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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, now it is time to roll up our sleeves and get started on forming a plan. Assessments are both a great place to start and a good way to maintain processes and controls. When you read the questions, think about how does maintenance personnel, activities and actions contribute to improving food safety.

The assessment below can be used as a guide for areas that your plant may want to look at in developing or improving your maintenance program. Before you start look at other assessments and audits that have been done. Keep a sharp eye open for problems that could have been prevented by a proactive maintenance program and should be added to this assessment. Good Manufacturing Practices can actually save your company money by increasing quality and reducing waste.

1. The assessment questions are only a beginning point and should be expanded upon or modified depending on your processes and condition of your facility. Citing the applicable GMP regulations, ( http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=110 ) will be helpful in verifying that your process complies with the requirements of the FDA and other external auditing bodies.

2. Rate each response either compliant or non-compliant. Make note of your evidence to support your rating.

3. When asked questions about batching and raw material sampling, think about access to do the activities, PM's performed in the area and potential food safety risks due to equipment, access and procedures. Use at least 3 production batches for sampling to verify the results. Testing should include all stages of the process from raw ingredients coming to the final product in the warehouse.

Good Manufacturing Processes:

Personnel and Training

Compliance Rating

Evidence Sighted and Observations

110.10(c) Plant personnel responsible for identifying plant sanitation failures or food contamination have been educated, tested and have experience to produce safe food.

110.10(c) Food handlers, Maintenance and supervisors have adequate training in proper food handling techniques and food protection principles to assure a safe food product.

Temporary employees, contractors, and outside service personnel are trained on basic food safety training.

Is there initial and periodic training for all who apply pesticides?

110.10(a) Employees, contractors are instructed to report health conditions to supervisors that might contaminate food, food product surfaces or food packaging materials.

New employees are trained on food safety and quality.

110.10(b) Employees and contractors are trained on proper attire and PPE to protect against contamination of food. (hair net, beard net, sanitized gloves, debris from microbiologically hot areas of the plant,etc.)

110.10(b) Employees and contractors training includes good hygiene practices of washing hands thoroughly and keeping proper attire clean..

110.10(b) A policy exists and all persons entering food preparation and packaging areas are trained to remove unsecured jewelry and other objects that might fall into food.

110.10(b) All personnel in the food manufacturing and packaging area are trained to confine eating, drinking, gum chewing, and use of tobacco to designated areas.

Procedures exist for determining cause and eliminate the causes of customer complaints, product adulteration, mis-formulation and packaging.

Documentation

A clear business process is in place for writing, approving, and distributing required procedures Operating, PM, policies, etc..

Business process is in place to review procedures on a regular basis to eliminate obsolete and ineffective procedures and to establish best practice.

Procedures are written to clearly identify roles and responsibilities for all involved positions and departments for implementing quality control/quality assurance such as forms, checklist and CMMS use.

Procedures are written to clearly identify roles and responsibilities for all involved positions and departments for implementing sanitation with proper tracking such as in CMMS.

Inspection of incoming raw materials is done by specific procedures.

Procedures for laboratory analysis and sampling are written and approved for all testing (in-house and outside laboratory) Procedures include lab PM’s.

Procedures are in place to prevent contamination of the food or ingredients from pests (rodents and insects) and any treatment to control pest activities pesticides, insecticides, etc.?

Cleaning activities are defined by procedures and are part of a master schedule of cleaning and sanitation activities and are used to identify abnormal states.

Procedures are in place defining roles and responsibilities for managing regulatory inspections?

Are adequate records maintained for LACF's per 113.100(a) for: retorts, extruders, Hydrostats, Aspetic processing and packaging systems, sterilizers, microbial control step of the process,etc.?

Maintenance records are maintained for all critical control points and controls.

Safety

Facility and organization has an effective plant safety program.

Material Safety Data Sheets are readily available for all chemicals used in the facility.

Safety tasks are defined within procedures, operating, PM’s, Job Plans, etc.

Properly maintained and appropriate sSafety equipment is readily available in all areas of the plant.

Employees and contractors have received adequate safety training.

Facility has restricted and controlled access to the site and within areas of the building.

Safety equipment is readily available in all areas of the plant.

Computers are regularly back-up by defined procedures with the data stored in a separate location. For all PLC, and process controls

Equipment

Suitable for intended use.

Appropriately installed, operated, and maintained and cleaned in accordance with documented procedures

Designed and arranged to permit cleaning, maintenance, and avoid contamination of product.

Calibrated where required and appropriately maintained

Cleaning and sanitizing procedures and schedules adequate and effective and include equipment condition inspection.


Tip provided by Submitted By Kevin Lewton, MetDemand

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