Where is the problem?

Having a severe headache could be dealt with perhaps rest, fresh air or some pain killers. The pain relieve for the moment is certainly something not to neglect but is the treatment addressing only the symptom or the root cause of the headache? But to be honest what is a headache?

Same situation occurs in a day to day business handling with deviations,quality events and CAPAs according to the ISO 13485. What has happened? Is this the root cause? What can we do now? Initial and immediate questions which rise after and during a quality events or a deviation.

Addressing these immediate questions correctly is high priority answering them wrong could lead to the wrong or incomplete actions solving the issue in a permanent manner. We tend to focus on the headache and the symptoms rather than the root cause of the issue. This is also the main issue detected in audits and FDA inspection when looking into CAPA Management and Deviation Management.

Wrong problem statement means wrong root cause

Most common mistake is the wrong problem statement or description of the CAPA event and deviation. To drive the failure investigation and root cause analysis into the wright direction it is crucial to have a problem statement which describes the real problem. Take the headache which we mentioned earlier. Telling the doctors, you have a headache won’t be helpful giving you the wright medication. You have to define the headache, the location, the occurrence rate or time, the position etc. With this, the doctor can give you the medics and address the root cause rather than curing just the symptom of headache. These can be addressed with your painkillers for the moment.

Above all in audits and inspection this is what results in audit deviations. During a CAPA and a deviation the root cause is never addressed and solved in a permanent manner. In other word, these kind of failure investigations and the corrective action only address the symptoms which is not the philosophy of a CAPA according to the ISO 13485. In short there is now CAPA Management or Deviation management, it is only a troubleshooting to cure the symptoms.

What should a problem statement contain?

To get a proper medication or solve the root cause keep the following in mind describing the headache or your problem:

• Make the problem measurable:
  • What is the problem? What was expected and was is actual?
  • Who detected it and how it was detected?
• Get the facts:
  • What is the frequency? How many products are affected?
  • Which specification was violated? (Nr. and revision of the specification)
  • Which batch and what part of it?
• Be objective:
  • Describe the problem not your opinion about the problem or your guesses about the root cause.
• Have a foresight:
  • What are the consequences of the failure for patient, process, and business?
  • Is this an isolated case or can it spread?

Describing your problem statement correctly will help you to determine the measures to take to prevent any harm for the patient, your process, and your business. In conclusion it will help you to be effective in detecting the root cause of the failure as you are able to select the best failure analysis tool for your cause. A clear problem statement will also focus the team during the failure investigation and lead to a much effective work environment.

Avumed can help you with your CAPAs

Avumed can help you defining and structuring your CAPA to be more effective and solving the roots cause of the failure in a permanent manner. We can provide your with checklist so you are able to walk through the CAPA adresseing the real root cause and not the headache.

Contact us today.