FDA Procedures for Standardization and Certification
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Cover Memo
Contents
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The purpose of the following chart is to tally the disagreement between the Candidate's and the Standard's responses on the FDA Standardization Inspection Report (Annex 2 Section 1). The Standard determines whether the Candidate properly identified and catergorized violative conditions on each of the "Interventions/Risk Factors" and the "Good Retail Practices (GRPs)" portions of the FDA Standardization Inspection Report. The Standard may mark an item "S" to reflect a disagreement in a case where the Candidate has the opportunity to make an observation or take a measurement and fails to do so, and intervention by the Standard would alert the Candidate to the missed opportunity.
| Chart 3: Performance Criteria Tally of Disagreements in Each Establishment | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Candidate's Name: | Standard's Name: | ||||||||||||||||||
| Candidate's Address: | Agency: | City: | State: | Zip: | County: | ||||||||||||||
| Standard's Address: | Agency: | City: | State: | Zip: | County: | ||||||||||||||
| Total Inspection Time : | Date: | Location of Standardization: | |||||||||||||||||
ESTABLISHMENTS |
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| Performance Area | 1 | 2 | 3 |
4 |
5 |
6 |
7 |
8 |
TOTAL (1-8) or |
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| Risk-Based Inspection | |||||||||||||||||||
| Good Retail Practices | |||||||||||||||||||
RISK-BASED INSPECTION:
To pass this section, the Candidate must achieve an average score of 90 percent (no more than 44 disagreements for all 8 establishments) with no more than 11 disagreements per establishment.
Step 1. Determine the number of disagreements per establishment and record it in the chart (Performance Criteria Tally of Disagreements).
If the disagreements/establishment is
12, proceed to step 2.
If the disagreements/establishment is
12, stop inspections. Candidate fails.
SCORING FORM AND INSTRUCTIONS FOR SCORING AND DETERMINING PERFORMANCE
Step 2. Total the number of disagreements on Interventions/Risk Factors for all the establishments.
If the disagreements are
44 for 8 establishments, the Candidate passes.
If the disagreements are
44 for 8 establishments, the Candidate fails.
If the disagreements are
33 for 6 establishments, the Candidate passes.
If the disagreements are
33 for 6 establishments, the Candidate fails.
Good Retail Practices:
To pass this section, the Candidate must achieve an average score of 85 percent (no more than 32 disagreements for all 8 establishments) and have no more than 5 disagreements on GRPs per establishment.
Step 1. Determine the number of disagreements per establishment.
If the disagreements/establishment are
6, proceed to step 2.
If the disagreements/establishment are
6, stop inspections. Candidate fails.
Step 2. Total the number of disagreements on GRPs for all establishments.
If the disagreements are
32 for 8 establishments, the Candidate passes.
If the disagreements are
32 for 8 establishments, the Candidate fails.
If the disagreements are
24 for 6 establishments, the Candidate passes.
If the disagreements are
24 for 6 establishments, the Candidate fails.
Application of HACCP Principles: A "satisfactory" score is
required to pass.
Refer to Chapter 3, Table 2
SCORING FORM (EXAMPLE #1)
Chart 3a: Sample Performance Criteria Tally of Disagreements in Each Establishment | ||||||||||||||
PERFORMANCE CRITERIA
TALLY OF DISAGREEMENTS IN EACH ESTABLISHMENT | ||||||||||||||
| Candidate's Name: Jane Smith | Standard's Name: George Harris | |||||||||||||
| Candidate's Address:1234 Anywhere Street | Agency: State | City: Nice | State: HI | Zip: 12345 | County: Franklin | |||||||||
| Standard's Address: 4321 Somewhere Street | Agency: FDA | City: Washington DC | State: | Zip: 20204 | County: | |||||||||
| Total Inspection Time: 72 hrs | Date: 7/25/02 | Location of Standardization: Washington D.C. | ||||||||||||
ESTABLISHMENTS |
||||||||||||||
| Performance Area | 1 | 2 | 3 |
4 |
5 |
6 |
7 |
8 |
TOTAL (1-8) |
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| Risk-Based Inspection | 9 |
11 |
11 |
5 |
2 |
2 |
3 |
1 |
44 |
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| Good Retail Practices | 3 |
2 |
2 |
5 |
3 |
3 |
2 |
2 |
22 |
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In this example, the Candidate passes both the Risk-Based Inspection and the Good Retail Practices portions. The number of disagreements for any one establishment did not exceed the maximum and the total number of disagreements for all the establishments also did not exceed the maximum number.
SCORING FORM (EXAMPLE #2)
Chart 3b: Sample Performance Criteria Tally of Disagreements in Each Establishment | ||||||||||||||
PERFORMANCE CRITERIA
TALLY OF DISAGREEMENTS IN EACH ESTABLISHMENT | ||||||||||||||
| Candidate's Name: Jane Smith | Standard's Name: George Harris | |||||||||||||
| Candidate's Address: 1234 Anywhere Street | Agency: State | City: Nice | State: HI | Zip: 12345 | County: Franklin | |||||||||
| Standard's Address: 4321 Somewhere Street | Agency: FDA | City: Washington D.C. | State: | Zip: 20204 | County: | |||||||||
| Total Inspection Time : 72 hrs | Date: 7/25/02 | Location of Standardization: Washington D.C. | ||||||||||||
ESTABLISHMENTS |
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| Performance Area | 1 | 2 | 3 |
4 |
5 |
6 |
7 |
8 |
TOTAL (1-8) Total (1-6) |
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| Risk-Based Inspection | 11 |
11 |
12 |
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| Good Retail Practices | 6 |
5 |
4 |
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Here the Candidate fails the Risk Based Inspection portion of this exercise. The Candidate was close to the maximum number of disagreements for any one establishment in the first two facilities and exceeded this maximum number of disagreements in the third establishment
FINAL SCORING REPORT
Chart #4: Candidate's Composite Performance Score |
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CANDIDATE'S FINAL PERFORMANCE SCORE |
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| Candidate's Name: | Title: | |||||
| Agency: | Office Telephone Number: | |||||
| Office Address: | City: | State: | Zip: | |||
| Standard's Name: | Standard's Title: | |||||
| Agency: | Office Telephone Number: | Location of Standardization: | ||||
| Office Address: | City: | State: | Zip: | |||
| Instructions: For the following Performance Areas circle the Level of Agreement. | ||||||
PERFORMANCE AREA |
LEVEL OF AGREEMENT |
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| 1. RISK-BASED INSPECTION | PASSES |
FAILS |
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| 2. GOOD RETAIL PRACTICES | PASSES |
FAILS |
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| 3. APPLICATION OF HACCP PRINCIPLES | SATISFACTORY |
UNSATISFACTORY | ||||
a. Process flow Charts |
Satisfactory | Unsatisfactory | ||||
b. Risk Control Plan |
Satisfactory | Unsatisfactory | ||||
c. Verification of HACCP Plans |
Satisfactory | Unsatisfactory | ||||
(Initial Certification only) |
Satisfactory | Unsatisfactory | ||||
| 4. INSPECTION EQUIPMENT | SATISFACTORY |
NEEDS IMPROVEMENT |
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| 5. COMMUNICATION | SATISFACTORY |
NEEDS IMPROVEMENT |
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Comments:
STANDARD'S SIGNATURE:
NAME (Print):_________________________________
NAME (Signature):______________________________ Date:_____________
Retail Food Inspections Table of Contents
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