Why we need Good Manufacturing Practices - Almond Board of

28 Pages·2010·1.18 MB·English

Good Manufacturing Practices
Why we need Good Manufacturing Practices
Food safety and product quality have always quirements for the food industry. Finally, GMPs,
been top priorities for the California Almond in- along with Good Agricultural Practices (GAPs)
dustry. The Almond Board’s Food Quality and and Sanitation Standard Operating Procedures
Safety Committee constantly examine quality (SSOPs), are prerequisite activities to the devel-
and safety issues. The committee also makes opment and writing of a Hazard Analysis and
recommendations on how to maintain and im- Critical Control Point (HACCP) plan unique and
prove almond quality and to protect consumers specific for each facility.
and industry from food safety problems.
Forms are recommended for use in several loca-
All food products are coming under increasing tions throughout these GMPs. These forms are
scrutiny by government agencies and consumer provided as samples only, and have not been
groups. With the fast growth of the California Al- approved for use by state or federal regulatory
mond industry comes the increasing risk of con- agencies. You may use them as is, modify them to
tamination from various sources, including unin- suit your needs, or create new ones as necessary.
tentional mixing of almonds with other nuts or ac- In all cases, forms and documents should first be
cidental exposure of almonds to microorganisms, reviewed by technical and/or legal experts before
foreign matter or pesticides. Remember, as an using to ensure their adequacy in meeting re-
almond processor, you are a food processor. The quirements under state and/or federal regulations.
almonds you process are going to be used as an
ingredient in other foods, or consumed directly. Risk reduction
By executing and documenting Good Manufactur- The GMP portion of the Food Quality and Safety
ing Practices (GMPs), California almond processors Program (FQSP) represents generally accepted,
can assure government regulators and customers broad-based guidelines, developed from scientif-
worldwide that our industry is diligent in its com- ically based principles and current knowledge of
mitment to processing safe, high-quality nuts. food safety practices. The guide focuses on risk
reduction--not risk elimination. Current technolo-
This guide is designed to help you examine and gies cannot eliminate all potential food safety
improve your own manufacturing practices and hazards from product eaten in a raw form.
ensure that they meet the generally accepted This guide should be used to help assess food
standards of Good Manufacturing Practices. safety hazards within the context of the specific
GMPs are the minimum sanitary and processing conditions (climatic, geographical, cultural, and
requirements necessary to ensure the production economic) that apply to your own operation, and
of wholesome food. They have been written and to implement appropriate and cost-effective risk-
organized with reference to the U.S. FDA GMP reduction strategies.
Regulations, Code of Federal Regulations (21 CFR
110). In no case do the recommendations in this A proactive approach
guide supersede applicable federal, state or local
laws or regulations for U.S. operators. Growers and handlers are urged to take a proac-
GMPs are broadly written and are not intended tive role in minimizing food safety hazards po-
to be plant specific, but instead, they explain re- tentially associated with almonds. Being aware of
Presented by the Almond Board of California • 1150 9th St, Suite 1500, Modesto, CA 95354. ©2009 Almond Board of California. 1
Good Manufacturing Practices
and addressing common risk factors will result in
a more effective, cohesive response to emerging
concerns about the safety of almonds.
The adoption of safe practices should be encour-
aged throughout the “farm-to-fork” food chain-
-including growers, huller/shellers, distributors,
custom processors, exporters, importers, retail-
ers, food service operators and consumers.
2 Presented by the Almond Board of California • 1150 9th St, Suite 1500, Modesto, CA 95354. ©2009 Almond Board of California.
Good Manufacturing Practices
1. Personnel
Employee training in good handling practices, educational background to support their work.
covering the key areas of sanitation and worker
hygiene, is critical to achieving the goals of the Company organization chart
almond industry’s Food Quality and Safety Pro-
gram (FQSP). Establishing a written training An organization chart helps clarify and docu-
program for employees that addresses general ment the roles of staff. This chart should identify
sanitation and good hygiene practices will help who is responsible for the various phases of your
reduce the risk of all forms of contamination. All operation. Identify who is responsible to answer
training programs should be evaluated routinely customer, consumer, or state and federal gov-
and updated as necessary. Documentation of ernment regulator inquiries. A job description
employee training is also necessary to verify that should contain each individual’s specific respon-
federal, state and local requirements for worker sibilities relevant to each aspect of GMPs, (e.g.,
safety training are met. pest control is the responsibility of the QA Man-
ager). These responsibilities should be written in
An integral part of employee training is educa- a manner that is clear and easy to understand to
tion on all aspects of Good Manufacturing Prac- avoid confusion when describing who is respon-
tices. All training should be documented with sible for making which decisions and for their
subsequent training provided periodically. It may consequences. The chart should include office,
be necessary to have bilingual training classes, cell, and home phone numbers, pager numbers,
depending on the composition of your work- and after hours emergency contact information
force. You can use the Employee Training Docu- for key staff members.
mentation in the Appendix to document the sub-
ject material covered during training classes and Basic personnel safety and hygiene requirements
attendees, or create one of your own.
The following steps should be taken to minimize
Past outbreaks of food-borne illness associated potential contamination associated with employ-
with raw and minimally processed product have ees and visitors to your plant.
usually been the result of product becoming con-
taminated with fecal material. Place a high prior- 1. Employees must wear clean outer garments
ity on ensuring the use of Good Agricultural and that protect against contamination of al-
Manufacturing Practices that minimize the poten- monds, almond-contact surfaces or almond
tial for direct or indirect contact between fecal packaging materials. Garments shall have no
material and raw almonds. shedding fibers. No tank tops are allowed.
Shoes must be in good repair and of leather
It is important to ensure that all personnel, in- construction. No open-toed shoes are allowed.
cluding those indirectly involved in almond oper- 2. All employees must wash hands with soap
ations such as equipment operators, buyers, pest and warm water before work, after using
control operators and visitors comply with estab- restrooms, upon returning to their work sta-
lished hygienic practices. Personnel responsible tion from break or lunch, or at any other time
for ensuring the sanitation of the plant should when their hands may have become soiled.
be experienced with sanitation practices or have Sanitizers are also recommended after wash-
Presented by the Almond Board of California • 1150 9th St, Suite 1500, Modesto, CA 95354. ©2009 Almond Board of California. 3
Good Manufacturing Practices
ing to afford additional protection, but they 14. Personnel working in the hulling/shelling or
are not a substitute for hand washing. other “dirty” areas of the plant should not en-
3. All employees are to wear effective hair re- ter other areas of the plant. The movement of
straints, including hairnets and beard and these workers into processed product areas
mustache covers where applicable. could possibly contaminate equipment and
4. No objects--pens, pencils, cell phones, etc.-- product with extraneous matter or patho-
shall be carried above the waist or placed in gens. Forklifts and other equipment used in
pockets above the belt. the hulling/shelling area also should not move
5. No food, candy, chewing gum, lozenges, or into processed product areas due to the risk
other comestibles are allowed in the plant. of contaminating finished product.
6. Personal items must be stored in lockers or
other designated locations outside processing Establish a training program
areas.
7. All jewelry must be removed when entering All employees, including supervisors, full-time,
the plant (plain wedding bands are frequently part-time and seasonal personnel, should have a
exempted from this requirement). No hairpins good working knowledge of basic sanitation and
or other objects that could fall into food may hygiene principles. They should understand the
be worn in the process areas. Fingernail pol- impact of poor personal cleanliness and unsani-
ish and false fingernails should not be allowed. tary practices on food safety. Good hygiene not
8. No employee infected with or showing symp- only protects the worker from illness, it also re-
toms of any infectious or communicable dis- duces the potential for contaminating almonds.,
ease, or that demonstrate open sores, boils, Contaminated almonds consumed by the public
infected wounds or any other affliction that could cause a large number of illnesses. The level
may spread disease, shall be in contact with of understanding needed will vary as determined
almonds, almond surfaces or almond pack- by the type of operation, the task, and the as-
aging materials. Supervisor shall monitor for signed responsibilities.
these conditions.
9. Monitor employees, conduct internal audits To ensure that every employee understands sani-
and record corrective action taken when ap- tation and hygiene principles, handlers should
propriate. develop a sanitation training program. All new
10. Visitors and contractors shall follow the same employees should be trained on basic sanitation
rules as employees. Use the Plant Visitor’s and hygiene principles. Depending on the situa-
Agreement sample form in Appendix, page 6. tion, formal presentations, one-on-one instruc-
11. No glass items of any kind are permitted in tion, or demonstrations may be appropriate.
the plant processing areas. Depending on the workers’ job requirements, pe-
12. If employees wear gloves they shall be of an riodic updates or follow-up training sessions may
impermeable material. Gloves shall be cleaned be needed.
and/or sanitized at the beginning of work, af-
ter returning to work station, or at any other Resources (Located under “Regulations and
time when the gloves become soiled. Guidelines”)
13. Tobacco is not permitted in the plant. Smok- • Occupational Safety Health Administration
ing is permitted only in designated areas out- - 29 CFR 1910.141(g) (Food and beverage con-
side the plant. sumption on premises)
4 Presented by the Almond Board of California • 1150 9th St, Suite 1500, Modesto, CA 95354. ©2009 Almond Board of California.
Good Manufacturing Practices
2. The Environment
Contamination can be significantly reduced cessing and support areas, including hand-
through effective housekeeping, maintenance washing areas, dressing and locker rooms,
and organization. The same steps used for main- restrooms, and all areas where almonds are
taining cleanliness inside your facility should be examined, processed or stored.
used for the exterior and perimeter of your op- 3. Whenever possible, glass and hard plastics
eration. are prohibited in food factories. However, a
glass-control policy should be implemented
Plant schematic defining procedures on how glass is moni-
tored and controlled when in the factory. This
Most operations have a plant schematic (a blue- includes a glass registry identifying all glass in
print or layout of the facility) on file. This is a the factory. All glass will be inspected at the
vital reference document for customers, govern- start of each day for any sign of damage or
ment regulators and anyone in your company breakage. The policy will also detail the ac-
involved in planning production changes or tions to be taken when glass breakage occurs.
implementing GMPs. If any processing steps are 4. Provide adequate space and layout to facili-
subcontracted to another facility, those subcon- tate production and prevent accidental con-
tracted operations should have GMPs of their tamination of almonds.
own and should be included in any third-party 5. Ensure that floors, walls, and ceilings are con-
audit or certification activity. Schematics should structed of appropriate materials that facili-
be reviewed and updated each year, or whenever tate cleaning and maintenance.
any process changes occur.A schematic can be a 6. Provide adequate ventilation or control equip-
simple line drawing by hand or an elaborate, me- ment to minimize odors and vapors (includ-
chanically drawn blueprint. ing steam and noxious fumes) in areas where
they may contaminate almonds. Locate and
In addition to a simple plant schematic, proces- operate fans and other air-blowing equipment
sors are advised to create a drawing that demon- in a manner that minimizes the potential for
strates the product or “process” flow. The pro- contaminating almonds, almond-packaging
cess flow schematic should briefly describe the materials, and almond-contact surfaces.
most relevant features of each processing step: 7. Develop procedures for reviewing any poten-
time, temperature, etc. tial changes in the facility for their impact on
GMPs and modify accordingly. This would in-
Plant environment clude changes in layout, infrastructure, equip-
ment or addition of new equipment. Changes
The following recommendations should be imple- should be reviewed in light of their effect on
mented to minimize the potential for contamina- executing current GMPs or the possible intro-
tion associated with the plant. duction of contaminants.
1. Ensure that all glass lights in processing and Grounds environment
warehouse areas are shielded or otherwise
protected. The following recommendations should be imple-
2. Provide adequate lighting in all almond pro- mented to minimize the potential for contamina-
Presented by the Almond Board of California • 1150 9th St, Suite 1500, Modesto, CA 95354. ©2009 Almond Board of California. 5
Good Manufacturing Practices
tion associated with plant grounds. Pest Control
1. Maintain plant grounds so as to reduce the The following recommendations should be imple-
potential for contamination. Grounds must be mented to minimize the potential for contamina-
free of trash and debris. Grounds must have tion associated with plant grounds
adequate grading and/or drainage to avoid
standing water. Vegetation should be con- All animals, including mammals, birds, reptiles,
trolled to prevent pest harborages. and insects, are potential sources of contamina-
2. If there are other activities on site of the facil- tion in processing environments because they
ity or nearby, preventive measures shall be harbor, or could be a vector for. a variety of
taken to prevent the cross contamination of pathogenic agents, such as Salmonella or E. coli.
almonds stored or processed on the facility Each facility should establish a pest control pro-
by biological, chemical or physical hazard. gram to reduce the risk of contamination by ro-
3. Building and grounds must be maintained to dents, insects, birds and any other pests.
prevent entry of pests. Provide, where neces-
sary, adequate screening or other protection 1. An effective pest control program should in-
against pests. Building roof, walls, doors, clude regular and frequent monitoring of af-
floor and windows shall be constructed and fected and treated areas to accurately assess
maintained to prevent pest entry. the program’s effectiveness. A staff member
4. Waste facilities must be well maintained and should be trained to implement the program
designed to prevent contamination of product and work with outside pest control contrac-
or packaging material. Waste containers must tors as needed. Detailed pest control logs
be clearly identified and emptied in a timely describing treatments and results should be
manner. maintained.
5. Roads, yards and parking lots must be main- 2. No pests or domestic animals shall be allowed
tained so they do not pose a threat of con- in any area of an almond plant.
tamination to any stored almonds on site. 3. Maintain the grounds in good condition.
6. Equipment stored on the grounds shall not Grounds in the immediate vicinity of all pack-
provide sources of contamination or pest har- ing areas should be cleared of all waste, lit-
borages. ter, and improperly stored garbage. Keep all
7. Conduct internal audits of grounds by in- grasses cut to discourage the breeding, har-
specting and recording observations concern- boring, and feeding of pests, such as rodents
ing items 1-6 above. If deviations are found, and reptiles. Remove any unnecessary items,
record them and take appropriate corrective including unused and inoperative equipment
action. to eliminate areas that harbor rodents and in-
8. Store, convey and dispose of rubbish and pro- sects.
cessing waste to minimize odor and the po- 4. Clean and sanitize daily to remove product or
tential for attracting flies and other pests and product remnants that attract pests in and
to protect against contamination of almonds, around the packing facility and any other lo-
almond contact surfaces, water supplies and cation where almonds are handled or stored.
ground surfaces. 5. Maintain adequate surface drainage to reduce
breeding places for pests and food contami-
nation by seepage.
6 Presented by the Almond Board of California • 1150 9th St, Suite 1500, Modesto, CA 95354. ©2009 Almond Board of California.
Good Manufacturing Practices
6. Operate water treatment and disposal sys- of pesticide residues in finished product.
tems so that they do not become a source of Please refer to the manufacturer’s recom-
contamination or pest attractant. If grounds mendation for proper use in food storage
not under your control border the processing areas.
plant, protect your facility by inspection, ex- 2. Records should be kept detailing pesticide
termination, or other means to exclude pests, usage, including date of application, loca-
dirt, and filth that may be a source of food tion, dosage rate, target pests, etc.
contamination.
7. Exclude pests by blocking areas, such as Resources (Located under “Regulations and
holes in walls, doors, flooring and vents, that Guidelines”)
allow entrance into the facility. Use screens, • Food and Drug Administration - 21 CFR
wind curtains and traps. 110.35(c) (Pest control)
8. Pest control procedures and logs should de-
scribe the location of any outdoor bait sta-
tions, glue boards, and insectocutors (bait
stations are not permitted inside the plant).
Trap or bait station locations should be docu-
mented with a schematic map. Traps and sta-
tions should be checked frequently to detect
activity and a record should be maintained.
Traps should be cleaned and maintained.
Dead pests should be removed immediately
and disposed of to prevent any potential con-
tamination or infestation.
1. A list should be maintained of all pesti-
cides used at the facility along with Manu-
facturer’s Safety Data Sheets (MSDS) and
recommendations. All pesticides shall be
used in accordance with manufacturer’s
labeled recommendations and State and
Federal regulations. Individuals using and
applying pesticides shall receive appropri-
ate training and shall have certificates or
licenses from appropriate authorities. A re-
cord should be maintained of all pesticide
applications, including name of chemical,
concentration, where applied, and date.
If the plant was fogged with insecticide,
clean, sanitize and inspect all equipment
afterwards to insure removal of all dead in-
sects and ensure that no residues of insec-
ticide remain. Use of pesticides in product
storage areas could lead to the detection
Presented by the Almond Board of California • 1150 9th St, Suite 1500, Modesto, CA 95354. ©2009 Almond Board of California. 7
Good Manufacturing Practices
3. Sanitary Operations
Cleaning and sanitation at the highest point of equipment and
work downward. Remove all almond
An effective cleaning and sanitation program is residues from equipment and surfaces.
critical for minimizing the potential for contami- vi. Where it is not possible to vacuum,
nation with microorganisms and foreign debris. carefully blow and/or sweep surfaces.
The following general practices should be imple- Special care must be taken to avoid
mented when appropriate. blowing foreign material throughout
the plant.
1. Establish a plant sanitation program that in- vii. Sanitize food contact surfaces with
cludes employee training for cleaning plant appropriate sanitizer (quaternary am-
equipment, the facility and utensils. Records monia or other sanitizer). Do not apply
of training should be maintained. sanitizers (quaternary ammonia or oth-
er sanitizer) directly on to edible prod-
2. All almond contact surfaces, including utensils uct. All sanitizers used on food contact
and almond contact surfaces of equipment, surfaces should be food grade.
shall be cleaned and sanitized as frequently as viii. Rinse off sanitizer and allow equipment
necessary to protect against contamination. to thoroughly dry before use. Alcohol-
3. General cleaning and sanitation procedures based sanitizers may be most appro-
for equipment. Research conducted by the priate where short drying times are
University of California, Davis, funded by the required.
Almond Board of California, has indicated ix. Refer to manufacturer’s recommenda-
that wet cleaning can lead to increased lev- tions for specific instructions on use.
els of pathogens in the plant environment if Follow all label and Manufacturer Safe-
the equipment is not thoroughly dried before ty Data Sheet precautions for chemi-
reuse. Because of this finding, it is not recom- cals.
mended that wet cleaning be conducted un- b. Wet Cleaning Procedures
less the equipment can be completely dried i. Lockout/Tagged procedure for power.
before reuse. ii. Remove all almonds from the area be-
a. Dry Cleaning Procedures ing cleaned.
i. Lockout/Tagged procedure for power. iii. Wear proper protective equipment.
ii. Remove all almonds from the area be- iv. Check for oil leaks on all gear boxes
ing cleaned. and motors, report problems to main-
iii. Wear proper protective equipment. tenance supervisor and document the
iv. Check for oil leaks on all gear boxes incident.
and motors and report problems to v. Vacuum all equipment, conveyors,
maintenance supervisor. Document the product contact surfaces, motors, sup-
incident. port frames, and any other exposed
v. Vacuum all equipment, conveyors, surfaces to remove all debris. Begin
product contact surfaces, motors, sup- at the highest point of equipment and
port frames, and any other exposed work downward. Remove all almond
surfaces to remove all debris. Begin residues from equipment and surfaces.
8 Presented by the Almond Board of California • 1150 9th St, Suite 1500, Modesto, CA 95354. ©2009 Almond Board of California.
Good Manufacturing Practices
vi. Where it is not possible to vacuum, supplier that meets government regulations.
carefully blow and/or sweep surfaces. 5. A master sanitation schedule and recordkeep-
Special care must be taken to avoid ing log should be developed for the facility
blowing foreign material throughout that lists the frequency of cleaning for all
the plant. equipment, surfaces, utensils and infrastruc-
vii. Check for oil leaks on all gear boxes ture. The schedule may need to be adjusted
and motors, report problems to mainte- depending on the results of your environmen-
nance supervisor and complete action tal monitoring program (see Environmental
slip. Monitoring Program).
viii. Vacuum all equipment and motors to 6. Develop written procedures that detail all
remove loose debris. Start at the high- steps in cleaning, including chemicals used,
est piece of equipment and work down. contact time, temperatures, and who con-
Remove all almond products from the ducts cleanup.
area. 7. Effectiveness of cleaning should be verified
ix. Cover all motors and gear boxes with by visual inspection or by other means, such
plastic coverings. as environmental testing with swabs and/or
x. Rinse with water, apply detergent with bioluminescence testing. Verification of clean-
hot water or steam clean. ing should be done at an interval that ensures
xi. Scrub with brushes and other cleaning that cleaning is effective and consistent and
tools as needed. Agitate all equipment a record should be kept (see Environmental
and food contact surfaces to remove Monitoring Program). If verification results in
dirt or residue buildup. an unacceptable condition, items should be
xii. Rinse with fresh water. re-cleaned or changes made in the cleaning
xiii. Sanitize food contact surfaces with procedures.
appropriate sanitizer (quaternary am-
monia or other sanitizer). Do not apply Chemicals
sanitizers (quaternary ammonia or oth-
er sanitizer) directly on to edible prod- Improper use of chemicals can pose a risk to
uct. All sanitizers used on food contact food and employees . Implementation of the fol-
surfaces should be food grade. lowing recommendations regarding chemical
xiv. Rinse off sanitizer and allow equipment handling and employee training are critical to
to dry thoroughly before use. minimizing issues associated with chemical use.
xv. Refer to manufacturer’s recommenda-
tions for specific instructions on use. 1. Those employees designated to handle haz-
Follow all label and Manufacturer Safe- ardous materials must be trained in proper
ty Data Sheet precautions for chemi- handling. Each employee should sign a certifi-
cals. cate after he or she has been properly trained.
4. Almond contact utensils and processing tools Maintain records of employee training and au-
should be cleaned and sanitized daily using thorizations as appropriate in employee files.
a food grade sanitizer. Utensils and process- Sample forms to document employee training
ing tools should be washed to remove dust are located in the Appendix.
and debris, then sanitized using a commercial 2. Chemicals must be stored away from almond
sanitizer of a concentration specified by the processing areas so as not to contaminate
Presented by the Almond Board of California • 1150 9th St, Suite 1500, Modesto, CA 95354. ©2009 Almond Board of California. 9
Good Manufacturing Practices
almonds, almond contact surfaces or almond es.
packaging materials. Store pesticides and 11. Manufacturers’ recommendations for use of
pesticide equipment separately from oils and chemicals used in or around food contact ar-
products used in food processing. When pos- eas should be adhered to.
sible chemicals should be stored in a non- 12. Records should be kept detailing chemical
food-product warehouse. usage, including date of application, location,
3. All chemicals must be properly labeled and dosage rate, purpose, etc.
packaged.
4. Procedures and controls should be estab-
lished for the securing, checkout and return of
chemicals to avoid unauthorized use.
5. Workers authorized to apply chemicals shall
receive appropriate training in the use, stor-
age, documentation and disposal of these
chemicals.
6. The plant should maintain an inventory and
Manufacturer Safety Data Sheets (MSDS) for
all chemicals used in the facility.
7. Chemical control procedures should be de-
veloped that outline procedures for listing all
chemicals used in the facility; the handling,
storage and labeling of chemicals; procedures
for distribution and control of chemicals; pro-
cedures for ensuring MSDSs are maintained
and are current; procedures for ensuring that
cleaners, sanitizers and lubricants have docu-
mentation that guarantees approved regula-
tory status; and procedures for disposition of
empty chemical containers or waste chemi-
cals.
8. Cleaning and sanitizing agents shall meet ap-
propriate regulations and documentation shall
be obtained from suppliers verifying this.
9. Chemicals that may contact almonds or al-
mond contact surfaces (such as lubricants)
must be food grade.
10. Disposal of empty containers or waste must
conform to local and state regulations for the
particular chemical. No empty containers
must ever be stored in areas that would pres-
ent the possibility of potential contamination
to almonds, almond packages, or water sourc-
10 Presented by the Almond Board of California • 1150 9th St, Suite 1500, Modesto, CA 95354. ©2009 Almond Board of California.