iso 07 english

© 2009 Coca‐Cola Company and Michigan State University, original at http://www.fskntraining.org, CC‐BY‐SA

Corrective Actions

ISO 7


HACCP Principle 5

• Establish corrective actions to be taken when monitoring indicates that there is a deviation from an established critical limit.


Corrective Actions

• NACMCF Definition (USA)

– “Procedures followed when a deviation occurs.”– Deviation = “Failure to meet a critical limit.”

• Codex Definition

– “Any action to be taken when the results of monitoring at the CCP indicate a loss of control.”


ISO 22000:2005 Definitions

• Correction– “Action to eliminate a detected nonconformity.”

– A correction relates to the handling of potentially unsafe products, and can be made in conjunction with a corrective action.

– Examples:• Reprocessing • Further processing • Elimination of the adverse consequences of the nonconformity


ISO 22000:2005 Definitions

• Corrective Action

– “Action to eliminate the cause of a detected nonconformity or other undesirable situation.”

– Corrective action includes cause analysis and is taken to prevent recurrence.

– There can be more than one cause of a nonconformity that must be addressed in a corrective action.

• Corrective actions should be pre‐planned to the greatest extent possible.


Corrective Action Components

• To correct and eliminate the cause of the deviation and restore process control

• To identify the product that was produced during the process deviation and determine its disposition


ISO 22000:2005 – Section 7.6.5

• Planned corrections and corrective actions to be taken when non‐conformities occur shall be specified in the food safety program to the extent possible.

• The actions shall ensure that:

– the cause of the nonconformity is identified,

– the parameter(s) is (are) brought back under control, and

– Recurrence is prevented.


Corrections – Section 7.10.1

• Corrections and control of nonconforming product:

• Establish and maintain a procedure to document :

– The identification and assessment of affected end products to determine their proper handling

– A review of the corrections carried out


Corrections – Section 7.10.1• Products manufactured under conditions where critical limits have been exceeded at CCPs are potentially unsafe – Handle according to Section 7.10.3

• Products manufactured under conditions where oPRPs have not been conformed with shall be evaluated with respect to the cause(s) of the nonconformity and to the consequences thereof in terms of food safety.– Where necessary, handle according to 7.10.3

• The evaluation must be recorded.


Corrections – Section 7.10.1

• All corrections shall be:

– Approved by the responsible person(s)– Recorded together with information on:

• The nature of the nonconformity

• The cause(s) and consequence(s),

• Include information needed for traceability of the nonconforming lots.


Corrective Actions – Section 7.10.2

• Monitoring data (oPRPs and CCPs) must be evaluated by designated individuals with knowledge and authority to initiate corrective actions.

• Corrective actions must be initiated when critical limits are exceeded or when there is a lack of conformity with oPRPs.


Corrective Actions – Section 7.10.2

• The organization must establish and maintain documented procedures that:

– Specify appropriate actions to identify and eliminate the cause of detected nonconformities

– Prevent recurrence of nonconformities

– Bring the process back into control after nonconformity is encountered.


Corrective Actions – Section 7.10.2• (Continued) These actions include:– Reviewing nonconformities (including customer complaints)

– Reviewing trends in monitoring results that may indicate development towards loss of control

– Determining the cause(s) of nonconformities– Evaluating the need for action to ensure that nonconformities do not recur

– Determining and implementing the actions needed– Recording the results of corrective actions taken– Reviewing corrective actions taken to ensure that they are effective.


Handling of Potentially Unsafe Products – Section 7.10.3

• Actions will be taken to prevent the nonconforming product from entering the food chain unless it can be assured that:– The food safety hazard(s) of concern has(have) been reduced to the defined acceptable levels,

– The food safety hazard(s) of concern will be reduced to identified acceptable levels prior to entering the food chain, or

– The product still meets the defined acceptable level(s) of the food safety hazard(s) of concern despite the nonconformity.


Handling of Potentially Unsafe Products – Section 7.10.3

• All lots of product associated with a nonconformity must be held under control of the organization until they have been evaluated.

• If products that have left control of the organization are subsequently determined to be unsafe, the organization must initiate a withdrawal.

• Steps taken to deal with potentially unsafe products shall be documented.


Evaluation for Release – Section 7.10.3

• Each lot of nonconforming product can only be released as safe when any of the following apply:

– Other evidence demonstrates that the control measures have been effective.

– Evidence shows that the combined effect of the control measures for that particular product complies with the performance intended.

– Sampling, analysis and/or other verification activities demonstrate that the affected product complies with the identified acceptable levels for the food safety hazard(s) concerned.


Disposition of Nonconforming Products –Section 7.10.3

• Following evaluation, if the lot of product is not acceptable for release it shall be:

– Reprocessed or further processed to eliminate the food safety hazard or reduced the hazard to acceptable levels.

– Destroyed and/or disposed as waste.


Withdrawals – Section 7.10.3

• To facilitate the complete and timely withdrawal of products which have been determined to be unsafe:– Top management must appoint personnel having the authority to initiate and execute a withdrawal

– The organization must establish and maintain a documented procedure for:• Notification to relevant interested parties• Handling of withdrawn products (and affected products still in stock)

• The sequence of actions to be taken



• Withdrawn products shall be secured or held under supervision until they are:

– Destroyed – Used for purposes other than originally intended – Determined to be safe for the intended use

– Determined to be safe for some other use

– Reprocessed in a manner to ensure they become safe



• The cause, extent and result of a withdrawal shall be recorded and reported to top management.

• The organization shall verify and record the effectiveness of the withdrawal program

–Mock or practice withdrawal


Summary1. Determine if the product presents a safety hazard,

based on:

– Expert evaluation

– Biological, chemical, or physical testing

2. If no hazard exists, the product may be released

3. If a potential hazard exists, determine if the product can be:

– Reworked/reprocessed

– Diverted for an alternate use

4. If potentially hazardous product cannot be handled as described in Step 3, the product must be destroyed


Records

• Records for corrective actions and nonconformities must include:– The actual production records for the product

– A standard form listing the following:• Hold number, deviation, reason for hold, date and code of product held, name of responsible individual

– Authority recommendations on final disposition of product in question

– Accurate accounting of all units in question

– Statement of the procedure for handling the nonconformity


QUESTIONS?


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