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: