1.1Purpose of the Code Checklist

Introduction

Section 1. Introduction

1.1Purpose of the Code Checklist

The purpose of the SQF Fundamentals Code checklist is to assist suppliers in performing internal audits and/or gap assessments to the SQF Fundamentals for Manufacturing - Intermediate, Edition 1 and with the organization, implementation, maintenance and audits of SQF Systems designed using the SQF Fundamentals Code.

The relevant Code version number is identified in the document header. Terms used in these documents are defined in Appendix 2: Glossary found in the SQF Fundamentals for Manufacturing- Intermediate, Edition 1.

This checklist is intended assist and support the SQF Fundamentals Code, but does not replace it. It is not an auditable document, nor is it definitive and applicable in every situation. Sites are required to understand the food safety risks in a given industry sector and are able to apply the SQF Fundamentals Code to effectively control those risks. It is recommended that the SQF Guidance Documents be used in conjunction with this document.

1.2Layout of the SQF Code

The SQF Fundamentals for Manufacturing - Intermediate, Edition 1consists of two parts and three appendices. Part A contains the criteria for implementing and maintaining the SQF Fundamentals for Manufacturing Code - Intermediate, Edition 1. Part B, the heart of the SQF Fundamentals Code, is made up of modules. Within each module are clauses or elements, which the site must implement as their SQF System. In module 2, the clauses encompass the system elements. Each element outlines where procedures need to be documented, where record keeping is required or where actions must be taken. Module 11 is the Good Manufacturing Practices (GMP) requirements applicable to various food industry sectors. Sites must meet the requirements of the module or modules applicable to their food industry sector.

The three appendices in the SQF Fundamentals Code provide additional information needed to implement an SQF System:

• Appendix 1: Food Sector Categories
• Appendix 2: Glossary
• Appendix 3: SQF Logo Rules of Use

This checklist will mirror the layout of the SQF Fundamentals Code.

Section 2. Introduction to this Checklist

2.1Scope of the Checklist

This checklist covers the requirements of all the modules in SQF Fundamentals for Manufacturing - Intermediate, Edition 1. All sites seeking certification to the SQF Fundamentals for Manufacturing - Intermediate, Edition 1must document, implement and maintain the system elements of module 2 plus the food safety fundamentals defined in the Modules 11 based on the facility’s food sector category (ies) (FSCs).

2.2Summary Table

In the beginning of this document, a summary table is provided for suppliers who conduct open and closing meetings during the internal audit. Only one summary table is needed for each type of facility audit (including internal audit, gap assessment, official certification, re-certification or surveillance audit):

Audit Statement
Header / Item / Evidence
Opening Meeting / People Present at the Opening Meeting (Please list names and roles in the following format Name: Role separated by comas)
Closing Meeting / People Present at the Closing Meeting (Please list names and roles in the following format Name: Role separated by comas)
Facility Description / Auditor Description of Facility (Please provide facility description include # of employees, size, production schedule, general layout, and any additional pertinent details
Auditor Recommendation / Auditor Recommendation

2.3Format of the Fundamentals Code Checklist

The following section explains the elements and sub-elements of the SQF Fundamentalsfor Manufacturing - Intermediate, Edition 1and provides guidance on what thesite needs to do to develop; document and implement a SQF System at this level, and provides information on what the auditor may be looking for to confirm compliance.

The following format is used throughout:

Element Number and Name
Element / Description / Primary Response / Evidence
Sub-element number and name. / This section describes what the SQF Fundamentals for Manufacturing – Intermediate, Edition 1requires. This is the text from the SQF Code, and is the auditable standard. Where there is disagreement between the text of the SQF Fundamentals for Manufacturing – Intermediate, Edition 1 and the guidance, the SQF Fundamentals for Manufacturing – Intermediate, Edition 1in English prevails. / This section is for sites to check the primary response for each element. / This section is provided for the site to write down evidence observed for each element during the audit.
Element Summary
All section summaries are to be completed by the auditor irrespective of whether or not a non-conformity has been identified within that section. Section summaries must clearly indicate:
a. Evidence of compliance
b. Summary of element(s) that are non-compliant
c. Reference to other sections or elements where similar issues have been identified (if appropriate)
d. Changes/improvements from previous audits (if appropriate)

SQF Fundamentals for Manufacturing - Intermediate, Edition 1Audit Checklist Page 1

SQFI Audit Report

1. Company Information

Company Name / Company #
Address 1
Address 2
City / State / Zip Code
Country / Phone #
SQF Practitioner / Email
Food Sector Categories
Modules Audited
Certified Products

1. Audit Schedule

Start Date / End Date
Scope of Certification

1. Certification Decision

Audit Score / Audit Rating

ConfidentialPage 1

1. Non-Conformities

Element / Description / Primary Response / Evidence

1. Root Cause Analysis

Element / Description / Primary Response / Root Cause

1. Corrective Actions

Clause / Primary Response / Corrective Action
(Supplier) / Required Completion Date / Close Out
Audit Statement
Header / Item / Evidence
Opening Meeting / People Present at the Opening Meeting (Please list names and roles in the following format Name: Role separated by comas)
Closing Meeting / People Present at the Closing Meeting (Please list names and roles in the following format Name: Role separated by comas)
Facility Description / Auditor Description of Facility (Please provide facility description include # of employees, size, production schedule, general layout, and any additional pertinent details
Auditor Recommendation / Auditor Recommendation
2.1.1 Food Safety Policy
Element / Description / Primary Response / Evidence
2.1.1.1 Food Safety Policy / Senior site management shall prepare and implement a policy statement that outlines as a minimum the:
i. The site's commitment to supply safe food;
ii. Methods used to comply with its customer and regulatory requirements; and
iii. The site's commitment to establish and review food safety objectives.
2.1.1 Food Safety Policy Summary
2.1.2 Management Responsibility
Element / Description / Primary Response / Evidence
2.1.2.1 Management Responsibility / The reporting structure describing those who have responsibility for food safety shall be documented, identified and communicated within the site.
2.1.2.2 Management Responsibility / The senior site management shall make provision to ensure fundamental food safety practices and all applicable requirements of the SQF System are adopted and maintained.
2.1.2.3 Management Responsibility / The senior site management shall ensure adequate resources are available to achieve food safety objectives and support the development, implementation, maintenance and ongoing improvement of the SQF System.
2.1.2.4 Management Responsibility / Senior site management shall designate a person responsible for each site with responsibility and authority to:
i. Lead the development and implementation of Good Manufacturing Practices (GMP) outlined in 2.4.2;
ii. Oversee the development, implementation, review and maintenance of the SQF System; and
iii.Take appropriate action to ensure the integrity of the SQF System.
2.1.2.5 Management Responsibility / The person responsible designated under 2.1.2.4 shall:
i. Be fully employed or contracted by the site as a company employee/contractor;
ii. Hold a position of responsibility in relation to the management of the site’s SQF System;
iii. Be competent to implement and maintain food safety fundamentals; and
iv. Have an understanding of the SQF Food Safety Fundamentals and the requirements to implement and maintain SQF System relevant to the site's scope of certification.
2.1.2.6 Management Responsibility / Job descriptions for those responsible for food safety shall be documented and include provision to cover for the absence of key personnel.
2.1.2 Management Responsibility Summary
2.1.3 Management Review
Element / Description / Primary Response / Evidence
2.1.3.1 Management Review / The senior site management shall be responsible for reviewing the SQF System and documenting the policy statement.
2.1.3.2 Management Review / The SQF System in its entirety shall be reviewed at least annually.
2.1.3.3 Management Review / The SQF System, and other aspects of Good Manufacturing Practices (GMP) shall be reviewed and updated as needed when any potential changes implemented have an impact on the site's ability to deliver safe food.
2.1.3.4 Management Review / All changes made to Good Manufacturing Practices (GMP) and other aspects of the SQF System shall be validated or justified.
2.1.3.5 Management Review / Records of all reviews, validations and changes to the SQF System shall be maintained.
2.1.3 Management Review Summary
2.1.4 Complaint Management
Element / Description / Primary Response / Evidence
2.1.4.1 Complaint Management / The methods and responsibility for handling and investigating the cause and resolution of complaints from customers and authorities, arising from products manufactured or handled on site, shall be documented and implemented.
2.1.4.2 Complaint Management / Records of customer complaints and their investigations shall be maintained.
2.1.4 Complaint Management Summary
2.1.5Crisis Management
Element / Description / Primary Response / Evidence
Not Applicable for SQF Fundamentals for Manufacturing - Intermediate
2.1.5Crisis ManagementSummary
2.2.1 Food Safety Manual
Element / Description / Primary Response / Evidence
2.2.1.1 Food Safety Manual / A food safety manual shall be documented and maintained in either electronic and/or hard copy form and include or reference the written procedures, pre-requisite programs and other documentation necessary to support the development and the implementation, maintenance and control of the SQF System.
2.2.1 Food Safety Manual Summary
2.2.2 Document Control
Element / Description / Primary Response / Evidence
2.2.2.1 Document Control / Documents shall be controlled in a manner that ensures employees use up to date and current policies, procedures and forms when food safety related activities are documented.
2.2.2.2 Document Control / A register of current SQF System documents and amendments to documents shall be maintained.
2.2.2 Document Control Summary
2.2.3 Records
Element / Description / Primary Response / Evidence
2.2.3.1 Records / All records shall be legible and suitably authorized by those undertaking monitoring activities that demonstrate inspections, analyses and other essential activities have been completed.
2.2.3.2 Records / Records shall be readily accessible, retrievable, securely stored to prevent damage and deterioration and shall be retained in accordance with periods specified by a customer or regulations.
2.2.3 Records Summary
2.3.1 Product Development and Realization
Element / Description / Primary Response / Evidence
Not applicable for SQF Fundamentals for Manufacturing - Intermediate
2.3.1 Product Development and Realization Summary
2.3.2 Raw and Packaging Materials
Element / Description / Primary Response / Evidence
2.3.2.1 Raw and Packaging Materials / Specifications for raw materials and packaging materials including, but not limited to ingredients, additives, hazardous chemicals and processing aids, that impact on finished product safety shall be documented, comply with relevant legislation, and kept current.
2.3.2 Raw and Packaging Materials Summary
2.3.3 Contract Service Providers
Element / Description / Primary Response / Evidence
Not applicable for SQF Fundamentals for Manufacturing - Intermediate
2.3.3 Contract Service Providers Summary
2.3.4 Contract Manufacturers
Element / Description / Primary Response / Evidence
Not applicable for SQF Fundamentals for Manufacturing - Intermediate
2.3.4 Contract Manufacturers Summary
2.3.5 Finished Product Specifications
Element / Description / Primary Response / Evidence
2.3.5.1 Finished Product Specifications / 2.3.5.1Finished product specifications shall be documented, current, approved by the site and their customer, accessible to relevant staff and may include:
i.Microbiological and chemical limits; and
ii.Labeling and packaging requirements.
2.3.5 Finished Product Specifications Summary
2.4.1 Food Legislation
Element / Description / Primary Response / Evidence
2.4.1.1 Food Legislation / The site shall ensure that, at the time of delivery to its customer, the food supplied shall comply with the legislation that applies to the food and its production in the country of its origin and destination if known. This includes compliance with legislative requirements applicable to maximum residue limits, food safety, packaging, product description; net weights, nutritional, allergen and additive labeling, any other criteria listed under food safety legislation, and to relevant established industry codes of practice.
2.4.1 Food Legislation Summary
2.4.2 Food Safety Fundamentals
Element / Description / Primary Response / Evidence
2.4.2.1 Food Safety Fundamentals / The site shall ensure the practices described in the relevant subsequent modules of this Code are applied or exempted according to a risk analysis outlining the justification for exclusion or evidence of the effectiveness of alternative control measures to ensure that food safety is not compromised.
2.4.2 Food Safety FundamentalsSummary
2.4.3 Food Safety Plan
Element / Description / Primary Response / Evidence
2.4.3.1 Food Safety Plan / The site shall have a HACCP-based reference Food Safety plan, developed by a responsible authority to meet regulatory and customer requirements or has developed their own plan following the Codex Alimentarius model.
The site’s written food safety plan shall include at minimum:
i. An established a multi-disciplinary food safety team;
ii. A description of the product and product category of all ingredients (including raw materials, packaging, finished product) and the required conditions for storage and distribution;
iii. A description of the intended use of the product and identify the target consumer;
iv. A description of all of the steps taken to produce the product in a process flow diagram; and
v. A comparison of the process flow diagram with the production process to ensure it is accurate.
2.4.3.2 Food Safety Plan / The site shall perform a hazard analysis of their food manufacturing process as a minimum step in order to determine if there are any hazards associated with the production of their food item. The site shall use the HACCP tool to accomplish this assessment. If hazards are identified within the manufacturing process, it is expected that the business will take appropriate action necessary to develop a HACCP Plan. The hazard analysis shall be conducted for each process step in the manufacturing of the food item.
2.4.3.3 Food Safety Plan / If the hazard analysis indicates any significant hazards not minimized or eliminated by Good Manufacturing Practices (GMPs) that are present within the food manufacturing process, they shall be identified as Critical Control Points (CCPs). The site shall ensure the following for each CCP:
i. Critical Limits are established for each CCP;
ii. Monitoring procedures are established for each CCP;
iii. CCPs are effectively implemented; and
iv. Corrective actions are established for each CCP in the event critical limits are exceeded.
2.4.3.4 Food Safety Plan / Verification procedures shall be established and effectively implemented.
2.4.3.5 Food Safety Plan / Record keeping and documentation for all HACCP-related procedures shall be established and effectively implemented.
2.4.3.6 Food Safety Plan / The site shall have implemented specific control measures for all relevant steps not identified as CCPs.
2.4.3 Food Safety Plan Summary
2.4.4Approved Supplier Program
Element / Description / Primary Response / Evidence
2.4.4.1 Approved Supplier Program / Raw materials, ingredients, packaging materials, and services that impact on finished product safety shall meet the agreed specification (refer to 2.3.2) and be supplied by an approved supplier.
2.4.4.2 Approved Supplier Program / Inspections and analyses shall conform to standard reference methods.
2.4.4.3 Approved Supplier Program / Records of inspections and analyses shall be maintained.
2.4.4Approved Supplier Program Summary
2.4.5 Non-conforming Product or Equipment
Element / Description / Primary Response / Evidence
2.4.5.1 Non-conforming Product or Equipment / Non-conforming product, raw material, ingredient, work-in-progress, packaging or equipment shall be quarantined, handled, re-worked or disposed of in a manner that minimizes the risk of inadvertent use, improper use or risk to the integrity of finished product.
2.4.5.2 Non-conforming Product or Equipment / Records of the handling and disposal of non-conforming product shall be maintained.
2.4.5 Non-conforming Product or Equipment Summary
2.4.6 Product Rework
Element / Description / Primary Response / Evidence
2.4.6.1 Product Rework / Rework (recycle or regroup) activities shall be controlled and traceability ensured.
2.4.6 Product Rework Summary
2.4.7 Product Release
Element / Description / Primary Response / Evidence
2.4.7.1 Product Release / The responsibility and methods for releasing products shall be documented and implemented. The methods applied shall ensure the product is released:
i. By authorized personnel; and
ii. Once all inspections and analyses are successfully completed and documented to verify legislative and other established food safety controls have been met.
2.4.7.2 Product Release / Records of all product release shall be maintained.
2.4.7 Product Release Summary
2.4.8Environmental Monitoring
Element / Description / Primary Response / Evidence
2.4.8.1 Environmental Monitoring / A risk-based environmental monitoring program shall be in place for all food manufacturing processes and consider the following:
i. Applicable pathogens or indicator organisms;
ii. Number and location of samples to be taken; and
iii. Frequency of sampling.
2.4.8Environmental Monitoring Summary
2.5.1 Validation and Effectiveness
Element / Description / Primary Response / Evidence
2.5.1.1 Validation and Effectiveness / The methods, responsibility and criteria for ensuring the effectiveness of all applicable elements of the SQF program shall be documented and implemented.
2.5.1.1 Validation and Effectiveness Summary
2.5.2 Verification Activities
Element / Description / Primary Response / Evidence
2.5.2.1 Verification Activities / A verification schedule outlining the verification activities, their frequency of completion and the person responsible for each activity shall be prepared and implemented.
2.5.2.2 Verification Activities / Monitoring activities associated with Good Manufacturing Practices (GMP), and other food safety controls, and the legality of certified products, shall be documented and implemented.