Auditing and Inspection Checklist for Sprouting Facilities

DRAFT

Auditing and inspection checklist for sprouting facilities

 

 

 

Firm's Information:                                                  Auditor Information:                       

 

Firm Name: _____________________________    Name:  ____________________________

 

Address: ________________________________   Agency: ___________________________

 

Phone: _________________________________     Phone: ____________________________

 

Date of audit: ________

 

Most Responsible Individual: _______________________________________

 

Purpose: 

 

This program is intended to assess a sprouting facility's efforts to minimize the risk of microbial contamination of sprouts.  The questions are designed based on HACCP principles and include elements of Good Manufacturing Practices and recommendations provided by international food safety guidelines for sprouts as listed below.

 

  1. U.S. Food and Drug Administration. 1999. Guidance for industry: Reducing microbial food safety hazards for sprouted seeds. Fed. Regist. 64:57893-57896. Available at: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ProduceandPlanProducts/ucm120244.htm

 

  1. U.S. Food and Drug Administration. 1999. Guidance for industry: Sampling and microbial testing of spent irrigation water during sprout production. Fed. Regist. 64:57896-57902. Available at: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ProduceandPlanProducts/ucm120246.htm

 

  1. Codex Alimentarius Committee. 2003. Code of hygienic practice for fresh fruit and vegetables. Annex II: Annex for sprout production. Available at: www.codexalimentarius.net/download/standards/10200/CXP_053e.pdf

 

  1. Canadian Food Inspection Agency. 2007. Code of practice for the hygienic production of sprouted seeds. Available at: http://www.inspection.gc.ca/english/fssa/frefra/safsal/sprointe.shtml

 

  1. Canadian Food Inspection Agency. 2008. Food safety practices guidance for sprout manufacturers. Available at: http://www.sproutnet.com/Reports/CFIA_FSPG_EN.pdf

 

Table of Contents: 

 

A. Documentation and Records

            1. Production Facility & Equipment

            2. Cleaning & Sanitation

            3. Pest Control

            4. Waste Management

            5. Personal Hygiene

            6. Control of General Operations

            7. Control of Sprouting Operations

                        a. Seed Purchasing, Receiving & Storage

                        b. Seed Disinfection/Treatment

                        c. Sprout Production

                        d. Post Harvest Washing, Dehulling and Dewatering

                        e. Packing & Labeling

                        f. Spent Irrigation Water Testing for Pathogens

            8. Storage & Distribution

            9. Traceback & Recalls

            10. Food and Facility Security Defense Program

            11. Training 

B.Site Inspection

1. Establishment for Sprout Production (Sprout Production Facility & Equipment

2. Cleaning and Sanitation

3. Pest Control

4. Waste Management

5. Personal Hygiene

6. Control of General Operations

7. Control of Sprouting Operations

                        a.  Seed Purchasing, Receiving and Storage

                        b.  Seed Disinfection/Treatment

                        c. Sprout Production

                        d.  Post Harvest Washing, Dehulling, and Dewatering

                        e. Packing & Labeling

                        f. Spent Irrigation Water Testing for Pathogens

8. Storage and Distribution

9. Traceback and Recalls

10. Food and Facility Security Defense Program

11. Training 

 

Sprout Specific Auditing and Inspection Check List

Stage I - Basic Requirements

 

To the Sprout Grower:

Have the following ready before the inspector arrives

1.      List all the different sprouts and sprout mixes you grow

-         Classify them into methods of seed sanitation used

-         Classify them into spent irrigation water sampling methods

-         For each product indicate which days you harvest per week (See attached sample grid)

-         For each product indicate the approximate # of pounds of seed planted per harvest

-         For each product indicate the approximate yield in lbs of sprouts per one lb of seeds

2.      Have written instructions available for:

-         Each seed sanitation method you use

                                                               i.     Which seeds or mixes are treated with each sanitation method

                                                             ii.     Which sanitizer and what concentration used for each method

                                                            iii.     How much sanitizer used per quantity of seed and water

                                                           iv.     Length of time and amount of stirring or agitation

-         Every Batch Hold and Release Program:

                                                               i.     Each method of sampling spent irrigation water and

1.      Which seeds are sampled by each method

2.      The upper limit of # of pounds of seed in each lab sample

3.      If/when more than one seed is sampled for a single sample, which seeds are pooled together

                                                             ii.     Sample preparation for lab, including

1.      lot code marking and tracking through from supplier to consumer

2.      name, address & phone # of lab

3.      rapid test method used

4.      confirmation method used in case of a presumptive positive

5.      Remediation required in case of a non-confirmed presumptive positive

6.      Remediation required in case of a confirmed positive

7.      System for holding finished product until lab results are returned before release to market.
 

Sample Grid for Sprout product harvest day, approx lbs, and Batch/Pool for sampling 

 

Sample Batch

Seed

Yield

Sun

Mon

Tues

Wed

Thurs

Fri

Sat

Alfalfa

Alfalfa

10

 

150

150

 

150

150

 

Beans

Mung

12

400

400

400

 

400

400

 

 Wheat

Wheat

1

 

300

 

300

 

300

 

Flavors

 Pooled:

 

 

 

 

 

 

 

 

 

Radish

8

 

 

10

 

10

10

 

 

Broccoli

8

 

20

20

 

20

20

 

 

Clover

12

 

10

10

 

10

10

 

 

Alf/Rad

12

 

 

5

 

5

5

 

 

Mix

1.5

5

 

5

 

5

 

 

Peas

Peas

2.7

 

200

200

 

200

200

 

 

To the Inspector:

1       Check the above list of sprouts grown and the instructions for sanitizing, sampling and lab preparation.  Are written instructions adequate and complete?

2        Request report from previous inspection. Check deficiencies.

3        Randomly select one week in the period since the last inspection. For each seed batch produced that week, examine:

a.      Sales records for quantities of each seed lot sold

b.     Seed sanitation records - do they match written instructions?

c.      Lab records - is there a negative result for each batch sold that week?

d.     Hold and release records - are they adequate to insure no contaminated product will get into the marketplace?

4        Based on the average yield for each sprout batch, check quantities sold against quantities sampled

5        Make sure the lot codes on invoices match codes on sanitation, sampling and test result records and confirm that the trace back is complete to the seed supplier.

6        Ask for most recent lab report of presumptive positive. Check the following: (Answer in I6q)

a.      Did the test go on to confirmation?

b.     Was it positive or negative?

c.      If positive or unconfirmed presumptive positive, check records for proper disposition of all product in that batch of seeds.

7        Examine purchasing records of sanitizers. Request two consecutive purchases to check quantities of sanitizers purchased to match the approximate volume of sprouts sold between the purchases. Use sprout sales records for random week to estimate amount used between purchases.

8        Examine Employee Training Program:

a.      Check training materials for sanitizing and Every Batch Testing, Hold and Release program

b.     Check signed records of training sessions

c.      Check training records for recent hires

d.     Check training records for regular refresher training for all employees.

9        Ask to observe a sanitation demonstration, a spent irrigation water sampling procedure, and sample preparation for lab. Note the following:

a.      Measurements of sanitation

b.     Confirmation of concentration

c.      Method of agitation

d.     Length of time of contact

e.     Method of disposal of sanitation material

f.       Cleanliness of sampling container

g.      Method of pooling sampling water

h.     Volume of sample - (should be 1 liter per sample)

i.        Accuracy of lab documentation (tracking sheet)


 

A. Documentation and Records

 

#

Questions

Yes

No

Doc

Comment

A1

Is there one person responsible for keeping and validating safety documentation records?

 

 

 

 

A1

With the responsible person, assess the company's record keeping system. Is it well organized and easy for multiple users to get forms, fill them out and save them for future inspection when necessary?

 

 

 

 

A2

Are records legible, accurate and signed and dated by individuals responsible?

 

 

 

 

A3

Do records include written procedures, controls, limits, monitoring results, corrective actions and follow-up documents, maintained for a minimum of one year, for each of the following?

 

seed sources and lot numbers

Source water analysis results

Sanitation checks

Pest control monitoring

Sprout lot codes

spent irrigation water analysis results

production volumes

storage temperature monitoring

product distribution and consumer complaints 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A5

Are records retained for at least one year for each lot of sprouts?

 

 

 

 

 

B. Establishment for Sprout Production

 

#

Questions

Yes

No

Doc

Comment

B1

Assess facility cleanliness  (e.g., food residues on floor, insufficient draining of excess water on floor, dripping from ceiling or light fixture, moldy wall, rusted equipment, water from floor contacting product)

Inspection

B2

Are buildings and surrounding areas designed, constructed and maintained in a manner which prevents conditions that may result in the contamination of food? (e.g., exterior has no unprotected openings to prevent entry of contaminants and pests, the roof, walls and foundation are maintained to prevent leakage, the surrounding land is maintained to control sources of contamination such as pest harborage areas, the building is not located in close proximity to any environmental contaminants, etc).

 

 

 

Inspection

B3

Does the facility layout permit good hygienic practices, including protection against cross-contamination between operations and during cleaning and sanitation of utensils and equipment?

 

 

 

Inspection

B4

Is the facility fully enclosed and protected from outside contaminants?

 

 

 

Inspection

B5

If the firm grows in green houses or screen houses, are they fully enclosed and protected from rodent or bird intrusion?

 

 

 

Inspection

B5

Are storage, seed disinfection, germination and packaging areas separated from each other or has the potential for cross contamination between them been otherwise adequately addressed.?

 

 

 

Inspection

B6

Are floors smooth, non porous, impervious to water and sufficiently sloped to permit proper drainage?

 

 

 

Inspection

B7

Are walls, doors and ceilings smooth, non porous, non-chipping and impervious to water? 

 

 

 

Inspection

B8

Is there a glass and brittle plastic program in place?

 

 

 

Document

B9

Are light bulbs and fixtures protected to prevent contamination of sprouts in case of breakage?

 

 

 

Inspection

B10

Is there a metal contamination prevention program in place (i.e. to prevent nuts &bolts from equipment from entering finished product)?

 

 

 

Document

B11

Are equipment and containers coming in contact with sprouts made of materials which have no leaching toxic effects?

 

 

 

Inspection

B12

Are equipment and utensils used during sprout production clean and well maintained and stored in such a manner as not to become contaminated?

 

 

 

Inspection

B13

Are equipment and utensils inspected to determine adequacy of cleaning and records of the sanitizing treatments and inspections kept? 

 

 

 

Document

B14

Are food-contact surfaces clean and free from potential contamination from dripping ceilings, floors, etc.

 

 

 

Inspection

B15

Does the facility have written programs to ensure water quality?

 

 

 

Document

B16

Is water used for irrigation and finished produce washing from a potable source?

 

 

 

inspection

B17

Describe the water source/sources used for sprout production and processing and include any microbiological or chemical test results within the last 12 months. 

Document

B18

If the water source is wells or cisterns, are they tested at least twice a year? Check documentation.

 

 

 

Document

B19

If the facility is on a municipal water supply, is there a current document (within 12 months) on file from the supplier that verifies that the water is of adequate quality?

 

 

 

Document

B20

Does the facility have adequate ventilation to prevent condensation, dust, and minimize entry of contaminated air? 

 

 

 

inspection

B21

Is the ventilation system constructed to avoid air flow from contaminated to clean areas?

 

 

 

inspection

B22

Is the ventilation system designed to be adequately maintained and cleaned?

 

 

 

inspection

B23

Are ventilation openings equipped with close-fitting screens or filters to reduce risk of contaminated air intakes?

 

 

 

inspection

B24

Are sewage, effluent and waste storage and disposal systems designed, constructed and maintained to prevent contamination?

 

 

 

inspection

B25

Are draining and sewage systems equipped with appropriate traps and vents?

 

 

 

inspection

B26

Is there evidence of cross-connection between the sewage system or other waste effluent systems and the sources of potable water?

 

 

 

inspection

 

 

 

 

 

 

 

C. Cleaning and Sanitation  

  

#

Questions

Yes

No

Doc

Comment

C1

Does the firm have written cleaning and sanitation program for the premises (production and storage areas)?

 

 

 

Document

C2

Does the firm have written cleaning and sanitation program for all equipment?

 

 

 

Document

C3

Does the written cleaning and sanitation program for facility, equipment and utensils include the following?   Document

 

 

 

 

 

      - name of the responsible person

- the frequency of the activity

- the procedures for cleaning, sanitizing and rising

- chemicals and concentrations used

- temperature requirements

- the type and frequency of inspection to verify the  effectiveness of the program

equipment and utensils used during sprout production

-disassembly/re-assembly instructions

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

C4

How often does the firm clean and sanitize each of the following, review records: Are the records consistent the written documentation? Document

 

 

 

 

 

 

- seed storage area/room and equipment

- seed disinfection area/room and equipment

- sprouting area/room  and equipment

- packaging area/room and equipment

     - sprout Coolers, drip pans and other cooler equipment

Yes

Comments how often

 

 

 

 

 

 

 

 

 

 

C5

What chemicals and concentrations are used to sanitize the following areas/rooms? Does documentation verify that chemicals are used in accordance with manufacturer's instructions?

 

 

 

 

 

 

 - seed storage area/room and equipment

- seed disinfection area/room and equipment

- sprouting area/room  and equipment

- packaging area/room and equipment

- sprout Coolers, drip pans and other cooler equipment

     - equipment and utensils used during sprout production

yes

Chemical / concentration

 

Document

 

 

 

 

 

 

 

 

 

 

C6

Is the sprouting area and food contact surfaces clean and well maintained?.

 

 

 

Inspection

C7

Does the firm have written procedures for routine verification of its cleaning and sanitation procedures?

 

 

 

Document

C8

Is a method in place to verify the effectiveness of cleaning and sanitation? 

 

 

 

Document

C9

Is there a written procedure for at least weekly sampling of equipment, floors, drains, cooler pans, etc. for Listeria sp?

 

 

 

Document

C10

Are there records for regular Listeria sp testing?

 

 

 

Document

C11

Does the firm have written SOPs for cleaning and disinfecting facility and equipment after contamination was found?
 

 

 

 

Document

C12

Does the firm have written procedures to verify the effectiveness of their cleaning and sanitation procedures?

 

 

 

Document

C13

Does the firm have written SOPs for corrective actions before resuming production after contamination is found?

 

 

 

Document

 

 

D. Pest Control

 

#

Questions

Yes

No

Doc

Comment

D1

Does the facility have a written pest control program? 

 

 

 

Document

D2

Does the firm use properly trained and licensed pest control technicians, whether internally employed or externally hired on at least a monthly basis?

 

 

 

Document

D3

Does the pest control service and/or the person applying chemicals or servicing the facility have a current license/permit

on file?

 

Check that the name of the responsible person, copies of applicators licenses for each application, name of pest control company and contact person and a copy of certificate of insurance for responsible entity, as applicable, are on file.

 

 

 

Document

D4

Does the facility have a complete list of pesticides approved for use and the designated areas where they are approved for application?

 

 

 

Document

D5

Are dilution and application information for chemicals on file?

 

 

 

Document

D6

Are Material Safety Data Sheets (MSDS) for chemical use on file?

 

 

 

Document

D7

Review the service report. Are chemicals applied appropriately?

Are usage levels as recommended?

 

 

 

Document

 

 

 

 

D8

If pest control chemicals are stored on site, are they secured in a locked cabinet or room?

 

 

 

Inspect

D9

Does the facility have a current plot diagram schematic that documents the locations, description and identifies markers of all stations (live traps, bait stations, glue boards ketchalls, tin-cats, & insectocutors)?

 

 

 

Document

D10

Are there inside rodent traps (ketchalls, tin-cats or glue boards etc.) against the wall on both sides of all  outside pedestrian, cooler and dock doors and every 30-40' (9-12m) against the inside of all exterior walls in the dry storage areas, boiler rooms, etc.?.    

 

 

 

Inspect

D11

Is the inspection of these traps documented weekly?

 

 

 

Document

D12

Do records indicate that the firm's management is doing their own inspection at least monthly?

 

 

 

Document

D13

Do the Pest Control Service reports show the conditions found and the corrective actions needed to prevent future pest problems?

 

 

 

Document

D14

If insect light traps are installed are they cleaned and operating properly, and do they have shields to prevent glass cross-contamination?

 

 

 

Inspect

D15

Are the locations of traps away from exposed food, food packaging materials and food processing equipment?

 

 

 

Inspect

D16

Is there a provision in the program for determining the effectiveness and servicing of traps weekly to remove dead pests and to try to identify the source of infestation?

 

 

 

Document

D17

Is there a perimeter maintained around the inside of exterior walls of the seed storage areas so as to facilitate the ability to do pest control? 

 

 

 

Inspect

D18

Are interior walls, floors and ceilings well maintained and free of major cracks and crevices that could be entry points?

 

 

 

Inspect

D19

Check outside traps or bait stations. Are stations clean, filled with fresh bait, undamaged, secured to the ground, free from dead rodents and properly serviced, with bait secured inside the station? 

 

 

 

Inspect

D20

Are the bait stations positioned every 50-70' (15-21m) against the outside walls of the facility all the way around?

 

 

 

Inspect

D21

Are there gaskets around dock levelers to reduce all gaps to less than 0.25" (6mm) to prevent rodent entry?

 

 

 

Inspect

D22

Are there screens on doors, windows and louvered ventilation fans?

 

 

 

Inspect

D23

Is there a lack of standing water on the outside perimeter of the building to prevent pest harborage?

 

 

 

Inspect

D24

Have trees, overhanging beams, ledges, etc. been treated to discourage birds from roosting near the facility?

 

 

 

Inspect

D25

To prevent pest harborage is there an 24" open area maintained around the perimeter of the building with no items stored up against the building?

 

 

 

Inspect

D26

Is the outside of the facility free of rodent burrows?

 

 

 

Inspect

D27

Are dumpsters in good repair and stored away from building?

 

 

 

Inspect

 

 

E. Waste Management

 

E1

Does the firm have written SOPs for the storage and removal of waste from production and outside areas, including the frequency of removal?

 

 

 

document

E2

Are waste storage areas separated from the plant? Away from seed and sprout handling and storage areas?

 

 

 

inspect

E3

Are all waste containers clearly labeled, leak-proof and where appropriate, covered?

 

 

 

inspect

 

 

F. Personal Hygiene

 

#

Questions

Yes

No

Doc

Comment

F1

Does the facility have adequate and conveniently located changing facilities and toilets?

 

 

 

Inspect

F2

Are toilet facilities designed to allow hygienic removal of waste and be segregated from production and storage areas?

 

 

 

Inspect

F3

Are toilet facilities maintained under sanitary conditions and good repair?

 

 

 

Inspect

F4

Does the facility provide adequate means of washing and drying hands, including wash basins, soap, disposable towels and a supply of hot and cold water adjacent to toilets?

 

 

 

Inspect

F5

Are hand washing and hand sanitizing stations located at all entrances and throughout sprouting and packaging rooms and properly maintained? 

 

 

 

Inspect

F6

Are boot sanitizing troughs or mats placed at all entrances to post seed disinfection areas?

 

 

 

Inspect

F7

Are sanitizer chemical levels checked and documented at a frequency sufficient to maintain the specified levels?

 

 

 

Inspect

F8

. Does the firm have a written worker health policy that:     Document

 

- Restricts employees and visitors with symptoms of potentially infectious illness such as diarrhea, fever, or vomiting from working with or being in the vicinity of seeds/sprouts or food-contact surfaces?

- Instructs employees to report any active case of illness to their supervisor before beginning work?

- Requires employees with open sores, cuts, burns, boils, and similar conditions report the conditions, and to not handle food or food contact surfaces unless the injury is completely protected by a secure waterproof covering (e.g., rubber gloves)?

- Has corrective action for instances of contamination?

 

 

 

 

 

 

 

 

F9

Does the firm have written requirements for cleanliness and personal behaviors that include:

 

 

-        Protective clothing, hair covering, footwear and gloves should be worn and maintained in a sanitary manner

-        Workers must wash and sanitize their hands before starting work each day, after visit to toilet facilities or blowing their nose, after other absence from the work station, and after handling contaminated materials (e.g., picking objects off the floor).

-        Waterproof gloves should be washed and sanitized similarly to hand washing.

-        Proper maintenance and cleaning of reusable gowns, aprons, boots and gloves?

-        Eating, using tobacco, chewing gum, or unhygienic practices such as spitting in food handling areas is prohibited

-    Jewelry shall not be worn

 

 

 

Document

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

F10

Are access by non plant personnel and visitors controlled to prevent contamination?

 

 

 

Inspect - redundant F11?

F11

Does the firm have a written policy to ensure good hygienic practices are followed by visitors?

 

 

 

 Document

 

 

 

 

 

 

 

 

 

 

G. Control of general operations

 

#

Questions

Yes

No

Doc

Comment

G1

Does the firm have a written description and procedures for control of entire production processes including

 

 

- Process flow diagram

- Incoming material control

- Packaging control

- Production preparation

- Product coding control

- Process control

- Labeling control

- Deviations and corrective actions

- Verification of product safety 

 

 

 

Document

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

G2

Does the firm have written procedures for incoming material controls? (including incoming seed control?) 

 

 

 

Document

G3

Does the firm have controls in place to prevent the presence of undeclared allergens, including prevention of cross-contamination or carry-over?

 

 

 

Document

I3d

Are production lines and equipment dedicated to one seed type where allergens are present?

 

 

 

Inspection

G4

Does the firm have effective systems to prevent the use of contaminated, damaged or defective containers (e.g., receiving and storage controls, visual examination prior to use)?

 

 

 

Document

G5

Are packaging materials new (or sanitized if reusable), clean and non toxic, posing no threat to the safety and suitability of sprouts under specified conditions of storage and use?

 

 

 

Document

G6

Is each lot of packaging material examined for physical damage, signs of contamination (e.g., stains, bird droppings, insect) and foreign material at receiving? Check receiving logs

 

 

 

Document

G7

When defects occur or limits of acceptability are exceeded, does the firm have written procedures to identify, isolate and evaluate affected products.

 

 

 

Master document

G8

Does the firm have written procedures for corrective actions following any deviation that include:

 

-Investigation to determine the cause of the deviation

-Preventative measure to prevent recurrence of deviation

-Verification of the effectiveness of the corrective action taken

 

 

 

Master document

 

 

 

 

 

 

 

 

G9

Does the firm use supplementary methods of evaluation to verify the conformance and effectiveness of controls affecting product safety. Methods of verification may include:

 

- Review all specifications for incoming ingredients and materials as well as letters of agreement at an adequate frequency.

- Development of a sampling plan to ensure the consistent collection of samples (e.g., spent irrigation water)  

- On-site assessment of the monitoring procedures

- Review of records for completeness

- Review of deviation records to ensure that appropriate corrective actions are taken

- Independent external or internal audits

- Analysis of consumer complaint trends

 

 

 

Master document? Covered in individual sections?

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

H: Control of Seed Supplier Sources

 

H1

Does the firm have a letter from each of its seed suppliers stating that they obtain their seed from growers following Good Agricultural Practices?

 

 

 

Document

H2

Does the firm have confirmation that each seed supplier has a documented food safety program?

 

 

 

Document

H3

Does the firm have a letter from each of its seed suppliers stating that they are planning to, or have already obtained annual 3rd party audits for GMPs?

 

 

 

Document

H4

Does the firm have documentation of seed supplier testing results as part of a certificate of analysis (COA) from the seed supplier for every seed lot received? 

 

 

 

Document

 

I. Control of sprouting operations

 

I.1. Seed Receiving and Storage

 

#

Questions

Yes

No

Doc

Comment

I1a

Does the firm have a written SOP for seed receiving and storage?

 

 

 

Document

I1b

Does the firm have written procedures for visual evaluation of seed shipments when seeds reach the sprouting facility?  For example, black light or visual exam examination of bags for evidence of rodents. 

 

 

 

Document

I1c

Does the firm maintain a seed log with seed lot used on each day to track seed (and lot #) through receipt, use, shipping or return to suppliers?

 

 

 

Document

I1d

How are seeds stored?   

 

Is storage area dry and clean?

Is there a dedicated seed storage area?

Stored off the floor and away from walls? 

Are opened bags of seed stored in containers?

Are containers emptied and sanitized between lots?

Are seed lot numbers clearly marked on storage containers?

Are seed storage containers covered/closed?

Sanitary?

 

 

 

Inspect

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

I1e

Are seed lots ever mixed? During Storage?

Production?

If so, are records kept?

 

 

 

 

Document

 

 

 

 

 

 

 

 

 

I.2. Seed Disinfection/Treatment - This section has not been examined in total.

 

#

Questions

Yes

No

Doc

Comment

I2a

Does the firm have written seed disinfection procedures? 

 

 

 

Document

I2b

Does the firm have written seed disinfection logs? 

 

 

 

Document

I2c

Does the firm have copies of invoices for disinfection chemicals purchased that approximate their written disinfection procedures?

 

 

 

Document

I2d

Is at least one effective antimicrobial treatment applied to seeds immediately before sprouting?. This treatment must be from a list of treatments suggested by industry, published in the scientific literature, peer reviewed and accepted by a review panel made up of scientists expert in the field.

 

 

 

Reservations.. what is effective?  How can we define it?

I2e

Have the firm re-create an actual seed disinfection process from mixing of chemicals to actual disinfection of seeds while you observe and record data.

 

a.    Describe process and observations

b.    Test the strength of the solution

c.    What volume of seed to what volume of solution is used?

d.    Is the seed/solution agitated during treatment?

e.    Method of agitation?

f.     How long is the treatment?

g.    Potable water being used?

h.    Are seeds pre-rinsed, prior to any antimicrobial treatment?

i.    Rinse after treatment?

j.    Method of disposal of sanitation material?

Inspect

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

I2f

Obtain the following information on antimicrobial treatment(s) used by the firm for each seed type:

 

Type of seed

Biocide (include brand)

Concentration

Treatment method

Duration of treatment

Document

 

 

 

 

I2g

Is the firm able to demonstrate that the concentration of the solution was within the established target range?

 

 

 

Inspect

I2h

How often does the firm check to verify that the concentration of antimicrobial was prepared according to the firm's SOP and is within the target range established by the firm? (daily, weekly, etc.)

Document

I2i

What method and procedures are used by the firm to check the concentration (e.g., test strips)?  Include brand, model and test range.

Document

I2j

How are the disinfected seeds transferred/transported to sprout production?

Inspect

 

 

I.3. Sprout Production

 

#

Questions

Yes

No

Doc

Comment

I3a

Does the firm have a written SOP for sprout production?

 

 

 

Document

I3b

Does the firm have written sprout production logs working in conjunction with the seed log, to show what seed lots were used on what production days? 

 

 

 

 

I3c

What types of seeds are sprouted at the facility? List all:

 

 

 

 

 

 

 

 

 

I3e

What is the source of water used for irrigation (e.g., municipal, well)? Potable water?

 

I3f

Is there a microbial control program for irrigation water?

Is it chlorinated or otherwise disinfected by the firm? If yes, what level of chlorine is used?

(note: chlorination of irrigation water may affect microbial testing of spent irrigation water)

 

 

 

 

 

I3g

Does the firm capture and reuse spent irrigation water?  If so,  does it have adequate treatment to prevent cross-contamination?

 

 

I.4. Post harvest washing, dehulling, and dewatering

 

#

Questions

Yes

No

Doc

Comment

I4a

Does the firm have a written SOP for the dehulling, washing, and dewatering processes?

 

 

 

document

I4b

Is the wash water recycled?

If so, is the sanitizer level tested prior to use?

 

 

 

document

 

 

 

 

 

I.5. Packing & Labeling- This is partially handled under hygiene, partly under traceback, partly under labeling for allergens. Do we want to discuss other labeling issues such as washing before use, accurate portrail of contents on the main panel, etc?

 

#

Questions

Yes

No

Doc

Comment

I5a

Does the firm have a written SOP for packing finished product?  

 

 

 

document

I5b

Is the packing area clean and protected from potential cross contamination. ?

 

 

 

inspect

I5c

Does the firm have controls in place to ensure that labels are complete and accurate?   

 

 

 

Document

I5d

Are sprouts labeled with the statement "Keep refrigerated"? 

 

 

 

Inspect

I5e

Are pre-packaged sprouts identified with sell-by, use by or best before on the label or container to allow the identification of product in the event of a recall?

 

 

 

inspect

I5f

Is the list of ingredients complete for each product?

 

 

 

Inspect

I5g

Is it clear from the name on the main identification panel what is in the product, based on the list of ingredients or the actual ingredients? (ie. labels are not misleading)

 

 

 

Inspect

 

 

 

 

 

 

 

I.6. Spent Irrigation Water Testing for Pathogens

 

#

Questions

Yes

No

Doc

Comment

I6a

Does the firm have a written SOP for microbial sampling and testing of spent irrigation water?

 

 

 

Document

I6b

Are there separate and appropriate spent irrigation water sampling procedures for drum grown, tray grown, or bin grown sprouts?

·         Are mung or soy bean bins sampled in such a way that a small amount of water has passed over the whole bin and been collected for testing?

·         If sprouts are grown in a rotary drum, is water sampled from each of the quads?

·         If sprouts are grown on trays, is water sampled from each of the trays in the tower?

 

 

 

Document

 

 

 

 

 

 

 

 

 

 

 

 

I6c

If the firm is growing sprouts in soil, is there a sampling protocol in place for soil grown sprouts or microgreens?

 

 

 

Document

I6d

Does the firm's written SOP have procedures for holding finished product until lab results (either preliminary or confirmed results) are returned before release to market? If yes, review copies of procedures

 

 

 

Document

I6e

Are soil grown sprouts or microgreens tested in a regular hold and release program?

 

 

 

Document

I6c

Does the firm have written microbial testing logs?  If yes, review test records for last year

 

 

 

Document

I6d

Does the firm collect spent irrigation water for microbiological testing? If yes, describe the procedure

 

·         Is spent irrigation water collected for microbiological testing for all sprouts grown every day? If not, comment which batches are not and how often.

·         Does the firm sample/test every homogenous production batch (ie. drum, rack of trays, bin, etc.) individually? (Pooling seed lots in less than production size batches up to 50 lbs of raw seed is considered acceptable.)

·         Are spent irrigation water samples collected after 48 hours of sprouting start?

·         If not, note the firm's justification for other time frame?

·         What is the volume of spent irrigation water collected per sample?

·          Are sampling containers clean, sterile and free of anti-microbials?

·          Is neutralizing chemical (e.g., sodium thiosulphate) added in the sampling container (this is needed if chlorinated water is used for irrigating sprouts)?  

·         How are samples stored prior to testing? (Include temperature)

·         What are the minimum and maximum amounts of time these samples are stored before arriving at the lab?

·         How are the samples transported to the testing lab?

·         Are samples clearly marked for tracking? 

·         Are samples shipped refrigerated? 

 

 

 

Document

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

I6e

Does the firm have sampling records that confirm the above answers?

 

 

 

Automatic Failure

I6f

Is spent irrigation water tested for:

E. coli O157:H7

Salmonella spp.

Others?  Specify.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

I6g

Is the initial microbial testing of spent irrigation water performed by a contract laboratory or the firm's in-house lab?

Document

I6h

If contract laboratory, is there documentation that the lab is A2LA and/or ISO 17025 certified?

 

 

 

Document

I6i

Does contract lab participate in the American Proficiency Institute "check sample program"?

 

 

 

Document

I6j

Call the lab to confirm the lab reports: Does the lab confirm they did the testing?

 

 

 

Automatic Failure

I6j

If firm's in-house lab, is the lab certification on file?

 

 

 

Document

I6k

Is the in-house technician certified to perform the tests?

 

 

 

Document

I6l

Method used for initial testing? (FDA BAM method, rapid test kits, PCR, other?)

This is for comment only. Are rapid test kits valid for hold and release?

I6m

If rapid test kits are used, list brand name for each test

Salmonella

-   E. coli O157:H7

-  Other (specify) 

 

 

 

I6n

Did the firm have any presumptive positive results?

 

 

 

 

 

I6o

Is a confirmation test done when a preliminary positive test result is received?

If yes,  check lab report results to verify

 

 

 

 

I6p

What is used for confirmation testing - spent irrigation water or enrichment media?

Should this be stated as a requirement?

I6q

If positive or unconfirmed presumptive positive, are there records to confirm proper disposition of all product in that batch of seeds?

 

 

 

Fatal flaw

I6r

Does the firm keep hold and release records adequate to ensure no contaminated product has gotten into the marketplace?

 

 

 

Document

I6s

Does the firm notify seed suppliers of positive results?

 

 

 

document

 

J. Storage and Distribution

 

#

Questions

Yes

No

Doc

Comment

J1

Does the firm cool their sprouts to 45 degrees Fahrenheit or below, prior to distribution? Check the core temperature of the sprouts that were placed under refrigeration at the end of the previous day's shift.

 

 

 

Inspect

J2

Are sprouts being cooled under sanitary conditions?

 

 

 

Inspect

J3

Is the cooler temperature checked at least twice a day?

 

 

 

Document

J4

Is the truck refrigeration temperature recorded on the truck log, monitoring device or invoices, etc.?

 

 

 

document

J5

Does the firm distribute sprouts under refrigeration? 

 

 

 

Inspect

 

K. Traceback and Recalls

 

#

Questions

Yes

No

Doc

Comment

K1

Does the firm have written procedures for the recall of product?

 

 

 

Document

K2

Has the firm tested its traceback and recall system twice a year at a minimum? Confirm with documentation.

 

 

 

Document

K3

Was all of the product accounted for in the recall test?

 

 

 

Document

K4

Was the traceback successful to the seed supplier and from the supplier to the farmer?

 

 

 

 Can we trace back to the field yet?

 

 

L. Food/Facility defense (security) program Do we need this?

 

M. Training

 

#

Questions

Yes

No

Doc

Comment

M1

Is management trained in GMPs?

 

 

 

Document

M2

Is management trained in HACCP?

 

 

 

Document

M3

Are personnel and supervisors responsible for the sanitation program trained to understand the principles and methods required for effective cleaning and sanitation?

 

 

 

Inspect

M4

Does the firm have a training program for personnel and supervisors to have adequate technical knowledge and understanding of the operations and procedures to maintain the safety of sprouts?

 

 

 

Inspect

M5

Does the firm have an appropriate training program in personal hygiene and hygienic handling of food?

 

 

 

Document

M6

Does the firm have training materials for:

 

seed sanitizing?

Every Batch Testing?

Hold and Release programs?

 

 

 

Document

 

 

 

 

 

 

 

 

M7

Are there proficiency criteria to show that the training was actually understood and retained by employees?

 

 

 

Inspect

M8

Does the firm have signed records of training sessions?

 

 

 

Document

M9

Does the firm have training records for recent hires?

 

 

 

Document

M10

Does the firm have training records for regular refresher training for all employees?

 

 

 

Document

M11

Are all training programs routinely reviewed and updated?

 

 

 

Document

M12

Does the firm have records documenting regular self-audits?

 

 

 

Document