FSNS Certification & Audit performs hundreds of food safety certification audits each year, including for FSSC 22000 certification. Our auditors have compiled a list of the top 10 reasons for an FSSC 22000 audit non-conformity to help you prepare for your next audit.
Below, we provide the appropriate clause and item from the FSSC 22000 code (version 5.1) for each of the top 10 non-conformities. Here’s the full list:
10) Management Review Input – 9.3.2
Our list of top 10 reasons for an FSSC 22000 audit non-conformity begins with management review. The clause states:
The management review shall consider:
- the status of actions from previous management reviews;
- changes in external and internal issues that are relevant to the FSMS, including changes in the organization and its context (see 4.1);
- information on the performance and the effectiveness of the FSMS, including trends in:
- result(s) of system updating activities (see 4.4 and 10.3);
- monitoring and measurement results;
- analysis of the results of verification activities related to PRPs and the hazard control plan (see 8.8.2);
- nonconformities and corrective actions;
- audit results (internal and external);
- inspections (e.g. regulatory, customer);
- the performance of external providers;
- the review of risks and opportunities and of the effectiveness of actions taken to address them (see 6.1);
- the extent to which objectives of the FSMS have been met;
- the adequacy of resources;
- any emergency situation, incident (see 8.4.2), or withdrawal/recall (see 8.9.5) that occurred;
- relevant information obtained through external (see 7.4.2) and internal (see 7.4.3) communication, including requests and complaints from interested parties;
- opportunities for continual improvement.
The data shall be presented in a manner that enables top management to relate the information to stated objectives of the FSMS.
Common Problems:
- Failure to include each one of the requirements in the management review to demonstrate what was determined.
Given all the requirements of this clause, it’s easy to understand why it makes the list of top non-conformities during an FSSC 22000 audit.
To avoid an observance, make sure your management review includes all the listed requirements.
9) Non-conformity and Corrective Action – 10.1.1
The ninth item on our list of top 10 reasons for an FSSC 22000 audit non-conformity involves non-conformities and corrective actions. The clause states:
When a nonconformity occurs, the organization shall:
- react to the non-conformity and, as applicable:
- take action to control and correct it;
- deal with the consequences;
- evaluate the need for action to eliminate the cause(s) of the non-conformity, in order that it does not recur or occur elsewhere, by:
- reviewing the non-conformity;
- determining the causes of the non-conformity;
- determining if similar non-conformities exist, or could potentially occur;
- implement any action needed;
- review the effectiveness of any corrective action taken;
- make changes to the FSMS, if necessary.
Corrective actions shall be appropriate to the effects of the non-conformities encountered.
Common Problems:
- Not following up on corrective actions.
- Failure to verify the effectiveness of corrective actions.
- Not evaluating deviations for potential trends.
Implementing corrective actions when faced with a non-conformity is the first step, but they require follow-up to verify their effectiveness. It’s also important to evaluate your data and look for possible trends that point to a fundamental problem in need of resolution.
8) Leadership and Commitment – 5.1
Top management shall demonstrate leadership and commitment with respect to the FSMS by:
- ensuring that the food safety policy and the objectives of the FSMS are established and are compatible with the strategic direction of the organization;
- ensuring the integration of the FSMS requirements into the organization’s business processes;
- ensuring that the resources needed for the FSMS are available;
- communicating the importance of effective food safety management and conforming to the FSMS requirements, applicable statutory and regulatory requirements, and mutually agreed customer requirements related to food safety;
- ensuring that the FSMS is evaluated and maintained to achieve its intended result(s) (see 4.1);
- directing and supporting persons to contribute to the effectiveness of the FSMS;
- promoting continual improvement;
- supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.
Common Problems:
- Employee feedback processes not incorporated to evaluate and improve food safety culture.
- The Food Safety Management System did not incorporate expectations regarding food safety culture.
FSSC offers a helpful guidance document that outlines its expectations for developing a strong food safety culture. Look it over to help strengthen your organization’s commitment to safety and as part of your preparation for an audit.
Make sure your process includes provisions for not only gathering employee feedback about your culture, but methods of incorporating it to improve the overall culture.
7) Traceability – 8.3
The traceability system shall be able to uniquely identify incoming material from the suppliers and the first stage of the distribution route of the end product. When establishing and implementing the traceability system, the following shall be considered as a minimum:
- relation of lots of received materials, ingredients, and intermediate products to the end products;
- reworking of materials/products;
- distribution of the end product.
The organization shall ensure that applicable statutory, regulatory, and customer requirements are identified. Documented information as evidence of the traceability system shall be retained for a defined period to include, as a minimum, the shelf-life of the product. The organization shall verify and test the effectiveness of the traceability system.
NOTE: Where appropriate, the verification of the system is expected to include the reconciliation of quantities of end products with the quantity of ingredients as evidence of effectiveness.
Common Problems:
- Traceability/Recall program did not include requirement for communicating with the certification body.
- Issues with traceability activities.
- Raw material lot numbers not properly documented.
- Amount of product produced not documented to allow for reconciliation.
6) Internal Structures and Fittings – 5.3
- Process area walls and floors shall be washable or cleanable, as appropriate for the process or product hazard. Materials of construction shall be resistant to the cleaning system applied.
- Wall floor junctions and corners shall be designed to facilitate cleaning.
- It is recommended that wall floor junctions be rounded in processing areas.
- Floors shall be designed to avoid standing water.
- In wet process areas, floors shall be sealed and drained. Drains shall be trapped and covered.
- Ceilings and overhead fixtures shall be designed to minimize build-up of dirt and condensation.
- External opening windows, roof vents or fan, where present, shall be insect screened.
- External opening doors shall be closed or screened when not in use.
Common Problems:
- Dock doors
- Condensation
- Peeling caulking
- Unsealed floors
Potential contamination can come from just about anywhere, including condensation dripping from an overhead line, peeling caulk or paint, rust flakes, peeling tape, and other sources. Improperly sealed dock doors and floors are another common observance our auditors find.
Read this clause closely and make sure your facilities meet the requirements.
5) Internal Audits – 9.2.2
The organization shall:
- plan, establish, implement and maintain (an) audit program(s), including the frequency, methods, responsibilities, planning requirements and reporting, which shall take into consideration the importance of the processes concerned, changes in the FSMS, and the results of monitoring, measurement and previous audits;
- define the audit criteria and scope for each audit;
- select competent auditors and conduct audits to ensure objectivity and the impartiality of the audit process;
- ensure that the results of the audits are reported to the food safety team and relevant management;
- retain documented information as evidence of the implementation of the audit program and the audit results;
- make the necessary correction and take the necessary corrective action within the agreed time frame;
- determine if the FSMS meets the intent of the food safety policy (see 5.2) and objectives of the FSMS (see 6.2).
Follow-up activities by the organization shall include the verification of the actions taken and the reporting of the verification results.
Common Problems:
- Failure to take corrective actions for findings identified in internal audits.
- Lack of evidence demonstrating that findings had been verified upon closure.
Internal audits are a big part of any food safety certification platform to help assess your organization’s performance. Those audits mean little, however, if you fail to take corrective actions based on the findings and to provide evidence that you verified those solutions.
Our FSSC 22000 Audit Checklist can help ensure your facility doesn’t receive any of the non-conformities on this list.
4) Selection and Management of Suppliers – 9.2
The #4 item on our list of top 10 reasons for an FSSC 22000 audit non-conformity involves your suppliers:
There shall be a defined process for the selection, approval, and monitoring of suppliers. The process used shall be justified by hazard assessment, including the potential risk to the final product, and shall include:
- assessment of the supplier’s ability to meet quality and food safety expectations, requirements, and specifications;
- description of how suppliers are assessed; NOTE: Examples of a description of how suppliers are assessed include:
- audit of the supplying site prior to accepting materials for production;
- appropriate third-party certification.
- monitoring the performance of the supplier to assure continued approval status.
NOTE: Monitoring includes conformity with material or product specifications, fulfilment of COA requirements, satisfactory audit outcomes.
Common Problems:
- List of approved suppliers was either not being used or was not in place.
- Failure to have evidence to provide the auditor demonstrating that GFSI certification was obtained by suppliers.
- Lack of evidence supporting supplier monitoring had occurred.
As food fraud issues increase, assessing and verifying your suppliers takes on added importance. Following the directives in this clause will help strengthen your supplier program and improve food safety standards.
3) Documentation Information Creating and Updating – 7.5.2
When creating and updating documented information, the organization shall ensure appropriate:
- identification and description (e.g. a title, date, author, or reference number);
- format (e.g. language, software version, graphics) and media (e.g. paper, electronic);
- review and approval for suitability and adequacy.
Common Problems:
- Failure to follow document control policies. Not including author, date, and revision as detailed in the site’s policy.
- Not including all applicable policies in the FSMS document system (i.e. supplier approval).
Number 3 on our list of top 10 reasons for an FSSC 22000 audit non-conformity is related to one of the most ubiquitous food safety certification requirements: documentation.
You can’t work in the food safety industry long without realizing the importance of documenting everything. As the clause states, you must ensure your documentation includes all the required information to avoid an observance during your next audit.
2) Preventive and Corrective Maintenance – 8.6
Number 2 on our list of top 10 reasons for an FSSC 22000 audit non-conformity covers your facility’s maintenance program:
A preventive maintenance program shall be in place. The preventive maintenance program shall include all devices used to monitor and/or control food safety hazards. NOTE: Examples of such devices include screens and filters (including air filters), magnets, metal detectors, and X-ray detectors.
- Corrective maintenance shall be carried out in such a way that production on adjoining lines or equipment Is not at risk of contamination.
- Maintenance requests that impact product safety shall be given priority.
- Temporary fixes shall not put product safety at risk. A request for replacement by a permanent repair shall be included in the maintenance schedule.
- Lubricants and heat transfer fluids shall be food grade where there is a risk of direct or indirect contact with the product.
- The procedure for releasing maintained equipment back to production shall include clean up, sanitizing, where specified in process sanitation procedures, and pre-use inspection.
- Local area PRP requirements shall apply to maintenance areas and maintenance activities in process areas. Maintenance personnel shall be trained in the product hazards associated with their activities.
Common Problems:
- Temporary repairs.
- Not verifying areas were clean following maintenance repairs.
One of the most common observances our auditors cite is temporary repairs that go unresolved for too long. As the clause indicates, temporary repairs are acceptable – provided they don’t jeopardize food safety and there is an adjoining maintenance request for a permanent repair in your maintenance schedule.
Also, make sure to verify and document that the affected area was properly cleaned following maintenance work.
1) Competence – 7.2
We have arrived at #1 on our list of the top 10 reasons for an FSSC 22000 audit non-conformity – Competence. The FSSC 22000 code (version 5.1) states:
The organization shall:
- determine the necessary competence of person(s), including external providers, doing work under its control that affects its food safety performance and effectiveness of the FSMS;
- ensure that these persons, including the food safety team and those responsible for the operation of the hazard control plan, are competent on the basis of appropriate education, training and/or experience;
- ensure that the food safety team has a combination of multi-disciplinary knowledge and experience in developing and implementing the FSMS (including, but not limited to, the organization’s products, processes, equipment and food safety hazards within the scope of the FSMS);
- where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness of the actions taken;
- retain appropriate documented information as evidence of competence.
NOTE Applicable actions can include, for example, the provision of training to, the mentoring of, or the re-assignment of currently employed persons; or the hiring or contracting of competent persons.
Common Problems:
- Not evaluating the effectiveness of training completed.
- Not including all topics outlined in 7.2 (i.e. food defense).
- Failure to have a process in place for evaluating competency.
A food safety management system is vital to producing food safely, but it does little good if the people involved lack the necessary education, training, or experience. FSSC 22000 requires your organization to ensure competency of everyone involved.
One effective way to achieve that goal is through ongoing FSSC 22000 and food safety training, such as the courses available through FSNS.
The Top 10 Reasons for an FSSC 22000 Audit Non-Conformity: Recap
Being aware of these top 10 reasons for an FSSC 22000 audit non-conformity can be invaluable in preparing for your next audit. Ensure everyone involved with your food safety management system is competent and trained, management has reviewed all required information, and your team properly addresses non-conformities.
Remember, these insights are drawn from common problems we’ve observed during audits, but each facility has unique challenges. Use this information to reach higher standards and help avoid non-conformities in future FSSC 22000 audits.
