Our glossary for guidance - Letter H

The HACCP principles are the basis for drawing up an appropriate HACCP plan:

1. carry out a hazard analysis.
2. determine the critical points (CCP)
3. define critical limits
4. establish a monitoring system for the critical points
5. define corrective actions if the monitoring system shows that one or more critical point(s) are not under control
6. establish verification procedures to confirm that the HACCP system is operating successfully
7. establish documentation covering all operations and records in accordance with the principles and their application.

Self-reflection - examining one's own approach, processes and behaviour.

Reflection meetings (created through the combination of Hansei and Kaizen).

A hardware FMEA (HW FMEA for short) examines the risks in the field of hardware and electronics.

‘Harmonised standard’ means a European standard as defined in point (1)(c) of Article 2 of Regulation (EU) No 1025/2012;

[Definition under (EU) 2017/745 Article 2 No. 70 also corresponds to definition under (EU) 2017/746 Article 2 No. 73]

‘Health institution’ means an organisation the primary purpose of which is the care or treatment of patients or the promotion of public health;

[Definition under (EU) 2017/745 Article 2 No. 36 also corresponds to definition under (EU) 2017/746 Article 2 No. 29]

This involves smoothing capacity utilisation and levelling out production to minimise the "whip effect" of order fluctuations.

Abbreviation for Highest In - First Out. The goods with the highest value are taken out first. It refers to a possible structure within a queue of goods or documents.

The histogram is a graphical evaluation / visualisation of a distribution function (frequency/time).

Intended for use in the home healthcare environment; intended for use by a lay operator; intended for use with patients who are dependent on mechanical ventilation for their life support. Depending on the intended purpose can be also used in the clinical setting (See e.g. EN ISO 80601-2-72:2015).

[Definition according to MDCG 2020-9 No. 2.1]