Our glossary for guidance - Letter 0-9

EU Medical Device Regulation.

On 26 May 2017, this EU regulation became binding in all EU member states and replaces the EU directives within the transition period of four years. The AIMD (90/385/EEC) and MDD (93/42/EEC) were replaced by the MDR (2017/745 EU) on 26 May 2021.

EU Regulation on In Vitro Diagnostic Medical Devices (In Vitro Diagnostics Regulation).

On 26 May 2017, this EU regulation came into binding force in all EU member states and replaces the EU directive within the transition period of five years. The IVDD (98/79/EC) will be replaced by the IVDR (2017/746 EU) on 26 May 2022.

100-percent test is a method that corresponds to the inspection of all units of an inspection lot. A distinction must be made as to whether this measure refers only to a specific test criteria or to the entire specification.

14 Points for Management include

1. Create constancy of purpose toward improvement of product and service, with the aim to become competitive and to stay in business and to provide jobs.
2. Adopt the new philosophy. We are in a new economic age. Western management must awaken to the challenge, must learn their responsibilities, and take on leadership for change.
3. Cease dependence on inspection to achieve quality. Eliminate the need for inspection on a mass basis by building quality into the product in the first place.
4. End the practice of awarding business on the basis of price tag. Instead, minimize total cost. Move toward a single supplier for any one item, on a long-term relationship of loyalty and trust.
5. Improve constantly and forever the system of production and service, to improve quality and productivity, and thus constantly decrease costs.
6. Institute training on the job.
7. Institute leadership. The aim of supervision should be to help people and machines and gadgets to do a better job. Supervision of management is in need of overhaul, as well as supervision of production workers.
8. Drive out fear, so that everyone may work effectively for the company.
9. Break down barriers between departments. People in research, design, sales, and production must work as a team, to foresee problems of production and in use that may be encountered with the product or service.
10. Eliminate slogans, exhortations, and targets for the work force asking for zero defects and new levels of productivity. Such exhortations only create adversarial relationships, as the bulk of the causes of low quality and low productivity belong to the system and thus lie beyond the power of the work force.
11. Eliminate work standards (quotas) on the factory floor. Substitute leadership. Eliminate management by objective. Eliminate management by numbers, numerical goals. Substitute leadership.
12. Remove barriers that rob the hourly worker of his right to pride of workmanship. The responsibility of supervisors must be changed from sheer numbers to quality. Remove barriers that rob people in management and in engineering of their right to pride of workmanship. This means, inter alia, abolishment of the annual or merit rating and of management by objective.
13. Institute a vigorous program of education and self-improvement.
14. Put everybody in the company to work to accomplish the transformation. The transformation is everybody’s job.

Source: Deming, W. Edwards. Out of The Crisis (MIT Press) (pp. 23-24), 1982

The three MU`s are a component of KAIZEN and refer to the three central causes of error

• Muda (waste of resources) (see 7 types of waste)
• Muri (overload related to employees and machines)
• Mura (imbalance or irregular processes)

The 4D report is a document that is used in the processing of internal complaints. This acronym stands for the four underlying process steps (disciplines):

• D1 - Error description
• D2 - Analyse cause(s) of error
• D3 - Determine immediate measures
• D4 - Establish corrective measures

The 4M refer to the original four branches of the Ishikawa diagram, which target possible causes of problems. Thereby the 4M stand for

• Man
• Machine
• Material and
• Method

The 4P marketing matrix is a term from business administration and refers to the four different "policies":

• Product policy
• Pricing policy
• Communication policy
• Distribution policy

The 5 Whys is a method for cause-effect analysis. The purpose of this method is to find the real cause of the problem that has occurred - as well as to safeguard the remedial action that has been identified.

Note: The number of whys is not limited to five! It should be continued until the real cause is found. This can already be achieved after asking three times.

The 5A methodology is a modified version of the 5S method and stands for:

• Sorting out (Aussortieren)
• Tidying up or ergonomically arranged work equipment (Aufräumen bzw. ergonomisch angeordnete Arbeitsmittel)
• Workplace cleanliness (Arbeitsplatzsauberkeit)
• Make arrangement a rule (Anordnung zur Regel machen)
•  Adhere to and improve all points (Alle Punkte einhalten und verbessern)

The 5S methodology is a component of KAIZEN and refers to the five principles for workplace design that are the basis for efficient and error-free work processes:

• Seri (tidy up)
• Seiton (Same place for the same object)
• Seiso (Keeping the workplace continuously clean)
• Seiketsu (standardize work processes)
• Shitsuke (Keep order and cleanliness)

The Six Thinking Hats by Dr. Edward de Bono is a creative technique for problem solving. Each hat represents a different perspective on a particular issue and is useful to prevent narrow thinking.

1. White Hat: Facts
2. Green Hat: Creativity
3. Yellow Hat: Benefits
4. Black Hat: Cautions
5. Red Hat: Feelings
6. Blue Hat: Procrss

The 635 method is a brainwriting technique (a form of creative techniques) and aims to find unusual ideas for problemsolving.
With this method, you can generated up to 108 ideas within 30 minutes (6 participants x 3 ideas x 6 lines).

To use this method you need:

• Equal-sized sheet with three columns and six rows each (18 boxes).
• Each participant (ideally six) formulates three ideas (one per column) in the first row.
• Each sheet is passed clockwise after a time reasonable for the the problem that needs to be solved (approx. 3-5 minutes).
• The next participant takes up the ideas that have already been mentioned and tries to develop them further.

The 6Rs are a lean management tool and aimed at optimal customer orientation:

• the right part or product
• in the right quantity
• at the right time
• at the right place
• in the right quality
• at the right price.

The 6W method uses the well-known "who, what, where, when, how and why" and combines them to a total of 36 questions. Each of the listed 6Ws is questioned six times with the same W.

1. What
2. Why
3. Where
4. Who
5. When
6. Which

The idea of asking six questions to analyse a project or problem comes from a poem by the famous poet Rudyard Kipling. However, the original poem mentioned 5Ws and an H. this is the more common approach than the 6Ws.

The "seven fatal diseases of a management system" described by Deming are:

1. Lack of a fixed organisational purpose
2. Emphasis on short-term profit
3. Annual evaluation, performance review and personal review system
4. High turnover in organisational leadership, jumping from company to company
5. Use of metrics by management - ignoring those that are unknown or unquantifiable
6. Excessive social costs
7. Excessive costs from product liability judgements

Waste in this context refers to the wasting of time or resources and does not create value. In particular there are the following seven types of waste (alternatively: TIMWOOD):

• T – Transport
• I – Inventory
• M – Motion
• W – Waiting
• O – Over-Production
• O – Over-Engineering
• D – Defects

The 8D report is a document that is used in the processing of a complaint. The acronym stands for the eight process steps (disciplines):

• D1 - Assembling the team
• D2 - Describing the problem
• D3 - Determine immediate measures
• D4 - Analyse the cause(s) of the problem
• D5 - Plan corrective action
• D6 - Implement corrective actions
• D7 - Prevent recurrence of error
• D8 - Appreciate the team's performance

The 8D methodology parallels the DMAIC methodology on which Six Sigma is based, with the disciplines D1, D2 and D5 corresponding to the "D" Define process, D3, D5 and D6 to the "I" Improve process, D4 to the "M" Measure or "A" Analyze process and D7 to the "C" Control process.

COUNCIL DIRECTIVE of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices.

Medical Device Directive: COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices.

DIRECTIVE 98/79/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 October 1998 on in vitro diagnostic medical devices.

The A3 problem-solving report is a document that is used for problemsolving and decision-making. This report should easily fit on one page. This acronym stands for the format DIN A3, which is the largest format that can be sent by fax. It is based on nine process steps (disciplines):

• D1 – Background and team building
• D2 – Description of the problem (e.g. pairwise comparison)
• D3 – Set goals and targets
• D4a – Root cause analysis (e.g. Ishikawa-diagramm)
• D4b – Root cause analysis (e.g. 5x Whys)
• D5 – Define and implement countermeasures
• D6 – Follow up
• D7 – Ensure successful solution
• D8 – Standartize or modify process
• D9 – Conclusion and break-up of the team