To define detail, scope and purpose.
To establish the developed detail in a viewable format to facilitate information.
To facilitate the application of the documentation.
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This information can be used to develop food safety and quality programs that meet the requirements of modern Regulatory, Customer and Industry Standards:
When considering the development, documentation, and implementation of Business Continuity and Crisis Management within food safety and quality management systems, the following information should be considered to ensure effective outcomes:

Business Continuity and Crisis Management plans are developed, documented, and implemented to ensure a food business has a structured and tested system to deal with known threats to the supply of safe and quality finished products. Business continuity plans may be strongly linked to other systemic elements, including those for Product Recall and Product Withdrawal.
Contemporary food businesses are expected to have business systems in place that support the production of safe and quality foodstuffs. These systems should also ensure, where possible, that the production and supply of foodstuffs to customers are not disrupted by manageable incidents or emergencies. Standards such as ISO 22301 provide a recognised framework for a business continuity management system.
Business Continuity and Crisis Management includes the development of plans to reduce the risk of a crisis occurring and to deal with any crises that do arise, and the implementation of these plans to minimise the impact of crises and assist the organisation to recover from them. Crises may occur as a result of external factors such as the actions of a competitor, changes in legislation, or an event affecting a key supplier, or internal factors such as a product failure or faulty decision making, and often involve the need to make quick decisions based on uncertain or incomplete information.
Within the context of food industry compliance standards, the terms Business Continuity and Crisis Management are often used interchangeably with other terms, including Emergency Preparedness and Incident Management.
It is important to consider that the Business Continuity and Crisis Management system may have strong links to the established Product Recall and Product Withdrawal systems within a food business. These links may become apparent both before and after activation of the Business Continuity and Crisis Management protocols. The following examples are provided as indicators of prospective related interactions:
Recovery time objectives (RTO) and the maximum tolerable outage for critical activities, such as production, dispatch, and communication, should be defined so that recovery plans can be prioritised and tested against realistic targets.
Business Continuity and Crisis Management review activities should be scheduled, conducted, and recorded on an ongoing basis. Such activities are similar to a Mock Recall, in which a hypothetical scenario is devised and the Business Continuity and Crisis Management system is activated within the food business. The procedures are followed, and records are maintained to show a diary of events and timeframes. Mock Business Continuity and Crisis Management exercises are commonly scheduled at least annually.

Elements of a Business Continuity and Crisis Management system usually consist of documented policies and procedures for:
Contact listings for Business Continuity and Crisis Management should include the following where applicable:
Business Continuity and Crisis Management systems are commonly developed, documented, and implemented in food businesses to define the procedures and responsibilities for handling contingencies such as Disruption to Key Services, Destruction of Premises or Equipment, or Malicious Contamination or Sabotage.
Many businesses define levels of response so that the scale of the response matches the scale of the event. An example structure is:
Documented triggers and the authority to activate each level should be clearly defined, so that decisions are not delayed during an incident.
Clear and consistent communication is a central part of an effective response. A Business Continuity and Crisis Management system should address:

Disruption of key services may include instances in which the following are impaired within a food business:

Destruction of premises or equipment may occur due to:

Although the likelihood of deliberate malicious contamination or sabotage is low, the consequences can be severe. It is therefore important to take reasonable steps to prevent deliberate malicious contamination or sabotage of products or processes.
Consideration of such prevention may take into account the following:
Requirements relating to the intentional adulteration of food are also addressed in the FDA Food Safety Modernization Act.

As with any food safety and quality system element, Business Continuity and Crisis Management requires a structured approach to defining the risk associated with the outcomes of food business incidents. A factual approach to decision-making defines a business’s ability to use accurate information and data as a foundation for decisions.
The benefits of a factual approach to decision-making include:

Risk management principles can be applied across food industry sectors and business systems, including food safety, food quality, workplace health and safety, finance, and operational management. ISO 31000 provides internationally recognised guidelines for risk management.
Risks are an unavoidable component of any business operation. Risk-taking is often essential to progress and success, and failure can be an important part of learning. Although some risks are inevitable, recognising and managing risk does not need to limit creativity. Risks are often known by management but may be poorly communicated, and communicating risks up the chain of command can be more difficult than communicating them down. The risk management process is ongoing and requires constant analysis, as actions need to be decided, implemented, and managed.
Risk management processes are best managed by multidisciplinary teams. When risk management teams use proactive risk management, the continuous assessment creates data and information that can be used for decision-making in all phases of the risk management activity. The team should ensure that risks are identified, managed, and resolved in a manner that supports continuous improvement for the business.
Contemporary risk management processes include the following five elements:
Risk identification is the first step in the proactive risk management process. Risks must be identified before they can be managed. Risk identification provides the risk management team with opportunities, stimuli, and information that allow them to surface major risks before they affect the business. This step involves adequate and appropriate communication between team members and stakeholders to be successful, and it is a powerful way to expose assumptions and differing viewpoints between all parties involved in the risk management process.
Risk analysis is the second step in the risk management process. It converts risk data into risk decision-making information, and thorough risk analysis helps ensure that the risk management team is managing the appropriate risks. During this step the team may use a system that identifies the following:
Risk action planning is the third step in the risk management process. It turns risk information into decisions and actions. Planning involves developing actions to address individual risks, prioritising risk actions, and creating an integrated risk management plan, which may contain the following:
Risk tracking is the fourth step in the risk management process. In this step the risk management team monitors the status of risks and the actions it has taken to observe and control them. Risk tracking is essential to effective risk action plan implementation. This means defining the risk measures and triggering events needed to ensure that the planned risk actions are working. Tracking is the observation function of the risk action plan. Risk reviews are recommended as part of each program review.
Risk control is the final step in the proactive risk management process, after which the process returns to risk analysis. Once the team has chosen the risk measures and triggering events, risk control becomes a component of the normal business management process. It is intended to manage the risk action plans, correct variations from those plans, respond to triggering events, and improve the general risk management process.
Where a Business Continuity and Crisis Management incident has arisen from a customer complaint, it is important to ensure that appropriate action is taken for the complaint, as well as for the other requirements of the system. See Customer Focus and Customer Complaint Management for further information.

The complaint should be investigated immediately by a suitably qualified person from the business, or by an approved external specialist.
The investigation should answer the following questions:
All products that may have been implicated by the problem should be immediately risk assessed and investigated.
Record in the customer complaint file:
Where customer complaints involve allegations such as foreign objects, samples of such objects may be provided by the complainant. During the investigative process, it is in the best interests of the food business to:
Where an identified foreign object is extremely unlikely to have originated from raw materials or processing, consideration should always be given to the potential for deliberate product contamination or a false complaint.
After giving the matter proper consideration, if key team members have reason to believe that a foodborne illness incident has occurred, the following contacts should be made within an appropriate timeframe:
Once the investigation has gathered as much information as possible from all relevant sources:
If the business supplies foodstuffs manufactured to a customer’s specifications, it may be required to contact the customer before notifying the nominated regulatory body, particularly where private label (house brand) products are involved. Legal accountability for the regulatory compliance of a foodstuff may remain with the brand owner rather than the manufacturer, depending on the jurisdiction and contract. Any specific Business Continuity and Crisis Management requirements relating to those items should also be considered.
A health authority notification contact list should contain the following information:
Outcomes of the notification process generally include details of:
The following details should be recorded as part of notifications:
For further information, see Customer Focus and Customer Complaint Management and Corrective Action and Preventative Action.
Document: A document provides guidance or direction for performing work, making decisions, or rendering judgments that affect the safety or quality of the products or services that customers receive.
Documented policies, procedures, work instructions, and schedules form the basis of any food safety and quality management system. The following documentation formats may be considered to ensure ongoing compliance with specified requirements for Business Continuity and Crisis Management:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Business Continuity and Crisis Management Documentation requirements in relation to their items.
You may wish to visit the Business Continuity and Crisis Management Templates section of haccp.com for examples of Business Continuity and Crisis Management documentation, record, and resource formats commonly applied within food safety and quality systems.
Implementation: Implementation is the application of documented food safety and quality system elements into the actual business operation.
The implementation of Business Continuity and Crisis Management within any food business requires genuine commitment from senior management, staff, contractors, and visitors to ensure the nominated goals of implementation are achievable on an ongoing basis. It is a step that requires significant planning and consideration of general and specific food business circumstances, so that the outcomes of Business Continuity and Crisis Management do not negatively affect the safety and quality of the food items dispatched from the business.
Implementation of Business Continuity and Crisis Management must include a clear definition of responsibilities and authorities for all levels of participation by senior management, staff, contractors, and visitors to the site.
When implementing Business Continuity and Crisis Management within a food safety and quality system, the following requirements may be considered before completion:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Business Continuity and Crisis Management Implementation requirements in relation to their items.
Monitoring: Monitoring is the act of reviewing and confirming measurable parameters of a defined process or product status.
Monitoring requirements within food industry sectors are generally identified against limits of acceptability defined within HACCP plans, implementation procedures, and work instructions. Monitoring usually includes some element of record-keeping, which may be maintained manually or through digital systems. Advancements in technology have produced many systems and processes that are self-monitored or self-adjusted when variances are identified. Regardless of the system used, the goal of any monitoring activity is to provide sufficient evidence that any limit of acceptability has been met.
Traditional Business Continuity and Crisis Management monitoring requirements include manual recording and the application of corrective actions when the results of monitoring are found to be outside acceptable limits. Corrective actions should also be strongly linked to the monitoring process to ensure full traceability of the actions applied.
Common monitoring activities and record formats that may apply to Business Continuity and Crisis Management include:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Business Continuity and Crisis Management Monitoring requirements in relation to their items.
You may wish to visit the Business Continuity and Crisis Management Templates section of haccp.com for examples of Business Continuity and Crisis Management documentation, record, and resource formats commonly applied within food safety and quality systems.
Corrective Action: Corrective action is mandatory action to be taken when a deviation from the quality system occurs, particularly in relation to a Critical Control Point.
Preventative Action: At any step in the process where a hazard has been identified, preventative action must be put into place to prevent recurrence.
Corrective action and preventative action are implemented to ensure that any identified non-conformance is documented, investigated, and rectified within appropriate timeframes. Corrective action is any action applied to regain control over a product, process, policy, or procedure that has been identified as non-conforming or outside nominated limits of acceptability. Preventative action is any action applied to prevent an identified non-conformance from recurring.
The outcomes of corrective and preventative actions should result in regained process control after effective application. Specified corrective actions are commonly linked to the HACCP plan and the food business certification process.
Below are corrective action and preventative action examples that may be associated with Business Continuity and Crisis Management non-conformance:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Business Continuity and Crisis Management Corrective Action requirements in relation to their items.
You may wish to visit the Corrective Action and Preventative Action section of haccp.com for examples of best practice applications for this food safety and quality system element.
Verification: The act of reviewing, inspecting, testing, checking, auditing, or otherwise establishing and documenting whether items, processes, services, or documents conform to specified requirements.
Verification is the detailed review of all food safety and quality system elements to confirm that they are effectively developed, documented, implemented, monitored, and reviewed. All food safety and quality system elements, including documented policies, procedures, training, HACCP plans, and their operational applications, should be verified on an ongoing scheduled basis. The verification process commonly includes a defined schedule of the verification activities required, how often they are conducted, who is responsible, and detailed documented procedures for each nominated verification activity.
The general goal of an established verification process is to ensure that any systemic non-conformance is identified and rectified within an appropriate timeframe. When non-conformance is identified through the verification process, corrective actions and preventative actions should be implemented to ensure it does not affect the effectiveness of the food safety and quality system.
The following examples of verification activities may apply to Business Continuity and Crisis Management:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Business Continuity and Crisis Management Verification requirements in relation to their items.
You may wish to visit the Verification Activities section of haccp.com for examples of best practice applications for this food safety and quality system element.
Validation: The process of gathering evidence to provide a scientific basis for the documented act of demonstrating that a procedure, process, or activity will consistently lead to the expected results. It often includes the qualification of systems and equipment.
Validation is the provision of evidence to support the limits of control or acceptability nominated within systemic elements. For Business Continuity and Crisis Management, this typically means confirming that the recovery timeframes, response targets, and resources defined in the plan are realistic and achievable.
Common sources of validation include regulatory and legislative standards, customer requirements, industry codes of practice and guidelines (such as ISO 22301), verified and validated research, historical incidents and process control outcomes, and the results of mock exercises.
Validation activities are commonly defined within the verification schedules and procedures of established food safety and quality management systems.
The following examples may apply to validation of Business Continuity and Crisis Management:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Business Continuity and Crisis Management Validation requirements in relation to their items.
You may wish to visit the Validation Activities section of haccp.com for examples of best practice applications for this food safety and quality system element.
Skills and Knowledge: Skills and knowledge are attributes of human interactions commonly linked to competency within any specified job-related task.
Training and competency requirements for Business Continuity and Crisis Management must be ongoing, including regularly scheduled reviews to ensure the effectiveness of training and competency outcomes.
Team members who have defined responsibilities regarding Business Continuity and Crisis Management should have knowledge including:
Team members who have defined responsibilities regarding Business Continuity and Crisis Management should have skills including:
Team members who have defined responsibilities regarding Business Continuity and Crisis Management should have access to resources including:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Business Continuity and Crisis Management Training, Competency, and Resources requirements in relation to their items.
You may wish to visit the Training, Competency, and Resources section of haccp.com for examples of best practice applications for this food safety and quality system element.