Microbiology procedure: Is there a procedure example?

Purpose and scope of the microbiology procedure

The aim of the microbiology procedure is demonstrable control of the microbiological condition of the products, environment, and hands (materials, equipment, environment, and people). The procedure comprises the process of sampling, analysis, registration, and processing of results and registration of measures taken in response to legislation, deviations, and trends. 

Definitions Microbiology

Micro-organism	Bacteria, yeasts and fungi, etc.
Material	Sustainable production aids such as machines, means of transport, and conveyor belts.
Counter sample	A sample that is kept on hand, without it being clear in advance whether and which analyzes will be carried out with it.
Microbiological shelf life research	A form of product research in which the retention period is determined or confirmed.
CFU	Colony-forming units, count of microorganisms.

Responsibility

Process	Responsible	Executed	Supportive
Process responsible	QA-manager	QA employee

Procedure

The microbiological examination is planned on the basis of the annual plan. This describes the minimum frequency of the various examinations. 

The microbiological research can be divided into product research (materials: raw material, semi-manufactured, or end product), environmental research (equipment, air, spaces) and examination of hands and gloves (humans). 

All microbiological and chemical research is outsourced. An external laboratory is used for this. To this end, a sampling and examination schedule is drawn up annually by the QA manager and his employees. 

Product examination

On the basis of an annual plan based on the EU regulation (EC) 2073/2005, a number of products are examined that fit into that series. 
Furthermore, a number of inspections are launched by means of iMIS that were recorded at item level. The (counter) samples are then taken upon arrival or production and placed in the warehouse of the QA department. The counter samples are kept at least until the best before date. 
Samples are taken from the stock of counter samples in accordance with the sample plan. These are analyzed by an external laboratory. It is also possible for employees of the QA department to take samples during production.
The standard against which is tested is given in the product specification of the relevant article. The results of the research are reviewed and archived. If desired, a research report can be drawn up. 

Environmental examination

The microbiological examination of cleaned and disinfected equipment and rooms is carried out using contact printing plates and / or swabs. 

There are a number of fixed sampling points in front of the contact printing plates which are periodically sampled to check the hygienic condition and whether cleaning is done properly. For the swabs, samples are taken over time, also to check the hygienic condition and whether cleaning is done properly. 

Every sampling point can be classified as high or low care if desired. High care are surfaces that can directly influence product quality. Examples of low care surfaces are floors and walls. 

A visual inspection precedes the sampling, because it makes no sense to sample visibly dirty surfaces. When a surface is optically dirty, this is stated and included in the score. An exception to this is taking environmental samples for the presence of Listeria monocytogenes. These should be taken immediately before cleaning, because then there are indications of the presence of Listeria monocytogenes sooner rather than after cleaning. The evaluation of the results of agar prints takes place according to the standard below.

Total CFU	Estimate	Coding
0 – 2	Good	0
3 – 9	Sufficient	1
10 – 29	Moderate	2
30 – 90	Insufficient	3
> 90	Bad	4

The results of the research are reviewed and archived. A report is drawn up of each investigation and distributed within the organization. Investigate the effect of cleaning hands (this is an optional investigation).

When investigating the effectiveness of washing and disinfecting hands and gloves before entering production, at least a number of people are checked by means of the rinsing method (sampling by putting their hand in a sampling liquid) or by taking a contact print. 

The tricky part of the hand examination is that there are no generally accepted standards for a cleaned and disinfected hand. It can also happen that a washed hand has a higher bacterial count than an unwashed one. This is caused by the bacteria that naturally occur in the skin coming to the surface through washing. 

The results of the research are reviewed and archived. A report is drawn up of each investigation and distributed within the organization (feedback).

Trend analyzes must be made of all microbiological studies and certainly those within the framework of Regulation 2073/2005. 

Abnormalities

When results deviate from the maximum standard then:
Report to the QA manager and production manager; appropriate measures are taken in the event of deviations related to insufficient cleaning and / or disinfection. Additional cleaning and disinfection is applied, especially if Listeria monocytogenes are found in the environmental samples. Additional training and extra instructions can also be drawn up or the cleaning and disinfection plan can be adjusted.

If food safety could be endangered because pathogenic microorganisms (or histamine) are found in end products, the recall team is called and the new Food and Consumer Product Safety Authority is informed of the exceedance (0800-0488). Additional measures are also taken to prevent subsequent contamination as described in Article 7 of Regulation (EC) 2073/2005. All actions are recorded in writing in a report. 

Inadequate results

Article 7 of the regulation EC 2073/2005
1. If inadequate results are obtained during testing against the criteria set out in Annex 1, food business operators shall take the measures set out in paragraphs 2, 3, and 4, as well as other corrective measures and other measures established in their HACCP-based procedures, are necessary to protect consumer health. In addition, they shall take measures to identify the cause of inadequate results in order to prevent the unacceptable microbiological contamination from recurring. Those measures may include changes to HACCP-based procedures or other food hygiene measures applied.

2. If unsatisfactory results are obtained during the testing, against the food safety criteria set out in Chapter 1 of Annex I, the product or batch of food shall be withdrawn from the market or recalled in accordance with Article 19 of Regulation 
(EC) no. 178/2002. However, products placed on the market that are not yet on the retail market and that do not meet food safety criteria may undergo further treatment to eliminate the hazard concerned. This treatment should only be carried out by food business operators not operating in the retail sector.
The food business operator may use the batch for purposes other than those for which it was originally intended, provided that this does not pose a risk to public or animal health, provided that such use has been decided in the framework of procedures based on HACCP principles and good hygiene practices and subject to the approval of the competent authority.