FDA 21 CFR 176.260

Pulp From Reclaimed Fiber FDA 21 CFR 176.260 

FDA 21 CFR was developed and published in the Federal register by Executive departments and agencies of the Federal Government to establish Codes (rules) for the FDA to ensure consistency across multiple industry sectors. Codes have been made available electronically (eCFR). 

FDA 21 CFR 176.260 – Pulp from Reclaimed Fiber Code provides rules for suppliers of paper and paperboard components that are Included in the category of 21 CFR 176 Indirect Food Additives. Reclaimed pulp is processed / prepared / treated / produced / manufactured for use in multiple industries. Examples of use include packing, packaging, transport, or food product containment. Food product contamination can be impacted through this indirect use of pulp product. 

It is important that a system is in place to ensure safe reclamation of pulp recovers fiber but excludes nonfibrous substances that may be poisonous or hazardous: 

  • Waste from the production process that may be retained in the pulp.  
  • Salvaged paper and paperboard that has retained poisonous or harmful substances in the pulp. 

Who Should Implement an FDA 21 CFR 176.20 Compliant System? 

  • Any facility Processing Pulp for use in paper and paperboard products that desires to ensure food safe packaging materials needs to implement 21 CFR 176.260.  
  • Any facility desirous of assuring customers about the effectiveness of their management system and wants to be able to demonstrate FDA compliance to 21 CFR 176.260.  
  • Any facility required to meet interests of stake holders and ensure adequate provision for mitigating risks in their processes. 
  • Any facility wanting a strong marketing tool to showcase the ability of their system to ensure capabilities to provide safe product. 
  • Any facility desiring to have a complete system which covers all aspects of operations in one single system for management review
  • Any facility whose management desires to have one single system through which management can build teamwork, review progress, measure, monitor, make corrections and ensure continual improvement. 

Process for Comprehensive FDA 21 CFR 176.260 System Implementation 

  • Process of FDA 21 CFR 176.260 Compliance starts with preparation of a Management System for pulp, paper, and paperboard products. 
  • QSE Consultants assist in developing a comprehensive management system to meet all requirements of FDA 21 CFR 176.260.  
  • An FDA 21 CFR 176.260 consulting firm provides the techniques for implementation, and trains organization’s internal auditors to become competent in performance of internal audits or provides Internal Auditing Services to audit all processes for FDA 21 CFR 176.260 Compliance. 
  • Facilities need to initiate corrective actions and continual improvement is realized through control of nonconforming products/services. 
  • Facilities need to implement the prepared compliant FDA 21 CFR 176.260 System for a minimum of 3 months and gather adequate data and record to show as evidence. 
  • Management of the facility needs to conduct one full scale review of the entire management system and ensure its adequacy for their organization.  
  • Management Team needs to identify action items to make corrections to any requirements not being fulfilled. 
  • Once a complaint FDA 21 CFR 176.260 System is ready, an internal audit is performed and one full set of management review takes place, the facility then develops audit corrective actions to ensure effective corrective action. 
  • Upon completion of audits and audit corrective actions, QSE offers to perform and external audit and provide a certificate of compliance. 

FDA 21 CFR 176.260 Consulting, Auditing, & Training Services from QSE 

  • QSE Consulting is the practice of assisting small, medium and large organizations in developing, training, implementing, and maintaining a documented management system achieving FDA 21 CFR 260 compliance.  
  • QSE Consultants can prepare your facility to be FDA 21 CFR 176.260 compliant through documents/records showing evidence of having effectively implemented the system. 
  • QSE always follows a tried and tested 10 step disciplined path in preparing facilities for a complete FDA 21 CFR 176.260 compliant system that ensure improvement. 
  • QSE Consultants assist facilities to prepare a comprehensive simplified documentation system to show as evidence of having a streamlined process that ensures safe quality product or service every time without fail; 
  • QSE consultants help in identifying issues and concerns of all stake holders and take them into account in preparing for FDA 21 CFR 176.260. 
  • QSE assists facilities in matching competence of personnel assigned to tasks, methods to select providers who supply safe quality products and services. 
  • QSE Consultants assist to build a robust system which compels task performers to have defined roles, responsibilities and controls to ensure safe product. 
  • QSE Consultants assist organizations to identify all manufacturing and nonmanufacturing processes and facilitate in establishing process performance metrics or process performance indicators (Key Process Indicators = KPIs) to effectively monitor and measure organizations intended Goals and Objectives. 
  • QSE Consulting services assist organizations in building a comprehensive management system to ensure FDA 21 CFR 176.260 compliance throughout the facility; 
  • Internal Audits conducted by QSE consultants, help the facilities to find all deficiencies in their implementation which are not normally found during organizations first party audits. 
  • QSE Consultants provide training to top management in promoting Risk-Based Thinking and Continual Improvement 
  • QSE consultants assist organizations to effectively control document information (Documents and Records) related to changes, conducting management review meetings covering all management review inputs.  
  • QSE consultants will ensure smooth, simplified compliance and offers third-party external compliance certification. 

The QSE Difference in Consulting, Auditing, & Training for the FDA 21 CFR 176.260 

  • QSE is a premier Consulting, Auditing, and Training firm engaged in food safety certification that is related to FDA 21 CFR 176 compliant companies. 
  • QSE has a unique 10 steps disciplined path to ensure FDA 21 CFR 176.260 compliance and improvement which is insensitive to failure. 
  • QSE has assisted over 900 facilities achieve various certifications 
  • QSE’s unique document simplification tools result in smooth implementation to achieve FDA 21 CFR 176.260. 
  • QSE identifies all processes from “Quote to Cash” in other words all activities from submission of quote, processing of the order, control, dispatch to customer and receive cash. All manufacturing and non-manufacturing processes are covered. 
  • QSE’ s documentation covers all requirements of customers and other interested parties, statutory and regulatory requirements. 
  • QSE’s unique simplified documented system is easy to integrate to other management systems. 
  • QSE engages qualified and competent auditors to conduct internal audits. 
  • QSE’s internal audits are more stringent than other FDA 21 CFR 176.260 audits and will help companies pass achieve compliance with minimum nonconformities or no nonconformity. 
  • QSE covers all the requirements of the standard including the implicit intent of the standard. 
  • QSE’s system development involves all relevant employees which lead to effective implementation. 
  • QSE’s Document Simplification is unique comprehensive single level documentation which ensures effective implementation. 
  • QSE’s documentation is unique, simple, lean and easy to implement and sustains certification audits in the long run. 
  • QSE’s FDAv21 CFR 176.260 Internal Auditing Services promote the unbiased assessment of system implementation and the extent of implementation. 
  • QSE ensures to provide implementation assistance or complete understanding of the documentation and requirements. 
  • QSE’s unique management review format results in no nonconformities against management review during certification audits. 
  • QSE does not simply tell our customers what to do but assists them on how to do.  
  • QSE’s 10-step disciplined path for FDA 21 CFR 176.260 compliance, achieves the organizations implementation completion in the shortest possible time. Usually within 5 months. 
  • QSE provides post internal auditing services and can provide external audits and compliance certification if requested. 

The Benefits of Having a 21 CFR 176.260 System for Pulp, Paper, and Paperboard Products 

The benefits of implementing FDA 21 CFR 176.260 management systems are diverse and seen in all departments of a given company.  

The benefits of compliance: 

  • Helps organizations in the pulp, paper, and paperboard sectors to minimize or eliminate instances of contamination, mix-ups, and errors. 
  • Meets mandatory requirements for facilities engaged in manufacture of pulp, paper, and paperboard. 
  • QSE provides the capability of developing an FDA 21 CFR 176.260 system that easily integrates with other standards. 
  • FDA 21 CFR 176.260 compliance is a great marketing tool to get market share of pulp, paper, and paperboard materials provided for food safety industries. 
  • FDA 21 CFR 176.260 compliance avoids or minimizes FDA audit findings. 

Case Studies 

QSE has assisted over 700 organization in obtaining ISO and other certifications, contact details can be furnished upon request for any certification. 

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