S1D3a-Los 10 Mayores Problemas de La Industria de Los Alimentos

7/30/2019 S1D3a-Los 10 Mayores Problemas de La Industria de Los Alimentos

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TOP TEN FOOD SAFETY PROBLEMSIN THE US FOOD PROCESSINGINDUSTRY

ByAylin Sertkaya, Eastern Research Group, Inc.*Ayesha Berlind, Eastern Research Group, Inc.

Rachel Lange, FDA Center for Food Safety and Applied NutritionDon L. Zink, FDA Center for Food Safety and Applied Nutrition

*Eastern Research Group, Inc. (ERG) 110 Hartwell Ave., Lexington, MA [email protected]


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ABSTRACTThe preventive controls at some food processing facilities are less rigorousthan those of others, potentially increasing the risk of microbiological,

chemical, as well as physical food safety hazards. We used a four-roundDelphi technique to interview nationally recognized food industry expertsas a way to identify the ten food safety hazards that are of utmost concernfor the food processing industry today, and the preventive controls thatshould address them. The expert panel members evaluated the frequencyand severity of the food safety risk posed for five food processing industrysectors (baked, dairy, frozen, refrigerated, and shelf-stable goods,excluding meat and poultry products) and three plant sizes for each of theten most important hazards identified. The experts collectively ranked

deficient employee training as the top hazard facing food processors todayfollowed by poor plant and equipment sanitation and contamination of raw materials. Other hazards included poor plant design and construction,

post-process contamination, difficult-to-clean equipment, and incorrect

labeling and packaging. The expert panels recommended controls can beused to determine the means to make our food supply safer.


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STUDY OBJECTIVESThe study had TWO primary objectives:

1. To identify the main problems that pose microbiological (i.e., pathogenic bacteria, viruses, and parasites), chemical (i.e., allergens,cleaners and solvents, and mycotoxins), and/or physical (i.e., foreignobjects such as glass and metal) safety hazards to food at the processor level, and

2. To determine the preventive controls that food manufacturers should

implement to address each of the problems identified.

by facility size (small, medium, and large) and type of food product (baked,dairy, frozen, refrigerated, and shelf-stable)


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METHODOLOGY The study objectives required gathering current data not accurately

known or available. Moreover, they did not easily lend themselves to

more precise analytical techniques, such as an industry survey designedto yield statistically valid estimates of population parameters.

The necessary information, however, can be gathered using thesubjective judgments of experts on a collective basis, the Delphimethod .

We used a four-round modified Delphi technique widely applied in theforecasting and policy arenas.


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The Delphi study included a 15-member expert panel comprising

nationally recognized experts in food safety, HACCP, food plantsanitation, quality systems, process optimization, GMP compliance,and food microbiology.

On average, each panel member possessed over 30 years of foodindustry experience in sectors, such as canned foods, fresh produce,meat and poultry products, and seafood.

Majority of panel members has served and/or are currently serving onnumerous national committees related to food safety, HACCP, andGMPs.

In identifying the experts, we used recommendations from FDA andvarious food industry personnel.


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Findings:

1. Refrigerated products is the one sector to which the majority of the foodsafety problems are applicable.

2. While some problems, such as deficient employee training, poor plant and equipment sanitation, contamination of raw materials, andpoor plant design and construction, are applicable to all food sectors,other problems, such as biofilms, and condensate on pipes and other

equipment, are more sector-specific.

3. The relative importance of a given food safety problem (measured bythe number of votes received) varies by sector.

4. Those problems with broad applicability (i.e., deficient employeetraining, contamination of raw materials, poor plant and equipmentsanitation, and poor plant design and construction) also rank highest

in the top ten food safety problems list.


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FIGURE 1: TOP TEN FOOD SAFETY PROBLEMS

7

9

9

10

10

11

12

12

12

15

Number of Votes

Deficient Employee Training

Contamination of Raw Materials

Poor Plant and Equipment Sanitation

Poor Plant Design and Construction

No Preventive Maintenance

Difficult-to-clean Equipment

Post-process Contamination at Manufacturing Plant

Contamination During Processing

Poor Employee Hygiene

Incorrect Labeling or Packaging


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RESULTS: Round 2Our goal was to determine whether each of the top ten problems identifiedin the previous round posed a sufficiently different food safety risk for a

particular food item (e.g., pies) within a major food category (e.g., bakedgoods) than the risk for the major food category as a whole.

Question:

Indicate whether a separate risk score is more appropriate for a listed fooditem within a major food category for each of the ten food safety

problems.

[To ensure consistency of responses, for each food sector, a list of product categories (obtained from IRI data) was included. ]


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Findings:

1. Overall, the number of food subsectors selected across the foodsectors was lowest for shelf-stable foods.

2. The refrigerated, frozen, and dairy sectors had the highest number of subsectors selected for scoring in the next round.

3. Total number of categories to score for general as well asallergen risks by facility size ranged from 70 to over 100 across theten food safety problems, substantially increasing the respondent

burden in the subsequent round.


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RESULTS: Round 3Our objectives with this round were (1) to assess the risk posed by each of the top ten food safety problems by food sector and facility size and (2) to

determine the types of preventive controls necessary to address each of these problems.

Questions:

1. Assign a general as well as an allergen risk score from 1 to 4 based on the problems frequency and severity by food sector andfacility size (small, medium, large), where

- General risk score reflects the risk of the food safety problemwith respect to all hazards (i.e., microbiological, physical, andchemical) except for allergens, and

- Allergen score should reflect the risk of the food safety problemwith respect to allergens only


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and where the assignment of risk scores followed:

2. To indicate the types of preventive controls that food processors needto address each of the ten food safety problems by facility size (small,medium, large) and major food sector (baked, dairy, refrigerated,

frozen, and shelf-stable) taking account of cost-effectiveness.

TABLE 1: RISK SCORING GRID

LowHigh

13Low

24High

Severity

Frequency


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Findings:

1. Overall, the general and allergen risk scores for small and medium-sized facilities were higher than those of large ones across all

problems and food sectors.

2. Problems that have received the highest general risk scores (2.75 or higher) included:

- deficient employee training,- poor plant and equipment sanitation,- difficult-to-clean equipment,

- poor employee hygiene, and- contamination of raw materials.


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3. The problems that have received the highest allergen scores were

incorrect labeling or packaging, followed by deficient employeetraining, and difficult-to-clean equipment.

4. The general risk scores assigned to the refrigerated food categoriestended to be higher than those of other food categories across all

problems. The next highest general risk scores were assigned tofrozen and dairy food categories.

Note: There is a certain degree of overlap among various food safety problems where some underlying factors (i.e., root causes), which aresmaller than the number of variables (i.e., number of food safety

problems), are expected to be mainly responsible for the covarianceamong our variables. Therefore, an exploratory factor analysis todetermine how many underlying dimensions there are for the risk scoredata collected is desirable.


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Risk Score Factor Analysis Results Factor analysis is a data reduction technique that reduces the number of variables used in an analysis by creating new variables (called factors) that

combine redundancy in the data.

With factor analysis, we generated two summaries of risk

An overall risk score by sector (see Figures 2 and 3)

Four factor risk scores by sector (see Figures 4 and 5)

for general and allergen risk categories separately.


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-0.058

0.837

0.232

1.098

-0.513-0.6

-0.4

-0.2

0

0.2

0.4

0.6

0.8

1

1.2

S t a n

d a r d

i z e

d A v e r a g e

S c o r e

Baked Goods Dairy Frozen Refrigerated Shelf-Stable

FIGURE 2: OVERALL GENERAL RISK SCORES(One-Factor Analysis)


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0.707

0.107

0.453

0.975

-0.527-0.6

-0.4

-0.2

0

0.2

0.4

0.6

0.8

1

S t a n

d a r d

i z e

d A v e r a g e

S c o r e


FIGURE 3: OVERALL ALLERGEN RISK SCORES(One-Factor Analysis)


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Both general and allergen risks are better described by a four-factor

model. The four factors, however, differ slightly between the generaland allergen categories.

The four factors in the GENERAL category are (see Table 2 and

Figure 4):

- Process-related contamination risk - loads highly on contaminationduring processing, contamination of raw materials, and poor employee hygiene

- Equipment risk - loads highly on poor plant design and construction,difficult-to-clean equipment, and poor plant and equipmentsanitation

- Quality control risk - loads highly on post-process contamination at plant, no preventative maintenance, and deficient employeetraining

- Input-related risk - loads highly on poor employee hygiene,difficult-to-clean equipment, and contamination of raw materials


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-0.3330.6680.2060.0780.542Input-relatedcontamination

-0.1020.182-0.0870.67-0.037Quality control

-0.3750.8480.2590.254-0.084Equipment

-0.2490.5180.1280.665-0.376Process-relatedcontamination

Shelf-stable

RefrigeratedFrozenDairyBakedGoodsRisk Factor

Food Sector

TABLE 2: FACTOR RISK SCORES, GENERAL RISK CATEGORY


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FIGURE 4: AVERAGE GENERAL RISK SCORES (Four-Factor Analysis)

-0.376

0.665

0.128

0.518

-0.249

-0.4

-0.2

0

0.2

0.4

0.6

0.8

S t a n

d a r d

i z e

d A v e r a g e

S c o r e


Process-related Contamination Risk

-0.084

0.254 0.259

0.848

-0.375-0.4

-0.2

0

0.2

0.4

0.6

0.8

1

S t a n

d a r d

i z e

d A v e r a g e

S c o r e


Equipment Risk

-0.037

0.67

-0.087

0.182

-0.102

-0.2

-0.1

0

0.1

0.20.3

0.4

0.5

0.6

0.7

S t a n

d a r d

i z e

d A v e r a g e

S c o r e


Quality Control Risk

0.542

0.078

0.206

0.668

-0.333-0.4

-0.2

0

0.2

0.4

0.6

0.8

S t a n

d a r d

i z e

d A v e r a g e

S c o r e


Input-related Contamination Risk


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The four factors in the ALLERGEN category are (see Table 3 and

Figure 5):

- In-process contamination risk - loads very highly on contaminationduring processing, and moderately high on incorrect labeling or

packaging- Quality control risk - loads highly on no preventative maintenance,

deficient employee training, and post-process contamination at plant

- Other contamination risk - loads highly on contamination or rawmaterials and poor employee hygiene.

- Equipment risk - loads highly on poor plant design and construction,poor plant and equipment sanitation, and difficult-to-cleanequipment.

Note: The fact that 10 variables can be described four underlying factorsdoes not imply that each variable is assigned to a specific factor. Variablescan and will be related to more than one factor. Further, the name of a

factor is subjective.


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-0.3510.7560.222-0.0050.47Equipment

-0.1840.2720.3010.017-0.007Other contamination

-0.2690.3640.2280.3910.434Quality control

-0.2610.5510.25-0.1020.197In-processcontamination

Shelf-stable

RefrigeratedFrozenDairyBakedGoodsRisk Factor

Food Sector

TABLE 3: FACTOR RISK SCORES, ALLERGEN RISK CATEGORY


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FIGURE 5: AVERAGE ALLERGEN RISK SCORES (Four-Factor Analysis)

0.197

-0.102

0.25

0.551

-0.261-0.3

-0.2

-0.1

0

0.1

0.2

0.3

0.4

0.5

0.6

S t a n

d a r d

i z e

d A v e r a g e

S c o r e


In-process Contamination Risk

0.4340.391

0.228

0.364

-0.269-0.3

-0.2

-0.1

0

0.1

0.2

0.3

0.4

0.5

S t a n

d a r d

i z e

d A v e r a g e

S c o r e


Quality Control Risk

-0.007

0.017

0.3010.272

-0.184-0.2

-0.15

-0.1

-0.05

0

0.050.1

0.15

0.2

0.25

0.3

0.35

S t a n

d a r d

i z e

d A v e r a g e

S c o r e


Other Contamination Risk

0.47

-0.005

0.222

0.756

-0.351-0.4

-0.2

0

0.2

0.4

0.6

0.8

S t a n

d a r d

i z e

d A v e r a g e

S c o r e


Equipment Risk


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Preventive Control Recommendations

The main recurring themes across all preventive controls and foodsafety problems include:

- Training - Ongoing and targeted training on issues ranging fromallergen control, cleaning and sanitation procedures, incomingingredient receipt protocol, and monitoring,; training of employees, management, as well as suppliers,

- Audits - Periodic audits and inspections of facility and rawmaterial suppliers either in-house or by third-party firms

- Documentation - Documentation of training activities, rawmaterial handling policies and activities, cleaning and sanitation,

receiving records, and use of sign-off logs- Validation/evaluation - Evaluation of training effectiveness and

establishment of accountability; validation of cleaning through testing(i.e., swabs, organoleptic evaluations, and bioluminescence tests)


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Other commonly noted food safety problem specific preventive

controls include:- Supplier audits and supplier certification programs for raw

material contamination problems- Plant design reconfiguration and use of outside consultants for

plant design, better sanitation, and improved flow and access toequipment for poor plant design and construction problems

- SSOPs and environmental sampling and other monitoring for

difficult-to-clean equipment problems- Use of preventive maintenance programs and documentation for deficiencies in preventive maintenance and assignment of accountability for contamination during processing problems

- Label review and verification for incorrect labeling or packagingproblems


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13%2Warehousing/inventory/storage records

67%10Supplier audits

20%3Receipts of incoming ingredients and raw materials60%9Personnel records

33%5Labeling and packaging

73%11Equipment maintenance records7%1Corrective action documentation

87%13Cleaning and sanitation

PercentCountRecord Type

FIGURE 7: Types of Records Recommended as Preventive Controls


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RESULTS: Round 4

Round 4 consisted of post-study discussions with select number of experts(4 total). The main topics investigated included:

Improved, documented training with a minimum set of universalrequirements

Role of recordkeeping in a few important areas, especially processcontrol

Allergen control, with documented allergen control programs,including training and label review

Importance of HACCP

Positive incentive programs for food processors, such as- OSHAs Voluntary Protection Program- Department of Commerce, National Marine Fisheries Services seafood

inspector certification program


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SUMMARY

The modified Delphi study identified the most significant food safety problems, foods with highest risks of food safety problems, and other

major areas of concern.

Based on the number of votes, deficient employee training ,contamination of raw materials , poor plant and equipment

sanitation , and poor plant design and construction were ranked asthe top four food safety problems faced by food manufacturers today.

Results from the study also indicated that refrigerated and dairy

foods have the highest general risk of food safety problems comparedto other food categories.

Baked and refrigerated foods pose the highest risk in terms of

allergen hazards.


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S1D3a-Los 10 Mayores Problemas de La Industria de Los Alimentos

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