https://schema.org Certification Quality Code, Edition 10 The Quality Program is designed to monitor and control food quality-related threats and works best for sites that have already implemented a successful, robust food safety plan. This program can be implemented in tandem with an existing food safety plan or as a stand-alone audit. http://www.sqfi.com/images/sqfilibraries/edition-10-images/code-10-module-covers/sqf-code-covers-for-website-1900x1900-quality.png?sfvrsn=e4a85ce5_9 Organization SQFI (Safe Quality Food Institute) https://www.sqfi.com FQ 00 - Quality DefinedTermSet Part A: Implementing and Maintaining the SQF Quality Code DefinedTerm A1 The Safe Quality Food Institute (SQFI) publishes a suite of globally recognized food safety and quality Codes that cover all aspects of the food supply chain from primary production through to retail and foodservice. All standards are available free of charge at www.sqfi.com.Before embarking on the SQF journey, sites are encouraged to download and review the SQF Code that best fits their needs. DefinedTerm A2 Achieving and Maintaining SQF Quality Certification DefinedTerm Introduction The SQF Quality Code builds on the system elements defined in the various SQF Food Safety Codes. Sites seeking to attain certification to the SQF Quality Code must be certified to the applicable SQF Food Safety Code for their industry sector. The SQF Quality Code does not apply to sites certified to SQF Food Safety Code: Retail or SQF Food Safety Code: Foodservice.Edition 10 of the SQF Quality Code can also be applied as a food quality certification to any food or feed manufacturing or storage site certified to a GFSI-recognized certification program, any GFSI technically equivalent standard or other food safety management standard (FSMS) including HACCP certification or ISO 22000:2018.The SQF Quality Code sets out the implementation, maintenance, and technical requirements for sites seeking to apply quality management principles to their operations.Part A (this part) sets out the process a site needs to take to implement and maintain certification to the SQF Quality Code.Part B is the auditable standard. It details the SQF Quality elements that must be met to achieve certification.Personnel at a site in a site management or technical role responsible for implementing the requirements of the relevant SQF Quality Code and can learn how to get started and implement their SQF System in several ways.SQFI has an online Implementing SQF Quality Systems training course, which can be accessed from www.sqfi.com. It is a web-based education tool where you can enroll and complete SQF Quality Systems training in your own time and at your own pace.An Implementing SQF Quality Systems training course is available through the SQFI network of licensed training centers. Details about the training centers and the countries in which they operate are available at www.sqfi.com.Individuals can become familiar with the SQF Quality Code by downloading the Code from www.sqfi.com free of charge.Although optional, it is recommended to utilize the services of a registered SQF consultant when first implementing an SQF System. All SQF consultants are registered by SQFI to work in specific food sector categories (FSCs) and are listed in the SQF directory, indicating the FSCs in which they are registered.Guidance documents are available for some SQF Code topics from www.sqfi.com. These documents can help the site interpret the requirements of the SQF Codes and assist with documenting and implementing an SQF System. The documents are developed with the assistance of food sector technical experts. The guidance documents are available to assist, but are not auditable documents. Where there is a divergence between the guidance document and the relevant Code, the SQF Code prevails. DefinedTerm A2:1 SQFI Assessment DatabaseSites are required to register in the SQFI Assessment Database at www.sqfi.com prior to their audit date and before any audit is initiated. At the time of registration, a fee must be paid (see the fee scale posted at www.sqfi.com). If the site does not maintain annual registration, the site certificate will be invalid until the site is registered on the SQFI Assessment Database.Sites seeking SQF quality certification as an adjunct to another food safety management certification, must register for both. DefinedTerm A2:2 SQF Quality PractitionerThe SQF Quality Code requires that every certified site has a suitably qualified primary SQF Quality Practitioner and a Substitute Practitioner to oversee the development, implementation, review, and maintenance of the SQF Quality System. The requirements for an SQF Quality Practitioner and Substitute Practitioner are described in the system elements, Part B: 2.1 Management Commitment. The site may choose to have additional practitioners to meet shift and operational requirements.SQF Practitioners may voluntarily choose to earn the Certified SQF Practitioner credential. This credential evaluates practitioner competencies and further demonstrates the ability to implement, maintain, and continuously improve an SQF Food Safety System. DefinedTerm A2:3 TrainingSQF Quality Practitioners are required to demonstrate knowledge of the SQF Code, including implementing and maintaining the requirements. Training required for the SQF Practitioners and other relevant personnel is defined in the SQF Code, Part B.An Implementing SQF Quality Systems training course is available online and through the SQFI network of licensed training centers. This training course is strongly recommended but not mandatory for SQF Quality practitioners. Training in other food industry disciplines, such as internal auditing, is encouraged and will help prepare the site for implementing it SQF Quality System. Licensed SQF training centers can provide details about the other training courses they offer. Details of the training courses are available at www.sqfi.com. DefinedTerm A2:4 Scope of CertificationBefore implementing the SQF Quality Code, the site must determine the scope of certification: the site premises, products, and processes to be included in your SQF Quality System.The scope of certification determines which elements of the SQF Quality Code are to be documented and implemented and will be audited. The scope must be agreed upon between the site and the Certification Body before the initial certification audit and cannot be changed during or immediately following a certification or re-certification audit for requirements on changing the scope of certification.For sites certified to one of the SQF Food Safety Codes, the scope of certification is the same as the site’s certification to the SQF Food Safety Code. Any agreed exclusions (refer Part A2:5) from the food safety certification are also excluded from the quality certification and the scope of quality certification cannot be extended or changed from the food safety certification.For sites certified to another FSMS, the scope of certification must be clearly identified and agreed by the certification body prior to the initial quality certification audit, and must include:The site. SQF quality certification is site specific. The entire site, including all premises, support buildings, silos, tanks, loading and unloading bays, and external grounds are identified and included in the scope of certification. If activities are carried out in different premises but are overseen by the same senior, operational, and technical management and are covered by a single SQF Quality System, the site can be expanded to include those premises.The products and processes. SQF quality certification is product specific. Within each applicable FSC, the site will need to identify the products and processes included in the SQF System. The manufacture and quality of all listed products will be audited for compliance to the SQF Quality Code and will be listed on the quality certificate unless you request an exclusion (refer to Part A, A2:5).Changes to the Scope of CertificationIf new food sector categories or new products are added to the scope of certification, the scope of its quality certification also changes.If the scope change is a new process or a major change to an existing process, a new product line, or a significant change in personnel, equipment, raw materials, packaging materials or ingredients, the Certification Body is required to be advised in writing. The Certification Body is required to review the additional process or product(s) and determine if a new certificate can be issued. If not, the CB is required to advise the site in writing.An audit for an expansion in scope does not change the re-certification date or certificate expiry date. When a new certificate is issued, the re-certification audit date and certificate expiry date remain the same as on the original certificate.When the scope of certification has been changed, the certification body makes the appropriate scope changes to your site record in the SQFI Assessment Database.If the request is received within thirty (30) days prior to the re-certification audit window, the Certification Body may defer the scope extension to the upcoming re-certification audit and advise you accordingly. No new certificate is issued until after a successful re-certification audit. DefinedTerm A2:5 Scope ExclusionsIf the site wishes to exclude specific products, processes, or a portion of the premises from the scope of certification, the request for exclusion must be submitted to the Certification Body in writing prior to the certification audit, detailing the reason for exclusion. Exclusions that apply to SQF food safety certification also apply to SQF quality certification. The site must be able to demonstrate that these exclusions do not cause a food safety risk with certified products.Exclusions may not be granted for the entire premises or for processes involved with the production, processing, and storage of certified products.If approved by the Certification Body, exclusions are listed in the site description on the SQFI Assessment Database, in audit reports, and on the audit certificate. Excluded products and portions of the site cannot be promoted as being covered by the SQF certification. Instances where the promotion of excluded items is identified and substantiated will result in the immediate withdrawal of the SQF certification.Sites that have been granted an exclusion shall have "Exclusions" indicated on the certificate, with the complete list of the products or processes that were excluded listed on the audit report. DefinedTerm A2:6 Document the SQF SystemThe SQF system elements (Module 2) of the SQF Quality Code must be documented. This requires preparing policies, procedures, work instructions, and specifications that meet the Code elements in these modules. In other words, “Say what you do.” DefinedTerm A2:7 Implement the SQF SystemOnce the SQF system is documented in policies, procedures, work instructions, specifications and other related documents and records, they must be implemented. This includes ensuring that all documented procedures are followed, and records are kept demonstrating compliance with the SQF Quality Code. In other words, “Do what you say.”For initial audits and when a recertification audit occurs during an edition change, SQFI recommends that a minimum of ninety (90) days of records, including all activities that are to be conducted at least annually, are available before a site audit is conducted. The Certification Body may require additional record requirements relevant to the site's scope. DefinedTerm A2:8 Auditable ClausesAll elements of the Code will be audited. These clauses must be documented, implemented, and audited for a site to achieve SQF certification. Not all elements are applicable and can be reported as not applicable (NA) or involve alternative controls, only when a justification and/or risk assessment is available during the audit. Failure to comply with an element results in a non-conformance.There are no mandatory elements in the SQF Quality Code. The mandatory elements that apply in the SQF Food Safety Codes are implemented and audited only if applicable in the SQF Quality Code. DefinedTerm A2:9 SQF Certification BodiesSQF Certification Bodies are licensed by SQFI to conduct SQF audits and issue SQF certificates. A list of licensed Certification Bodies that operate in the site's region or country is available at www.sqfi.com and in the SQFI Assessment Database. SQFI recommends that the same Certification Body that provided certification to the SQF Food Safety Code (or other food safety management certification, if applicable) is also contracted to certify the SQF Quality Code. SQFI-licensed Certification Bodies are accredited to the international standard ISO/IEC 17065:2012 (or subsequent versions as applicable) and are subject to annual assessments of their certification activities by SQFI-licensed accreditation bodies. The site must have an agreement with a Certification Body in place, outlining the agreed SQF certification services to be provided and shall include:The scope of certification (refer to A2:4), including any approved exclusions (refer to A2:5);The expected audit duration and the reporting requirements;The Certification Body’s fee structure includes audit costs, travel time and expenses, report writing costs, ancillary costs, and costs for closing out non-conformances;The conditions under which the SQF quality certificate is issued, withdrawn, or suspended;The Certification Body’s appeals and complaints process; andThe availability of SQF quality registered auditor(s). Changing the Certification BodyThe SQF certified site can change to another SQF-licensed Certification Body:After the certificate has been issued;After closure of all outstanding non-conformances;Prior to the start of the site's next audit window; andThe certification is in good standing (ie. not suspended, under threat of suspension or withdrawal or pending a surveillance audit). A site can change Certification Bodies only after the surveillance audit is conducted or by written approval from SQF Compliance (compliance@sqfi.com). When a site changes Certification Bodies, the certificate issued by the previous Certification Body remains valid until the expected expiration date. The certification number and re-certification date are transferred with the site to the new Certification Body. The new Certification Body is required to undertake a review of the site’s certification before the transfer is complete to:Confirm the certificate is current, valid, and relates to the SQF Quality System as certified;Confirm the site falls within the new Certification Body’s scope of accreditation;Confirm that any complaints received are actioned;Review of the site’s audit history, including past audit reports and unresolved non-conformances, to satisfy the new Certification Body; andEnsure the usage of the SQF Quality Shield, if applicable, complies with the requirements of Quality Shield Rules of Use. Sites are required to make the last recertification audit report and surveillance audit report (if applicable) available to the new Certification Body. DefinedTerm A2:10 The SQF Quality Audit TeamThe SQF quality auditor is selected by the Certification Body. The Certification Body must advise the site of the auditor's name and, except when scheduled in conjuntion with unannounced food safety audit, date and time of the SQF audit is scheduled.The auditor is required to be employed by or contracted to the Certification Body and registered with SQFI as a quality auditor. The auditor registration is available at www.sqfi.com.The Certification Body is required to ensure that no SQF quality auditor conducts audits of the same site for more than three (3) consecutive certification cycles. An SQF auditor cannot audit a site where they have participated in a consulting role or have a conflict of interest with anyone at the site within the last two (2) years. The site can refuse the service of an SQF quality auditor if the site can demonstrate the auditor has a conflict of interest, or for other valid reasons. In such circumstances, the site shall to outline the reasons in writing to the Certification Body. DefinedTerm A2:11 The Quality Certification AuditAn SQF audit of the SQF Quality Code is an assessment by a qualified and registered SQF quality auditor (or audit team) to ensure that the documentation (refer to A2:6) complies with the SQF Quality Code and that quality and related management practices (refer to A2:7) are carried out according to that documentation. The scope of certification (refer to A2:4) cannot be changed after the audit has started.The auditor will conduct a process-based audit using a vertical audit approach to traceback targeted product(s) through the manufacturing process and form the basis for reviewing all policies, procedures, Standard Operating Procedures (SOPs)/Work Instructions (WI), records and other documentation related to the Quality System.To achieve and maintain SQF quality certification, the site is required to attain and maintain a certification to the SQF Food Safety Code or other applicable food safety management standard, ensure that quality surveillance and/or quality re-certification audits occur within the required time frame, and ensure that all quality deviations are corrected within the time frame specified.Re-certification Audits are conducted within thirty (30) calendar days on either side of the anniversary of the last day of the initial certification audit. These audits are conducted to verify the continued effectiveness of the site’s SQF Quality System.A portion of each audit, with exception of unannounced audits (refer to A2:13), may be conducted remotely using information and communication technology (ICT). At least half of the allocated audit duration must be conducted on-site by the auditor. Remote activities can only be conducted by agreement between the site and the Certification Body and are dependent on the ICT capability and information security requirements. The off-site and on-site portions are conducted at a time agreed between the site and the Certification Body, with the on-site portion only when the main processes are operating.When the quality audit is conducted independent of the food safety audit and the auditor identifies a significant food safety issue, the auditor is required to report the food safety finding in the audit report under “auditor recommendation” and notify the Certification Body for potential follow-up action. DefinedTerm A2:12 Audit DurationThe audit duration varies depending on the certification audit option selected, (i.e. an extension of the food safety audit, or a separate, stand-alone audit (refer to A2:11).The Certification Body determines the audit duration and advises the site in writing with an estimate of the time it will take to complete the certification audit. The audit duration must be sufficient for auditors to:Observe processes and employee behaviors throughout the inspection;Audit all processes covered under the certification;Conduct interviews with personnel across various shifts and positions;Follow up on deviations as they occur, ensuring proper management and corrective actions; andReview and analyze records thoroughly to make informed assessments.As a guide, SQFI expects a certification audit to the SQF Quality Code, combined with a certification audit to the SQF Food Safety Code to add a minimum of half a day, while a stand-alone quality certification audit will be a minimum of one day. DefinedTerm A2:13 Unannounced AuditsThere is no specific requirement for an unannounced audit of the SQF Quality Code.Where a site selects to incorporate their quality audit with their SQF food safety audit, or another food safety management standard, the quality audit is unannounced when aligned with an unannounced food safety audit. DefinedTerm A2:14 Corporate AuditsIf the site is part of a larger corporation and some quality functions are conducted at a separate corporate head office (e.g., an office that does not process or handle products), an optional corporate audit of the Quality Code elements managed by that office can be conducted. The decision on whether a separate corporate audit should be conducted is made by agreement between the Certification Body and the corporation. The corporate office should communicate this to the SQF-certified sites they support.The corporate audit portion may be conducted remotely using ICT. All identified corporate non-conformances must be closed out before the associated site audits are conducted. Any open non-conformances that are not closed out are attributed to the site(s). During the site audit, the SQF quality auditor audits the application of the implementation of the applicable corporate-managed policies and procedures at the site level, according to the scope of certification. All applicable elements of the SQF Quality Code are audited at each site regardless of the findings of the corporate audit. DefinedTerm A2:15 Language Used During the AuditThe Certification Body ensures the SQF quality auditor competently communicates in the spoken and written language of the site. A translator is provided by the Certification Body with the knowledge of the technical terms used in the audit, is independent of the site, and has no conflict of interest. The site is to be notified of any increase in the audit duration and cost associated with the use of a translator. If there is a conflict, the English version of the SQF Food Safety Code prevails. DefinedTerm A2:16 Conducting the AuditThe SQF quality auditor(s) will use a vertical audit exercise to review the documentation and the effectiveness of the implemented SQF Quality System. The auditor(s) collects evidence of compliance or deviations for all applicable elements of the SQF Code by reviewing documentation, including policies, procedures, specifications, and records; interviewing key personnel; and observing the condition of the site, operational activities, and cleaning activities.The auditor will review the entire site, including the interior and exterior of the buildings and representative commodities, regardless of the scope of certification and agreed upon exclusions. The site audit includes a review of all operational and cleaning shifts and pre-operational inspections, where applicable.When remote ICT audit methods are used, SQFI expects that the auditor will spend eighty (80)% of the on-site audit time making observations and conducting interviews. DefinedTerm A2:17 DeviationsDuring each audit, the SQF quality auditor(s) will advise the site of the number of deviations, including both the associated code element and the description for each.Deviations against the SQF Quality Code are graded as follows:A minor quality deviation is an omission or deficiency in the quality system that produces unsatisfactory conditions that if not addressed may lead to a quality threat but not likely to cause a system element breakdown.A major quality deviation is an omission or deficiency in the quality system producing unsatisfactory conditions that carry a significant quality threat and are likely to result in a system element breakdown.No critical deviations are raised at an SQF Quality Code audit. DefinedTerm A2:18 Audit ScoreThere is no score or rating issued for SQF Quality System audits. The score and ratings that apply to SQF Food Safety certification audits do not extend to the SQF Quality Code certification audit, even if the quality system audit is conducted as an extension of the food safety audit. DefinedTerm A2:19 Audit Report Review ProcessAt the end of the site audit, the audit report is in draft form. The audit evidence is deemed the auditor’s recommendation until it is reviewed and approved by the authorized person of the Certification Body for technical content and application of the SQF Quality Code. SQFI requires:The SQF quality auditor must report on all applicable elements (refer to A2:8) as compliant or non-compliant before the SQF quality audit report may be submitted.The SQF quality auditor must report all deviations to the site before the closing of the site audit in a written format.Deviations (refer to A2:17) identified during the site audit must be accurately described in the SQF quality audit report, including the element of the SQF Quality Code and the evidence of deviation.The draft audit report is completed by the SQF quality auditor and provided to the Certification Body for technical review.The Certification Body reviews and approves the audit evidence and makes the report available to the site within ten (10) calendar days from the last day of the audit. DefinedTerm A2:20 Corrective ActionsAll minor and major deviations must be addressed through corrective actions that eliminate the root cause and prevent recurrence. Documented evidence of both the root cause analysis and corrective actions must be submitted to the Certification Body. The SQF quality auditor, or Certification Body designee, will verify that the response adequately addresses the deviations in a timely manner.All corrective actions must be approved by the auditor, or Certification Body designee, and closed in the SQFI Assessment Database within forty (40) calendar days of the site audit’s completion. Failure to provide root cause analysis, submit corrective actions, or obtain auditor verification within this timeframe will result in the site being ineligible for certification (refer to A2:27).Extensions may be granted for minor or major deviation by the certification body upon request when:No immediate threat is identified to product quality and temporary controls are in place;Corrective actions involve structural changes;Affected by seasonal constraints; orRequire long lead-time installations.In all cases, the site must provided justification for extension and interim controls mitigate product quality risks. The deviations must be marked as closed with extension in the database within the 40-day window. The auditor will document the justification for the extension, the risk control measures, and the agreed completion date.When there is a repeat deviation from the previous audit, the auditor, at their discretion, may assign additional nonconformances under the corrective and preventative action clause. DefinedTerm A2:21 Granting Quality CertificationThe Certification Body makes the certification decision based on the evidence of compliance and non-compliance requirements and the effectiveness of the closeout of deviations and the recommendation of the SQF quality auditor. Although SQFI provides guidance on certification, the Certification Body is responsible for deciding if certification is justified and granted, based on the objective evidence provided by the SQF quality auditor.Any certification decisions that are made outside the scope of this clause require the Certification Body to provide written justification to SQFI. The final audit report with completed and approved corrective actions is made available to the site. The SQF quality audit report is the property of the site and cannot be distributed to other parties without the site’s permission.Certification of the SQF Quality System is awarded to sites when all quality deviations are closed within the required timeframe. The Certification Body makes the certification decision no more than fifty (50) calendar days from the last day of the site audit. Once SQF certification is granted, SQFI issues a unique SQFI Identification Number (SIN), which is specific to that site. The SIN applies to their SQF food safety and quality certification and remains with that site as long as they hold their SQF certification.Sites that are certified to another food safety management standard and meet the requirements of the SQF Quality Code are granted a new SIN by their Certification Body. DefinedTerm A2:22 Quality Certificate IssueWithin five (5) calendar days of granting certification, the Certification Body will provide the site with an electronic and/or hard copy of the certificate. The certificate is valid for seventy-five (75) days beyond the anniversary of the initial certification audit date. Certified site information is posted on www.sqfi.com. The certificate remains the property of the Certification Body and in a form approved by SQFI. It must include the following information:Name and address of the site as listed on the SQFI Assessment Database;Name, address, and logo of the Certification Body;Logo of the accreditation body and the Certification Body’s accreditation number;Heading “certificate”;Phrase “(site name) is registered as meeting the requirements of the relevant SQF Quality Code, Edition 10";Products included in the scope of certification;Dates of on-site audit, date of next re-certification audit, date of certification decision, and date of certificate expiry;Signatures of the authorized officer and/or issuing officer of the Certification Body;SQF Quality Shield; andCertificate number.Certified site information is posted on www.sqfi.com.Certificates are published in English. However certified sites in non-English-speaking countries may require a certificate in a local language. SQFI allows the Certification Body to issue local language certificates on request as long as:The certificate information listed above is included; andThe Certification Body has a protocol in place for translation and can verify the translation. DefinedTerm A2:23 SQF Quality ShieldCertified sites may choose to apply the SQF quality shield to packaging of certified products or to marketing materials. The Certification Body grants permission for usage of SQF quality shield and provides an electronic file on request. The provided electronic file of SQF quality shield contains the Certification Body name and site certification number to the certified site.The SQF quality shield can only be used in accordance with the SQF Quality Shield Rules of Use. The use and application of the quality shield is auditable. DefinedTerm A2:24 Failure to ComplyWhere a site fails to close out quality deviations within the required time frame, the site is considered to have failed their SQF quality certification audit.For initial certification audits, the site must reapply for a new certification audit.For recertification audits, the site will be immediately suspended (refer to A2:27). Certification will only be reinstated following a successful site visit and corrective action plan has been successfully implemented. DefinedTerm A2:25 Appeals and ComplaintsEach Certification Body has its own documented procedure for handling and resolving appeals and complaints made by the site or by another party about the site.Appeals:The Certification Body's appeals procedure is to be publicly available. Appeals to a decision made by the SQF quality auditor in regard to the audit or an action taken by the Certification Body in regard to the certification must first be lodged directly with the Certification Body. Appeals regarding suspension and/or withdrawal of the SQF certification by a Certification Body do not delay the decision to suspend or withdraw the certification. The Certification Body is required to investigate and resolve appeals without delay and must keep a record of all appeals and their resolution.Appeals to the audit must be made to the Certification Body within fifteen (15) days from when the technically reviewed evidence is issued to the site. Certification Bodies are required to respond within fifteen (15) calendar days. If the appeal has first been referred to the Certification Body and cannot be satisfactorily resolved by them, the matter may then be referred to SQFI following the process listed on the Integrity Program page on www.sqfi.com. In the event that the appeal cannot be satisfactorily resolved, the site has fifty-five (55) days from the last day of the audit to refer the matter to SQFI.Complaints:Complaints about the conduct or behavior of an SQF-registered auditor or other Certification Body personnel and complaints about an SQF-certified site from other parties are to be lodged directly with the Certification Body. The Certification Body is required to investigate and resolve complaints without delay and must keep a record of all complaints and their resolution. If, upon the investigation of a complaint, it is determined that there has been a substantiated breakdown of the site’s SQF Quality System or any other condition not in compliance with the SQF Quality Code, the Certification Body is required to suspend certification.Complaints about SQFI, the SQF Codes, the SQFI Assessment Database, SQF training centers, and SQF professionals and unresolved complaints lodged with Certification Bodies can be referred to SQFI via the Integrity Program page on sqfi.com. Any complaint that pertains to an audit is to be filed with the Certification Body or SQFI within eighty-five (85) days from the last day of the audit. DefinedTerm A2:26 Surveillance AuditsA quality surveillance audit is only required as an extension of a food safety surveillance audit or when, in the opinion of the Certification Body, a quality surveillance audit is necessary to maintain the integrity of the site’s quality system.If a quality surveillance audit is conducted, all deviations must be closed out according to A2:20. DefinedTerm A2:27 SuspensionThe Certification Body is required to suspend the SQF certificate if the site:Fails to permit the re-certification or surveillance audit within the 60-day audit window or approved extension;Fails to take corrective action within the time frame specified;Refuses entry to an auditor or SQFI during a non-audit event, such as an SQFI validation audit or verification of corrective action;Fails to maintain the requirements of the SQF Quality Code; orFails to meet the agreements set forth by the Certification Body.If the site’s certificate is suspended, the Certification Body immediately amends the site details on the SQFI Assessment Database to “suspended” status, indicating the reason for the suspension and the effective date. The Certification Body must inform the site in writing of the reasons for the suspension and the effective date. The site must acknowledge receipt of the suspension notification. Sites with a suspended SQF certificate may not represent themselves as holding an SQF certificate or use the Quality Shield in any way outlined in Quality Shield Rules of use for the duration of the suspension.Appeals regarding decisions on the suspension of the SQF certification by a Certification Body shall not delay the decision to suspend or withdraw the certification (refer to A2:25). DefinedTerm A2:27-1 Reporting suspension in the event the site does not permit the audit to occurIF: The site fails to permit the audit during the sixty (60) day audit window or approved extension:THEN: The Certification Body requests that within forty-eight (48) hours of receiving notice of the suspension, the site provide a plan detailing the justification for the delay and the timetable for the rescheduled audit (must be no more than thirty (30) days from the audit window).The Certification Body conducts an announced on-site recertification or surveillance audit (as applicable) within thirty (30) calendar days of receiving the corrective action plan.If the site successfully completes the SQF audit, the Certification Body reinstates the site status on the SQFI Assessment Database and provides the site with written notice that the certificate is no longer suspended.Since the site failed to permit the re-certification audit in the designated time frame, the Certification Body conducts an additional unannounced surveillance audit no more than six (6) months after the suspension to verify continued compliance with the SQF Code. DefinedTerm A2:27-2 Reporting suspension in the event the site fails to take corrective actionIF: The site does not take corrective action within the time frame specified:THEN: The Certification Body requests that within forty-eight (48) hours of receiving notice of the suspension, the site provide a detailed plan outlining the corrective actions to be taken to resolve the outstanding deviations.The Certification Body verifies that the corrective action plan has been implemented through an on-site visit within thirty (30) calendar days of receiving the corrective action plan.When the corrective action plan has been successfully implemented, the Certification Body reinstates the site status on the SQFI Assessment Database and provides the site with written notice that the certificate is no longer suspended. DefinedTerm A2:27-3 Reporting suspension in the event the site fails to maintain the requirements of the SQF Quality CodeIF: The site does not maintain the requirements of the SQF Quality Code:THEN: The Certification Body requests that within forty-eight (48) hours of receiving notice of the suspension, the site provide a detailed plan outlining the corrective actions to be taken regarding the failure to maintain the SQF Quality Code regarding the specific incident.The Certification Body verifies the corrective actions have been implemented by means of an on-site visit within thirty (30) calendar days of receiving the corrective action plan. When the corrective action plan has been successfully implemented, the Certification Body reinstates the site status on the SQFI Assessment Database and provides the site with written notice that the certificate is no longer suspended. DefinedTerm A2:27-4 Reporting Suspension in the event the site fails to meet the agreements set forth by the Certification BodyIF: The site fails to meet the agreements set forth by the Certification Body:THEN: The Certification Body requests that within forty-eight (48) hours of receiving notice of the suspension, the site provide a plan detailing the actions to be taken to meet the agreements set forth by the Certification Body.When the agreement between the Certification Body and the site has been successfully met, the Certification Body reinstates the site status on the SQFI Assessment Database and provides the site with written notice that the certificate is no longer suspended. DefinedTerm A2:28 Withdrawing Quality CertificationThe Certification Body withdraws the certificate if the site:Has been placed under suspension and fails to follow the suspension protocol, as defined by the Certification Body in your notice of suspension;Fails to take approved corrective action within the time frames specified, as determined by the Certification Body;Has intentionally and systemically falsified its records; orFails to maintain the integrity of the SQF Quality certificate.If the site’s certificate is withdrawn, the Certification Body immediately amends the site details on the SQFI Assessment Database to a “withdrawn” status, indicating the reason for the withdrawal and the effective date. The Certification Body must informs the site in writing of the reasons for withdrawal and the effective date.The site must acknowledge receipt of the withdrawal notification and return the certificate within thirty (30) days of notification. If the certificate is withdrawn, the site is not permitted to re-apply for certification for twelve (12) months from the date the certificate was withdrawn by the Certification Body.Withdrawn sites cannot use the SQF Quality Shield on packaging or other printed materials (refer to Quality Shield Rules of Use). DefinedTerm A2:29 Changes to Site SQF RequirementsThe SQF Quality Code enables sites to change the audit requirements based on changing business arrangements. These include changes and additions in product scope, changing your Certification Body, site relocation, and changes in business ownership. If assistance with any of these changes is needed, the site may contact the SQFI customer service team at info@sqfi.com. DefinedTerm A2:30 Changes to Audit DatesAll requests regarding temporary or permanent certification date changes for legitimate business reasons (such as changes to seasonal operation timeframe, temporary site closures, acts of nature, or extreme weather) must be sent to the site's current SQF Certification Body. Valid requests must then be submitted to SQFI by the site's Certification Body. Written approval by SQFI Compliance is required to issue a date extension to the site’s certificate or a temporary or permanent change to the site’s re-certification audit time frame. DefinedTerm A2:31 Relocation of PremisesSQF certification is site-specific (refer to step A2:4); if the site relocates its business premises, the site’s certification does not transfer to the new site location. A successful certification of the new site location is required. An initial certification audit must be completed for the new site. DefinedTerm A2:32 Change of Business OwnershipIf the ownership of a certified site changes (e.g., the site’s business has been sold), within thirty (30) calendar days of the change of ownership, the new owner is required to notify the Certification Body and apply to retain the SQF certification with the existing certification number.The Certification Body shall retain the existing audit frequency status and existing certification number if the site personnel with major responsibility for the management and oversight of the SQF Quality System has been retained.The Certification Body is required to complete an initial certification audit, issue a new certificate and certification number, and apply audit frequency applicable to a new certification if the site has significant changes in site management and personnel. DefinedTerm A2:33 The SQFI Compliance and Integrity ProgramTo meet the requirements of SQFI’s Compliance and Integrity Program, SQFI may randomly monitor the activities of the Certification Bodies and their auditors through techniques that include but are not limited to validation and/or witness audits.While conducting these additional monitoring activities, the site is required to allow SQFI- authorized representatives into the site during or after the audit has taken place. The attendance of an SQFI representative does not interfere with the site’s operations or result in additional audit time or non-conformances, and it will not increase the cost charged by the Certification Body for the audit. DefinedTermSet Module 2: System Elements - Quality DefinedTerm 2.5.2.1 The methods, responsibility, and criteria for verifying the effectiveness of monitoring critical quality points and other process and quality controls shall be documented and implemented.The methods applied shall:Ensure that responsible personnel authorize each verified record to demonstrate proper completion of the monitoring activities;Require verification of certificates of conformance, certificates of analysis, letter of guarantee, and/or inspection and testing for all raw materials including food contact packaging; andRequire comparison between process control limits and specification limits to ensure alignment and appropriate process control corrections. DefinedTerm 2.3.2.1 The methods and responsibility for developing, managing, and approving raw material, finished product, and packaging quality specifications shall be documented. DefinedTerm 2.4.1.1 The methods and responsibilities for managing customer requirements and/or consumer expectations shall be documented and implemented. They shall include at a minimum:A review and approval process for all new or revised customer requirements, as they occur;A process for collection and analysis of data for product quality attributes to ensure specifications continue to meet consumer expectations; andA communication process to notify identified customers when the ability to supply compliant products is temporarily halted.If customer does not have a quality specification, internal quality specification must be met at minimum. DefinedTerm 2.3.1 Product Development DefinedTerm 2.4.3.1 The food quality plan shall outline how the site controls and assures the quality attributes of all products or product groups and their associated processes included in the scope of SQF certification.More than one food quality plan may be required to cover all products included in the scope of certification. DefinedTerm 2.3.4.1 The methods and responsibility for selecting, evaluating, approving, and monitoring suppliers, including emergency suppliers and suppliers under the same corporate ownership, shall be documented, implemented and include, at a minimum:Past performance of a supplier;Risk level of the supplied product;Agreed specifications;Summary of the quality controls implemented by the supplier;Methods for granting approval and reviewing supplier status;Methods and frequency of monitoring supplier performance;Methods and frequency of verification of supplied product including packaging; andSupplier contact details. DefinedTerm 2.4.6.1 The responsibility and methods outlining how ingredients, packaging, or products are reworked, or similar activities (i.e. reconditioning, recoup) to ensure that the quality or formulation of the finished product is not compromised shall be documented and implemented. The methods applied shall ensure rework is:Overseen by qualified personnel;Clearly identified and traceable;Processed in accordance with the site’s quality plan; andInspected, analyzed and released as required in 2.4.4 and 2.4.7. DefinedTerm 2.7.1.1 The methods, responsibility, and criteria for identifying the site's vulnerability to food fraud that could adversely impact food quality, including susceptibility to raw material or ingredient substitution, finished product mislabeling, dilution, or counterfeiting, shall be documented, implemented, and maintained.This assessment may address both food safety and quality. DefinedTerm 2.6.1 Product Identification DefinedTerm 2.4.4.1 The methods, responsibility, and criteria for sampling, inspecting, and/or analyzing raw materials, work-in-progress, finished product, and other quality parameters evaluations shall be documented and implemented. Processing parameters or in-process measurements shall be established, validated, and verified at a determined frequency to meet all customer, regulatory, and/or internal requirements. DefinedTerm 2.2.2.1 The methods and responsibility for maintaining document control and ensuring personnel have access to current requirements and instructions shall be documented and implemented. Current quality documents shall be maintained and changes communicated to relevant personnel when documents have been revised. DefinedTerm 2.1.1 Management Responsibility DefinedTerm 2.9.1 Training Program DefinedTerm 2.4.7.1 The responsibility and methods for product positive release procedures shall be documented and implemented. The methods applied shall ensure at time deliver product complies with:All internal, regulatory, and/or agreed customer requirements;Product specifications, including sensory attributes;Packaging and package integrity;Labeling requirements; andDelivery and service requirements. DefinedTerm 2.1.3.1 The methods and responsibilities for for handling, investigating, and resolving quality complaints from customers, consumers, and authorities, arising from products manufactured or handled on-site or co-manufactured, shall be documented and implemented. DefinedTerm 2.4.3.2 A food quality plan shall be developed, effectively implemented, and maintained by a multidisciplinary team including SQF quality practitioner in accordance with a risk-based method. Quality threats and critical quality points and their controls must be identified. Where the relevant expertise is not available on-site, advice may be obtained from other sources to assist the food safety team.The food quality plan may be combined with or independent from the food safety plan. DefinedTerm 2.5.1.1 The methods, responsibility, and criteria for ensuring effectiveness of critical quality limits, process controls, and other quality tests established to meet internal and customer requirements shall be documented and implemented.The methods applied shall validate that food quality plans, including critical quality limits, are effective at implementation and re-validated or justified by regulatory standards when changes occur. DefinedTerm 2.4.5.1 The responsibility and methods outlining how to handle non-conforming product, raw material, ingredient, work-in-progress, packaging or equipment, which is detected during receipt, storage, processing, handling, or delivery, shall be documented and implemented. The methods applied shall ensure:Non-conforming product or equipment is identified, quarantined, assessed/evaluated, and/or dispositioned in a manner that minimizes the risk of inadvertent/improper use, or risk to the integrity of finished product;All relevant personnel are aware of the site’s quarantine and release requirements applicable to product/equipment placed under quarantine status;All products of unknown status are included in this process; andNon-conforming product determine to be reworked must comply with 2.4.6. DefinedTerm 2.4.1 Customer Requirements DefinedTerm 2.2.3.1 The site shall maintain relevant and appropriate records, as necessary, to demonstrate the effective implementation, maintenance, and continuous improvement of the quality management system. The methods and responsibility for maintaining and retaining records shall be documented and implemented. DefinedTerm 2.8.1.1 The methods and responsibility for the identification, label approval, and processing of food and other products requiring the preservation of their identity preserved status (e.g., Kosher, Halal, organic, GMO free, regional provenance, free from, free trade, etc.) shall be documented and implemented. DefinedTerm 2.3.3.1 All agreements with contract manufacturers, third-party storage and distribution facilities and contract service providers that have an impact on product quality shall be documented and include:Information to ensure all food quality requirements are met; andA full description of the product and services to be provided.These agreements shall be approved by both parties, communicated to relevant personnel, and kept current. DefinedTerm 2.7.1 Food Fraud DefinedTerm 2.6.2.1 The methods and responsibility used to trace product shall be documented and implemented to ensure:Finished product is traceable at least one step forward to the customer;Raw materials, ingredients, food contact packaging, and other inputs including processing aids are traceable at least one step back from the process to the manufacturing supplier and includes documentation of all receipt dates;Traceability is maintained where product is reworked (refer to 2.4.6); andThe effectiveness of the product trace system is tested at least annually and shall be carried out on products from different shifts and for materials (including bulk materials) that are used across a range of products and/or products that are shipped to a wide range of customers. DefinedTerm 2.4.2.1 The buildings and equipment shall be constructed, designed, and maintained to facilitate the manufacture, handling, storage, and/or delivery of product that meets customer specifications, regulatory, and/or internal quality requirements. DefinedTerm 2.5.4.1 The methods and responsibility for scheduling and conducting internal audits to verify the effectiveness of the entire SQF Quality System shall be documented and implemented. Internal audits must be conducted at least annually.The methods applied shall ensure:Personnel conducting internal audits have understanding of quality processes and process controls and are independent of the function audited, where practical;All applicable requirements of the SQF Quality Code are audited per the SQF audit checklist or a similar tool;Objective evidence is recorded to verify compliance and/or non-compliance;Root cause analysis, corrections, and corrective and preventative actions,for deficiencies or trends indicating potential deficiencies, identified during the internal audits are undertaken according to 2.5.3; andAudit results are communicated to relevant site leadership and personnel responsible for implementing and verifying the effectiveness of actions taken according to 2.5.3. DefinedTerm 2.2.1.1 The site shall ensure that all documentation used to meet the requirements of the SQF Quality Code are established, implemented, maintained, kept current, and made available to the relevant personnel. Documentation may be in electronic and/or hard copy form.The quality system manual may be incorporated into or be independent of the food safety system manual. DefinedTerm 2.1.2.1 The SQF Quality System shall be reviewed by site management at least annually and include:Changes to quality management system documentation;Monitor compliance to quality specifications and customer requirements;Trends related to the quality management system (e.g., audit findings, complaints);Performance towards quality culture performance;Performance to quality objectives and measures;Review of quality recalls; andFollow-up action items from previous management reviews. DefinedTerm 2.6.4.1 A crisis management plan shall document the known potential dangers that can impact the site's ability to deliver quality product and outline the methods the site shall implement to cope with such a crisis. The crisis management plan shall include at a minimum:A senior manager responsible for decision-making, oversight, and initiating actions arising from a crisis management incident;The selection of a crisis management team;The controls implemented to ensure any responses do not compromise product quality;The measures to isolate and identify product affected by a response to a crisis;The measures taken to verify the acceptability of product prior to release;The preparation and maintenance of a current crisis alert contact list, including supply chain customers;Sources of legal and expert advice; andThe responsibility for internal communications and communicating with authorities, external organizations, and media. DefinedTerm 2.6.1.1 The methods and responsibility for identifying raw materials, ingredients, packaging, work-in-progress, process inputs, and finished product shall be documented and implemented to ensure:Clear identification during all stages of receipt, production, storage, and dispatch; andLabeling is completed according to internal, customer, and/or regulatory requirements.This shall include identification and labeling in accordance with the regulatory requirements of those products produced on production lines and equipment on which foods containing identity preserved foods are manufactured. DefinedTerm 2.6.3.1 The methods and responsibility used to withdraw or recall product due to failure to meet customer, regulatory, or internal quality requirements shall be documented and implemented. The procedure shall:Identify those responsible for initiating, managing, and investigating a quality product withdrawal or recall;Provide essential traceability information;Outline a communication plan to inform personnel, customers, consumers, authorities, and other essential bodies in a timely manner appropriate about the nature of the incident. DefinedTerm 2.5.3.1 The responsibility and methods outlining how quality issues, deviations, and non-conformances are investigated and resolved shall be documented and implemented. These shall include, but not be limited to, deviations of critical quality limits, complaints, findings at internal and external audits, non-conforming product, verification and validation activities, withdrawals and recalls, and negative trends of the food quality system.This procedure shall include, at a minimum, the:Use of corrections, as applicable, to address the identified issue;Method(s) of analysis used to investigate and identify the root cause:Process for determining and implementing the corrective and preventative actions needed to address the root cause;Verification of effectiveness of the implemented actions to prevent reoccurrence; andCommunication of results to relevant site leadership and personnel. DefinedTerm 2.9.1.1 A training program shall be documented and implemented that at a minimum:Establishes the training needs of the personnel to ensure they have the required competencies to carry out those functions essential to the effective implementation of the SQF Quality System;Identifies the training methods to be applied;Provides the appropriate training and training materials, in language(s) understood by personnel, to ensure products meet legal, customer, company, and SQF Code requirements;Determines the frequency that training is to be conducted; andIncludes provisions for identifying and implementing the refresher training needs of personnel. DefinedTerm 2.1 Management Commitment DefinedTerm 2.3.1.1 The methods and responsibility for designing, developing and implementing new products into production shall be documented and implemented.This process shall include a comparison of process controls with specification limits (i.e., process capability analysis) to ensure that processes can consistently supply products that meet specifications.Products not in production for more than a year shall be assessed to ensure controls are still effective for changes that have occurred to processes or procedures. DefinedTerm 2.3.5.1 The site shall document and implement a procedure to evaluate any changes, including temporary, emergency, unplanned or those made as a result of the corrective action process, that could impact quality or the quality system to ensure that controls are still effective.This procedure, at a minimum, shall include changes in:Product formulations and manufacturing processes for products included in the scope of certification;Materials, ingredients, labels, other inputs, equipment or other resources;Specifications for raw materials and packaging, chemicals, processing aids, contract services, and finished products; andThe quality plan including critical quality limits.Changes shall be confirmed or validated, documented and communicated, as necessary, in a timeframe that ensures quality is maintained. DefinedTerm 2.5.1 Validation and Effectiveness DefinedTerm 2.1.1.1 A food quality policy, signed by the senior site manager is to be established and maintained that outlines at a minimum the commitment of all site management to:Supply product in compliance with all customer, regulatory, and internal quality requirements;Establish and maintain the site's quality performance;Establish and continually improve the site's food quality management system; andEffectively communicate this policy to all personnel in a language(s) they understand.It may be included in or separate from the organization’s food safety policy. DefinedTerm 2.3.2 Specifications (Raw Material, Packaging, and Finished Product) DefinedTerm 2.2.1 Quality Management System DefinedTerm 2.2.3.2 Records shall be legible, readily accessible, retrievable, and securely stored to prevent unauthorized access, loss, damage, and deterioration. Retention periods shall be in accordance with customer or regulations, at minimum the product shelf life or established by the site if no shelf life exists. DefinedTerm 2.8.1 Identity Preserved Foods DefinedTerm 2.6.2 Product Trace DefinedTerm 2.4.3.3 The scope of the food quality plan shall be developed and documented, including the start and endpoints of the processes under consideration and all relevant inputs and outputs. DefinedTerm 2.3.4.2 Supplier audits shall be based on risk and shall be conducted by personnel knowledgeable of applicable regulatory and quality requirements. DefinedTerm 2.8.1.2 Identification shall include a statement of the product’s identity preserved status of all ingredients, including additives, preservatives, processing aids, and flavorings. DefinedTerm 2.1.2.2 Site management shall be updated at least monthly and include:Matters impacting the implementation or maintenance of the SQF Quality system;Corrections, and corrective and preventative actions;Results from internal and external audits;Quality complaints; andVerification and validation activities. DefinedTerm 2.9.1.2 Training shall be provided for all personnel involved in:Developing and maintaining food quality plans;Monitoring critical quality points;Implementing the corrective action process, including root cause analysis;Conducting audits (internal and supplier); andAny other tasks identified as critical to meeting the effective implementation and maintenance of the SQF Quality Code.A documented assessment shall be included as part of the training. DefinedTerm 2.3.2.2 Specifications for all raw materials and packaging, including, but not limited to, ingredients, additives, agricultural inputs (where applicable), hazardous chemicals, processing aids, and packaging that impact finished product quality shall be documented and kept current. DefinedTerm 2.7.1.2 A food fraud mitigation plan shall be developed and implemented that specifies the methods by which the identified food fraud vulnerabilities that could adversely impact food quality shall be controlled, including identified quality vulnerabilities of ingredients and materials. DefinedTerm 2.3.3 Contractual Agreements DefinedTerm 2.5.2 Verification Activities DefinedTerm 2.4.1.2 Where customer products, materials, or equipment are used within the facility, the site shall have measures in place to safeguard customer property and ensure its correct and proper use. DefinedTerm 2.5.2.2 A verification schedule outlining the verification activities, their frequency of completion, and the person responsible for each activity shall be prepared and implemented. DefinedTerm 2.1.1.2 Site management will build a positive quality culture within the site that ensures at a minimum:Quality practices and all applicable requirements of the SQF Quality Code are implemented and maintained;Personnel are informed and held accountable for their requirements of the SQF Quality Code responsibilities, including to meet objectives;Personnel are encouraged and required to notify management about actual or potential quality issues; andPersonnel are empowered to act to resolve quality deviations within their scope of work. DefinedTerm 2.3.3.2 For products and processes of co-manufacturers and third-party storage and distribution facilities, the site shall:Ensure that they are confirmed to be in compliance with the SQF Quality Code, customer, and corporate quality requirements, where applicable. Confirmation is determined relevant to the risk level, through an audit by the site, a third-party agency, or other suitable means.Determine and document the quality risk level of contract manufactured and/or contract stored product. DefinedTerm 2.6.1.2 Product start-up, product changeover, and packaging changeover (including label changes) procedures shall be documented and implemented to include verification of quality attributes required to meet finished product specifications and customer requirements. DefinedTerm 2.4.2 Quality Fundamentals DefinedTerm 2.2.2 Document Control DefinedTerm 2.1.3.2 Trends of quality complaint data shall be investigated and analyzed. Root cause analysis and the corrective action process shall be completed for all adverse trends as outlined in 2.5.3. DefinedTerm 2.2 Documentation and Records DefinedTerm 2.1.2 Management Review DefinedTerm 2.4.4.2 Internal laboratories and inspection stations shall be equipped and resourced to enable testing of in-process and finished products to meet customer, regulatory, and/or internal requirements and meet quality objectives. Proficiency testing shall be completed in accordance with requirements of ISO/IEC 17025. DefinedTerm 2.4.2.2 The methods and responsibility for the calibration of measuring, test, and inspection equipment used for quality testing of raw materials, work-in-progress, and finished product, for food quality plans and other process controls, or to demonstrate compliance with internal and customer specifications, shall be documented and implemented. Software used for such activities shall be validated as appropriate. DefinedTerm 2.3.1.2 Product formulations shall be developed by authorized personnel to ensure that they meet the intended use. Where necessary, shelf life trials shall be conducted to ensure products meet quality requirements. Consideration shall be given, where applicable, to:Pre-consumer and consumer preparation, storage and handling requirements, including the establishment of “use by,” “best before dates,” or equivalent terminology;Food contact packaging adequacy;Customer requirements; andLabeling requirements. DefinedTerm 2.4.2.3 Storage and transport of raw materials, work-in-progress, and finished product shall be suitable to maintain the integrity of the product without loss, waste, or damage and to meet internal and customer requirements for inventory management and transportation, where applicable. DefinedTerm 2.6.3 Product Withdrawal and Recall DefinedTerm 2.8.1.3 Requirements regarding identity preserved foods raw materials and ingredients shall be documented for handling, transport, storage and delivery prior to use. DefinedTerm 2.2.3.3 Records to support the completion of all annual requirements shall be maintained and include at a minimum:Management review (refer to 2.1.2);Internal audits (refer to 2.5.4);Food fraud vulnerability assessment review (refer to 2.7.1);Traceability test (refer to 2.6.2);Crisis management test (refer to 2.6.4);Recall test (refer to 2.6.3); andFood quality plan review (refer to 2.4.3). DefinedTerm 2.3 Specifications, Product Development, and Supplier Approval DefinedTerm 2.9.1.3 Instruction shall be provided, at a minimum, to all relevant personnel and contractors involved in the effective implementation and maintenance of the following programs or plans:Sensory EvaluationsFood fraud mitigation;Recall;Traceability;Supplier and co-manufacturer audits; andSampling and testing of all raw materials including packaging, work-in-progress, and finished products. DefinedTerm 2.2.3 Records DefinedTerm 2.4.4.3 Process control methods shall be used to effectively control and optimize production processes to improve process efficiency, product quality, and reduce waste. Control charts and/or other quality tools shall be used for control of key processes. DefinedTerm 2.3.4 Approved Supplier Program DefinedTerm 2.1.1.3 Site management shall establish, document, and communicate to all personnel quality objectives and performance measures. They will ensure departments and operations are appropriately staffed and organizationally aligned with adequate resources to meet and maintain these quality objectivesThe reporting structure shall:Document the job functions for key personnel whose activities affect quality;Identify a backup(s) for these key personnel; andEnsure the integrity and continued operation of the quality system in the event of organizational or personnel changes. DefinedTerm 2.1.3 Complaint Management DefinedTerm 2.3.2.3 Raw materials, packaging, and ingredient specifications shall be reviewed and confirmed to ensure product quality is not compromised and the material is fit for its intended purpose. DefinedTerm 2.5.3 Corrections, and Corrective and Preventative Actions DefinedTerm 2.4.3 Food Quality Plan DefinedTerm 2.4.3.4 Product descriptions shall be developed and documented for all products included in the scope of the food quality plan. This shall include information in the finished product specifications (refer to 2.3.2.2) plus any additional quality or service attributes established by agreement with the customers. DefinedTerm 2.6.4 Crisis Management Planning DefinedTerm 2.1.1.4 A primary and substitute SQF Quality Practitioner shall be designated with responsibility and authority to:Oversee the development, implementation, review, and maintenance of the SQF Quality System, including quality fundamentals;Take appropriate action to ensure the integrity of the SQF Quality System and escalate to site management key quality issues or events;Communicate to relevant personnel all information essential to ensure the effective implementation and maintenance of the SQF Quality System; andEnsure the proper use of the SQF Quality Shield, according to the requirements in SQF Quality Shield Rules of Use.The primary and substitute SQF Quality Practitioner shall:Be employed at the site (while designated as the primary SQF Quality Practitioner);Understand the Quality Code and the requirements to implement and maintain a quality management system using a risk-based methodology; andBe competent, through training or experience, in process control and/or other quality tools to reduce process variation impacting quality and achieve customer requirements. DefinedTerm 2.4 Food Quality System DefinedTerm 2.8.1.4 Assurances concerning the raw material or ingredient’s identity preserved status shall be by agreement with the supplier of the material. DefinedTerm 2.2.3.4 Where applicable, records demonstrating implementation of the quality management system shall be maintained and include:Monthly management updates (refer to 2.1.2);Product development approvals (refer to 2.3.1);Supplier approvals (refer to 2.3.4);Root cause analysis and the corrective action process (refer to 2.5.3);Validation and verification records (refer to 2.5.1 and 2.5.2);Change management (refer to 2.3.5);Complaints, investigation and resolutions (refer to 2.1.3); andContractual agreements (refer to 2.3.3). DefinedTerm 2.9.1.4 Training records shall be maintained and include:Participant name;Description of necessary skills;Description of the training provided;Date training completed;Trainer or training provider; andVerification that the trainee is competent to complete the required tasks. DefinedTerm 2.4.4 Sampling, Inspection, and Analysis DefinedTerm 2.5.4 Internal Audits DefinedTerm 2.3.5 Change Management DefinedTerm 2.3.2.4 Product labels shall be accurate, comply with customer requirements, internal requirements, and be approved by qualified personnel.Records of customer approvals shall be maintained. DefinedTerm 2.4.4.4 A sensory evaluation program shall be in place to ensure alignment with agreed customer and/or internal requirements. Sensory evaluation results shall be documented and communicated with relevant personnel and with customers where appropriate. DefinedTerm 2.4.3.5 The intended use of each product shall be determined and documented by the food quality team. This shall include, as appropriate, target consumer groups, ease of use by consumers, consumer instructions, evidence of tampering, other applicable information affecting product quality, requirements for further processing if applicable, and potential alternative uses of the product. DefinedTerm 2.4.4.5 External laboratories shall be accredited to ISO/IEC 17025, or equivalent. The tests performed shall be included on the laboratory's scope of accreditation. DefinedTerm 2.5 Validation and Verification DefinedTerm 2.4.5 Non-conforming Product or Equipment DefinedTerm 2.8.1.5 The processing of identity preserved foods shall be conducted under controlled conditions such that:Ingredients are physically separated from ingredients identified as incompatible with the identity preserved food;Processing is completed in separate rooms, scheduled as the first production run, or carried out after completion of thorough sanitation of the processing area and equipment; andFinished product is stored and transported in separate units or isolated by a physical barrier from the non-specialty product. DefinedTerm 2.2.3.5 Where applicable, records to support the quality programs shall be maintained and include:Product rework (refer to 2.4.6);Inspection and analysis (refer to 2.4.4);Product release (refer to 2.4.7);Product changeover (refer to 2.6.1);Critical quality point monitoring (refer to 2.4.3);Non-conforming Product or Equipment (refer to 2.4.5); andProduct traceability and recall (refer to 2.6.2 and 2.6.3). DefinedTerm 2.4.3.6 The food quality team shall develop and document a flow diagram covering the scope of each food quality plan.The flow diagrams shall be verified by the food quality team to ensure process steps, process delays, inputs and outputs that impact product quality are included. DefinedTerm 2.3.2.5 Finished product specifications shall be documented, current, accessible to relevant personnel, and shall include, where applicable:Product quality attributes;Labeling and packaging requirements;Storage, distribution, and handling conditions; andThe shelf life of the product.All finished product specifications shall be approved by the site, and, when required, by its customer. DefinedTerm 2.4.6 Product Rework DefinedTerm 2.8.1.6 Customer-specific requirements for identity preserved foods shall be included in the finished product specification, as described in 2.3.2.5, or approved alternative location and implemented by the site. DefinedTerm 2.4.3.7 The food quality team shall identify and document all quality threats that can reasonably be expected to occur at each step in the processes, including raw materials and other inputs. DefinedTerm 2.6 Product Traceability and Crisis Management DefinedTerm 2.4.4.6 Retention samples, if required by customers, shall be stored according to the typical storage conditions for the product and maintained for the stated shelf life of the product. DefinedTerm 2.7 Food Fraud DefinedTerm 2.4.7 Product Release DefinedTerm 2.4.3.8 The food quality team shall conduct a quality threat analysis for every identified quality threat to determine significant of threats, i.e., their elimination or reduction to an acceptable level is necessary to ensure or maintain product quality. The methodology for determining threat significance shall be documented and used consistently to assess all potential quality threats. DefinedTerm 2.8 Identity Preserved Foods DefinedTerm 2.4.3.9 The food quality team shall determine and document the control measures that must be applied to all significant quality threats. More than one control measure may be required to control an identified threat, and more than one significant threat may be controlled by a specific control measure. DefinedTerm 2.4.3.10 Based on the results of the threat analysis (refer to 2.4.3.8), the food quality team shall identify the steps in the processes where control must be applied to eliminate a significant threat or reduce it to an acceptable level. These steps shall be identified as Critical Quality Points or CQPs. DefinedTerm 2.9 Training DefinedTerm 2.4.3.11 For each identified CQP, the food quality team shall identify and document the quality limits that separate acceptable from unacceptable product. The food quality team shall validate the critical quality limits to ensure the designated level of control of the identified quality threat(s), and that all critical quality limits and control measures individually or in combination effectively provide the level of control required.Critical quality limits are reviewed annually, at a minimum. DefinedTerm 2.4.3.12 The food quality team shall develop and document procedures to monitor CQPs to ensure they remain within the established limits (refer to 2.4.3.11). Monitoring procedures shall identify the personnel assigned to conduct testing, the sampling and test methods, and the test frequency. DefinedTerm 2.4.3.13 The food quality team shall develop and document deviation procedures that identify the disposition of affected product when monitoring indicates a loss of control at a CQP. The procedures shall include root cause analysis, corrections, and corrective and preventative actions to correct the process step to prevent recurrence of the quality failure. DefinedTerm 2.4.3.14 The documented and approved food quality plan, including critical quality limits, shall be implemented in full and reviewed annually.