Institution
Laboratory name
Location
Head/Responsible person / Standard Operating Procedure (SOP)
Internal audit / Code:
Version: no.
Date: of release
Page: 1of 11

1. Internal Audit
2. Objectives and scope

The purpose of this procedure is to provide instructions and to assign responsibilities for the internal audits performed at the laboratory. The laboratory willensure that internal audit of the Quality Management System (QMS) is undertaken in order to continuously assess the state of conformance with approved quality system policies and procedures, as well as the requirements of the ISO 15189:2007 standard and that corrective and preventive action are taken when necessary.

This procedure applies to all processes and activities of the QMS at the laborator and all areas where the quality system has been implemented.

This procedure covers the responsibilities, planning, execution and reporting of internal audits and the coordination of corrective action for any observed non-conformances.

This SOP is applicable to all laboratory employees.

3. Abbreviations, definitions and terms

•NTPNational Tuberculosis Programme

•N.A.Not applicable

•QMQuality Manager

•QAQuality Assurance

•SMARTSpecific, Measurable, Applicable, Realistic, Time bound

•GCLP Good Clinical Laboratory Practices

•SOPStandard Operating Procedure

Internal Quality Audits: Quality Audits conducted within the laboratory to assess compliance with ISO 15189:2007 and laboratory procedures.

Auditor: The person trained either internally or externally, and qualified to perform an audit of the QMS

Auditee: Person being audited.

4. Tasks, responsibilities and accountabilities

Task / Responsible / Accountable
Authorizing auditors; ensure that staff is available to audit; Approve internal audit year plan, report and action plan; Carrying out actions described in the action plan. / Lab director / Lab director
Planning and coordination internal audit; designing action plan; following up actions described in the action plan; archiving internal audit reports and action plans; / Quality manager / Lab director
Discuss internal audit report and the following actions in a meeting. / Quality manager / Lab director

5. Safety and environment

Where applicable wear protective clothing during interviews.

6. Procedure

6.1 Internal Audit Process:

As a measure to ensure compliance in accordance to ISO 15189:2007, applicable GCLP, and to detect areas for improvement, the audit team of the laboratory will examine all quality processes supporting the laboratory activities at a minimum once a year. Parameters to be reviewed concern logistics, organization and personnel, facilities, equipment, environment, examination procedures, nonconformities, resolution of complaints, the complete analysis of samples, reporting and archiving, Quality Manual and SOPs. These parameters are audited in the following sections:

  1. Decontamination and LJ Culture
  2. Sample reception and results tracking
  3. Smears; staining and microscopy
  4. MGIT culture and DST
  5. LJ DST and HAIN
  6. Culture reading and storage of isolates
  7. Reagent and Media preparation + General sanitation and support duties
  8. Data
  9. Procurement, logistics and coordination
  10. National Specimen referral duties
  11. EQA + IQA
  12. Quality system

6.2 Audit Planning:

In December the Quality manager prepares and distributes the annual “Internal Audit Year Plan” (appendix 1). The quality officer discusses the plan in a meeting. When approved the lab director dates and signs the plan. Approximately one month in advance a final date is fixed and announced in a meeting. The lab director ensures that staff is available to be audited on that date. The quality officer ensures the availability of the required documentation for the audit. The following information will be included in the internal audit year plan:

  • Planned month
  • Name of the section i.e. process or sub-process or activity/activities to be audited.
  • Auditor(s) name
  • Date of definite Report
  • Date action plan prepared.
  • Date audit plan discussed
  • Date and initials for agreement Director

6.3 Audit Team

At least two members of the Internal Audit Team, one of whom should be a member of the QA team and is able to interpret the ISO 15189:2007 standard. The second person has technical knowledge of the audited section. All the internal auditors are officially appointed by the lab director and are preferably independent to the audited subject.

6.4 Method for internal auditing

An internal audit consists of assessing the quality documentation and a visit to the work station (interviewing and observing of the practical implementation of the documents). The observations need to be judged objectively in accordance to the ISO15189:2007 standard, the national rules and regulations and agreements within the NTP and the laboratory. Since there are twelve sections to be audited in order to cover the whole standard yearly, each month one section will be audited (see appendix 1, “Internal Audit Year Plan”).

6.5 Audit Checklist

The Internal Audit team members performing the audit will utilize the Internal Audit Checklist in part where only one process is being audited. To ensure that all the items of the ISO 15189:2007 are covered, the quality officer keeps an overview in which all the subjects of the standard are listed. The quality officer updates the list after every internal audit so that a clear overview of the audited subjects is achieved. In preparation of the next internal audit, the quality officer indicates which subjects of the standard need to be audited. The Audit Checklist will include, but not be limited to the following:

  • Process, sub process or activities being audited
  • Questions relevant to these actions.
  • Follow-up of action points of previous audits
  • Subjects indicated by the Quality manager

The checklist will be filled out during the audit and will be used to prepare the internal audit report.An example of the audit checklist is included in appendix 2. The completed checklist will be kept in the internal audit checklist binder.

6.6 Audit

The Internal Audit team will perform the internal audit using the audit checklist and record all the information provided by the auditee.An internal audit consists of three phases:

  1. Quality Documentation

Before the audit team starts the interview(s), the quality documentation will be checked. The quality officer provides all the needed documentation, including previous audit reports, action plans, management reviews etc., but also SOPs and Quality Manual Chapters. By inspecting the documentation beforehand, the audit team can indentify subjects to focus on.

  1. Interviews

Before starting the interview(s) the audit team gives an introduction to the auditees, explaining the purpose of the audit, the roles of members of the audit team (who is the interviewer, who makes notes) and the approximate duration of the interview. Also the following items can be highlighted:

  • confidentiality of the internal audit
  • auditing is sampling
  • ask if all the auditees have been informed about the internal audit
  • explain that feedback will be given after the internal audit (on the same day)
  • answer remaining questions
  1. Feedback

After conducting the internal audit, the audit team will summarize their findings for a brief feedback. The feedback will be given the same day as the internal audit has been conducted:

  • Summarize the content and the purpose of the internal audit
  • Stress that this internal audit was only a sample
  • Thank everyone for their openness, time and information
  • Indicate the main positive findings
  • Indicate the importance of continuous improvement and list the points for improving

6.7 Audit Report

The internal audit team will prepare the Audit Report (appendix 3 “Format audit report”) within two weeks after the internal audit has been performed. A good report has the following characteristics:

  • The findings are traceable
  • There are no opinions, only facts
  • There are no deductions mentioned
  • The findings are objective
  • The findings are specific

The audit team scores their findings, in accordance to the ISO15189:2007 standard:

1:No deviation observed;

2:Deviation which in the long term may have a negative impact on the functioning of the quality system;

3:Deviation which has a negative effect on the competency and/or quality system;

4:Nonconformity which has an immediate and critical effect on the competency and/or quality system.

After filling out the checklist, the list will be sorted according to the scores: the highest scores on top, followed by the lower scores, so that the subjects with the highest priority are on top of the list.

The following will be included in the Audit Report:

  • Section, process or sub-process or activity/activities audited.
  • Date of audit
  • Auditor(s)
  • Date of Audit Report
  • Findings
  • Scoring
  • Plan of action
  • The audit report must be signed by the auditor(s) if the report has been closed. The report will be archived by the quality officer.

The audit report will be discussed in a meeting and after approval it will be dated and signed by the lab director.

6.8 Plan of action following internal audit

The Quality manager provides a filled in plan of action by copy-pasting the numbers and the corresponding findings with a score of 2 and higher to the plan of action form: appendix 4.

The following will be included in the plan of action form:

  • Findings
  • Action/corrective measures
  • Who is responsible
  • Deadline of completion
  • Date of completion + initials

The QA team is responsible for ensuring prompt corrective action is taken, when an audit detects deviations from the approved procedures: the QA team completes the plan of action provided by the quality manager by filling out the in the rest of the columns (SMART defined).

After completing the plan of action, it will be discussed during a work meeting. After approval the lab director dates and signs the plan of action. The Quality manager archives the plan of action in the Quality Plan File located in the Quality Files Cabinet.

6.9 Follow-up

Every month the progress of the corrective actions will be discussed in a meeting with the QA team to follow-up the actions. After conducting all the actions the plan of action can be closed and will be dated and signed by the lab director. The quality officer archives the closed action plan.

6.10 Archiving

Archiving of the Internal Audit documents will be as follows:

–Audit year plan in the audit year plan file

–Updated overview checklist will be an excel file on the server under, Quality/Internal Audit.

–Internal audit report (dated and signed) and the plan of action (with non completed actions, as well as the one with all the actions fulfilled) will be archived in the quality documents cabinet.

7. Related documents

Quality Manual chapter 15, Quality Assurance

Complete Audit checklist, archived in the Internal audit Checklist Binder

Overview internal audit checklist: excel file located on the server under Quality/Internal audits.

8. Related forms

Format audit report

Format audit plan

9. References

ISO 15189

10. Attachments/annexes

Appendix 1 “Internal Audit Year Plan”

Appendix 2 “Example Audit Checklist”

Appendix 3 “Format Audit Report”

Appendix 4 “Format Plan of Action”

Source: GLI Stepwise Implementation Guide towards TB Laboratory Accreditation

Institution
Laboratory name
Location
Head/Responsible person / Standard Operating Procedure (SOP)
Internal audit / Code:
Version: no.
Date: of release
Page: 1of 11

Internal Audit Year Plan

Planning internal audits for the year: …………

Month / Section / Auditor(s) / Date definite report / Date action plan prepared

Sections to be audited:

  1. Quality system
  2. ZN/FM microscopy
  3. Decontamination and culture
  4. …

Date audit plan discussed:………………………………………………………………..

Date and initials for agreement Director:………………………………………….

Institution
Laboratory name
Location
Head/Responsible person / Standard Operating Procedure (SOP)
Internal audit / Code:
Version: no.
Date: of release
Page: 1of 11

Example Audit Checklist

Nr:Corresponding number in the audit report with the checklist internal audit

QM: Quality Manual

No. / Subject / Score / Findings
8 / 4.2.1 Does the management ensure that the documents are understood and implemented?
14 / 4.2.4 Are the roles and responsibilities of technical management and the quality manager, including their responsibility for ensuring compliance with the ISO defined in the quality manual?
19 / 4.3.1 Has the laboratory defined, documented and maintained procedures to control all documents and information (from internal and external sources) that form its quality documentation?
20 / 4.3.1 Is a copy of each of these controlled documents archived for later reference?
22 / 4.3.2 Are the procedures adopted to ensure points a-h?
23 / 4.3.3 Are all documents uniquely identified including: title; edition or current revision date, or revision number, or all these; number of pages (where applicable); authority for issue; source identification.
104 / 5.1.7 Does the laboratory management authorize personnel to perform particular tasks such as sampling, examination and operation of particular types of equipment, including use of computers in the laboratory information system? See annex B
107 / 5.1.10 Are employees trained to prevent or contain the effects of adverse incidents?
113 / 5.1.13 Is confidentiality of information regarding patients maintained by all personnel?
114 / 5.2.1 Does the laboratory have space allocated so that its workload can be performed without compromising the quality of work, quality control procedures, safety of personnel or patient care services?
115 / 5.2.2 Is the laboratory designed for the efficiency of its operation, to optimize the comfort of its occupants and to minimize the risk of injury and occupational illness?
117 / 5.2.4 Is the laboratory design and environment suitable for the tasks carried out therein?
5.2.6 Is there effective separation between adjacent laboratory sections in which there are incompatible activities?
122 / 5.2.7 Is access to, and use of, areas affecting the quality of the examinations controlled?
125 / 5.2.10 Are work areas clean and well maintained?
127 / 5.3.1 Is the laboratory furnished with all items of equipment required for the provision of services (including primary sample collection, and sample preparation and processing, examination and storage)?
128 / 5.3.2 Has equipment shown (upon installation and in routine use) to be capable of achieving the performance required and does it comply with specifications relevant to the examinations concerned?
129 / 5.3.2 Has the laboratory management established a programme that regularly monitors and demonstrates proper calibration and function of instruments, reagents and analytical systems?
130 / 5.3.2 Does it also have a documented and recorded programme of preventive maintenance (see 4.2.5), which, at a minimum, follows the manufacturer’s
recommendations?
131 / 5.3.3 Is each item of equipment uniquely labelled, marked or otherwise identified?
132 / 5.3.4 Are records maintained for each item of equipment contributing to the performance of examinations, including points a-k?
133 / 5.3.4 Are these records maintained and readily available for the life span of the equipment or for any time period required by national, regional and local regulations?
136 / 5.3.6 Is equipment maintained in a safe working condition?

Format Audit Report

Internal audit (system or technical):
Date of audit:

Name of internal auditor(s):

Date audit report

1. Introduction

During the audit observations were done and interviews were done with:

-Interviewees in alphabetical order

In addition, the following documents were assessed during the audit:

-SOP #, title, version# and effective date

-Worksheet #, title, version# and effective date

-Logbook title

-Any other documents

2. Findings.

Below the findings of the audit are listed item by item in the table. Every finding is numbered and is given a score: the degree to which a finding deviates from the ISO 15189 standard or from agreed policies in quality documents. The highest scores are listed first followed by the lower scores. Only the audited items are mentioned in this report.

Scoring

1:No deviation observed;

2:Deviation which in the long term may have a negative impact on the functioning of the quality system;

3:Deviation which has a negative effect on the competency and/or quality system;

4:Nonconformity which has an immediate and critical effect on the competency and/or quality system.

Nr:Corresponding number in the audit report with the checklist internal audit

QM: Quality Manual

No. / Subject / Score / Findings

3. Date and signature for receipt and agreement:

Date of meeting in which report was discussed:……………………….………………………

Date and signature for agreement responsible officer: ……………………………………

4. Plan of action

This plan of action has to be developed within 2 weeks after this report has been signed for agreement. The final plan of action has to be signed for agreement by the laboratory director.

Institution
Laboratory name
Location
Head/Responsible person / Standard Operating Procedure (SOP)
Internal audit / Code:
Version: no.
Date: of release
Page: 1of 11

Action plan: [name of audit]

Description of action plan targets: / Developed by:
Date and initials lab supervisor:
No. / Description of action / Desired result / Task assigned to / Deadline realisation / Date realisation and initials
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Date / Signature
Date and signature of the lab supervisor when all actions are completed: