Procedure for abnormal work

1. complaints

It is Nordtec Instruments’ ambition to maintain a high level of service and for all customers to be satisfied. A complaint is defined as a customer expressing a concrete dissatisfaction with the handling of a calibration service. According to this policy, Nordtec Instrument:

  • Make it easy for the customer to make a complaint if necessary.
  • Address the complaint as quickly as possible
  • Ensure that the customer is satisfied with the way the complaint was handled.
  • Ensure that the customer suffers as little as possible if Nordtec Instrument has acted improperly.

A complaint can be submitted by e-mail, telephone or post. Name, company, contact details and a clear description of the complaint should be provided. The quality manager is responsible for handling complaints if he or she has not been involved in the case. When this occurs, the case is handled by the designated person of the quality manager. Each individual staff member who worked on the case must not take decisions on the case as there is a risk of impartiality. The work on the complaint is recorded and documented in Annex 13 and follows the procedures below.

2. Other non-standard work

If any part of the calibration work, or the result of this work, does not follow its own procedures or meet the requirements agreed with the customer, the following applies:

  • In the case of calibration work where an error occurs that could affect the mission, all staff members are responsible for:
    • – Cancel the calibration mission and record the deviation in Annex 13.
    • – Notify the quality manager of the situation.
  • An evaluation of the non-standard work is made in the form.
  • The customer must be informed and approve the work, where appropriate.
  • The Administrative and Quality Manager or Technical Manager is responsible for approving or rejecting further work.
  • The Administration and Quality Manager or Technical Manager is responsible for ensuring that the work is handled according to procedure.
  • Where identified non-conformities or deviations raise doubts about the laboratory’s ability to operate in accordance with its policies and procedures, or its ability to meet the requirements of the standard, the laboratory shall ensure that the relevant activities are audited in accordance with KM 10 Internal audits as soon as possible.

3. Management of abnormal work

3.1 General

All anomalous work should be documented in Annex 13 below is information on how we should act at each stage of the investigation. All staff are responsible for writing down the deviant work. Persons involved in the deviation should not carry out the investigative work.

First, access the register of deviations at K:\\deviations\current year. Fill in the register with the next number and fill in the same number on the form.
We categorize our non-conformities into three main groups: Internal, Complaints or Internal Audit Check the box that corresponds to the non-conformity you are working on.

3.2 Description of the findings

What has happened? Write down in detail what caused the abnormal work. Be clear in your description so that it cannot be misinterpreted in the future. If a customer contacts us with a complaint, write down what was said in the phone call or attach the email conversation with a clear reference in the box. Is any customer affected by this anomaly? Circle the answer on the form.

Then submit the form to the quality manager for further processing.
The quality manager reviews the description and decides who will be responsible for the investigation. What is important to bear in mind is that those involved in the deviant work should not carry out the investigation in order to reduce the risk of impartiality. All staff can carry out investigations by following this procedure.

3.3 Causal analysis

Why has this anomaly occurred? Ask yourself why in several ways. It is important that we find the root causes of non-compliant work so that next time we can get it right from the start.

Example: A certificate has been sent with an incorrect measurement result.

  1. Why? The analyst has made a mistake
  2. Why? They have not looked closely enough
  3. Why? The audit procedure is difficult to follow
  4. Why? We do not really understand what is meant in the text
  5. Why? The procedure is flawed.

Above you can see how easy it is to dwell on the fact that we as individuals make mistakes. But the problem is not that we are bad analysts, but that our procedures were flawed. That was the root cause of this discrepancy. This approach can be applied to all non-standard work. Write down your 5 whys and the results of your causal analysis.

3.4 Corrective action

Once we have found our root cause, it is time to move on to what to do in this particular case. Continuation of examples from above. Immediately afterwards, a new correct calibration certificate must be issued to the customer according to the change of certificate procedure. Please include the deviation number as a comment in case the customer has questions about our investigation of the deviating work.

3.5 Trend analysis

The next step is to investigate whether this error has occurred in the past. Review anomalies a few years back to find similar problems. Check in root causes what has happened, deviations that look different on a quick read through may ultimately have the same root cause. Document the deviations you find with the same root cause and look at what preventive measures were taken in the deviations and why they did not have the designated effect.

3.6 Preventive action

How do we ensure that the same mistakes do not happen again? In the example case, it is quite obvious that we need to update the procedure so that it is more easily understood. It is important that everyone who uses the procedure understands the purpose of the procedure and that everyone can work according to it.

3.7 Closure of deviation

The quality manager or technical manager can close the deviation after the root cause is defined, corrective actions are performed, a trend analysis is made and the preventive actions are completed.

3.8 Follow-up of non-conforming work

At least once a year, all deviations since the last review shall be reviewed to ensure that the preventive measures have had the desired effect. If there is no effect, the root cause analysis should be repeated and the deviation reopened for further work.