Who Qualifies as a Food Process Authority
By Rick Falkenberg Ph.D.
As a certified process authority, I am often asked what a process authority is and what their responsibilities are. The answers to these questions give us a better understanding of the process authority's essential role in the food processing industry.
The View from FDA and USDA
Various FDA personnel have tried to further define the question of process authority. Although the FDA does not maintain a list of individuals or groups who qualify as process authorities, FDA has acknowledged that there are certain individuals or groups whose training and experience qualify them to develop processes and evaluate the public health significance of any process deviation. There are certain organizations whose knowledge and methods are generally recognized by their peers as constituting competency. Basically, this should be a body of collective individuals who routinely make thermal process determinations in a production plant environment, not someone who does this as a sideline activity or as one of many other professional duties.
Process Authorities Must Have Ongoing Experience
To qualify as a process authority, the individual or group must have the expert knowledge that comes from developing processes and evaluating process deviations on a regular basis.
A Person or an Organization
With respect to low-acid canned foods, it is extremely difficult — if not impossible — for any individual, acting alone, without any input/review from others, to be singularly knowledgeable about all the factors related to heat resistance, temperature distribution, and how any given product would heat in any given container. ... It is worth noting that 114.83 states that scheduled processes for acidified foods shall be established by "a qualified person", while CFR 113.83 states they shall be established by "qualified persons". The rather lengthy description of required procedures and data in 113.83, as well as the emphasis on having adequate facilities, virtually ensures the difficulty of a single individual, acting alone, in being considered a process authority.
Thus, while an individual may sign a letter to the firm which delineates the factors critical to temperature distribution or process establishment, this is done on the letterhead of an organization, which, in turn, purports to stand behind the statements made by the individual. "The source of the thermal process is the very foundation of everything you do in a low-acid canned food or acidified food operation. ... Short changing your process authority on the information he or she needs to establish the process can result in one which is inadequate."
In the FDA's Inspection Operation Manual, Inspectional Methods, a section addresses what information is to be requested about a firm's processing authority, by the FDA investigators where FDA is not familiar with the particular process authority named by the processor. In such a case, the investigator is instructed to request the following information:
- Individual's name
- Individual's work affiliation
- The individual's academic and industrial experience related to thermal processing work
- General procedures used to evaluate deviations, such as an overall experimental plan for development of data, penetration and distribution test data and microbiological data when appropriate.
- Details of actual experimental methods used, including heat penetration and distribution test data, and microbiological data when appropriate
- Protocol for making conclusions based on experimental data.
- The Fo value (a measure of lethality) judged necessary to destroy spores of Clostridium botulinum in each product under consideration and the method of calculation of the Fo value
- The equipment used to perform the experiments, including manufacturer, model number, state of repair, and other pertinent data
- The accuracy of the test instruments and other equipment, and the record showing that the instruments were routinely calibrated with an accurate standard
- Any other facts which have a bearing on the adequacy of the evaluations The FDA's views on process authorities have been defined for the industry:
". . . 113.83 states they (scheduled processes) shall be established by 'qualified persons'. The rather lengthy description of required procedures and data in 113.83, as well as the emphasis on having adequate facilities, virtually ensures the difficulty of a single individual, acting alone, in being considered a process authority." ". . .with respect to low-acid canned foods it is extremely difficult -- if not impossible -- for any individual, acting alone, without any input/review from others, to be singularly knowledgeable about all the factors related to heat resistance, temperature distribution, and how any given product would heat in any given container." 1
In 1983, the FDA further defined the role of a process authority:
"Basically a processing authority is a person who has expert knowledge of thermal processing requirements for low-acid foods packaged in hermetically-sealed containers or has expert knowledge in the acidification and processing of acidified foods." "The term 'expert' implies experience, knowledge, and achievement, as well as recognition as an authority on a subject, usually by ones peers." "Being a processing authority requires knowledge in a variety of disciplines such as microbiology, engineering, mathematics, food technology, chemistry, metallurgy, and physics. More importantly, practical experience under actual operating conditions is essential. What happens in the text books or laboratory does not always happen in the plant and vice versa."
"The FDA has no specific statutory authority to require that processors obtain our prior approval before engaging the services of an individual or an organization to act as a processing authority. We do not intend to institute such approval procedures nor to generate a list of competent processing authorities. The regulations are intended to govern the end product of a processing authority's work rather than that person's qualifications to conduct the work. However, we may need to review a person's qualifications and the procedures and methods used to evaluate the adequacy of the final work product."
"There are certain groups and individuals whom we generally recognize as processing authorities. We recognize them as processing authorities primarily because they are routinely engaged in such activities and because of our knowledge of the qualifications of their personnel for establishing processes and for conducting evaluations in accordance with procedures recognized by competent processing authorities as being adequate to detect any potential public health hazard. The acceptability of a person as a processing authority is determined by the acceptability of the procedures used and the proficiency of the execution of those procedures. Even though we recognize certain groups or individuals as being processing authorities, this does not imply that we will never question their work. Some of you have been questioned by us in the past. We do not blindly accept the word of these individuals or organizations all the time, but review each situation on its own merits. We may scrutinize a particular situation less if we have had experience with the individuals as to their methods and procedures and are familiar with the product involved. I do not want to imply that we play favoritism. If identical situations occurred where we questioned a process or deviation evaluation, we would request an explanation or data substantiating the conclusions regardless of whether we had knowledge of the person's qualifications."
"Processing authorities have many responsibilities under the regulations. They must establish processes, evaluate processing deviations, and keep records of the work done in these areas."
"Another responsibility of a processing authority is to keep records of the work done. 21 CFR 113.83 states: 'Complete records covering all aspects of the establishment of a process and associated incubation tests shall be prepared and shall be permanently retained by the person or organization making the determination.' 21 CFR 113.89 states: 'A record shall be made of the evaluation procedures used and the results.' "
"The sections of the regulations dealing with venting require that heat distribution data, or documentary proof demonstrating that adequate venting is achieved, be kept on file. The reason for keeping these records is that Section 108.35 (c) (3) (ii) states that when requested by FDA in writing, a processor shall provide FDA with 'any information, concerning processes and procedures, which is deemed necessary . . . to determine the adequacy of the process.' "
"If an investigator is not familiar with the person conducting this work, he may request information about the person's work affiliation, academic and industrial experience (as related to thermal processing), procedures and methods used, details of the actual tests conducted, protocol for making conclusions, minimum health and commercial sterility sterilizing values, heating factors used or obtained, accuracy of test equipment, etc."
"It is essential that persons who are involved in process establishment, deviation evaluation, and other aspects of the thermal processing of low-acid canned foods maintain current knowledge of new developments in the canning industry."
"A processing authority must always keep in mind that his ultimate responsibility is to protect the public health. To do this you must maintain your expertise. You must also be familiar with federal regulations and policies in order to provide the processor with appropriate information." 2 3
USDA 9CFR 318.302(b) "Source of Process Schedules" states:
Process schedules used by the establishment shall be developed by a process authority. Any change in product formulations, ingredients or the treatments that may affect either the product heat penetration profile or the sterilizing value requirements shall be reviewed by the firm's process authority. Complete records concerning all aspects of the development or determination of a process shall be made available to USDA.
In a very clear definition, both the USDA and FDA insist upon the use of knowledgeable persons or organizations in process establishment activities, including products in novel containers. (continue reading >>)
- ^ William R. Cole, Investigator, USFDA Office of Regulatory Affairs, Division of Field Investigations, International Programs and Technical Support Branch, in his opening remarks to the Better Process Control School.
- ^ "The View from FDA" included in "Capitalizing on Aseptic". William R. Cole, Fred A. Phillips, USFDA Center for Food Safety and Applied Nutrition, Office of Field Programs, Division of Enforcement, presented at NFPA's October 1983.
- ^ "Regulatory Aspects of Process Authorities in Low-Acid Canned Food Matters" William R. Cole, Fred A. Phillips, presented at Second Annual Conference on the Responsibilities of Process Authorities sponsored by the Institute of Thermal Processing Specialists (IFTPS). November 1982.