FSMA-FSSC 22000 Addendum

FSMA addendum is an additional and optional audit established by FSSC 22000, which helps a certified company in this program to detect gaps between the FSSC 22000 Food Safety Management System requirements and the FSMA Preventive Human Food Controls (PCHF). A certification body licensed by FSSC 22000 qualifies to perform this audit, like Global STD.

This audit supported on the CFR 21 requirements, section 117: Current Good Manufacturing Practices, Risks Analysis, and Preventive Controls based on Human Food Hazards (HFH). The current scope for evaluation applies only for human food production and no other FSMA regulations, for instance, the Foreign Supplier Verification Program (FSVP) or Sanitary Transportation.


When the FSSC 22000 V5 audit takes place, a report shall be filled out at the applicant´s site, to supply a general overview of FSMA regulations that are more specific than FSSC 22000.


Benefits:

• Identify gaps between FSMA regulations (PCHF) and FSSC 22000.
• Only an FSSC 22000 approved auditor can perform the assessment.
• Prove compliance with the FSMA Act.

GOOD MANUFACTURING PRACTICES IN COSMETIC PRODUCTS BASED ON THE FDA INDUSTRY GUIDELINES

The U.S. Federal Food, Drug, and Cosmetic Act description of cosmetics define any product used for rubbing, pouring, spraying, atomizing, or applying on humans to clean, beautify, become more attractive or modify the appearance of someone. Among these are moisturizing, perfumes, lipsticks, nail polish, eye shadow and foundation, shampoo and permanent, hair dye, toothpaste and deodorant, and any other cosmetic component.


The cosmetic manufacturer lowers the risk of adulterate or mislabels products by following this guide. And by the evaluation of a third party certification body, like GlobalSTD, you will execute compliance audits under the regulations guide in your activities and products.

SQF BASIS PROGRAM

SQF launched the Foundation Food Manufacturing and Primary Production Program, which include a basic and intermediate level with a detailed safety management approach. The aim is to admit entrepreneurs paying attention to the supply chain safety.


This program meets the retail concerns for small and medium-sized suppliers not having established a safety management or those wanting to upgrade their system.


Benefits:

• To have a Food Safety certificate granted by SQF.
• The technical requirements for all the basic codes fulfill the GFSI Global Markets Program.
• By implementing the foundation's program requirements leads to get a GFSI certificate.

ISO 11620, INFORMATION AND DOCUMENTS, LIBRARY PERFORMANCE INDICATOR

This international regulation supports and establishes performance indicators that measures quality in library services, by providing general terminology and concise definitions. Also, includes a detailed description for collecting and analyzing data in time and function from other similar sources of information to conclude if goals were accurately established.


Benefits:

• A tool used for comparing internally and with similar companies.
• Establishes the extent of the explicit financial impact

ISO 22716, GUIDELINES FOR GOOD MANUFACTURING PRACTICES IN COSMETIC PRODUCTS

This international standard combines Good Manufacturing Practices, Cosmetic Products Safety, and Continual Improvement to meet worldwide consumer demand.


This standard firmly relates to social liability since entails suitable management in every production stage, assuring the safety, quality, and no health risks of products. It should be noted that this standard doesn't layout employees' health and safety, neither environmental topics.


Benefits:

• The standard supports compliance and foresees legal requirements and future applicable regulations.
• Adds value to the organization by complying with the main market demands, according to international regulations, enabling the company to enter regulated markets around the world.

PRODUCTS AND SERVICES NOM-259-SSAI-2022, GOOD MANUFACTURING PRACTICES IN BEAUTY PRODUCTS

This standard establishes the minimum requirements for Good Manufacturing Practices in Beauty Products recognizing the manufacturing procedures, quality control, and stability testing, also the procedures of sanitary regulation in Mexico.

The quality control of beauty products heeds raw material, packaging material, and finished product, and a physical-chemical and microbiological study, stability testing, and sanitary regulations of beauty products; as well as organoleptic properties (smell, color, and taste), viscosity, pH, scattered particles (in the event of suspension), among others.

PROPOSITION 65 LAW OF CALIFORNIA STATE. SAFE DRINKING WATER AND TOXIC ENFORCEMENT ACT.

Every consumer shall know proposition 65 laws; it is a list with more than 800 chemical products that might cause cancer, congenital malformations, or other reproductive toxicity. It is updated once a year, affecting every consumer good around the California area.


Companies complying with proposition 65 shall provide a warning unless they assure an element of the list doesn´t have a significant risk level, in regards to carcinogenic products, or congenital malformations, or any other reproductive toxicity.


If an item exceeds a chemical shall send a warning and place it on the products label. Unless noted otherwise, the company shall not endanger people by these chemicals or pour these substances into drinking water without a warning.

HAZARDS ANALYSIS AND PREVENTIVE RISK CONTROL (HARPC) (BASED IN CFR 21, PART 117)

This system was established in the Food Safety Modernization Act (FSMA) of the FDA, use to implement preventive controls and avoid threats by guaranteeing food safety.


Companies must set a plan to identify hazards, steps to minimize or prevent hazards, as well as monitoring procedures, register results, and corrective actions to fix issues. GlobalSTD will assess and verify the implementation and compliance of the plan, which shall include a hazard analysis supervised and managed by preventive controls.

ISO 20700, GUIDELINES FOR MANAGEMENT CONSULTING SERVICES

ISO 20700 is based on good practices of consultancy management by suggesting ways to improve explanations, execution, acceptance of results, and conclusion. Considers a greater range of consulting management with experience, research, and client (known as MCSP). The target is to improve transparency between clients and suppliers by achieving better results in their projects.


An MCSP proposition includes distinction, innovation, and ethical behavior based on results, emphasizing on the client´s needs.


Benefits:

• Grants value to users and lower the risks of management consulting tasks.
• When quality improves, professionalism, ethical behavior, and interoperability optimize and hastens the management consultancy industry.

COSTO ADDENDUM

The Costco Addendum audit compiles accurate information supplier’s food safety general condition, so the company continues improving and enrichment.


Every manufacturer of goods (food, beverages, and supplements), consumables, or packaging material having contact with Costco food shall have an annual Food Safety Audit or GFSI certification audit.


Remember evaluating is not consulting. The auditor shall never advise about how to improve or handle gaps or nonconformances.

MCDONALD´S ADDENDUM

McDonald´s Global Supply Chain & Sustainability designed an addendum for their goods manufacturers, harvesters, and distributors providing confidence in their products.


Annually, the supplier shall verify each facility keeps complying with the SQMS by an external audit. The supplier's warehouse of raw material, packages, and in-products or finished products shall comply with the same safety and quality standards.