Food Safety Magazine

PROCESS CONTROL | February/March 2008

Creating a Paper Trail That Works

By John E. Rushing, Ph.D.

Creating a Paper Trail That Works

As the practices of food safety and food regulation move into a new era, we can expect to see changes in many of the things we now do as a matter of course. While many government committees are attempting to hash out these changes, it is difficult to predict what the new requirements will be. However, one thing is for sure. Processors will be even more dependent on accurate and properly maintained records and documentation for all parts of their operations.

In addition to the usual records maintained by any enterprise, many other types of records and documents are maintained in a food processing operation. Some records are the documentation of standard procedures and some are records of testing, while other records document the history and disposition of products and ingredients. There are still other records that are specifically required in government regulations, and others that are implied by requirements to comply with certain procedures.

Records, Records Everywhere
While the variety and types of records can vary considerably depending on the kind of food processing operation, records can be grouped into several different categories and range from the simple to the complex. Records development can be as simple as reviewing and logging or filing incoming documents, such as supplier guarantees, or certificates of pest control treatments. Some records are automatically generated by equipment, such as in the case of temperature control charts or tanker wash charts. Management also produces and requires records, as in assignment of duties. Other records may document calibration of equipment or the results of tests required for quality control. We maintain records of processes and registration of facilities.

With all these documents for so many purposes and from so many sources, it is necessary to have a record control plan. Recently, a good friend let me in on his record control and retention plan. He said, “I just never throw anything away.” Everyone seems to have had the experience in which they have discarded something seeming unimportant just to need it shortly afterward. So, how best should organization be handled to maintain an effective record control plan? Not being an expert in this field, I canvassed several sources to glean basic rules and found some consensus in formulating a plan:

1. Have a specific purpose for every record your company generates or for each document it collects.

2. Realize and plan for some records that have only short-term value or usefulness, while others are to be maintained for extended periods.

3. No document should be filed without review to make sure it is complete and any action required to complete its purpose has been initiated—and documented, of course.

4. Records do not always need to be printed or copied. Electronic retention often fills the bill.

5. Electronic records must be backed up and protected from unauthorized changes.

6. Related records, for instance all ingredient, processing and shipping records for a particular batch or lot, must have a method for linking them together. Give each record and document generated by your company, a unique name and a form and version number. All documents produced should be dated.

7. A record retention plan should be formulated and address all records that are maintained by a company.

Whatever the type of record, filing and maintenance should be in accordance with the company’s record control plan to ensure they can be easily stored, identified and retrieved. Each record should have a unique title, should be dated, and should identify who completed it. There should be space to record the lot or batch number, time, appropriate data, comments or corrective action, and verification by a representative of management.

Records and Recalls
With all the rules and suggestions above, an obvious question is, “How do I know that my record-keeping is effective?” It can be a sobering experience when a recall is announced by a company for a few defective lots initially but then is very quickly expanded due to inadequate records documenting ingredients, processes or lots. This can result in a devastating, and probably unnecessary economic hit to a company.

Since recalls test a company’s recordkeeping in a very profound way, a “mock recall” is a common tool used to test the effectiveness of the company’s recall plan and the effectiveness of its record-keeping system. The mock recall is an exercise which assumes a recall of a particular item or group of items based on an ingredient or processing deviation. This exercise can either be a “tabletop” exercise for a particular lot, or a full-blown test of the system with a large number of key employees involved.

Kinds of Records
In general, records should be maintained that document a processed food’s safety and compliance with the regulations. In addition, records should be maintained to assist in decision-making about particular lots of products and ingredients, such as might be needed for a recall.

What follows is an attempt to classify records by type in such a manner that a processor could use this information to help decide the breadth of records that should be maintained for his particular company. The following is a list of typical records needed:

Registrations. Documentation of registrations with government agencies or other process authorities is useful when a company is required to show proof of registering for mandated programs. These may include:

• Copy of the facility’s registration under the Bioterrorism Act
• Copy of establishment registration with FDA (required for low acid and acidified foods processors)
• Copies of filed processes and letters from the process authority (required for low acid and acidified foods processors)
• Copies of supplemental processes from equipment manufacturers to supplement the filed processes

Management and Personnel. It is critical to maintain updated records pertaining to employee qualications, certifications and chain of command responsibilities, including:

• Documentation which clearly assigns compliance with the regulations to qualified supervisory personnel
• Records of assignment of qualified supervisor(s) for overall sanitation of the plant
• Records of training for supervisors and employees which document competency to identify sanitation failures or food contamination
• Certificate of supervisors’ successful completion of Good Manufacturing Practice (GMP) schools under 21 CFR 108 (required for low acid and acidified foods processors)

Procedures. These types of records form the bulk of the basic documentation from an operations standpoint:

• Personnel procedures for hygiene and proper food handling
• Cleaning and sanitizing procedures
• Quality control procedures
• Allergen control procedures
Listeria monocytogenes control plan
• Recall procedures
• Hazard Analysis and Critical Control Points Plan

Supplier Guarantees. A product’s life cycle through the supply chain should be documented to enhance traceability in the event that a contamination problem arises, and should include records for:

• Raw materials, packaging materials and ingredients
• Cleaning and sanitizing materials
• Records of pest control measures and treatments
• Water safety and testing documentation
• Boiler and gasses indirect additives

Quality Control and Testing. With increased demand for test results that document that quality control measures are effective, the list of possible records is lengthy and will likely include one or more of the following:

• Records documenting compliance with written procedures
• Measuring instrument calibration records
• Records of inspection of incoming raw materials, packaging materials and ingredients
• Records of sanitation testing and allergen testing
• Records of testing for aflatoxin and naturally occurring toxins (if needed)
• Records of testing for unavoidable defects (if needed)
• Records of inspection and control of physical hazards
• Records of validation of preventative controls
• Monitoring of final control parameters such as pH and Aw

Production. These day-to-day records must be updated and maintained with as much accuracy as possible:

• Batch control records identifying ingredients
• Records of batches, lots and coding
• Records of in-process controls of critical parameters, including storage temperatures
• Records of reconditioning and rework
• Distribution records
• Pre-shipment or pre-distribution records verification
• Non-carrier source of ingredients and transport records
• Transportation and initial distribution of finished product

While this is neither an exhaustive list of records that might be required under federal regulations, nor are all the records listed required to be maintained in all circumstances, this list gives processors a guide to evaluate what kinds of records should be maintained in light of their particular operation. Processors can find some useful checklists in the U.S. Food and Drug Administration’s Food GMP Inspection Report available at www.fda.gov/opacom/morechoices/fdaforms/FDA-2966.doc.

Some Other Rules to Consider
Data should be recorded at the time the observations or measurements are made. The person producing the record should certify this record with their initials or signature, and the record should be reviewed before the product leaves the control of the facility. Files of records should be stored for ready access. Records of perishable products are usually maintained for one year after the end of shelf life, nonperishable products for two years, and records of acidified and low acid canned foods for three years.

Good records can be one of a company’s greatest assets—like a friend in times of need. Inaccurate or incomplete records can only be a liability and lead to problems. As the regulation of this nation’s food supply continues to move toward increased documentation, sound record policies and accurate records will take on an increased importance to food processing companies.

John E. Rushing, Ph.D., is Professor of Food Science, North Carolina State University and Department Extension Leader, NC Cooperative Extension Service. He works with the dairy and foods processing industries in North Carolina to improve the safety, quality and value of foods. He also provides training, technical assistance and guidance to extension agents, regulatory and public health agencies, and food entrepreneurs. A leader in various state, regional and national organizations, Rushing has served on the board of directors of the Food Processors Institute and has chaired both the Dairy Foods Division and the Extension Technology Division of the Institute of Food Technologists. Rushing has served several years on the NCIMS Dairy Foods HACCP Committee, which has written rule changes to the Grade A Pasteurized Milk Ordinance, conducted HACCP training for regulators and processing plant personnel, and produced a pilot study of the process in six states nationally. As the Executive Director of the Southeastern Food Processors Association, and the Corresponding Secretary for the North Carolina Dairy Technology Society, he works to provide education and interchange of ideas between processors in the region. He can be reached at jrushing@unity.ncsu.edu.

Categories: Process Control: Best Practices, Process Validation