Workshop - internal audit

Aims

Photo from Oxford workshop on internal audit

The aim of this workshop is to train the participants to efficiently and effectively direct and/or participate in a laboratory audit in the spirit of peer review and education.

Participants are motivated to exchange ideas and learn from each other and the experts, by general presentations, role play, video fragments and group discussions.

The participants of this workshop should have a basic knowledge of accreditation and ISO (15189, 17025) or national standards (CPA, CCKL).

This workshop is mainly set up for those who are involved or will be involved in carrying out internal audits. The training will include preparation, execution and evaluation of an internal audit. A basic knowledge of accreditation and ISO (15189, 17025) or national standards (CPA, CCKL) is required.

The workshop language is English.

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Report on 'Workshop on internal audit - Oxford'

June 22-23, 2006, held at the Oxford Spires Four Pillars Hotel, Oxford, United Kingdom

a. Focus and approach

The first workshop of 2006 was dedicated to internal auditing. The aim was to train participants to efficiently and effectively direct and/or participate in a laboratory audit in the spirit of peer review and education. Participants were motivated to exchange ideas and learn from each other and the experts, through general presentations, role-play, video clips and group 's.

b. Outcome

A general presentation, alternated with practical exercises, touched upon all the different aspects of auditing, categorized in the “why, what, who and how” of internal audit (box 6).

BOX 6 - WHY, WHAT, WHO AND HOW OF INTERNAL AUDITING

WHY?

An accredited laboratory should carry out internal audits at regular intervals to ensure that its quality system is fully implemented in practice.
The main elements of the quality system should normally be subject to an internal audit once every twelve months¹.

Audits are an essential part of a quality system
The process is not an inspection but a peer review
The primary goal is working towards improvement

ISO 15189:2003 -> 4.14.2
ISO 17025:2005 -> 4.14.1

WHAT?

Horizontal audit

A detailed check of a particular aspect of the documentation and implementation of the quality management system or examination processes. E.g. examine a number of reports to see whether appropriate interpretative comments and/or follow-up of abnormal results had been provided. Vertical audit A detailed check that all elements, associated with a chosen examination (test), are implemented.E.g. Select a single request form and its associated sample (input) and follow it through every element of the process until the report (output) is produced ².

WHO?

Character: fair, intelligent, tenacious, logical, sensitive, analytical, calm, respectful, trustworthy and open-minded.
Knowledgeable: his/her under-standing of quality procedures should be current and accurate.
General qualities: Communicative, competent to examine, question, evaluate and report, able to work within a team.
Technical qualities : knowledge of methods, instruments, calibration, able to judge the competence of the laboratory, observation of the work performance of personnel.
Responsibilities: communicate and explain, plan; perform and report the results, keep confidentiality, ensure co-operation within and support of the team.

HOW?

Keep it simple
Stay on track and finish the job
Do it in an effective and efficient way
Perform the audit with regard to the requirements
Do interviews, documentation checking, observations, and cross-checks
Document and discuss findings
Respect the feelings of all participants
Resist the pressure to change the truth
Avoid judgmental tones and body language
Manage personal and interpersonal stress
Evaluate evidence in a fair and impartial manner
Do appropriate follow-upw

The exercises, including role-play, short video clips and group 's, were divided into three categories: the execution of an audit, completed by communication and behaviour skills, the preparation beforehand and finally the reporting and follow-up afterwards.

Experienced auditors and people who never performed an audit before were mixed and divided into small groups, each of which received a case description of a realistic laboratory situation. The group had to enact the situation, in which both auditors and auditees were present. Based on the feelings and experiences of auditor and auditee during the role play, a list was compiled of what went well and what could be improved when doing an audit. Furthermore, small video fragments gave extra information how you should behave and handle situations during an audit. All the raised elements were discussed further.

It is important that the auditor starts with and mostly uses open questions, which are simple and straightforward. If necessary, subsequent questions may be asked to develop deeper answers, but ‘why’ questions should be avoided as they often trigger defensive reactions. It is preferable to start with ‘how’ questions, based on what can be seen. The use of words like ‘maybe’, ‘a little bit’, ‘could’, etc. may have miscellaneous effects. On the one hand, they make the message less direct or threatening; on the other, they may give the impression that the auditor is not sure about himself. The auditor should mention when something is not conforming to the procedure, so that the auditee already understands during the audit that not everything was perfect. At the end of an internal audit, the auditor should focus on solutions and improvement and should include suggestions as well as positive feedback.

The behaviour of an auditor, as well as his way of communicating, can be crucial for a successful audit. When the auditor begins, he should make the auditee feel at ease by being polite and not too formal. He should explain the planning and make clear that it is the system and not the person that is being audited; no “blame” will be attached to the person. It is essential to find the balance between confrontation and empathy. Although it is essential not to hide or minimize when something is wrong, the auditor should stay calm and must not raise his voice. A good auditor always stays objective and independent, and will adapt to the behaviour of the auditee. Finally, he has regular eye contact and does not interrupt the auditee, which additionally helps in monitoring the body language.

It is impossible to perform a good audit without thorough preparation. The audit plan should be flexible to permit changes, and should include the objectives and scope of the audit. Furthermore, the individuals who have direct responsibilities, should be identified and informed if a date and time is known, as well as the people who will be directly involved in the audit. The preparation should also include the identification of all reference documents (Standard Operating Procedures, standards etc.). Working documents, like checklists and observation forms, are helpful to facilitate the auditor’s investigations and to document and report the results.

Taking accurate notes during the audit is essential. Based on these, the auditor will make a clear and structured audit report within a defined time limit. This report should include the major and minor non-conformities, as well as mentioning positive points. Following the report, an action plan must be developed, identifying for each action the responsible person and a deadline. General elements, like the auditor’s name, the date and the standard used should be present, in addition to specific details such as the Standard Operating Procedure (SOP) number, equipment number etc. An example of a report is shown in figure 3.

FIGURE 3 - EXAMPLE OF AN AUDIT REPORT

PP00129 revision 2
LiPA compounds and test analysis

LiPA compounds test analysis room

Description	Item	Class	Action	Responsible	Deadline
The audit took place in the LiPA compounds test analysis room, during routine working conditions. All necessary documents were readily available. The SOP was easy to follow, well documented. Good laboratory practice was observed throughout. Several non compliances were detected and these need to be addressed.
Document control 4.3
1. It was noted that there had been an amendment to the working document where the incubation time had been decreased from 30 to 20 minutes. There appeared to be no technical validation of this critical step. The change was made by pencil.	4.3.2	B	Amendments should be in pen and announced at the weekly meeting.	Sue Davids	10/06/06
2. A database system exists to follow-up changes.	4.3.2	+
Identification and control of non-conformities 4.9
1. Documentation of non-conformity concerning the storage of reagents was well documented, however, it was noted that a reagent had frozen during storage.	4.9.1	+
Personnel 5.1
1. Training records were not up to date, last record training states from 2004	5.1.2	+ +*	All training files will be checked if they are up to date.	Brian Alvey	01/07/06
Laboratory equipment 5.3
1. Maintenance records for the main incubation machine was two weeks overdue for calibration due to Holiday of responsible person	5.3.2	B	A better follow-up of absences is necessary. Action plan will be set up at next weekly meeting.	Richard Torn	15/08/06
2. Equipment is uniquely labelled and the status of calibration is indicated	5.3.3 5.3.9	+ +

Signature

Following classification with the definition of the codes is used

A	Major non-conformity which is a direct danger for the quality and means that the quality system is not conform the pre-defined accreditation criteria
B	Non-conformity that could influence the reliability of the results and the effectiveness of the quality system on the long-term
+*	Recommendation, will be evaluated next time
+	Is implemented or operational conform with the standard

c. Discussion

A laboratory is committed to constantly evaluate its activities and to maintain and improve its quality. Performing internal audits is one tool to evaluate and improve a quality system and to detect non-conformities. Other possibilities are participating in external quality assessment (EQA) schemes or undergoing an external audit, conducted by an external independent organization such as a national accreditation body. An internal audit is conducted by the laboratory itself on different aspects of the laboratory 3 . The auditor could be confronted with some minor and major non-conformities during the audit. Consequently, an action plan needs to be set up to eliminate the non-conformity in the future. During the next internal audit, these elements could be checked again to evaluate if the action plan was effectively implemented. This process refers to the Plan-Do-Check-Act (PDCA) circle, also known as the 'Deming wheel' 4 . It is a very simple concept which helps coordinate your quality improvement efforts: just as a circle has no end, the PDCA cycle repeatedly executes in pursuit of continual improvement. It emphasizes and demonstrates that improvement programs must start with careful planning, must result in effective action, and must move on again to careful planning in a continuous cycle (figure 4).

FIGURE 4 - DEMING WHEEL FOR CONTINUAL IMPROVEMENT

Plan: Evaluate the current situation. Define a plan how and which activities need improvement.
Do: Conduct a small-scale implementation of the plan.
Check: Monitor and evaluate the plan. Adopt and adjust the plan where necessary.
Act: Implement the definitive plan.
The process is not finished; a new circle starts in order to continually improve the system and assure the quality.

In conclusion, internal audits are designed and should be used to continually improve the quality system, and not to inspect the people working within the quality system. The involvement of the whole group is important to achieve successful improvement. A thorough knowledge of the quality standard and of the quality manual is essential when performing audits.

(The whole report can be downloaded in html or pdf Download PDF Document .)

References

International Organization of Standardization (ISO): http://www.iso.org/.
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D. Burnett, C.B. Standards for the medical laboratory - harmonization and subsidiarity. Clinica Chimica Acta 309, 137-145 (2001).
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D. Burnett. ISO 15189:2003 - Quality management, evaluation and continual improvement. Clin Chem Lab Med 44, 733-739 (2006).
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W. E. Deming. Out of the crisis, (The MIT Press, 2000).
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Last changed: 2008-02-06

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