CRL 1-hr: Nov 7 Introduction to Uptime Elements Reliability Framework and Asset Management System

Subpart E - Production and Process Controls

Reliability begins with following and understanding best practices. Good Manufacturing Practices (GMPs) are the foundation to building operational and maintenance best practices to manage food safety risks. For the food industry, GMP's come from the FDA in 21 CFR- Part 110 .

So far in this series we have discussed parts of 21 CFR- part 110, and an assessment which can used by operation and Maintenance partners to determine their readiness for improving their food safety program. In this tip, we have modified section 110.80 of 21 CFR - Part 110 to demonstrate the role of Maintenance (keeping and preserving) in managing the processes and controls used to produce food.

110.80 Processes and controls (modified to a show a maintenance perspective)

All operations in the receiving, inspecting, transporting, segregating, preparing, manufacturing, packaging, and storing of food shall be conducted in accordance with adequate sanitation principles and maintained to prevent adulteration of food. . Appropriate quality control operations shall be employed and maintained to ensure that food is suitable for human consumption and that food packaging materials are safe and suitable. Overall sanitation of the plant shall be under the supervision of one or more competent individuals assigned responsibility for this function. All reasonable precautions shall be taken to ensure that production and maintenance procedures do not contribute contamination from any source. Chemical, microbial, or extraneous-material testing procedures shall be used where necessary to identify sanitation failures or possible food contamination. All food that has become contaminated to the extent that it is adulterated within the meaning of the act shall be rejected, or if permissible, treated or processed to eliminate the contamination.

Section B-

(b) Manufacturing operations.

(1) Equipment and utensils and finished food containers shall be maintained (KEPT AND PERSERVED) in a condition to meet the intended function. This means all maintenance activities including appropriate cleaning and sanitizing and where appropriate the disassembling of the equipment for a thorough cleaning.

(2) All food manufacturing, processing, packaging and storage will be controlled and managed to minimize the risk of adulteration of the food through microbiological, physical, or chemical contamination. Instruments, Lab instruments, and process control systems monitoring of physical factors such as time, temperature, humidity, aw, pH, pressure, flow rate, and manufacturing operations such as freezing, dehydration, heat processing, acidification, and refrigeration must be accurate. This is accomplished through routine calibrations, statistical process control (SPC) and proactive maintenance practices minimize breakdowns, time delays, process variations, and other factors do not contribute to the adulteration of the food.

(3) Food that can support the rapid growth of undesirable microorganisms shall be held in a manner that prevents the food from becoming adulterated. Process which are used to accomplish Compliance with this requirement may be accomplished by any effective means, including:

(i) Maintaining refrigerated foods at appropriate temperature 45F (7.2C) or below depending on the type of food material.

(ii) Maintaining frozen foods in a frozen state.

(iii) Maintaining hot foods at 140 F (60C) or above.

(iv) Maintaining proper heat treating or acidification of the foods to destroy mesophilic microorganisms when those foods which are in hermetically sealed containers at ambient temperatures.

(4) Maintenance of devices such as sterilizing, irradiating, pasteurizing, freezing, refrigerating, pH control or aw control that are to destroy or prevent the growth of undesirable microorganisms, shall be adequate to manufacture, handling, and distribute without being adulterated.

(5) Maintenance of equipment and controls and operating practices used in to manage work-in-process shall be handled in a manner that protects against contamination.

(6) Maintaining effective measures shall be taken to protect finished food from contamination by raw materials, other ingredients, or refuse.

(7) Equipment, containers, and utensils used to convey, hold, or store raw materials, work-in-process, rework, or food shall be constructed, handled, and maintained during manufacturing or storage in a manner that protects against contamination.

(8) Equipment (sieves, traps, magnets, electronic metal detectors, etc.) will be maintained and effective measures shall be taken to protect against the inclusion of metal or other extraneous material in food.

(9) Equipment and control must be maintained for food, raw materials, and other ingredients that are adulterated to protects against the contamination of other food.

(10) Mechanical manufacturing steps such as washing, peeling, trimming, cutting, sorting and inspecting, mashing, dewatering, cooling, shredding, extruding, drying, whipping, defatting, and forming have the appropriate level of maintenance (cleaning, sanitatizing, proactive maintenance) to function so to protect food against contamination.

(11) Heat blanching of food, should be properly maintained through proper heating of the food for the appropriate period of time and periodic cleaning.

(12) Batters, breading, sauces, gravies, dressings, and other similar preparations shall be maintained in such a manner that they are protected against contamination.

(i) Use ingredients free of contamination.

(ii) Employ and Maintain adequate heat processes.

(iii) Maintain adequate time and temperature controls.

(iv) Maintain the surrounding facility to provide physical protection of food and food surfaces from contaminants that may drip, drain, or be drawn into them.

(v) Maintaining cooling to an adequate temperature during manufacturing.

(13) Filling, assembling, packaging, and other operations shall be performed and Maintained in such a way that the food is protected against contamination. Compliance with this requirement may be accomplished by any effective means, including:

(i) Use of a quality control operation in which the critical control points are identified and control is maintained during manufacturing.

(ii) Adequate maintenance (cleaning and sanitizing) of all food-contact surfaces and food containers.

(iii) Using materials for food containers and food- packaging materials that are safe and suitable, as defined in § 130.3(d) of this chapter.

(iv) Providing physical protection from contamination, particularly airborne contamination.

(v) Using sanitary handling procedures.

(14) Food such as, but not limited to, dry mixes, nuts, intermediate moisture food, and dehydrated food, that relies on the control of aw for preventing the growth of undesirable microorganisms shall be processed to and maintained at a safe moisture level. Compliance with this requirement may be accomplished by any effective means, including employment of one or more of the following practices:

(i) Monitoring the aw of food.

(ii) Controlling the soluble solids-water ratio in finished food.

(iii) Protecting finished food from moisture pickup, by use of a moisture barrier or by other means, so that the aw of the food does not increase to an unsafe level.

(15) Food such as, but not limited to, acid and acidified food, that relies principally on the control of pH for preventing the growth of undesirable microorganisms shall be monitored and maintained at a pH of 4.6 or below. Compliance with this requirement may be accomplished by any effective means, including employment of one or more of the following practices:

(i) Monitoring the pH of raw materials, food in process, and finished food.

(ii) Controlling the amount of acid or acidified food added to low-acid food.

Production, Quality Assurance and Maintenance needs to develop a partnership and an integrated Maintenance strategy which targets the elimination of all defects: quality, downtime and safety. By having an integrated Maintenance strategy the maintenance investment can be optimized to meet all requirements: customers, regulatory and employees.

Tip provided by: MetDemand

Contact: Kevin Lewton at for more information on integrating Maintenance, Food Safety (HAACP) and Quality Systems to optimize the Maintenance investment in food manufacturing plants.

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