SQF Fundamentals Checklist: Basic Level for Manufacturing

SQF Fundamentals Checklist: Basic Level for Manufacturing

Section 1. Introduction

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, Basic 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 - Basic 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.

Layout of the SQF Code

The SQF Fundamentals for Manufacturing, Basic Edition 1 consists of two parts and three appendices. Part A contains the criteria for implementing and maintaining the SQF Fundamentals for Manufacturing - Basic 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:

o Appendix 1: Food Sector Categories

o Appendix 2: Glossary

o Appendix 3: SQF Logo Rules of Use

Section 2. Introduction to this Checklist

2.1 Scope of the Checklist

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

2.2 Summary 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

2.3 Format of the Code Checklist

The following section explains the elements and sub-elements of the SQF Fundamentals for Manufacturing – Basic, Edition 1 and provides guidance on what the site 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: Sub-element number and name.

Description: This section describes what the SQF Fundamentals for Manufacturing, Basic element requires. This is the text from the SQF Fundamentals Code, and is the auditable standard. Where there is disagreement between the text of the SQF Fundamentals for Manufacturing – Basic, Edition 1 and the guidance, the SQF Fundamentals for Manufacturing – Basic, Edition 1 in English prevails.

Primary Response: This section is for sites to check the primary response for each element.

Evidence: This section is provided for the site to write down evidence observed for each element during the audit.

Element Summary

I. Company Information

II. Audit Schedule

III. Certification Decision

I. Non-Conformities

II. Root Cause Analysis

III. Corrective Actions

2.1.1 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.

2.1.2 Management Responsibility

2.1.2.1 Management Responsibility

The senior site management shall be responsible for verifying and documenting the completion of:

i. An annual review of the SQF System to ensure control measures for identified hazards have been completed and are appropriate;

iii. Corrective actions and/or records that support compliance to relevant food legislation in the country of its origin and destination.

iii. Corrective actions and/or records that support compliance to relevant food legislation in the country of its origin and destination.

2.1.2.2 Management Responsibility

Senior site management shall designate a person who shall:

i. Be employed by the site on a full time basis;

ii. Be responsible for the development, implementation and maintenance of the SQF food safety system;

iii. Have an understanding of the SQF Food Safety Fundamentals and the requirements to implement and maintain the SQF system relevant to the site’s scope of certification.

2.2.1 Food Safety Manual

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.

2.2.2.1 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.

2.2.3.1 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.

2.3.1.1 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.

2.3.1.2 Raw and Packaging Materials

Raw materials, ingredients, packaging materials, and services that impact on finished product safety shall meet the agreed specification and be supplied by an approved supplier. Inspections and analysis shall conform to standard reference methods and records of audit, inspections and analyses shall be maintained.

2.3.2 Finished Product

2.3.2.1 Finished Product

Finished 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.

2.4.1.1 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

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.

2.4.2 Food Safety Plan

2.4.2.1 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.

v. A comparison of the process flow diagram with the production process to ensure it is accurate.

2.4.3 Complaints, Corrective Action and Non-conforming Product or Equipment

2.4.3.1 Complaints, Corrective Action and Non-conforming Product or Equipment

The responsibility and methods for corrective actions resulting from food safety non-conformities and complaints shall be documented and implemented. Records shall include issues, complaint or the cause of food safety incidences and resulting corrective actions to resolve them.

2.4.3.2 Complaints, Corrective Action and 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. Records of the handling and disposal of non-conforming product shall be maintained.

2.4.4 Product and Process Testing and Verification

2.4.4.1 Product and Process Testing and Verification

The methods, responsibility and criteria for sampling, inspecting and/or analyzing raw materials, finished product and work in progress shall be documented and implemented. The methods applied shall ensure:

i. Inspections and analyses are completed at regular intervals as required and to agreed specification and legal requirements;

ii. Inspections are conducted to ensure raw materials, work in process and finished products comply with the relevant specification, regulatory requirements and are true to label; and

iii. All analyses are conducted to nationally recognized methods or alternative methods which are validated as equivalent to the nationally recognized methods.

iv. Records of all inspections and analyses shall be maintained.

2.4.4.2 Product and Process Testing and Verification

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;

ii. Once all inspections and analyses are successfully completed and documented to verify legislative and other established food safety controls have been met; and

iii. Records to support product release are completed.

2.4.4.3 Product and Process Testing and Verification

Where external laboratories are utilized to conduct input or product analysis, the laboratories shall be accredited to ISO 17025 or an equivalent national standard.

2.4.4.4 Product and Process Testing and Verification

Verification of adherence to Good Manufacturing Practices shall be documented and implemented. Activities can include:

i. Periodic inspections of all process, buildings, grounds and storage facilities; and

ii. Review and possible corrective action follow-up of all records that support evidence of compliance to the sites document GMP procedures and product/process testing.

Primary Response

Evidence

2.5 SQF System Verification

Not applicable for SQF Fundamentals for Manufacturing - Basic

2.6.1 Product Identification

2.6.1.1 Product Identification

A product identification system shall be implemented to ensure:

i. Product is clearly identified during all stages of receipt, production, storage and dispatch; and

ii. Finished product is labeled to the customer specification and/or regulatory requirements.

2.6.2 Product Trace

2.6.2.1 Product Trace

A product trace system shall be implemented to ensure:

i. Finished product is traceable to the customer (one up) and provides traceability through the process to the manufacturing supplier and date of receipt of raw materials, food contact packaging and materials and other inputs (one back);

ii. Traceability is maintained where product is reworked;

iii. The effectiveness of the product trace system shall be reviewed at least annually; and

iv. Records of raw and packaging material receipt and use, and finished product dispatch and destination shall be maintained.

2.6.3 Product Withdrawal and Recall

2.6.3.1 Product Withdrawal and Recall

The site shall outline the methods and responsibility for notifying their customers and other essential bodies where circumstances arise that require product to be withdrawn or recalled from distribution.

This could include failures in the food safety system or a crisis caused by unplanned events such as floods, water advisory, fire etc. Records of all product withdrawals, recalls and mock recalls shall be maintained. SQFI and the certification body shall be notified in writing within 24 hours upon identification of a food safety event that requires public notification. SQFI shall be notified at foodsafetycrisis@sqfi.com.

2.7 Food Defense and Food Fraud

Not applicable for SQF Fundamentals for Manufacturing - Basic

2.8.1 Allergen Management for Food Manufacturing

2.8.1.1 Allergen Management for Food Manufacturing

The responsibility and methods used to control allergens and to prevent sources of allergens from contaminating product shall be documented and implemented. The allergen management program shall include:

i. A risk analysis of those raw materials, ingredients and processing aids, including food grade lubricants, that contain food allergens;

ii. An assessment of workplace-related food allergens from locker rooms, vending machines, lunch rooms, visitors;

iii. A register of allergens which is applicable in the country of manufacture and the country(ies) of destination if known;

iv. A list of allergens and instructions on how to handle them is accessible by relevant staff;

v. The hazards associated with allergens and their control incorporated into the food safety plan; and

vi. A management plan for control of identified allergens.

2.8.1.2 Allergen Management for Food Manufacturing

Provision shall be made to clearly identify and segregate foods that contain allergens. Segregation procedures shall be implemented and continually monitored.

2.8.1.3 Allergen Management for Food Manufacturing

Where allergenic material may be intentionally or unintentionally present, cleaning and sanitation of product contact surfaces between line changeovers shall be effective, appropriate to the risk and legal requirements, and sufficient to remove all potential target allergens from product contact surfaces, including aerosols as appropriate, to prevent cross contact. Separate handling and production equipment shall be provided where satisfactory line hygiene and clean-up or segregation is not possible.

2.8.1.4 Allergen Management for Food Manufacturing

Based on risk assessment, procedures for validation and verification of the effectiveness of the cleaning and sanitation of areas and equipment in which allergens are used shall be effectively implemented.

2.8.1.5 Allergen Management for Food Manufacturing

Where allergenic material may be present, product changeover procedures shall be documented and implemented to eliminate the risk of cross-contact.

2.8.1.6 Allergen Management for Food Manufacturing

The product identification system shall make provision for clear identification and labeling in accordance with regulatory requirements of those products produced on production lines and equipment on which foods containing allergens were manufactured.

2.8.1.7 Allergen Management for Food Manufacturing

The site shall document and implement methods to control the accuracy of finished product labels (or consumer information where applicable) and assure work in progress and finished product is true to label with regard to allergens. Such measures may include label approvals at receipt, label reconciliations during production, destruction of obsolete labels and verification of labels on finished product as appropriate and product change over procedures.