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food safety plan — Blog — FDA Reader
Posts tagged food safety plan
A correction means taking action in a timely manner to identify and correct a minor and isolated problem that does not directly impact product safety.
Examples of corrections include:
Re-cleaning the production line if it appears dirty after the first clean.
An employee is asked to leave the production area and put on the proper attire before re-entering the production area.
The temperature of a walk-in refrigerator is adjusted because it is a time of high traffic and the temperature is approaching the critical limit.
Corrections occur in the moment and don't require any documentation
A corrective action is a procedure that must be taken if a corrective action is not properly implemented. This must be documented and the record should describe:
How the problem was corrected
How it will be avoided in the future
What was done with the product in question
Examples where corrective action is required include:
A sample of canned salsa is tested and the pH exceeds the requirement of <4.3.
A refrigerator is found to have exceeded the temperature requirement of ≤41ºF for several hours.
The producer of bottled juice realizes that during the last production run, numerous bottles were not properly sealed by the capping machine, possibly due to defective packaging.
For more about corrective actions, see our full guide
Correction or Corrective Action?
The following examples illustrate how an operator may choose between a correction and a corrective action
Cookies on a conveyer oven are finished in 8 minutes instead of the required 10 minute cook time Corrective Action The cook step is (presumably) a preventive control used to kill bacteria present in raw cookie dough. Because the product failed to achieve the 10 minute cook time, then the preventive control has failed and a corrective action is required. 1. Adjust the belt temperature to reseet to 10 minute cook time.
2. Test to confirm the belt speed has increased the cook time to 10 minutes.
3. Re-cook the cookies for an additional 2 minutes (or discard)
4. Record this on a corrective action form.
Cookies on a conveyer oven are completed in 12 minutes instead of the required 10 minute cook time Correction Since the product was overcooked, it still achieved the preventive control that requires a >10 minute cook time. Adjust the belt speed to reduce the cook time to 10 minutes. Consider testing the overcooked product for quality
Sheet pans are observed to be unclean immediately after being run through the dishwasher Correction This is a minor problem that poses no risk to the safety of the food if it is corrected. Re-run the dishes through the dishwasher and confirm they are clean.
The dispenser for dishwasher sanitizer chemical is discovered to be empty after a day of production Corrective Action It is possible that many utensils and dishes were used in production without having been sanitized. This directly impacts food safety of product that was produced and so corrective action should be taken. 1. Refill the sanitizer chemical in the dish machine and confirm it is being applied during the cycle.
2. Assess why the sanitizer ran out and whether chemical levels should be checked more frequently to avoid this problem recurring.
3. Evaluate the food that contacted the un-sanitized utensils/dishes and determine whether it should be discarded, re-worked or served. If the food cannot be proven to be safe then it should be discarded.
Article, ClarificationNed Klein February 11, 2019 Food safety, pathogenic bacteria, preventive controls, food safety plan, title corrections vs. corrective actions in food processing
Validation answers the question “How do you know it works?”
You must validate that the preventive controls that you implement actually work.
Validation activities includes using scientific and technical evidence (or conducting your own studies)
Example of Validation: Collecting scientific research, and conducting tests to prove that the cooking temperature in your recipe is effective in killing the harmful bacteria in the product.
Hint: you can find information to validate many food processing practices on the FDA website.
When is Validation Required?
You are required to validate every preventive control you are implementing. This means that if you use cooking as a means to kill bacteria, then you need to show that the time and temperature are a valid method for killing that bacteria type. This can often be achieved by referencing FDA guidance materials.
You are not required to validate the following types of preventive controls:
Who Conducts Validation?
All validation activities must be performed by a preventive controls qualified individual.
When do I need to validate my preventive controls?
You must validate your preventive controls:
Within 90 days of beginning production or there must be written justification for why if >90 days after production begins.
Whenever a change is made that could impact how a hazard is controlled.
Whenever the food safety plan is reanalyzed.
What Part of My Food Safety Plan Require Validation?
Some parts of your food safety plan do not need to be validated. Sanitation activities, for example, do not need to be validated because most people use a small set of scientifically proven processes (i.e. soap and water, common chemical sanitizers). As a result, there is no need to require each business to prove their sanitation practices actually work.
The following activities do not require validation
Other preventive controls if the PCQI prepares the written justification that a validation is not applicable based the nature of the hazard and the preventive control.
FDA Regulation on Validation
Guidance Document, ClarificationNed Klein February 10, 2019 food processing facilities, Food Safety Plan, Food safety validation, validation, record keeping, fda regulation, preventive controls, haccp, food producer requirements, title validation, food safety plan, food regulation
There is a clear path to bringing a new ingredient to market and getting FDA approval. First, the ingredient must be “generally recognized as safe”.
What are the requirements for FDA facility registration in a shared kitchen? We explore requirements for the operator and users in an incubator kitchen
What is the difference between an incubator kitchen and a ghost kitchen? Or a commissary kitchen and a cloud kitchen?
A preventive control is a strategy implemented to eliminate a hazard in a food manufacturing environment
You must identify and implement preventive controls when you identify a hazard that is reasonably likely to cause injury to a customer if left unaddressed.
Preventive controls include Critical Control Points and other types of controls.
Preventive controls must be written
Types of Preventive Controls
These are procedures and processes that are used to control parameters of processing (i.e. acidifying, refrigerating, cooking.) They must be written in a way that is specific to your process and they must include:
parameters associated with controlling the hazard (i.e. if you are using cooking as a process control, then you must include the required cook temperature and cook time)
The maximum or minimum values required to control the hazard.
These include processes to control food allergens. These are implemented to:
Protect food from allergen cross contact
Label food properly with allergens to ensure it isn't misbranded
Sanitation Controls:
These are practices to ensure the facility is kept clean and to minimize biological hazards. They relate to:
Cleanliness of food-contact surfaces (equipment, utensils, tables)
Prevention of contamination of food from dirty sources (i.e. dirty people, dirty food, dirty packaging, dirty raw ingredients)
Supply Chain Controls:
Supply Chain Controls are described fully in Part G
You may have other types of controls (i.e. hygiene training and current good manufacturing practices)
What To Do If You Implement a Preventive Control
If you implement one or more preventive controls then you must conduct the following activities for each one:
Circumstances Where Preventive Controls Are Not Required
You aren't required to implement preventive controls if any of the following apply:
The food cannot be consumed without application of an appropriate control (i.e. coffee beans cannot be consumed without pouring boiling water on them, which would kill any bacteria on the bean. By preparing coffee the consumer is inherently applying the necessary control)
You rely on your customer, who is subject to this subpart, to ensure that the hazard is mitigated. You must:
i. Disclose in writing that the food is "not processed to control [identify hazard]" and
ii. Annually obtain written assurance that the customer is following the procedures you have provided, which will eliminate the hazard.
3. You rely on the customer who is not subject to this subpart to eliminate the hazard. You must:
4. You rely on the customer to provide assurance that the food will be processed to control the hazard by a subsequent entity in the supply chain
ii. Annually obtain written assurance that your customer will:
A. Disclose in documents accompanying the food that it is "not processed to control [identify hazard]"
B. Will only sell to another entity that agrees in writing that it will mitigate the hazard and obtain similar written assurance from subsequent customers.
5. You have established and implemented a system that ensures control of the hazards in your product, at the distribution step.
Note: You must document any circumstance (related to the section above) that applies to you, including written assurances from customers.
∆ You manage a facility that makes, holds, or packs food.
∆ You have identified a hazard in your hazard analysis
∆ You are subject to Part 117 Subpart C (very small businesses are exempt from this requirement)
Introduction to Record Keeping
This is a regulation summary For a more general guide to Food Safety Plans, start here
This section outlines the pre-requisite for a food safety plan and associated operational and documentation requirements.
Summary of Subpart C: Hazard Analysis and Risk-Based Preventive Controls
Below is a summary of Subpart C so that you can get a quick sense of the requirements. If you want to read the original text, check out the source texts, linked below.
This text is aligned with the coding used in the FDA Regulations so that you can hunt down the corresponding section with ease. For example, you have a question about my wording in §117.126 (a) (2) then just look up this same code in the CFR.
§117.126 Food Safety Plan
a. Requirement for a food safety plan:
You must have a written and implemented food safety plan
It must be prepared or overseen by a Preventive Controls Qualified Individual
b. Contents of a food safety plan
It must include the following, in writing:
Preventive controls (if you identified a hazard in your hazard analysis that you deem requires a preventive control)
Procedures for monitoring your preventive controls
c. Records: The records generated are subject to regulations under Subpart F. (i.e. you must store them either in print or electronically)
§117.130 Hazard Analysis
a. Requirement for a hazard analysis:
1. You must conduct a hazard analysis for each type of food manufactured, processed, packed, or held at your facility.
2. The hazard analysis must be written.
b. Hazard Identification: This must consider
1. known or reasonable hazards, including:
i. Biological Hazards (bacteria, parasites, etc.)
ii. Chemical hazards (i.e. toxins, pesticides, food allergens)
iii. Physical hazards (i.e. stone, glass, metal fragments)
2. Hazards that could be present in the food because:
i. the hazard occurs naturally (i.e. toxins in fish)
ii. The hazard may be accidentally introduced (jewelry from employee falls into food)
iii. The hazard may be introduced intentionally for economic gain (i.e. sabotage by a competitor)
c. Hazard Evaluation:
i. the hazard analysis must evaluate the hazards identified to assess the severity of illness or injury that would occur and the probability that it would occur if left unaddressed.
ii. The hazard evaluation must consider environmental pathogens whenever a ready-to-eat (RTE) food is exposed to the environment before packaging.
2. The hazard analysis must consider these effects on the food:
i. formulation of the food
ii. condition and design of the facility
iii. Raw materials and other ingredients
iv. Transportation practices
v. Processing procedures
vi. Packaging and labeling activities
vii. Storage and distribution
viii. intended use of the product
ix. Sanitation, including employee hygiene
x. any other relevant factors (i.e. weather, natural toxins)
§117.135 Preventive Controls
You must identify and implement preventive controls when required by your hazard analysis.
Preventive controls include: Critical Control Points and other controls.
b. Preventive controls must be written
c. Preventive controls include:
Process Controls: These are procedures and processes that are used to control parameters of processing (i.e. acidifying, refrigerating, cooking.) They must be written in a way that is specific to your process and they must include:
i. parameters associated with controlling the hazard (i.e. if you are using cooking as a process control, then you must include the required cook temperature and cook time)
ii. The maximum or minimum values required to control the hazard.
2. Food Allergen Controls include processes to control food allergens. These are implemented to:
i. Protect food from allergen cross contact
ii. Label food properly with allergens to ensure it isn't misbranded
3. Sanitation Controls: Practices to ensure the facility is kept clean and to minimize biological hazards. These relate to:
i. Cleanliness of food-contact surfaces (equipment, utensils, tables)
ii. Prevention of contamination of food from dirty sources (i.e. dirty people, dirty food, dirty packaging, dirty raw ingredients)
4. Supply Chain Controls: This is described fully in Part G
5. Recall Plan: You are required to have a recall plan (see below)
6. Other Controls: You may have other types of controls (i.e. hygiene training and current good manufacturing practices)
§117.136 Circumstances in which preventive controls are not required
a. Circumstances You aren't required to implement preventive controls if any of the following apply:
The food cannot be consumed without application of an appropriate control (i.e. coffee beans cannot be consumed without pouring boiling water on them, which would kill any bacteria on the bean)
b. Records: You must document any circumstance (related to a., above) that applies to you, including written assurances from customers.
§117.139 Recall Plan
If your food has a hazard that requires a preventive control,
a. You must establish a written recall plan.
b. The recall plan must include a procedure for a recall scenario and assign responsibility for taking those steps. It must address how to:
Directly notify recipients of the product being recalled and how to dispose of/return the food.
Notify the public about any hazard in the food, when this is required to protect public health.
Conduct effectiveness checks to verify the recall is carried out.
Dispose of recalled food.
§117.140 Preventive Control Management Components
a. You must conduct the following activities for each of your preventive controls:
b. You must conduct the following activities for your supply-chain program:
corrective actions, especially related to supplier non-conformance.
Re-analysis of your supply chain program over time and as it changes.
c. You do not need to conduct the following activities for your recall plan: monitoring, corrective actions, verification activities.
§117.145 Monitoring
as appropriate to the nature of the preventive control, you must implement
a. Written Procedures: You must have written procedures for how and how often you will monitor preventive controls.
b. Monitoring: You must monitor preventive controls enough to ensure they are being peformed.
You must document your monitoring actions and verify this (see §117.165)
Exception Records: You can use exception records (i.e. the record only shows when a deviation occured.) For example, a log monitoring refrigeration may only show records when the temperature is unacceptable
§117.159 Corrective Actions and Corrections
a. Corrective Action Procedures:
You must establish and implement written corrective action procedures. They must address:
i. the presence of a pathogen in a ready-to-eat product
ii. the presence of an environmental pathogen detected.
2. Corrective Action Procedures must describe the steps to be taken to ensure that:
i. appropriate action is taken to correct a problem associated with a preventive control.
ii. Appropriate action is taken to reduce the likelihood that the problem will recur.
iii. All affected food is evaluated for safety
iv. All affected food is prevented from entering commerce.
b. Corrective Action in the Event of an unanticipated food safety problem:
You must follow the procedure in (b)(2) if
i. a preventive control fails and a corrective action hasn't been established.
ii. a preventive control is found to be ineffective
iii. Verification records are found to be incomplete or improper decisions were made about corrective action
2. If any of the circumstances above in (b) (1) apply, you must:
i. Take corrective action, Ensure it doesn't happen again, re-evaluate all food for safety.
ii. reanalyze your food safety plan to see if changes are required.
c. Corrections: You don't need to follow sections (a) and (b) above if
You take action to correct a minor and isolated problem, insofar as these are not related to allergen controls or sanitation controls.
You take action in a timely manner to correct a minor and isolated problem insofar as it doesn't directly impact product safety
d. Records: All corrective actions taken in this section must be documented. Corrective actions must also be verified according to §117.155
§117.155 Verification
Note: The Verification process is one that verifies various other parts of the plans have been undertaken as specified. This can take the form of a supervisor regularly reviewing records and verifying them with a signature.
a. Verification Activities: As it relates to a preventive control, you must verify
That the preventive control is valid
that monitoring is being conducted as required.
that appropriate decisions are being made in relation to corrective action.
that the preventive control is implemented and effective.
the reanalysis of your preventive controls (as your process changes or at minimum every 3 years)
b. Documentation: All verification activities must be documented in records.
§117.160 Validation
a. You must validate that the preventive controls implemented actually work.
b. Your validation must:
1. Be performed by a Preventive Controls Qualified Individual (PCQI)
i. Within 90 days of beginning production or there must be written justification for why if >90 days after production begins.
ii. Whenever a change is made that could impact how a hazard is controlled.
iii. Whenever the food safety plan is reanalyzed.
2. Must include scientific and technical evidence (or conducting your own studies) to determine whether preventive controls will control the hazards.
c. You do not need to validate:
§117.165 Verification of Implementation and Effectiveness
a. Verification Activities: You must verify that preventive controls are consistently implemented and effective. This includes doing the following:
Calibrating instruments for accuracy
Review of records to ensure they are complete and activities were performed according to the plan
i. Records of monitoring and corrective action must occur within 7 days (or provide a written justification for why not)
ii. Other records (calibration, supplier, product testing) must occur in a reasonable amount of time.
b. Written Procedures: The following activities must be written:
The method and frequency of calibrating tools
Product testing. These procedures must be scientifically valid, they must identify the tests conducted, the methods used, the pathogens, the laboratory conducting the testing, and the corrective action procedures.
Environmental monitoring must be: scientifically valid, identify the locations and sites to be tested, the timing and frequency of these samplings, the tests conducted and methods used, the laboratory, and the corrective action procedures.
§117.170 Reanalysis
a. You must reanalyze your food safety plan every 3 years.
b. You must reanalyze your plan whenever:
A change creates a new hazard or increases an existing hazard
Whenever you become aware of a new hazard
Whenever appropriate after an unanticipated food safety problem.
When you find a part of your plan or a preventive control is ineffective
c. You must complete the reanalysis
before any changes in activities OR
Within 90 days of the beginning of production for a new product (or >90 days if written justification is provided)
d. You must also document the basis for the conclusion that no revisions are required.
e. A preventive controls qualified individual must oversee this reanalysis.
f. You must conduct a reanalysis when the FDA determines necessary and when there are new developments in scientific understandings.
§117.180 Requirements Applicable to a Preventive Control Qualified Individual and a Qualified Auditor
a. One or more PQCI must do or oversee the following:
written justification for >90 day time frame for validation
Determination that validation is not necessary.
Written justification for exceeding 7 day time frame for reviewing records.
determination that reanalysis can be completed in a time frame that >90 days of the production of the new food being produced.
b. A qualified auditor must consult an onsite audit:
To be a PCQI, one must have completed training equivalent to that developed by the FDA or be qualified through job experience. This individual may or may not be an employee of the facility.
To be a qualified auditor requires technical expertise achieved through training, education, or experience.
d. All training in the development and applications of preventive controls must be documented in records.
§117.190 Implementation Records Required for this Subpart
a. You must establish records regarding the implementation of a food safety plan, including:
Documentation for not establishing a preventive control (you can do this in the hazard analysis using our template)
Records documenting the monitoring of preventive controls
Records documenting corrective actions
Records that document verification, as related to
ii. Verification of monitoring
iii. Verification of corrective actions
iv. Calibration of process monitoring and verification instruments
v. Product testing
vi. Environmental monitoring
vii. Records review
5. Records documenting the supply chain program
6. Records documenting training for the Preventive Conrols Qualified Individual and qualified auditor.
b. These records are subject to requirements in subpart F.
FDA Regulation Title 21 — Part 117 — Subpart C Hazard Analysis and Risk-Based Preventive Controls
Verification means conducting a review to confirm a process was performed correctly. Verification answers the question "How do you know it actually happened?"
Example: A manager in a cookie factory reviews production records to confirm that the cookies were baked to the temperature described in the recipe.
Validation refers to the requirement that a food processor use scientifically proven methods to control a hazard. Validation answers the question "How do you know it works?"
Example: A food safety manager collects scientific research to demonstrate that the cooking temperature used in the recipe is effective in eliminating harmful bacteria in the raw product.
Why Verification and Validation are Important:
Both verification and validation are required or else food-safe outcomes may not be achieved.
Validation Without Verification...
Hand washing with soap is a valid method for removing dirt/grime from hands. However, if verification does not occur and employees do not actually wash their hands, then it doesn't matter how scientifically-proven the strategy is.
Verification Without Validation...
Hand washing without soap is not a valid method for cleaning hands. Even if a manager verifies that hand washing is occurring as required, it doesn't matter because hand washing without soap is not a valid method for cleaning hands.
Calibrating thermometers - this verifies that they are reading properly
Environmental monitoring - testing your production space for pathogens living on surfaces, in drains, etc.
Supplier Verification - reviewing a supplier's records to confirm they are faithful to their food safety practices and claims.
Other verification records, such as instrument calibration, product testing, and environmental monitoring, must be verified "within a reasonable amount of time" as determined by the producer.
All verification activities must be performed by a preventive controls qualified individual.
Example of Preventive Control
Verification Required?
Cooking Chicken to a temp of 165ºF as a preventive control to reduce the hazard of Salmonella Bacteria Yes The cook step is a preventive control. Therefore, the production record containing the cook temp/time must be verified A manager reads the cook log and confirms that all chicken cooked that day was cooked to 165º
Fermentation and low pH are used as a method to prevent bacterial growth in pickled cucumbers stored at room temperature Yes Low pH is a preventive control applied to stop bacteria growth. Therefore, the pH records must be verified. A manager reviews the daily production records to confirm the pH was below the required threshold in all batches. If there is a deviation, the manger verifies that the appropriate corrective action was taken.
Preservatives are used to kill harmful bacteria in chicken meat so that it can be consumed raw Yes This is a preventive control and must be verified A manager confirms that the appropriate level of preservative was used to render the product safe. Additionally, in such a high-risk scenario, it may be advisable to test the chicken for pathogens.
Chlorine sanitizer used to sanitize dishes Possibly Depending on the nature of the product, it may not be a requirement to verify that the appropriate concentration of sanitizer was used. Manager verifies a record showing that the sanitizer was tested and the chemical concentration fell into the designated range.
Items containing peanuts are stored in different-colored containers from non-peanut products No There is no requirement to verify the implementation of storage practices to mitigate an allergen concern, although it may be a good idea. A manager may inspect storage spaces occasionally to confirm that practices are being followed to avoid allergen contact.
∆ You are developing a food safety plan or a HACCP plan.
∆ You are an FDA regulated food facility.
Food Safety Plan Guide to Validation
Food Safety Plan Guide to Verification
ClarificationNed Klein August 15, 2018 verification, validation, food safety plan, fda regulation, title verification vs validation, supplier verification