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Quality Audit Systems in Food Safety Management System:

• A systematic and independent examination to determine whether activities and related results comply with planned arrangements and whether these arrangements are implemented effectively to achieve objectives
• Typically performed at defined intervals (monthly, annual, biannual)
• Any failure in their proper implementation may be published publicly and may lead to a revocation of quality certification

Objectives Of Quality Audit:

Food manufacturers commonly use audits as an effective mechanism to verify compliance with GMP regulation (GMP). GMP audits have two important goals

• Audits are intended to verify that manufacturing and Control systems are operating under a state of control.
• Audits permit timely correction of potential problems that may otherwise result in higher quality loss (cost).

Types Of Quality Audit:

The quality audit system is mainly classified in three different categories:

• Internal Audit
• External Audits
• Regulatory Audit

In food industries all three-audit system may be used to carry out

1. Product manufacturing audit
2. Plant sanitation/GMP audit
3. Product Quality audit
4. HACCP audit

Internal Audit

Purpose of Internal audit: –

• To ensure that adequate Quality systems are maintained
• To asses compliance with the C-GMP’s and firms standard operating procedures (SOPs)
• To achieve consistency between manufacturing and testing facilities
• To identify problems internally and Correct problems prior to a external or regulatory audit

External Audit

Purpose of External Audit: –

• Ensuring that requirements are well understood
• Enabling reduction of in-house QC testing of raw materials
• Reducing the risk of failure
• Carried Out by a company on its vendors or sub contractors
• External auditors have experience of GMP and as well as regularly audited by their certification body

Regulatory Audit

Purpose of Regulatory audit: –

• Networking and confidence-building between national inspection authorities
• Development of quality systems plan
• Work towards global harmonization of GMP principles
• Carried out by regulatory bodies such as US FDA, national regulatory bodies
• Failure of regulatory audit: withdrawal of a manufacturing or import/export license
• After regulatory audit, a formal report will be delivered

What is to be audited: –

• Premises
• Primary materials
• People
• Procedures
• Processes defined and Recorded

Plant facilities– floors, walls, ceilings, windows for more effective food safety environment

Employee Hygiene-how employee’s hygiene may affect food safety risk should be observed

In-process control– food safety and sanitation policy, raw materials, operation conditions

Pest control-to be outsourced from a trained firm and record should be kept

Role of GMP Audits in Q.A And Q.C programme

GMP audits find objectionable condition that is unknown to responsible production , QC ,QA or management personnel.

The auditor will see whether such actions are frequent or not from this he can signal other GMP problems. 

Audits may be effective in: –

• changing SOPs, modifying manufacturing equipment or procedure
• upgrading equipment or procedure
• Improving employee training programme
• Developing new or revised documentary system

Selecting Audit teams:

Limitations of Personnel audit

• Experience and knowledge, which is individual.
• Emphasize on familiar issues as well as particular area
• Team is required to cover many different systems and large amount of data.
• Leader is usually a senior auditor who has extensive knowledge of the firm’s operations and exhibit strong leadership qualities.

Reporting Audit Finding:

• Audit reports should contain complete details of the problem detected.
• Corrective action is taken to eliminate problems and to measure the overall adequacy of the audit program uses reports

There are two important reporting phases: –

• Preliminary reports during the audit
• Final report to the management

Preliminary reports during the audit:

Benefits can be gained from having dialogues with employees

Finding is communicated with affected personnel.

Discussion may help the employees to learn why problems happened.

Final report to the management:

• Management must review the final reports and determine what steps need to be taken to eliminate deficiencies.
• Management should sincerely encourage detection of problems and express appreciation for being able to improve quality operations.
• The audit reports may be shared with manger supervisor who may discuss finding with employees.
• The workers and supervisory personnel should be given the opportunity to explain their views and ideas about the audit findings.

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