Michigan Food Safety Auditing – Food Safety of Michigan
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The Food Safety Auditing Process
Nowadays, technology plays an important role in food safety audits. The maintenance of the necessary food safety checklists and quality insurance documents requires the management of large amounts of data. Furthermore, the access to these data/documents and their analyses is of paramount importance for a successful audit and can be used to prove that a high level of food safety has been ensured. For example, a convenient auditing app can assist in managing documents and workflows for auditing, as well as in improving daily business operations. An auditing app can also assist with processes that include management and archiving of training and certification records, statistics, and data collection and analysis, which can all be easily accessed using, for example, an iPad (Brun 2015).
Many organizations categorize their auditing program into: (1) external audits, which are audits conducted by a third‐party organization, and (2) internal audits, which are audits conducted by internal auditors that work for the organization. Most companies have experience in external auditing processes. These auditing processes involve detailed assessments in which the companies frequently focus principally on passing the audit. This way of approaching external auditing has resulted in the conduction of misunderstood or underutilized internal auditing. Instead of approaching the internal audits as a necessity to pass an external audit, they need to be seen as an important tool of quality management systems (QMSs) that can contribute to the continuous improvement and validation of the food safety systems (Driscoll 2012). Audits can be categorized, based on auditor–auditee relationship, into:
- (1)First‐Party Audits: A self‐assessment, that offers internal verification that procedures and management strategies meet the requirements of a standard and represent the business objectives.
- (2)Second‐Party Audits: Also commonly known as proprietary audits, these audits assess the performance of suppliers or contractors.
- (3)Third‐Party Audits: These audits involve the conduction of audits by independent auditors that are not employed by the auditee and often lead to certification.
Regardless of their type, food safety audits are usually conducted following the under‐mentioned steps:
- (3)Corrective and preventive action
- (5)Audit evaluation (GFSR 2016).
Planning and preparation of on‐site auditing activities should be carried out by the auditors. These activities may include the preparation of an audit plan or a review of the documented food safety program of the company, to confirm that it is in compliance with the requirements of the standard against which the audit will be held. In the case of large and complex companies, an audit team is required. An audit plan should assist in ensuring that the audit team members are properly organized and also give the company an idea of timings for the audit. Prior to an on‐site assessment, the auditor should review the company’s documented food safety program to confirm that it is in compliance with the requirements of the standard against which the assessment will be made. This can be an indication of whether an on‐site audit should follow. This review can be conducted on‐ or off‐site, a decision that depends on logistical constraints and the degree of complexity of the food safety system. In cases that nonconformities are found, they are usually better resolved before an on‐site audit is organized (ANZFA 2001).
The actual conduction of the audit is the collection of data that starts with arrival at the audit location and ends with the exit meeting. An on‐site audit involves on‐site audit‐management, a meeting with the representatives of the company, gaining an understanding of the process and system control measures, verification that these measures work effectively and communication of results and observations among team members and with the auditee (ASQ 2013). A process audit is carried out through performing a review of procedures and documentation, and interviewing members of the personnel directly involved in the process being subjected to audit. At the next step the auditor evaluates the responses and decides whether they are consistent and in accordance with documented policies, objectives, procedures, and records. Inconsistency of responses would mean that the auditor would have to continue searching for the reasons of the inconsistencies and find the necessary proof that support the inconsistencies. Therefore, audit trails are an important part of the auditing process. The auditor seeks to identify the reason of the inconsistency and then correlate it with the management system and a standard, giving the food company the tools they need to identify and address the inconsistency. The use of this system requires the substitution of the detailed audit checklist by a less detailed checklist (a memory aid) that aims at simultaneously assessing various elements of a food safety management system (FSMS) (Surak and Lorca 2007).
According to Westcott (2005), “A corrective action deals with a nonconformity that has occurred, and a preventive action addresses the potential for non‐conformity to occur. The corrective action process generally involves locating and documenting the root cause of the non‐conformities, scanning the entire system to ensure no other similar nonconformities could occur, analysing the effect such a nonconformity may have had on a product or service produced before the nonconformity was discovered, and taking action appropriate to the severity of the situation by either recalling the product, notifying the customer, downgrading or scrapping product.” It is also of paramount importance to follow‐up with checks on whether any corrections are effective and recurrence can be prevented. The preventive action process commonly involves the establishment of proactive measures to prevent a potential nonconformity from occurring, and the conduction of thorough process and system analysis in order to determine what actions are required and what controls should be in place to prevent a nonconformity (for example, using Failure Mode and Effects Analysis [FMEA] to determine risks and possible deficiencies and define priorities for improving the current system) (Westcott 2005).
The verification stage of an audit involves the conduction of an assessment that aims at evaluating how effective the corrective and preventative actions are in achieving their purpose, as detailed in the management strategy. The individual responsible for conducting the food safety audit should not be the same individual who determined the corrective action, to add a degree of impartiality and a 2nd viewpoint. Further verification can be possible through the review of all collective outputs of a given action, as well as by following up with mini‐audits and short confirmatory interviews (GFSR 2016).
It is always imperative that the audit processes used are reviewed and improved at frequent intervals. Furthermore, third‐party audits, being only 1 performance indicator, usually need to be supported by microbial testing, second‐party audits of suppliers and the organization’s ability to analyze the results and outcomes of audits and inspections. None of the raw product suppliers should be excluded from the audit scope. Audit systems incorporating unannounced visits in combination with supporting information are more effective and cover internal audits‐ records, regulatory compliance, laboratory results, and raw material certifications. Some food businesses employ auditors as direct stakeholders to carry out internal audits. Other auditors are employed by second‐party purchasers or third‐party auditing agencies. There are also buyers that perform their own audits or additional testing, while others rely on the results of third‐party audits. Third‐party auditors, though, base their audits on a variety of food safety standards and the majority of them do not have any involvement with the products being sold. The conduction of audits is carried out under a proprietary standard, while the conduction of food safety inspections is commonly performed within a legal framework. It is important to note that there have been many foodborne illness outbreaks associated with food businesses that have been successful in third‐party audits and inspections, which renders the utility of these practices questionable. People supporting the role of third‐party audits claim that they can ensure food safety, even when the economic resources are limited. People criticizing external audits and inspection, though, claim that although they are useful tools, their results represent only a snapshot in time (Powell and others 2013). Albersmeier and others (2009) reported that weak auditing procedures may be currently used in quality certification systems in the agricultural sector. Not only case studies, anecdotal information or rumors, but also statistical analyses now confirm that there are differences between different certification bodies (auditors). Despite the fact that the results do not prove that there is any significant reason for the variations presented among certification bodies and auditors, they still clearly hint at problems and inefficiencies in the control system. It is now accepted that there can be no guarantees over the validity and reliability of audits, and is therefore questionable whether third‐party certification really achieves its purpose.
The standard audited can greatly affect the way an audit is conducted as well as its outcome. However, another very important factor in the auditing process is the auditor. The competence degree of an auditor is of paramount importance and can vary depending on several factors. The personnel responsible for developing and managing the audit programs should determine in advance the criteria and requirements in relation to auditors and their competencies (Safefood 360 2013).
The Role of Safety and Quality Control Systems
Food crises are one of the reasons why food quality and food safety are frequently discussed in the media. Very often the terms food quality and food safety are not clearly differentiated. There are significant differences though, in particular, when consumer perceptions are considered. Public authorities are leading the food and feed industries into the development of robust QMSs aiming at improving food safety, restructuring the food inspection system and enhancing the level of information provided to consumers (Röhr and others 2005). According to Holleran and others (1999), “quality assurance systems are designed to assure customers that contracted product characteristics and/or production processes are consistently delivered. They play an essential role in an exchange because food safety and quality attributes may not be directly observable. Food safety and quality assurance systems can take many forms: (1) private voluntary international quality assurance standards, such as ISO 9000; (2) national farm level assurance systems, such as Farm Assured British Pigs; and (3) proprietary quality assurance systems, such as those maintained by the large retail food chains in the U.K. Albeit with differing origins, quality assurance systems share two common features: (1) a reliance on documentation of production processes and practices and (2) third‐party auditing and certification.” An organization can take advantage of a QMS, especially when critical areas are considered that need to be suitably controlled, to reduce the appearance of defective products but also to improve internal communication, increase customer’s satisfaction, and therefore share market, and increase the opportunities for expansion in new markets and regions (Aggelogiannopoulos and others 2007).
Hazard Analysis and Critical Control Points (HACCP) assessment is a valuable tool that can be used for verifying whether a food manufacturer or distributor can produce or distribute safe products. This can be “translated” to specific and complementary roles for the food industry and the public authorities. Food manufacturers conduct in‐house HACCP assessments using internal resources and, if necessary, external expertise. It should be noted that the effective implementation of HACCP requires that the food manufacturers implement procedures in order to verify whether the HACCP system works properly. This internal verification should suffice for ensuring that the adequate level of information is available to evaluate the effectiveness of HACCP (Ababouch 2000). In 1990s in Brazil, a range of private food standards had gradually been promoted by the private sector to assure quality and safety in a highly competitive market. These private standards had been implemented partly due to the lack of public standards, and in an effort to differentiate products and increase consumer’s trust. Furthermore, private standards were strongly associated with meta‐management systems that assured both quality and safety along the supply chain, mainly by enforcing the use of process standards. The privatization of standards was proven to be very important for both buyers and suppliers in the supply chain. These standards were developed to meet the needs of retailers and processors. It is considered that they offered a competitive advantage. It has been stated, however, that a relatively low percentage of suppliers found that abiding by the standards and obtaining a formal certification was beneficial for their business and offered them new opportunities. The rest of them found themselves relegated to waning and unprofitable markets. Examples of industries affected by the trends above were the coffee, wheat, and coconut industries in Brazil (Reardon and Farina 2002).
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