Chapter 1. Introduction

 

Title 9 of the Code of Federal Regulations at Parts 318.4(d ) and 381.145(d) require Federal meat and poultry processing plants to establish and maintain written records for each critical check or critical control point and make the records available to FSIS inspection personnel up on request.

  • Although the regulatory requirement for FSIS to review and approve PQC programs has been rescinded, the new regulatory requirements in 318.4(d) and 381.145(d ) provide information to plants about the necessary steps they must take to meet the new record keeping requirements in a Pathogen Reduction and HACCP inspection environment.
  • FSIS will continue to provide guidance to establishments to ensure that their Partial Quality Control (PQC) programs for specific products and processes are adequate to ensure product compliance with regulatory requirements. The information in this document is intended to be used as guidance material and is based on FSIS’ experience and historical perspective reviewing and approving PQC programs.A few model PQC programs, representative of many products and processes, are presented below.

     

Chapter 2. Components of PQC Programs

PQC programs should address four areas: (1) raw materials control; (2) process control; (3) records control; and (4) corrective/preventive action.

1. Raw Materials Control

Raw materials control involves the receiving and stocking of only those materials that conform to established specifications. To ensure successful control of raw materials, establishments should consider the following:

  • To begin the development of a raw materials control procedure, plants should list each of the materials used to produce the product.
  • Once the list has been created, establishments should develop a receiving inspection procedure.
  • The procedure may address raw materials specifications, proper materials handling, proper storage, and disposal of non-conforming materials.
  • Materials should be routinely monitored to ensure they are meeting the established procedures.

2. Process Control

Process control programs ensure continuous control of particular processes so that product standards will be met. Process control programs should meet the following criteria:

  • They should identify the products or processes to be controlled.
  • They should identify the control features necessary for product compliance.
  • They should establish control limits.
  • They should establish procedures for meeting the established limits.
  • They should provide monitoring procedures for ensuring that procedures are followed. An important aspect of process control is effective data collection and analysis. Process control programs should include sampling plans that permit reliable collection and analysis of data. After sampling plans have been developed, process limits can be established.
  • The limits established should be appropriate to ensure that quality standards will be met.
  • The limits established should be appropriate to ensure that meet regulatory or label limits for the product or process will be met.
  • Variation in materials, methods, processes, and products requires the setting of a tolerance for each quality standard. A tolerance limit is the total allowable deviation from an established standard. The limit allows for the normal variability which is inherent in any process.
  • Tolerance limits may need to be continuously adjusted to prevent problems.
  • Limits for certain processes have been established and used historically by industry; these limits are reflected in PQC programs previously approved by FSIS. The tolerances meet the intent of the requirements in 318.4(d) and 318.145(d)(2)(ii) and may continue to be used.
  • Establishments may elect to use these previously established tolerances or develop their own by following the requirements outlined in the regulation.

3. Records

An important aspect of quality control is process documentation. Adequate records are essential to the system’s capacity to provide the necessary controls. The records provide a history of the process and document when the process is working and when problems are occurring. The use of standard sheets, check-off forms, and other simple records is generally more successful than a complicated system. Charts and graphs already in use may be all that is necessary to document the system. The degree of record keeping and the complexity of the records depend, in large part, on the scope of the processing operation. In reviewing records, plant management should:

  • Look at those aspects of production most likely to cause problems. This procedure also can be useful in determining what critical checks need to be incorporated in to a quality control program.
  • Correct problems as they occur. Proper documentation of the process can save time and money because it provides an establishment an opportunity to correct a problem before the finished product has been completed.
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