Thursday, November 28, 2024

Ensuring Safety and Quality in Animal Feed with FAMI-QS Implementation

 


Ensuring quality and safety in the manufacture of animal feed is crucial for protecting animal health and consumer confidence. To accomplish these objectives, FAMI-QS implementation is essential since it offers an accepted standard for feed safety management systems. This certification increases market competitiveness and industry reputation in addition to guaranteeing adherence to exact rules.

Understanding the Implementation of FAMI-QS

The feed industry is the target market for FAMI-QS (Feed Additive and Premixture Quality System), a certification program that addresses the safety, quality, and regulatory compliance of feed additives and premixtures. By emphasizing quality control, regulatory compliance, hazard analysis and critical control points (HACCP), it sets requirements for feed safety management systems.

Key Components of FAMI-QS Implementation

  • Quality Management System: Implementing a strong quality control system that addresses each aspect of the manufacture of feed additives and premixtures, from locating source materials to ultimate transmission.
  • HACCP: HACCP stands for Hazard Analysis and Critical Control Points. Carrying out a comprehensive hazard analysis to recognize, assess, and manage possible risks in feed manufacturing operations.
  • GMP: GMP stands for "good manufacturing practices," and following them will guarantee that feed additives and premixtures are consistently produced in a way that is both safe and high-quality.
  • Control and Monitoring Suppliers: Putting in a place processes to assess, authorize, and keep an eye on suppliers to ensure the quality and security of ingredients.
  • Traceability: Implementing processes for product recall and traceability will allow for a prompt response to any instances involving non-compliance or safety concerns.
  • Continual Improvement: Encouraging a culture of continuous improvement by regularly updating feed safety management systems and conducting audits, reviews, and upgrades.

 The Significance of Implementing FAMI-QS Certification 

Obtaining FAMI-QS Certification has the following advantages for producers of premixtures and feed additives:

  •  Compliance: Showing adherence to international norms and EU legislation to gain access to international markets.
  •  Improved Product Quality: Enforcing strict safety and quality guidelines to provide premixtures and feed additives that either match or surpass consumer expectations.
  • Gaining Market Access and Credibility: Requires adhering to the strict guidelines set forth by international food safety and quality standards.
  • Risk management: It is the process of reducing the likelihood of product recalls, feed safety issues, and possible legal ramifications.
  • Consumer Confidence: Assuring the safety and dependability of animal feed products helps to foster confidence among stakeholders, such as farmers, and regulatory bodies.

Challenges and Consideration

  1.     Resource Allocation: A significant amount of time, money, and staff are needed to implement FAMI-QS.
  2.   Culture Change: Adopting a quality-focused culture could require modifications, to the organization and support from the workforce.
  3.      Complexity: Because FAMI-QS is a comprehensive standard, it might be difficult to ensure full compliance.
  4.     Sustaining FAMI-QS Certification: It necessitates a constant dedication to enhancement and adjustment to evolving regulations.

Manufacturers of premixtures and feed additives who wish to maintain the highest standards of quality, safety, and legal compliance in the production of animal feed must implement FAMI-QS. Organizations can successfully traverse the intricacies of certification requirements and achieve compliance with international standards. To increase credibility, reduce risks, and guarantee the manufacture of dependable feed additives and premixtures for animal health and welfare, invest in FAMI-QS implementation.

For the FAMI-QS Documents

FAMI-QS is the only global Quality and Feed Safety Management System for Specialty Feed Ingredients. The ready-to-use editable documentation package that meets FAMI-QS (Version 6) requirements. Customers can save money by purchasing FAMI-QS documentation toolkit, which includes editable documents in plain English and is available in editable formats. This provides true value for money for those seeking FAMI-QS certification. To save money, a lot of clients search for pre-made FAMI-QS documents, such as the audit checklist, procedures, and manual.

Source Link: https://documentationconsultancy.wordpress.com/

 

Monday, November 18, 2024

How to Structure the ISO 13485 Medical Devices QMS Documents?

 


Do you envision structure of documentation when you think about Quality Management System (QMS) documentation? Perhaps needless processes and concerned much about effectiveness? This is the sad truth for certain businesses, who erroneously believe that the more documentation they provide, the more compliant they would seem. Avoid falling into this trap with your company.

The three main goals of ISO 13485 documentation are as follows:

·         To offer an accurate framework for the business's activities

·         To improve comprehension of the Quality Management System and promote process consistency

·         To demonstrate that the business has accomplished its aims and objectives.

Therefore, when you start writing your QMS documentation, you should concentrate on efficiency and only write procedures and papers that will be advantageous to your company.

Medical Devices QMS Documents Structure

Among the many documents found in a typical QMS are the following:

·         Quality Manual

·         Quality Policy

·         Procedures

·         Quality Plans and Records

Not all information must have a distinct document, however, the ISO 13485 standard mandates that different kinds of information be documented. An organization can use the standard to determine how much documentation it needs and how much detail to add. Small businesses might decide to provide a basic summary of their processes in the Quality Manual, for example.

How to Structure Medical Devices QMS Documentation?

"ISO 10013:2001 Guidelines for Quality Management System Documentation" is a separate standard that guides the quantity and dimensions of documents that your company is likely to require. It also offers instructions on how each document should be organized and what should be included. Some of these ISO 10013 guidelines are summarized here.

Quality Manual: The Quality Manual should contain the rules that apply to the organization, with reasons provided for any that are left away according to ISO 13485:2016 article 4.2.2. The organization itself, including its size, complexity of operations, and personnel skills, will determine the contents of the book and its general structure. Although a small business may likely document its full quality management system in a single manual, a huge multinational corporation might require many quality manuals in addition to all other necessary documentation.

A quality manual should include;

·         The table of contents and title

·         Details regarding the approvals and versions of the documents

·         An explanation of the QMS

·         The extent of the QMS

·         Any modifications from ISO 13485 and justification for them

·         The business process model used by the corporation

Quality Policy: The company’s dedication to quality, compliance with legal and regulatory requirements, and ongoing improvements are outlined in the Quality Policy. It describes your company’s quality targets, which are determined by measuring them. Keep the Quality policy short and simple because some businesses decide to use it for marketing.

Quality Procedures: An organization's quality management system is based on its quality procedures. Their goal is to put procedures in place that will guarantee the business's operations meet ISO 13485 criteria. Quality processes can take many different forms. They can take the shape of stories, which are descriptive; more structured tables; flow charts, which are more shown; or a mix of such formats.

The following components must be incorporated into quality procedures:

·         The title to determine the process

·         Its objective, or the rationale behind the process

·         Defining its scope, or what is and is not part of the process

·         The authority, roles, and duties of people doing the procedure

·         A list and definition of the documents produced by the procedure's activities

·         Identification of modifications, the document's version, and the date of review and approval, in compliance with accepted document management procedures

An explanation of the steps involved in the process (the procedure's major body) that includes what needs to be done, how, when, where, and by whom. In certain situations, the "why" should also be explained, along with the inputs and outputs of the duties, as well as the required materials. If necessary, supplementary.

Records: The low-level records that demonstrate that a process is in place and being carried out by the work instruction or procedure are these. Inspection documents, for instance, provide proof that an inspection was conducted in addition to certain particular conclusions.

Audit Checklist: Audit questions are covered by the ISO 13485 Audit Checklist, which is based on the department- and clause-by-department requirements of ISO 13485:2016. You can create your internal audit checklist by altering this ISO 13485 checklist.