Industrial Hygiene & HACCP

To avoid impurities or contamination and thus ensure hygienic safety of the plant and the products, certain operational hygiene measures must be implemented.

Industrial hygiene in the food industry

Particularly in the food industry, attention must be paid to a high standard of hygiene, regardless of whether the respective company is active in food production, food retail or wholesale, or in the gastronomic sector. This is to ensure a high level of consumer protection.

The following elementary measures should be observed for in-house hygiene, by Annex II of Regulation (EC) No. 852/2004:

• Compliance with the general cleanliness of all rooms, outdoor facilities, equipment, machinery, and equipment of the enterprise
• Regular cleaning and disinfection of all rooms (including floors, walls, ceilings, windows, doors, all surfaces) and objects that have direct contact with foodstuffs
• Maintenance of all equipment and objects that have direct contact with foodstuffs
• Hygienic storage, handling, processing, and warehousing of food, avoiding adverse impact, e.g., from contamination, microorganisms, animal pests, waste, and inappropriate treatment and preparation methods
• Maintaining the cold chain, especially when handling perishable foods (eggs, fish, meat, poultry, and dairy products)
• Collecting all waste in sealable containers and disposing of it promptly, but no later than the end of operations
• Wearing suitable and clean work or protective clothing (appropriate changing rooms must be accessible to personnel)
• Thorough hand washing and hand disinfection by personnel after visiting the restroom facilities (appropriate hand washbasins with soap and hygienic hand drying facilities must be available in the restrooms; if necessary, additional disinfection dispensers must be installed)
• Smoking ban in all areas where food is produced or processed (private food and drinks may only be consumed in staff or social rooms)
• Companies are obliged to provide their employees with sufficient and regular training on health risks and food hygiene

The basic hygienic requirements for the production, processing, and placing on the market of foodstuffs are regulated in Regulation (EC) No. 852/2004 (food hygiene) and Regulation (EC) No. 853/2004 (hygiene rules for food of animal origin).

Industrial hygiene in the pharmaceutical sector

In the pharmaceutical sector, a hygienic environment is also mandatory and aims to protect pharmaceuticals and medicines from contamination as well as other adverse effects.

The pharmaceutical regulations include the EU GMP Guidelines. GMP stands for "Good Manufacturing Practice". This refers to specific guidelines to ensure the quality standards of the production processes and environment in the manufacturing process.

Detailed compliance with the requirements is checked in demanding approval processes and closely monitored by recurring inspections by the relevant authorities.

Industrial hygiene in cosmetics companies

However, essential framework conditions must also be observed in cosmetics. The basis for this is the internationally applicable standard ISO 22716:2007 " Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices", known as cosmetics GMP for short. The guideline contains the hygienic and qualitative requirements for the manufacturing process, quality monitoring, storage, and shipping of cosmetic products.

The general legal basis in the EU is the Regulation (EC) No. 1223/2009, which regulates the general requirements and obligations for cosmetic products. In the various countries, other national laws could also take effect.

Regulation (EC) No. 852/2004 also specifies how hygiene regulations are to be implemented: based on the seven principles and the 12 steps of the HACCP concept. The acronym HACCP stands for Hazard Analysis and Critical Control Points.

The HACCP system is the basis for every food safety standard. It is based on self-monitoring and is used to analyze, evaluate, and eliminate microbiological, chemical, or physical hazards that arise in the handling of food and may pose a health risk to consumers.

The HACCP concept is based on seven principles:

1. Hazard analysis
2. Critical control points
3. Limit values
4. Continuous monitoring
5. Corrective actions
6. Documentation
7. Regular verification

Each food company must establish its own HACCP system, as the critical control points vary from company to company. In addition, compliance with and implementation of the measures must also be documented in writing. In the event of inspections by the health authorities, this evidence must be presented.

Establishing effective hygiene management should be an important focus in your company. It is advisable to appoint at least one well-trained person as a hygiene officer and to assign this person the responsibility for maintaining, monitoring, and continuously optimizing all hygiene measures.

To keep up to date with all legally applicable hygiene regulations, regular hygiene training is essential for the hygiene officer on the one hand, but also for the entire staff.

The following points form the basis for effective hygiene management:

1. Establishment of a self-checking system
2. Regular hygiene audits by external auditors
3. Creation, implementation and compliance with HACCP and hygiene concepts
4. Regular hygiene training for employees

We offer hygiene training and instruction in accordance with the Infection Protection Act. Whether, at your site, online or in our seminar rooms - the choice is yours. Tentamus' experts will address the specific situation of your company and conduct practice-oriented training and seminars on the topics you require.

Our trainers have an academic background in a food-related field (e.g., food technologists, nutritionists, engineers for hygiene and nutrition technology).

Our experienced trainers, consultants and auditors have a wide range of knowledge in the field of industrial hygiene and are familiar with the current ordinances and regulations. In addition, some of them are officially approved trainers and auditors e.g., IFS or BRC for many years.

We conduct trainings and seminars in the following areas:

• General and basic food hygiene
• Basics of microbiology
• Personnel hygiene and operational hygiene (production, equipment, environmental hygiene)
• Company-specific self-control systems Instruction according to § 43 (4) Infection Protection Act
• Sampling procedure
• HACCP training
• Training of internal auditors
• IFS Food & BRC
• System training e.g., on beef labeling, Marine Stewardship Council (MSC), Quality and Safety (QS), organic/organic regulations etc.
• Sensory training

Tentamus offers you effective support in complying with all legal regulations: Our experienced auditors will thoroughly check your hygiene concept. Together with you, we work out any hygiene gaps and optimize your hygiene management.

The improved process flows save personnel and financial resources. The costs and risks that can result from poor operational hygiene are thus sustainably reduced.

Verification of the implementation of "Good Manufacturing Practice" (GMP).

The implementation of hygiene audits and the review of the company's self-checking systems in the various areas of responsibility in the food industry are the main tasks of our colleagues in Hygiene & Quality Assurance. Tentamus hygiene audits are voluntary and are planned individually with you. However, they are usually unannounced. Internal audits as a Quality Management element are announced.

According to the product liability law, those placing foodstuffs on the market have the duty of proof and must be able to prove that all hygienic and legal regulations have been complied with from the receipt of goods to their dispatch (in production, trade, or gastronomy).

The focus of the audits therefore includes the examination of personnel and production hygiene, but also of the entire environment and equipment of the facility, as well as compliance with legal regulations. The advisory character and thus the dialog with the employees of the audited company is always in the foreground.

Detailed documentation of the audits

For this reason, all results are summarized in a detailed report with the help of the hygiene software developed by Tentamus, which also includes action plans and pictures. A uniform layout makes it easy to compare the current hygiene audit with past ones. Trend analyses from several reports can also be generated and used to verify the company's own quality management system. The reports make it possible to immediately identify serious deviations. An individual action plan and image attachments can also be included.

External hygiene audits as part of quality management

External consulting and training are essential aspects of implementing the Internal Quality Management System.

By arranging external audits, if necessary, with sampling - as proof of your operational due diligence - you can demonstrate in an emergency that everything has been done to avoid a loss event.

External audits can thus help you to meet the constantly growing demand for transparency from authorities, consumer organizations, or initiatives with well-trained employees.

Legal basis

As of 01 January 2006, Regulation (EC) No. 852/2004 concerns any food business operators operating at any level of production, processing, or distribution of food. They are obliged to establish, implement, and maintain one or more permanent procedures based on the HACCP principles, which ensure the safety of consumer health protection. This is the basis of our advisory services.

Creation of hygiene concepts

The experienced and competent team of the Tentamus Group assist your company in the in the development and creation of an individual hygiene concept.

Constant sampling for the HACCP concept is the prerequisite for the chemical and microbiological examination of food, drinking water, and tobacco products. For the realization of laboratory orders, our qualified employees of hygiene and quality assurance take a variety of different samples at your site or pick up the provided samples at your site.

If desired, sample collection also includes the provision of packaging and shipping materials.

The focus is on the following sample collections:

• Food samples for microbiological analysis within the framework of the self-checking system, as well as to meet the requirements of Regulation (EC) No. 2073/2005*.
• Fruit and vegetable samples for residue analysis
• Drinking water samples for analysis in accordance with the Drinking Water Ordinance
• Samples for the determination of surface microbial counts to check cleaning and disinfection measures
• Samples for the determination of airborne germ counts

* This service does not fall within the scope of accreditation

The following locations of the Tentamus Group offer audits and trainings: