Risk Management


FMEA means Failure Mode Effects Analysis and is a proactive method of analysis. The method can be used to carry out in-depth analysis of a delimited working process for the purpose of implementation of improvements.

This method is useful when there in a department is suspicion that some processes contain unidentified risk factors. If several identified internal failures or adverse events related to a specific process are detected.

All potential risk factors has to be identified, both directly observed as indirectly that can not be readily seen. This assumes, of course, a professional and independent auditor, with extensive experience in analysis and auditing of business processes.

Any risk assessment can be made generally or at a specific process. At a general assessment there will be taking into account all the extensive measuring equipment, appliances, decor, applicable procedures, communication, learning and training of staff.

Detecting of any risks to a specific process, is directly comparable to audit of the process, where assessing the risk starts at first contact and continuous throughout the process. Is the whole process ‘In Compliance’ or is there any discrepancy in greater or lesser degree.

It is based on the following:

  • Procedures/Instructions/Specifications (availability)
  • Validity of appliances and Measurement
  • Working environment
  • Introduction, training and education
  • Communication
  • Barriers against failures

Objective evidence uncovered for established risk factors, the analyzes documented in subsequent reporting and last but not less important, prepared action plan for implementation of improvement measures.


FDA Validation

ISO 9001- the series was the most common method up through the 90s and was used to create customer confidence. Confidence from customers is still the most important, but today companies focus on 0-failures philosophy, process optimization and minimization of wastage expressed through LEAN, Six Sigma or FDA validation (0-failures production).

Validation is to avoid failures opposite sorting.

When a company such as exporting food, dietary supplements, cosmetics, medical devices, pharmaceuticals or blood products to the United States, it is a requirement that the manufacturer validates the process to ensure flawless products.

NOTE that this is a legal requirement!

If the manufacturer not complies with this requirement, the FDA (Food and Drug Administration) can go to courts and demand the product removed from the market.

How to set up production to produce without failures?

Any failure freedom begins with product development, because failures and delays can be expected. Parallel to the development of a new product, validation can be carried out to ensure that the initial start-up results in a flawless issue, and the minimum cycle time. Troubleshooting avoided and the subsequent production results in lowest unit cost.

How to realize 0-failures production through FDA-validation?

A plan for process validation consists of 5 basic elements, see the table below:

1 IQ Installation Qualification Prove that production equipment, and other equipment are connected as prescribed and that alle supplies meet specifications. Note that it is not enough to refer to the supplier’s own testing equipment!
2 OQ Operationel Qualification Establish limits for process control that ensures production of approved products.
3 PQ Production Qualification Prove that the process is reproducible, as documented by completing 3 productions. These 3 productions shall be carried out in normally occurring production conditions. (eg. shiftwork). Statistics evidence within 95% confidence
4 PC Process Control (control and monitoring) Process Control, a key part of process validation “process monitoring and real-time process control”. The company must prove that the process is monitored and that there is a valid method to control when monitoring indicates a change. To respond in “real time”, ie. The current production. Collecting data is processed and presented to the operator who   can intervene immediately. Corrections can similarly be automatic when monitoring data are stored as evidence that the process has been in control.
5 ReVal Repetition of Validation Saved data from monitoring should be archived, as evidence that the process produces within specified limits. This will be sufficient evidence for a “renewal” of validation.


Are we aware of the risks?

When we think about risk in all business processes it often turns out to be significant.

SWOT [Strengths – Weakness – Opportunities – Treats] reveals the weakness and threats it faces, but also the strengths and opportunities are available.

  • Is the strategy of the company well known throughout the organization?
  • Are all employees informed about the vision/mission and goals?
  • Who are our closest competitors and in which direction have they chosen?
  • Continuously ensuring the company in being at the forefront?
  • Are we aware of expiring date of our patents?
  • Are there new products/services in pipeline?
  • Are we in compliance with FDA requirements? FDA = Food and Drug Administration
  • Have we ensured that all the equipment in the production is validated?
  • Are we using validated software?
  • What about IT security?
  • Is the customer satisfaction measurements contained in the strategy?
  • Do we know the real value of the inventory?

It is fundamental to any company’s competitiveness that it keeps abreast of risks, through continuous monitoring and identification of issues that may arise. Focus on risk management is essential, especially when companies operate at international level, with many comparable and competing companies.

Always doing what they are best at, and what it takes being even better? If they do not notify focus on risks, there is high probability that competitors show that they can deliver similar, or worse yet maybe even a better product or a better service?

Have we asked our customers / employee what they are happy with and where we can be better?

Ongoing focus at performance and development by identification all resources available and/or lack of training?

Customer satisfaction measurements are an excellent tool in implementing process improvements and setting up an overview facing all risk concerning the company and its products.

Risk Management and Quality Management being ‘a must’ in companies’ strategy to achieve best practice and high performance through all business processes.