Food Safety Standard

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

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).

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

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

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

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.

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.

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: –

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.

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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