat Processes

Businesses and manufacturing companies in the United States today use many quality systems and variations in systems. Some of these systems are: the U. S. national quality standard known as the Malcom Baldrige standard; continuous quality improvement (CQI); the international quality standard ISO 9000; total quality management (TQM); quality control systems focused on product inspection and test such as HACCP; and ad hoc systems developed by individual companies.

TQM and Malcom Baldrige systems are excellent quality systems but are not necessarily the best starting point for a quality system for a new start-up company. This is especially true for a company in the meat industry, which is regulated by the United States Department of Agriculture (USDA).

What is Quality?
For purposes of this manual, the ISO 9000 definition of quality is used. Quality is defined as the “totality of characteristics of an entity that bears on its ability to satisfy stated and implied needs.” An “entity” is defined as an item that can be individually described and considered. An entity may be, for example, a process, a product or an organization.” (EN ISO 8402:1995)

This study will focus on the three systems most likely to impact a meat processing facility. The first is a HACCP system required by the USDA. The other two systems are optional, ISO 9000 and the USDA’s American Meat Marketing Services MSC Instruction 913-1.

HACCP
HACCP stands for Hazard Analysis Critical Control Points. The Food Safety and Inspection Service (FSIS) of the USDA administers the program. The HACCP system is the new system for meat processing facilities. It is designed to place responsibility for meat quality with the processor rather than with government inspectors. HACCP can be described as a “common-sense, risk-based, approach to preventing food contamination.” (Food Processing Industry Quality System Guidelines, ASQ) It is a “logical, scientific system that can control safety problems in food production. HACCP is now being adopted worldwide. It works with any type of food production system and with any food. It works by controlling food safety hazards throughout the process. The hazards can be biological, chemical or physical . . . . When a company adopts HACCP, it puts controls into place at each point in the production system where safety problems could occur from biological, chemical or physical hazards.” (USDA Guidebook for the Preparation of HACCP Plans)

Seven principles make up HACCP plans:
  1. Conduct a hazard analysis.
  2. Identify critical control points.
  3. Establish critical limits for each critical control point.
  4. Establish monitoring procedures.
  5. Establish corrective actions.
  6. Establish record keeping procedures.
  7. Establish verification procedures.
Sources of information and assistance
A USDA document, Guidebook for The Preparation of HACCP Plans, outlines the basics of the system. Model HACCP plans for beef and pork slaughter are also available, along with 11 other plans related to processing of meat. The information is available on the internet at:
http://www.usda.gov/agency/fis
http://www.foodsafety.org/other/haccpmod.htm
http://usda.gov/fsis/keyfacts.htm
http://usda.gov/agency/fsis/toc.htm

The guidebook is recommended reading for new business start-ups. It explains how to write a plan using a five-step process:
  1. Bring together your HACCP resources/assemble the HACCP team.
  2. Describe the food and its method of distribution.
  3. Identify the intended use and consumers of the food.
  4. Develop a process flow diagram.
  5. Verify the diagram in the operation it is meant to represent.
Those interested in implementation assistance and training from Iowa State University Extension may contact Joe Cordray, professor of animal science, at (515) 294-4266: e-mail at jcordray@iastate.edu. Web site: http://www.iowahaccp.iastate.edu

ISO 9000 – A Quality System for the Present and the Future
Most manufacturers have heard of this controversial concept called ISO 9000. Some have heard that it is only for companies that export, that it may cost a lot of money to implement, or that it may not improve the quality of the products of services of the company. While there may be some truth to aspects of the above statements, few understand the positive aspects of ISO 9000 and what it can mean for their companies.

Throughout the arguments, one interesting fact remains true: More U.S. companies are seeking certification to the ISO 9000 standards with each passing month.

What is ISO 9000?
ISO 9000 is a term for a set of quality standards developed by the International Organization for Standardization (ISO) of Geneva, Switzerland. It is a model for a quality system that is not specific to a product, service or market, but to the quality process itself. The ISO 9000 quality system is generic and universal in nature in the sense that the system can be adopted by a variety of businesses from manufacturers to service organizations, from small firms to large, multinational, multi-site firms. ISO 9000 is independent of any specific industry or economic segment. Individual companies determine how to implement the standard to meet their specific needs and the needs of their customers.

A customer that adopts and implements the standard can receive worldwide recognition of its quality system through an audit of the facility by a registrar, who certifies that the company’s quality system complies with one of the three ISO 9000 models. The registrar will certify that the company has documented the quality system to meet the requirements of the standard and that the employees are doing what the quality system documentation states.

The ISO was founded in 1946 to promote the development of international standards and related activities, including quality assessment, and to facilitate the exchange of goods and services worldwide. The United States, one of 90 member countries, is represented by the American National Standards Institute (ANSI).

In 1987, ISO’s Technical Committee 176 on quality systems published a series of five international quality standards under the numbering system of ISO 9000, designed to provide guidance and set a standard for the development of a company’s quality system. The basis for ISO 9000 is the U.S. Department of Defense MIL-Q-9858 (1959) and the British Standard 5750 (1979). The standards were developed primarily for use in twoparty contractual situations or for internal auditing.

Context Broadens
ISO 9000 is now used in a much broader context to show a firm’s commitment to quality and a quality process. This commitment is demonstrated by the adoption of one of the ISO 9000 quality system models with verifications of the system through an audit by a registered, independent auditor.

ISO 9000 is an international standard for establishing, documenting and maintaining a quality system within an organization. The standard has created a consistent, international “language of quality.”

While European governments, such as the United Kingdom, have taken the lead in adopting and promoting ISO 9000, more than 74 countries have adopted it, either under the ISO designation or under a country’s own designation. In almost every case, the adopting countries have not significantly changed the wording, meaning or requirements of ISO 9000. In Europe, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC) have adopted the standard as EN 29000.

In the United States, the ISO 9000 standard has been adopted as the ANSI/ASQC Q90 series, also known as the Q9000 series. The U.S. Department of Defense authorizes the optional use of the ISO 9000 standards on military contracts instead of MIL-Q-9858; the FDA is incorporating the ISO 9001 standard into the Good Manufacturing Practices (GMP) for medical devices. The Big-Three auto makers are accepting ISO 9000 registration in lieu of their formal quality system.

The ISO 9000 standard has been universally adopted and is now understood internationally to represent a company’s commitment to a quality process. The standard is a quality system, based on the idea of building quality into every aspect of the company with an integrated quality management system. ISO 9004 states that the quality system involves all processes in the life cycle of a product that affects quality, from initial identification of market needs to final satisfaction of requirements. Thus, a company’s managers must first decide what a quality means to them and their customers.

The ISO 9000 quality system relies heavily on the concept that quality management is an integral part of a company’s overall management organization and that quality management cannot be separated from general management. The quality system also provides quality assurance. This includes planned and systematic quality activities designed to prevent problems from occurring, detect them when they do occur and prevent them from recurring.

Parts of the Standard
The ISO 9000 (ANSI/ASQC Q90) series of standards contains five basic parts:
  • ISO 9001 (ANSI/ASQC Q91)—This standard consists of 20 elements for a quality system or model for the design/development, production, installation and servicing of products.
  • ISO 9002 (ANSI/ASQC Q92)—A model for quality assurance in production and installation consisting of 18 parts.
  • ISO 9003 (ANSI/ASQC Q93)—A model for quality assurance in final inspection and testing.
  • ISO 9000 (ANSI/ASQC Q90)*—Quality management and quality assurance standards-guidelines for selection and use.
  • ISO 9004 (ANSI/ASQC Q94)*—Quality Management and Quality System Elements— Guidelines
*The last two parts are designed to increase the understanding of the use of the standards.

Many quality systems most commonly involve only the production side, ignoring administrative and support areas, such as marketing or engineering. ISO as a model involves all aspects and functions of a company and is, therefore, more comprehensive in application and scope.

ISO also does not replace the need for product testing or meeting industry or government products standards like those found with electrical (UL) ratings. However, some products in Europe are required to be produced by companies who have attained ISO 9000 certification. The products are commercial scales, industrial safety equipment, medical devices, gas appliances, construction products and telecommunications terminal equipment.

ISO 9000 System Requirements
Three aspects of ISO 9000 separate it from some other quality and management processes and systems. One is the visible commitment required by management, another is the documentation required to support the process and a third is the unique verification/audit process to make sure a company who says they have adopted the standard have, in fact, done that.

Quality Documents Required
The ISO 9000 standard defines the documents required for an ISO 9000 system. ISO 9000 documentation is described in terms of levels. Level one is the quality manual. At level two are procedures. At level three are job work instructions. This is depicted in the triangle in Figure 1. Element 4.2, Quality System outlines the documentation requirements by stating a quality shall be prepared which makes reference to quality system procedures and outlines the structure of the documentation used in the quality system. Sub-element 4.2.2 Quality System Procedures states that documented procedures shall be prepared. Work instructions are not required, but a procedure may reference such a document.

The ISO 9000 standard also calls for quality records that supply information to management on the how well the system is working.

Figure 1. ISO 9001 Documentation Structure

ISO 9001: 20 Elements
ISO 9001 and ISO 9002 are the two standards that will apply to most firms. ISO 9001 is the most comprehensive standard and contains 20 elements. ISO 9002 contains 19 elements found in ISO 9001. The difference between the two standards is ISO 9002 does not contain element 4.4, design control.

4 Quality System Requirements
4.1 Management responsibility: responsibility and authority, quality policy, resources, management review, management representative.
4.2 Quality system: establish, document and maintain a quality system, quality system procedures, quality planning.
4.3 Contract review: procedure required for contract review, amendment to a contract, records.
4.4 Design control (does not apply to ISO 9002): procedure required for design and development planning, organizational and technical interfaces, design input, design output, design review, design verification, design validation, design changes.
4.5 Document and data control: procedure required for document and data approval and issue, document and data changes.
4.6 Purchasing: procedure required for evaluation of subcontractors, purchasing data, verification of purchased product (supplier and customer verification of subcontracted product).
4.7 Control of customer supplied product: procedure required for control, storage and maintenance of customer supplied product.
4.8 Product identification and traceability: procedure required for identifying products and for unique identification, where required.
4.9 Process control: procedures to identify and plan production, installation and servicing processes.
4.10 Receiving inspection and test: procedures required for receiving inspection and testing, in process inspection and testing, final inspection and testing, inspection and test records.
4.11 Control of inspection, measuring and test equipment: procedures required to control, calibrate and maintain inspection and test equipment.
4.12 Inspection and test status: a procedure or quality plan to identify the acceptability of product.
4.13 Control of nonconforming product: procedure required for review and disposition of nonconforming material.
4.14 Corrective and preventative action: procedure required for corrective action and for preventative action.
4.15 Handling, storage, packaging, preservation and delivery: procedure required for handling, storage, packaging, preservation and delivery.
4.16 Control of quality records: procedure for handling quality records.
4.17 Internal quality audits: procedure for the internal audit activity.
4.18 Training: procedures for identifying and providing training needs and for qualification of personnel.
4.19 Servicing: where required, a procedure for servicing.
4.20 Statistical techniques: procedure for implementation and control of statistical techniques where need is identified.

Benefits of Adopting ISO 9000
Companies have adopted ISO 9000 for three common reasons.
  • They seek to improve quality and adopt ISO 9000 as a model for a comprehensive quality system.
  • A major customer wants them to use the ISO 9000 system to ensure supplier quality through adoption of the standard and third party audits.
  • Companies see ISO 9000 as giving them a marketing advantage.
Marketing is the biggest reason companies take the ISO 9000 road. Some firms see ISO certification as a marketing tool in exporting to European countries and a way to prevent exclusion from European markets. (No country currently excludes exports because products are from a company without ISO 9000 certification.)

Benefits of ISO 9000 can be market or contract driven. Examples might be creating access to future markets; as a marketing tool; prevention from future exclusion to domestic or foreign markets; or as protection against loss of a customer contract or exclusion from the ability to bid on a government or private contract.

However, internal benefits to a company may far exceed any marketing benefits. Internal benefits derived as a result of adopting ISO standards may include: increased quality awareness; consistent direction for quality; improved communication throughout the organization; involvement of a firm’s entire management and staff in the quality system; control of quality costs; improved supplier quality; standardization of processes; and use of customer feedback to improve processes and products.

ISO and HACCP
ISO 9000 and HACCP are two systems that have similar requirements. One way to understand the interrelationship between the two standards is to outline where the required HACCP elements fit in with the ISO 9000 elements.

Comparing ISO 9000 to HACCP

 ISO Element

HACCP 

 4.4 Design control Principle #4, monitoring requirements
Principle #5, HACCP deviation and
corrective action
Principle #7, issuance of production forms
to document deviation  
 4.10 Inspection & test, including in-process and final Principle #6, verification procedures
 4.13 Control of non-conforming product Any product not passing requirements
 4.11 Control of inspection and test equipment.
 4.17 Internal quality audits 		Periodic HACCP verification
 4.18 Training needs I.D. training needs to perform mandated HACCP programs
 4.20 Statistical methods I.D. variability and trends in processes
 4.6 Purchasing Evaluate supplier inputs and monitor certifications, etc.
 4.5 Document and data control All records
 4.16 Quality records Retention and storage requirements
 4.8 Product I.D. and trace Recall requirements
 4.9 Process control
 4.15 Handle, etc. 		(SSOP) Standard Sanitation Operating Procedures, which can include cleaning, start-up and in-process inspections and also control of chemicals, lubricants, etc.
 4.14 Corrective and preventive action Food safety consumer complaints and
investigations
 4.17 Internal quality audits. Satisfy management review needs
 4.16 Quality records Control of all required data records

Comparing HACCP Principles to ISO 9000

HACCP 

 ISO Element

PRINCIPLE 1: Hazard analysis of ingredients
and process steps, judging hazard severity
and likelihood of occurrence. 		When new products, processes or ingredient
substitutions are under consideration,
element 4.4, Design Control, takes a lead
role in reviewing raw materials. Clause 4.4.4,
 Design Inputs, can incorporate the
requirement to use HACCP criteria, and Food
and Drug Administration (FDA) defect
action levels for allowable contamination.
 PRINCIPLE 2: Identify critical control points.  Elements 4.4.7 and 4.4.8 of Design Output,
include the requirements to verify and
validate a new product or process.
 PRINCIPLE 3: Establish critical limits.  Element 4.4.5 Design Output, “Design output
shall documented and expressed in terms
that . . .4.4.5 c) identify those characteristics
of the design that are crucial to the safe and
proper functioning of the product. . . .” This,
along with element 4.2.3, Quality Planning,
which guides collection and review of data
upon which to establish the validity of these
limits are relevant clauses.
 PRINCIPLE 4: Monitor results.  Element 4.9 (d), Process Control, “The
supplier shall . . . ensure that processes are
carried our under controlled conditions.
Controlled conditions shall include; (d)
monitoring and control of suitable process
parameters . . . .”
 PRINCIPLE 5: Corrective action for HACCP
deviations. 		 Element 4.14, Corrective and Preventive
Action, “The supplier shall establish and
maintain documented procedures for
implementing . . . 4.14.2 (a) the effective
handling of customer complaints and reports
of product nonconformity.”
 PRINCIPLE 6: Verify HACCP procedures.  Element 4.10, Inspection and Testing, “The
supplier shall establish and maintain
documented procedures . . . to verify the
specified requirements for the product are
met.” This includes 4.10.2, Receiving
Inspection; 4. 10.3, In-process Inspection and
Testing; and 4.10.5 Final Inspection and Testing.
 PRINCIPLE 7: Documenting the HACCP
procedure. 		 Element 4.9 Process Control, “The supplier
. . . shall ensure that these processes are
carried out under controlled conditions.
Controlled conditions shall include the
following: 4.9, (a) Documented procedures
defining the manner of production . . . where
the absence of such procedures would
adversely affect quality.”

USDA Agricultural Marketing Service (AMS)
USDA-certified Marketing Programs
The USDA has established a quality program for livestock and meat processing operations
based on the ISO 9000 international quality standard. The criteria established for the
program, the documentation requirements and the audit practices have been taken from
the ISO 9000 standards. The system is titled the “Quality System Certification Program.”

Advantages of this system for U.S. producers:
  1. You will have a certification that can be used on your marketing materials and products.
  2. The system should be lower in cost to implement and maintain.
  3. The criteria only include those portions of the ISO standards most likely to be needed by an ag program.
  4. Federal government officials give the approval and federal employees do the auditing, which should result in lower cost.
Disadvantages of the system:
  1. The certification will not be recognized and accepted worldwide as the ISO 9000 certification is.
  2. Because this standard has fewer criteria to meet, your program will not be as comprehensive as a system based on ISO 9000.
  3. This system calls for unannounced inspections, which is not a part of an ISO 9000 system.
The Web site for all certified marketing programs: http://www.ams.gov/lsg/certprog/industry.htm.

The Livestock and Seed Division (LS) of the USDA-AMS will certify livestock and meat marketing programs based on documented quality management systems. The basic
steps to become certified are:
  1. Document your program to MGC Instruction 913-1, Standards for Approval of USDAcertified Marketing Programs, or other published program criteria, as appropriate.
  2. Once you have documented your program, LS Division will initially review, approve and audit the program to ensure the program meets stated objectives. That is, LS checks to see if you are doing what you said you would do in your quality plan. This step will be accomplished with a representative for the meat and grading certification (MGC) branch and the LMS branch. The committee will approve or disapprove the program. approved, a controlled copy of the program documentation will be retained for future reference.

A lead auditor and an audit team will conduct the audit portion. During the audit, deficiencies will be noted for the company to correct. The corrective actions taken will be reviewed and verified by the audit team.

The audit team will submit its audit report to the MGC Quality Manager who will amend or approve the final program as necessary. Final approval of the program will fall into one of three categories. If the program is approved with corrective actions to be completed, a timetable for completion of the actions will be established.
a. Approval for operation: Program approved for normal operation with regular audits every six months.
b. Conditional approval: Program is approved to operate provided all noncompliances are corrected within a specified time period.
c. Request for approval denied: Programs showing significant nonconformances may be denied approval. Previously approved programs are withdrawn and Food Safety and Inspection Service (FSIS) and MGC branch offices are notified that the program is no longer valid. Applicants may redraft and resubmit programs for subsequent approval and auditing.

   3. After initial approval, programs are subject to surveillance audits at least once every six   months to ensure the program is still in use and reflects actual practices.

Also, the LS Division will conduct unannounced reviews. The Livestock and Meat
Standardization (LMS) Branch must approve any changes to the quality plan. This is not
a free service. A fee will be assessed on a cost recovery basis for travel and auditing.

AMS Program Requirements
These criteria must be met in your quality program in order for it to be approved.
  1. Management Responsibility: A management representative must be appointed who has the authority to act on behalf of the organization responsible for the program. All responsibilities and authority for persons involved in the program must be defined.
  2. Management Review: Management must hold annual review meetings with a review of internal audit results and corrective and preventative actions. The purpose of the review is to ensure that the program objectives are still being met.
  3. Documentation Requirements: The documentation for the program must include a quality manual and the objectives of the program. A manual must be retained at all sites covered by the program.
  4. Document Control: A document control system is required that provides a one-year audit trail. A master list must be developed that shows all system documents, their revision levels and current status. Any “substantive changes” to documents affecting “product characteristics or product control and traceability” require prior approval.
  5. Product Identification and Traceability: A program must provide for identification of products from receipt through all stages of production and delivery. The identification must provide for unique identification numbers where required and must be recorded.
  6. Internal Review: An internal audit process must be established and implemented for the program. The process must include records of all nonconformances and all corrective and preventative actions taken.
  7. Process Control: Procedures must be written for “all activities associated with the program.” The procedures must be available for use. In addition, objective criteria must be established for acceptability of products for “further processing and final acceptance.” Also, instructions must be established for “controlling prescribed levels of quality through all stages of production.”
  8. Inspection and Testing: Procedures must be established and written to support all necessary testing required by the program. Records of the inspection must be maintained.
  9. Inspection and Test Status: This involves two aspects. One is the identification and segregation of unacceptable product from acceptable product. The second is identification of acceptable product at all stages from receipt to shipping. Procedures must be written for both parts.
  10. Training: A training program must be established which provides training to employees associated with the certified program. Criteria for certification of personnel must be established and records of training kept.
  11. Statistical Procedures: Procedures must be established to provide for the use of statistical techniques when required.

Credits
Written with ith contributions from Don Brown and Merle Pochop, CIRAS. Brown works
out of the ISU Outreach Center, P.O. Box 2068, Cedar Rapids, IA 52406-2068; phone
(319) 398-1272; e-mail at x1brown@exnet.iastate.edu. Pochop may be reached at the ISU Outreach Center, WITCC Bldg. B, 4647 Stone Ave., Sioux City, IA 51102-3007; phone (712) 274-0048; email at x1pochop@exnet.iastate.edu.

Resources
Bennet, William L., and Steed, Leonard L., Quality Progress; AID International; February
1999.

Breitenberg, Maurice, ISO 9000 Questions and Answers on Quality;U.S. Department of Commerce, National Institute of Standards and Technology (NIST); Gaithersburg, MD; 1992.

Clements, Richard Barrett, Quality Manager’s Complete Guide to ISO 9000; Prentice-Hall; Englewood Cliffs, NJ; 1993.

Johnson, Perry L., ISO 9000: The Standard for World Class Quality, An Executive Overview; Perry Johnson, Inc.; Southfield, MI; 1992. Peach, Robert W., The ISO 9000 Handbook; CEEM Information Services; Fairfax, VA; 1994