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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 Internal Auditing within food safety and quality management systems, the following information should be considered to ensure effective outcomes:
Internal audits are scheduled, conducted, and recorded to ensure a food business has the stimulus to maintain its food safety and quality programs. Internal audits should be scheduled to include all elements of the food safety and quality systems and should be conducted by competent internal auditors at a frequency relevant to the risk of the processes and products involved. Outcomes of the internal auditing process should be communicated to senior management and should include a formalized corrective action process for any identified non-conformance. The Internal Auditing processes within leading food businesses are strongly linked to the Continuous Improvement Process.
Similar Code of Conduct expectations apply for Internal Auditors as those that apply for external or regulatory auditors.
Basic expectations of Internal Auditors include:
Internal Auditors are commonly either employees of the business being audited or strategically sourced external consultants. It is commonly considered appropriate for a food business to have access to some internal auditors up to 10% of the total number of employees within the business operation. The actual percentage of Internal Auditors available to a business is generally based upon the volume of total employees within the business up to a point where it is not suitable to train Internal Auditors. For example, in a business with 20 employees, it is realistic to expect that 2 Internal Auditors are trained, whereas, in a business with 1000 employees, it would not generally be appropriate to train and use 100 Internal Auditors.
The number of Internal Auditors available to any food business should be based upon risk and should ensure a thorough and effective Internal Auditing process where such auditors ideally do not audit their work.
It is generally accepted a conflict of interest for an Internal Auditor to conduct an audit on their work. This is an important consideration for smaller businesses, where internal resources may not be specifically available to facilitate an Internal Audit where the food safety and quality system elements are maintained by the Internal Auditor.
As with any other business process, Internal Audits should be well structured to ensure appropriate and effective outcomes for the food business being audited.
The following steps are provided as a guideline for an Internal Audit in a logical sequence:
Scheduling of Internal Audits is usually facilitated against a predetermined frequency. This frequency is commonly defined within the food safety and quality system verification schedule. The frequency of Internal Audits is usually defined by the risk-based scope and purpose of the food business operation, though it is common for customers or regulatory requirements to define a minimum schedule for all elements of the food safety and quality system elements. It is important to ensure that the nominated frequency for Internal Audits can realistically identify and correct any systemic deficiencies before they potentially impact food safety or quality or regulatory control of the product.
When defining the exact date and time of the commencement of the Internal Audit, it is important to ensure that the documented and operational systems being audited are available, so that their development, documentation, and implementation can be objectively reviewed as an element of the Internal Auditing process. Where applicable, agreed schedules, dates, and times for Internal Audits should be agreed in writing by all relevant parties.
The notification of the proposed Internal Audit schedule will usually be defined by the scope and purpose of the Internal Auditing activity. If the Internal Audit is an announced Internal Audit, notification should be provided to relevant parties to ensure general awareness and preparation for the audit. If the Internal Audit is an un-announced Internal Audit, no notifications may be required providing all of the food business’ notification requirements have been met – It is common for Senior Management to be informed of the intention of ‘un-announced Internal Audits’ to be conducted to ensure availability of resources as required.
Internal Audits are conducted by nominated individuals or an Internal Audit team, depending on the size, scope, and purpose of your food business and the Internal Audit Activity. An audit team is usually made of suitably qualified and experienced internal auditors who take direction from a lead internal auditor. Audit teams provide flexibility to the internal audit system, particularly for audits of complex systemic elements that require a range of technical expertise. Each member of the audit team must have the skills, knowledge, and experience required to audit the specific parts of the food business to which he or she is assigned.
Likewise, individual Internal Auditors are suitably skilled and competent regarding the Internal Auditing process. When considering employees for conducting Internal Audits, considerations should be given to those that have strength in investigating issues and that are good communicators. Higher skilled and more suitable employees will provide more effective and efficient Internal Auditing outcomes for your food business.
The most important element of establishing an Internal Auditing team is to clearly define the Internal Audit Team Leader, and to delegate the role, responsibility, and authority of such within the context of the proposed Internal Auditing activity.
Internal Auditors, whether as individuals or as part of an Internal Audit team should consider the following elements of the Internal Auditing planning step:
Internal Audits create a fantastic opportunity for any food business to improve the skill and knowledge of key employees. The Internal Audit process can be an invaluable training and development resource for introducing less skilled or experienced or prospective future Internal Auditors to its requirements. This not only provides the opportunity for up-skilling of key employees but also creates an environment in which general and specific food safety and quality awareness can be transmitted across the entire business operation.
The opening meeting is the formal presentation of the Internal Audit scope and purpose, and should ideally be facilitated to include senior management and relevant parties from within the business operation. The purpose of the opening meeting is to ensure awareness of the Internal Audit activity and to set the parameters for the application of such.
The opening meeting should generally include the following elements:
Key information from the opening meeting should be included within the documented Internal Audit findings.
The techniques used for conducting an Internal Audit are similar to those employed by external auditors.
The following points should be considered by Internal Auditors to ensure the most effective outcomes when conducting an Internal Audit:
Questioning techniques are important for any Internal Audit, as they provide opportunities to gather information critical to the outcomes of the activity. In this context, it is important to ensure open questions are used when addressing people during the Internal Auditing process. Open questions commonly begin with words such as Who, What, When, Where, Why, and How.
Following are examples of open question structures that can be beneficial to the efficiency and appropriateness of Internal Audit outcomes:
Closed questions can commonly be answered with a yes or no answer. These are generally avoided within an Internal Audit process as they do not provide informative answers which can be used by the Internal Auditor to gather quality evidence that can be used to justify conformance or non-conformance as Internal Audit outcomes.
Documentation of Internal Audit Findings is important to ensure evidence is available to support the identification of conformance, non-conformance, and opportunities for improvements as Internal Audit outcomes. The precise format of a documented Internal Audit report, checklist, or summary generally depends on the systems through which the Internal Audit outcomes are managed. For example, in larger food businesses, electronic databases may be used; smaller businesses may use a simple paper-based format.
Regardless of their format, documented Internal Audit findings commonly include:
Where non-conformance is identified, Corrective Action Requests are commonly raised to identify general and specific requirements. These should also be traceable to the documented Internal Audit findings with designated responsibility for each, and allocated timeframes for closure.
Where the full Internal Audit report or report summary is not available to present to relevant parties at the closing meeting, it is important to ensure the final report is available to relevant parties as soon as possible after the completion of the Internal Audit.
The closing meeting is the formal presentation of Internal Audit outcomes, and should ideally include the delivery of an Internal Audit report or report summary to all relevant parties. A common element of conducting an Internal Audit closing meeting is to take a listing of the attendees and add to the final documented Internal Audit findings.
When delivering Internal Audit outcomes, it is important to convey conformance as well as non-conformance. This can be done by delivering what is commonly termed as a ‘feedback sandwich’. This involves delivering a positive, followed by a negative, followed by another positive. This approach ensures the outcomes are presented in a manner that acknowledges the positive aspects of the Internal Audit, rather than just the negatives; Leaving all relevant parties with an objective outcome.
When delivering negative Internal Audit outcomes, whether these are non-conformance or opportunities for improvements, the auditee and other relevant parties must be aware of the systemic requirement against which the non-conformance or opportunity has been noted. This will ensure the application of any required corrective action is targeted in its approach, and that the expectations of the relevant systemic requirement, whether based on internal policies and procedures, regulatory, industry sector, or customer standards can be met.
The Internal Audit closing meeting should also permit the concise answering of questions from auditees regarding expectations for the closure of identified non-conformance issues. Any issued Corrective Actions should include an agreed timeframe and specified requirements for closure by the Internal Auditor or other authorized party.
After the Internal Audit, it can be beneficial to hold a meeting to discuss the outcomes of the audit process, and the performance of the Internal Audit, Internal Auditors, or Internal Audit team. This is a good opportunity to address opportunities for improvements within the Internal Auditing Process. It is also important to consider that the outcomes of Internal Audits should be reviewed on an ongoing basis as elements of the Management Review process to ensure the effective applications of the Internal Auditing process and the status of Corrective Actions where applicable.
As with external audits are their auditors, internal auditors and their auditees must behave in a manner that provides appropriate outcomes for the internal auditing process.
Internal Auditors should:
Likewise, the auditee being audited within the Internal Audit activity should reciprocate and facilitate these requirements as a component of their commitment to maintaining the integrity of the auditing and certification process. It is generally not considered appropriate for a business being internally audited to pick and choose auditors based upon their reputation.
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Internal Auditing Development requirements in relation to their items.
Document: A document provides guidance and/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 Internal Auditing:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Internal Auditing Documentation requirements in relation to their items.
You may wish to visit the Internal Auditing Templates section of haccp.com for examples of Internal Auditing 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 Internal Auditing within any food business requires genuine commitment from senior management, staff, 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 to ensure the outcomes of Internal Auditing do not negatively impact the safety and quality of the food items dispatched from the business.
Implementation of Internal Auditing must include a clear definition of responsibilities and authorities for all levels of participation by senior management, staff, and visitors to the site.
When implementing Internal Auditing within a food safety and quality system, you may wish to consider the following requirements before completion:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Internal Auditing Implementation requirements in relation to their items.
Need Help with Internal Auditing?
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Through Alimentex (our exclusive consulting Partner), haccp.com offers a range of unique tailored packages to assist you and your business to improve Internal Audit and System Review outcomes through mentoring and other site-based activities. If you’d like an Internationally Acknowledged Food Safety and Quality Expert to assist you in achieving Food Safety and Quality Greatness – Please contact us today!
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. It is important to consider that advancements in technology have spawned many systems and processes which are self-monitored and 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 Internal Auditing 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 generally be strongly linked to the monitoring process where applied to ensure full traceability of the applied actions.
Common monitoring activities and record formats may apply to Internal Auditing:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Internal Auditing Monitoring requirements in relation to their items.
You may wish to visit the Internal Auditing Templates section of haccp.com for examples of Internal Auditing 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 to the Quality System occurs, particularly 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 re-occurrence.
Corrective Action and Preventative Action are implemented to ensure that any identified non-conformance issues are documented, investigated, and rectified within appropriate time frames. Corrective action is any action applied to regain control over a product, process, policy, or procedure that has been identified as being non-conforming or outside nominated limits of acceptability. Preventative action is any action applied to prevent any identified non-conformance from reoccurring.
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 Plans and the food business certification process.
Below are Corrective Action and Preventative Action examples which may be associated with Internal Auditing related non-conformance:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Internal Auditing 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 must be verified on an ongoing scheduled basis. The verification process commonly includes a defined schedule for which verification activities are 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 any systemic non-conformance issues are identified and rectified within an appropriate time frame. When non-conformance issues are identified through the verification process, Corrective Actions and Preventative Actions should be implemented to ensure they do not impact the effectiveness of the food safety and quality system.
The following examples of verification activities may apply to Internal Auditing:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Internal Auditing 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, and 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 for food safety or quality parameters nominated within systemic elements. Limits of control or acceptability are commonly included within documented food safety and quality systems elements such as procedures, HACCP plans, and specifications.
Common sources of validation include regulatory and legislative standards, finished product specifications and customer requirements, industry codes of practice and guidelines, verified and validated research, historical product, and process control outcomes, and analytical testing.
The general goal of an established validation process is to ensure any systemic non-conformance issues are identified and rectified within an appropriate time frame. When non-conformance issues are identified through the verification process, Corrective Actions and Preventative Actions should be implemented to ensure they do not impact the effectiveness of the food safety and quality system.
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 the limits of control or acceptability for Internal Auditing:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Internal Auditing 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 Internal Auditing must be ongoing, including regularly scheduled reviews to ensure the effectiveness of training and competency outcomes.
Team members who have defined responsibilities regarding Internal Auditing should have knowledge including:
Team members who have defined responsibilities regarding Internal Auditing should have skills including:
Team members who have defined responsibilities regarding Internal Auditing 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 Internal Auditing 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.
haccp.com was created to support food businesses and food industry professionals in achieving and maintaining the stringent requirements of food industry compliance.