qa audit by signorina y. bueno (wmsu-zc)

QA AUDITS

Typically two classes of audits

• Internal quality audits carried out by the company’s QA department on its own plants

• external or third party audits are usually carried out by clients to certify the manufacturing quality of their products

• Examples:– that audit carried out by rabbis to certify the kosher status – among the internal quality audits, the QA department

carries out several types (manufacturing, sanitation, finished product quality, etc.)

The most common types of audits carried out in the food industry include the following:

1. Product manufacturing2. Plant sanitation/GMP3. Product quality4. HACCP

Important PointsSpecial audit on QC programs (including methodology performance in all shifts), on temperature controls, on ingredient qualification programs, or on batching and formulation practices could very well be advisable in order to specifically determine actual practices and controls in these important areas of manufacturing operations.

What is a special audit on QC programs?

• referred to simply as a quality audit, or an audit• are the eyes and ears of top management– their task is to make an independent assessment of

compliance to standards and procedures and evaluate whether those standards and procedures are adequate, effective, and efficient.

• This helps management to obtain factual information about the status of the quality program and identify opportunities for improvement. It also helps to improve communications and can be used as tools for training personnel

• Top management should commit the organization to conducting quality audits on a regular, scheduled basis, report the results, and follow up with corrective actions as appropriate.

• Audit findings are an important input to adjusting and improving the quality program and to management’s review of the quality program. The quality manual should contain this policy statement.

Conducting an AuditA unit being audited should be notified of a planned audit well in advance of the scheduled date

Every manufacturing process is accomplished through an interconnected number of procedures described in different types of documents (training manuals, etc)

A manufacturing process is audited by auditing theprocedures that accomplish the process. This is done because a procedureis detailed in a corresponding document, specifying not only what workis to be accomplished but also where and who will do it

Purposes of Audit As a basis for development of the QC procedures

For most food processing operations, the developed control procedures should include HACCP techniques,in-process inspection, testing and monitoring, and the use of appropriate statistical procedures.

To confirm that procedures are being carried out — under normal conditions of operation —as prescribed in the manufacturing documents, and to report deviationsfrom the procedures to promote their correction or implementation.

The Audit Report includes:• any nonconformities that were observed• any observations of potential

nonconformities, lack of effectiveness, or lack of relevance of process steps

• A detailed the corrective action taken by plant management (but should not make suggestions or recommendations for solving a problem; that should be left to management

Types of Audits• Product Manufacturing Audits– operation and control of the process should show that

manufacturing is carried out in a suitable environment, under accepted manufacturing and sanitary conditions as designed and described in the corresponding manufacturing documents

– this include documented work instructions, suitable equipment, samples or criteria for workmanship, and compliance with relevant standards and quality plans. Process and product characteristics should be monitored during production, warehousing, distribution, and sales at the consumer level

Plant Sanitation/GMP Audits

• Plant Facilities– Building and facilities, including the areas of

warehousing and storage (storage conditions, code dating, separation of allergen-containing ingredients, proper label declarations, specifications

– plant and grounds maintenance, walls, floors, and ceilings are closely scrutinized. Utilities and support services, including sanitary operations, sanitary facilities, and maintenance are evaluated


• Employee Hygiene– Procedures and practices are inspected and

evaluated. Control and enforcement of personal hygienic practices, control of employee health conditions, proper use of gloves and outer garments are reviewed

– appropriateness of plant practices relative to food risks associated with the products manufactured


• Pest Control– food company should not attempt to perform its

own pest control but rather should rely on a dependable outside firm. Still, it is important for the sanitation manager or someone in QA to be trained in the area of pest control. QA should be aware of the warning signs of potential problems or infestations

Product Quality Audits

To determine the degree of compliance to established QC specification and to evaluate its performance over time, when available to the consumer at the retail level• To compare the results of the audit to the limits of the

company’s QC specifications• To compare the quality of the company’s product to

the quality of competitive brands• To compare the quality of the company’s product to

that of the same product in previous years• To compare the quality of the product as

manufactured by the company’s different plants

HACCP Audits• An internationally recognized means of assuring

food safety from harvest to consumption. Recognized by “Code Alimentarius” of the United Nations

• The audit includes a detailed observation of a manufacturing process to ensure that the appropriate significant hazards have been identified, that hazards are being effectively controlled, and the appropriate critical limits have been specifically validated or proven effective

HACCP Audits• Monitoring records are evaluated,

concentrating on the critical control points (CCPs) in the process to ensure appropriate maintenance of the program and that corrective actions are taken when critical limits are exceeded

Special Audits• Document Control Audits– the status and issue of forms, procedures, and

work instructions; controlled copies of documentation (in electronic or hard copy format); maintaining records of changes and backups; and removing obsolete documentation

• Supplier Audits– suppliers are certified, which means that they

agree to a set of specifications and that they will deliver what they are contracted for

Special Audits• QC/Instrument Calibration and Maintenance

Audits– helps to track correct application of methods,

method steps, and of measuring and testing instruments. It includes review of individual records maintained for each piece of equipment or instrument; calibration frequency, checkpoints, and tolerances; program for next calibration schedule; calibration data and maintenance of historical records

QA DOCUMENTATION SYSTEM• An SOP is a set of written instructions that

provides a step-by-step process documenting a routine or repetitive activity conducted or followed by an organization.

• SOPs document the way activities are to be performed to facilitate consistent conformance to safety and quality system requirements.

• SOPs are intended to be specific to the organization or facility whose activities are described

Quality Manual• The company’s quality policy and the descriptions of its

processes must be contained in a corporate quality manual. It should express the organization’s total commitment to quality, how it is organized to fulfill that commitment, and its approach to fulfilling it. The purpose of the manual is to outline the quality program, including procedures and detailed instructions, and to serve as a reference.

• In general, the term document is used for items that describe a quality program; record is used for evidence to demonstrate effective operation of the program. Thus, description of a process is a document; a test report is a record

SOP (Manufacturing and Quality) Documents• A quality program is a collection of procedures that

specifies the major activities of an organization and the way they are to be performed. A procedure is “a specified way to perform an activity”

• According to an ISO definition, Procedures describe what is to be done and why, who (by organizational title) is responsible for doing it, where it is to be done, and when (that is, the order in which procedures are to be accomplished).

SOP (Manufacturing and Quality) Documents• This family of documents includes: product

specific manufacturing (PSM) documents, general manufacturing operation (GMO) documents, quality control analytical methods (QCA) documents, good manufacturing practices/sanitation (GMP) documents, equipment specific sanitation documents, and preoperation sanitation documents

PSM Documents• A description in detail of the procedures for

manufacturing a specific product, including batching and formulation, processing, packaging, coding, and storage requirements.

• GMO documents, ingredient specification documents, sanitation documents, HACCP documents, and QC method documents are referred to in this document, as needed, and contribute to the number of requirements for the quality manufacturing process of the product.

An example of a PSM document.

GMO Documents

• This type of document describes a certain activity related to the manufacturing process of a specific product; it is used in conjunction with the prescribed PSM document. For example:

“The can/glass container packaging document addresses the procedure by which a product is canned, labeled, coded and the container handled, to the warehouse, so as to preserve the container intact. The weight control document addresses the procedure for determining the net weight of a product during manufacture.”

An example of an analytical method used for determinationof ascorbic acid (vitamin C)

SSOP usually includes:

• Activity name• Place where it is performed• List of equipment and material necessary to

perform activity• Frequency of performance• Approximate time of performance• Responsible individual(s)• Description of each performance step

GMP Documents• Each manager and supervisor must assume responsibility

for the safety, cleanliness, and wholesomeness of the environment in which food products are produced. Cleaning and sanitizing procedures, appropriate chemicals and concentrations, surfaces, cleaning frequencies, and instructions for workers should be written down and filed so that every employee can be properly trained in what to do and why he or she is doing it.

• Sanitation employees must be instructed on how to clean individual pieces of equipment; also, employees should be responsible for monitoring the condition of their own personal protective equipment.

The SSOP written for a food processing plant should be a comprehensive document and must include the following areas for monitoring:

• Hygiene and personnel practicesRegardless of the type of processing or food handling operation, the first consideration in food sanitation is people. People set, follow, and break the rules of sanitation.• Sanitation principles and food handling practicesPersonnel training should nurture an understanding of processes and technologies involved in manufacturing and handling food products.• Manufacturing controls of operations Production personnel must be trained in the critical elements of the operations for which they are responsible.


• Communicable diseases/injuries. Persons known to be suffering from, or known to be carriers of, a disease likely to be transmitted through food must be restricted from any food-handling area.• Handwashing. Facilities with hot water for handwashing must be provided and must be conveniently located in food handling areas.• Personal cleanliness and conduct. Personal cleanliness must be maintained while involved in food handling operations.


• Traffic control/controlled access.Personnel and visitor access to specific food-product handling areas must be restricted.• Outside surroundings. Outside surroundings to a manufacturing plant should be evaluated for sources of contamination such as vermin, bird harborage areas, drainage problems, odor problems, debris, refuse, smoke, dust, and other contaminants.


• Buildings and facilities.Food processing and handling areas should be cleanable, and so designed and constructed.• Building construction. Floors, walls, and ceilings must be constructed of suitable, approved materials that are durable, smooth, and easy to clean.• Overhead structures and lighting. Should be situated and constructed so as to prevent contamination of food products; lighting must be protected with properly sealed, safety-type overhead fixtures.


• Heating, ventilation, air conditioning. Must be designed and installed to prevent buildup of heat, steam, condensation, or dust, and to remove contaminated air. Positive air pressure is required in microbiologically sensitive areas.• Drainage and sewage systems. Appropriate traps and vents are to be used throughout.• Waste facilities. Facilities should be designed so as to prevent contamination and for the sanitary storage of waste and inedible materials prior to their removal from the plant or its surroundings


• General protection from contamination. The facilities and nonproduct contact surfaces and equipment must be evaluated to assess potential for food product contamination.• Flow-through pathways. A well-designed food processing or handling facility should be constructed to minimize traffic and to prevent cross-contamination from raw product to finished product.• Washrooms, lunchrooms, changing rooms. Self-closing doors must be provided for these rooms. The areas must be separate from and not directly entered from food processing and handling areas.


• Returned foods. Foods returned from retail outlets must be clearly and stored in a designated area for appropriate disposition.• Nonfood chemicals. Detergents, sanitizers, and other chemicals must be properly labeled, stored, and used in a manner that prevents contamination of food, packaging materials, and food contact surfaces.• General cleanliness and housekeeping. All food processing, food handling, and other rooms must be maintained in a clean, sanitary manner.• Equipment construction and maintenance. Equipment for food processing and food handling operations must be designed and constructed in a manner that makes them cleanable and maintained in such a manner as to prevent contamination.

An example of a Sanitation Report in a Food Manufacturing Plant

qa audit by signorina y. bueno (wmsu-zc)

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