Checklist

Have the staff adequately been instructed on the symptoms of infection with Mycobacterium tuberculosis, the HIV virus and other pathogens worked with in the laboratory?

Activity

Is there a written procedure on how to act in case of a suspected laboratory associated infection/laboratory accident whereby a staff-member has potentially become infected?

Activity

Is access to the laboratory facility controlled against unauthorized persons?

Activity

Can the access control system, protecting the laboratory from unauthorized access, be overridden for evacuation in case of an emergency such as fire?

Activity

Is access to first aid ensured at the laboratory?

Activity

In laboratories where the presence of first aid providers is necessary: have enough staff members been appointed as first aid provider such that continuous presence of at least one first aid provider is ensured?

Activity

Is the training of the first aid providers up-to-date?

Activity

Does the Biosafety Manual contain an explanation of the tasks and responsibilities of first aid providers?

Activity

Is the laboratory staff aware of who the first aid providers are?

Activity

Have the Personal Job Descrptions of the first aid providers been adapted to reflect the authorizations of their position as first aid provider?

Activity

Is there an action plan to upgrade the facilities and safety to comply with the essential TB laboratory safety requirements of the WHO TB Laboratory Biosafety Manual?

Activity

Are primary sample collection facilities separated from the laboratory rooms?

Activity

Is the sample processing room separated from the room where PCR is performed?

Activity

Are laboratory rooms where incompatible procedures are being undertaken separated from each other?

Activity

Are rooms for cleaning of laboratory glassware and tools separated from the laboratory rooms?

Activity

Are the rooms designed and furnished in a logical way enabling a unidirectional workflow and preventing unnecessary movements of people through the rooms?

Activity

Is office space separated from laboratory rooms?

Activity

Is there a dedicated area for breaks/lunches?

Activity

Is the biosafety level III laboratory equipped with a negative pressure system?

Activity

Is the pressure of the biosafety level III regularly monitored and recorded?

Activity

Is the negative pressure system connected to a backup electricity supply to ensure that it keeps functioning during a power failure?

Activity

Is the negative pressure system included in the preventive maintenance program of the laboratory?

Activity

Is access into the BSL III laboratory controlled to prevent unauthorized access?

Activity

Has the Risk Group for each laboratory room been determined?

Activity

Is there an action plan to upgrade the facilities and safety to get each laboratory room into compliance with the risk group defined for that room (based on the WHO TB Laboratory Biosafety Manual)?

Activity

Is communication from the laboratory room to outside possible without leaving the room?

Activity

Are emergency numbers available near telephones and clearly visible?

Activity

Is the use of mobile phones forbidden inside all laboratory rooms?

Activity

Is a primary sample collection facility available and physically separate from the laboratory activities?

Activity

Are patients in the waiting area and primary sample collection facility protected against rain and direct sunlight?

Activity

Does the patient sample collection facility allow for the protection of privacy of patients?

Activity

Are there enough chairs in the waiting area and primary sample collection facility so that every patient can sit?

Activity

Is the waiting area and primary sample collection facility accessible for physically handicapped patients?

Activity

Does the laboratory have a procedure for processing and disposal of the different types of waste produced?

Activity

Does the laboratory demonstrably adhere to procedures for processing and disposal of different types of waste produced?

Activity

Are up-to-date guidelines present on safe disposal of waste?

Activity

Does lab staff adhere to guidelines on safe disposal of waste?

Activity

Is potentially infectious waste safely and securely stored before incineration?

Activity

Is potentially infectious material properly incinerated?

Activity

Are sharps securely and safely incinerated without the risk for needle accidents?

Activity

Is the area around the fire pit/incinerator free from clutter?

Activity

Is infectious glassware for re-use autoclaved correctly?

Activity

Are separate, clearly distinguishable containers present for different types of chemical waste?

Activity

Is chemical waste processed correctly?

Activity

Are trashcans for (bio)hazardous waste clearly distinguishable to prevent confusion with the bins for normal waste?

Activity

Is normal waste processed according to local/national regulations (if applicable)?

Activity

Is continuous delivery of electricity guaranteed through a working generator and/or Uninterrupted Power Supply (UPS) system in case of a power failure?

Activity

Is all the essential/critical equipment locked onto the generator?

Activity

Are samples stored under appropriate conditions, protected from unauthorized access and demonstrably easily retrievable?

Activity

Are all reagents and supplies stored under the proper conditions, protected from unauthorized access and easily retrievable?

Activity

Is equipment stored under appropriate conditions protected from unauthorized use?

Activity

Is defective equipment demonstrably contaminated and stored outside the laboratory protected from use?

Activity

Are documents and records stored under appropriate conditions, protected from fire, insects, humidity and other harmful elements?

Activity

Are documents and records protected from unauthorized access?

Activity

Are documents and records stored in a logical manner so that they are demonstrably easily retrievable?

Activity

Is an up-to-date Biosafety Manual present in the laboratory?

Activity

Does the biological safety manual have a logical structure with table of contents, an introduction and a title page clearly stating the words “Biosafety Manual”?

Activity

Does the Biosafety Manual contain general safety rules for working in the laboratory with human material?

Activity

Does the Biosafety Manual contain preventive safety procedures?

Activity

Does the Biosafety Manual contain procedures for emergency situations?

Activity

Are the Biosafety Manual chapters signed by the author, reviewer and Laboratory Management?

Activity

Is the Biosafety Manual easily accessible for all staff members at a logical location?

Activity

Is the Biosafety Manual read and signed by all staff members?

Activity

Is an indicator placed in relevant rooms for monitoring the air flow and preventing that pathogens are blown towards the staff working in the laboratory?

Activity

Does the retention schedule for storing different types of materials include the storage durations for samples and slides?

Activity

Does the retention schedule for storing different types of materials include the following documents:

  • Replaced SOPs
  • Completed worksheets
  • Completed log sheets
  • Completed Request Forms
  • Patient reports
  • Result registers
  • All contracts of the laboratory with external parties
  • Personnel data

Activity

Is an SOP present describing how to clean the laboratory building?

Activity

Does the SOP on cleaning of the laboratory building include a section with specific guidelines for cleaning laboratory rooms?

Activity

Is a cleaning schedule present?

Activity

Does the cleaning schedule show what should be cleaned by who and when?

Activity

Is the laboratory cleaned on a regular basis?

Activity

Are all hazardous materials in the laboratory registered?

Take a sample by identifying some hazardous materials and looking them up in the register.

Activity

Is the Hazardous Material Register up to date?

Take a sample by comparing the amount of several materials as noted in the register and in reality.

Activity

Are MSDS Sheets present for all hazardous materials in the laboratory?

Take a sample and check.

Activity

Are there spill kits present in adequate numbers and are these kits complete

Activity

Is there an SOP that provides procedures for dealing with the different types of spills?

Activity

Have critical environmental/equipment parameters been identified?

Activity

Are all critical environmental/equipment parameters monitored adequately?

Activity

Are all Critical Parameter Log Sheets filled out completely and up-to-date?

Activity

Are all Critical Parameter Log Sheets placed at a logical location?

Activity

Are first aid providers present in the laboratory?

Activity

Are first aid kits present and placed at accessible locations?

Activity

Is the implementation of the quality management system coordinated through a Quality Project Team?

Activity

Does the laboratory have a Quality Focal Point to which staff can turn to for information about the quality management system?

Activity

Are Quality Project Team meetings held on a regular basis?

The presence of minutes serve as prove for this.

Activity

Is the Quality Project Team functioning correctly?

Look into the minutes to find indications of the quality of functioning of the team; look at the action points, if these are often not completed on/before their deadline this is a sign that the team has trouble implementing activities. In this case, try to find out via signs in the minutes and interviewing team members what the cause of the problem is.

Activity

Has a Quality Officer been appointed?

Activity

Is the position of Quality Officer visible, at the right place, in the Organizational Chart?

Activity

Does the laboratory have a job description of the position of Quality Officer?

Activity

Is the position of Quality Officer included in the Authorization Matrix?

Activity

Do the Quality Officer and Laboratory Manager have regular bilateral meetings to discuss proceedings?

Ask the Quality Officer.

Activity

If a staff member was appointed as Quality Officer, has his former position been filled by a new/another staff member if necessary?

Activity

In this phase the management cycle will be implemented. This is a cycle of continuous improvement where the management plans activities, monitors their execution, check if they were done correctly, and based on that, plans for implementing improvement activities for the next year. This facilitates efficient planning and management of the laboratory. However, planning without having a clear goal in mind is impossible. Before implementing the management cycle one has to develop a clear Vision, Mission, long-term goals, and long-term planning, which will result in a Quality Policy.

Activity

Is the SOP on performing a management review up-to-date?

Compare elements in the Management Review Report with required elements defined in the SOP.

Activity

Does the laboratory make use of action plans with SMART formulated action points?

Activity

Are action plans all stored together in one folder, with a logical structure (e.g. completed action plans in the back, open action plans in the front, sorted on date, etc.)?

Activity

Is the completion of action points and action plans checked on a monthly basis and, if necessary, followed-up?

I.e. do you see action points that have not been completed while their deadline has passed?

Activity

Implementing a quality management system is a process of change. By reacting correctly to critical remarks and resistance towards implementing the quality management system the Laboratory Manager can prevent that staff stops cooperating. This is called change management. Change management is necessary to keep all the staff as possible involved in this process.

Activity

Does the laboratory have a clear Mission?

Activity

Is the Mission of the laboratory documented and stored?

Activity

p>Are staff meetings held regularly (weekly)?

Activity

Are minutes made of weekly staff meetings?

Activity

Do the minutes of weekly staff meetings include a summary of discussions, SMART action points and the agenda for next week?

Activity

Are the minutes of weekly staff meetings stored in a well-organized way?

Activity

Does the laboratory have an up-to-date routine work schedule?

Activity

Is this Daily Routine Work Schedule placed at a visible location accessible to all staff?

Activity

Do all staff members know where to find the Daily Routine Work Schedule?

Take a sample by asking this question to several staff members.

Activity

Does the laboratory have long-term goals?

Activity

Are the long-term goals of the laboratory covering all the core-activities?

Activity

Are the long-term goals of the laboratory aimed at improvement?

Activity

Are the long-term goals of the laboratory documented and stored?

Activity

Has a Biosafety Officer been appointed?

Activity

Is there a description of the tasks and responsibilities of the Biosafety Officer?

Activity

Do all the staff members know who the Biosafety Officer is?

Activity

Do all the staff members know the function of the Biosafety Officer?

Activity

Is the laboratory legally identifiable?

Activity

Is the laboratory and its status recognized by the appropriate authorities?

Activity

Does the laboratory have a Quality Policy?

Activity

Does the Quality Policy describe clearly the scope of the laboratory services?

Activity

Does the Quality Policy describe clearly the Long Term Goals and what the laboratory will do to achieve these goals?

Activity

Does the Quality Policy contain a statement of the management’s commitment to implement and maintain the quality management system?

Activity

Does the Quality Policy contain a statement of the laboratory’s commitment to provide good professional practice, quality examinations, in compliance with the quality management system adhering to ISO 15189?

Activity

Does the Quality Policy contain a requirement that all staff members of the laboratory must be familiar with the policies and procedures of the laboratory and implement these?

Activity

Are staff aware of existence of the Quality Policy?

Take a sample by randomly asking staff members.

Activity

Are staff familiar with the contents of the Quality Policy?

Take a sample by randomly asking staff members.

Activity

Have all staff members read the Quality Policy?

Request proof such as the Read & Understand List and interview staff members about the contents of the quality policy).

Activity

Has an Equipment Officer been appointed?

Activity

Is the Equipment Officer trained in calibration and technical maintenance of equipment (if necessary)?

Activity

Is the Equipment Officer protected against overburdening of work by allocating tasks of his/her former work to other staff members (if necessary)?

Activity

Are the Organizational Charts up-to-date?

Activity

Are the Organizational Charts signed and dated by the appropriate management?

Activity

Does the laboratory have measures to prevent interruption of services due to break down of old equipment?

Activity

Is purchasing of new equipment taken into account in making the laboratory budget for the next year?

Activity

Are maintenance costs (including repairs) taken into account in the laboratory budget?

Activity

Does the laboratory have a designated person who is responsible for monitoring stocks and ordering supplies and reagents (called a “Stock Officer”)?

Activity

Are all laboratory staff members aware of the existence of the position of Stock Officer?

Activity

Do all laboratory staff members know who the Stock Officer is?

Activity

Do all laboratory staff members know what the tasks of the Stock Officer are?

Activity

Did the laboratory formulate goals for the coming year prior to drafting the Quality Year Plan?

Activity

If the laboratory is part of a bigger organization: does the laboratory have an Organizational Chart that clearly shows the position of the laboratory within the total organization?

Activity

Is the Organizational Chart that shows the position of the laboratory in the total organization signed and dated by the management of the total organization?

Activity

Does the laboratory have an Organizational Chart showing the organization of all positions within the laboratory?

Activity

Is the chart showing the organization of positions within the laboratory signed and dated by the Laboratory Manager?

Activity

Are the Organizational Charts stored in a folder that is accessible to all the staff members of the laboratory?

Activity

Does the laboratory plan its activities through a Quality Year Plan?

Activity

Is the Quality Year Plan complete (does it cover all the aspects of the quality management system)?

Activity

Has the Quality Year Plan been formulated with input from the Quality Officer?

Take a sample by asking the Quality Officer and some members of the Quality Project Team.

Activity

Is the Quality Year Plan appropriately stored and easily retrievable?

Activity

Is the Quality Year Plan signed and dated by management?

Activity

Is the Quality Year Plan translated into an action plan?

Activity

Is this action plan of the Quality Year Plan signed and dated by the Laboratory Manager for approval?

Activity

Is staff aware of the existence of the Quality Year Plan?

Take a sample by asking some random staff member to explain what the Quality Year Plan is.

Activity

Are staff members aware of action points assigned to them?

Take a sample by asking staff members about action points assigned to them.

Activity

Is the quality management system appropriately documented in a quality manual, i.e. does it include information on each of the 12 quality system essentials and how these are implemented in the laboratory?

Activity

Is the quality manual part of the document control system?

Activity

Have all staff members read the quality manual?

Activity

Is the performance of the quality management system recorded in Quarterly Reports?

Activity

Is the functioning of the quality management system reviewed annually by laboratory management?

Activity

Are reports drafted of management reviews?

Activity

Do Management Review Reports include action points if applicable?

Activity

Are the result of the management review presented to all staff?

See meeting minutes.

Activity

Are Management Review Reports securely and orderly stored?

Activity

After the management review has been completed, is a new quality year plan drafted, (among others) based on the findings from the management review?

Activity

Have all the policy cycle activities been documented in an SOP (i.e. drafting a quality year plan, monitoring of performance of the quality management system and drafting quarterly reports, and performing a management review)?

Activity

Has commitment to implement a quality management system been created among laboratory staff?

Interview various staff members to find out if a meeting was held and if this was successful.

Activity

Has an SOP for Competency Assessment been developed?

Activity

Does this SOP contain one or more standardized form(s) that must be used to record the findings of the assessment?

Activity

Are competency assessments done annually for each staff member?

Activity

Is a report made of each competency assessment?

Activity

Are the points for improvement described in the report of a competency assessment, including with a description of the strategy on how to improve these points?

Activity

Are the reports of the competency assessments stored in the personnel files?

Activity

If training needs are identified during competency assessment, is the staff member send to the appropriate training?

Activity

Is the competency of the Laboratory Manager annually assessed?

Activity

Has the laboratory investigated if there are potential conflicts of interest among laboratory staff?

Activity

If potential conflicts of interest among laboratory staff were identified, were they appropriately solved and documented?

Activity

Is staff safeguarded from overburdening?

Activity

Have all staff members participated in an introductory course in quality management for medical laboratories?

Activity

Have certificates of the introductory course in quality management been stored in the Personnel Files folder?

Activity

Does the laboratory have an induction program for new staff?

Activity

Is the procedure of the induction program documented in an SOP?

Activity

Does the SOP for Induction of New Personnel include a checklist for verifying correct completion of the program?

Activity

Are completed checklists stored at a logical location (e.g. in the personnel file of the new staff member)?

Activity

Is a personnel replacement matrix present in the laboratory?

Activity

Is a backup staff member defined for each staff member in the laboratory?

Activity

Is the competency of the backup staff members checked for the tasks they need to take over from absent staff members?

Activity

Is the laboratory staff aware of the existence of the personnel replacement matrix and which purpose it serves?

Take a sample by interviewing some staff members.

Activity

Does the laboratory have a standardized procedure for hiring new permanent and temporary staff, and having guests?

Activity

Is the procedure for hiring new permanent and temporary staff and having guests correctly documented?

Activity

Does the procedure for hiring new permanent and temporary staff cover all the following elements:

  • Regarding permanent and temporary staff:
    • Criteria with which all applicants must comply
    • Procedure for defining specific criteria for the vacancy
    • Procedure of drafting and publishing the vacancy
    • Procedure of selecting suitable applicants based on application letters/CVs
    • Procedure of inviting applicants and organizing the application interview
    • Procedure of selecting applicants based on the application interview
    • Procedure of hiring suitable applicant, including:
      • Determining salary
      • Writing Personal Job Description
      • Adapting Authorization Matrix
      • Creating a personnel file
      • Ensuring that staff member is properly induced according to the SOP for Induction of New Personnel
      • Providing training to new staff (e.g. training into quality management to ensure that the staff member understands and works via the quality management system).
  • Regarding guests:
    • Procedure of identification and recording of guest details
    • Procedure of recording details of the visit
    • Procedure of allowing access of the staff member to the laboratory (including a health check to determine if the guest’s health allows for accessing the testing areas).

Activity

Has the Biosafety Officer received laboratory biosafety training?

Activity

Is the certificate of the laboratory biosafety training of the Biosafety Officer stored in a folder called “Personnel Files”?

Activity

Are performance appraisals performed for all staff members at least once per two years?

Activity

Are findings of performance appraisals discussed with staff members that were assessed to find the root cause and come to a good approach on eliminating this root cause and improving performance?

Activity

Are findings of performance appraisals recorded, including the identification of root causes behind poor performance and the approach chosen to eliminate these and improve performance?

Activity

Are all staff members appropriately trained for the tasks performed?

Activity

Are educational needs consistently assessed in competency assessments and performance appraisals?

Activity

Are training needs consistently fulfilled?

Activity

Does the laboratory have an Authorization Matrix, showing for each position in the laboratory the authorizations, responsibilities and tasks?

Activity

Is the Authorization Matrix signed and dated by the Laboratory Manager?

Activity

Is the Authorization Matrix accessible to all staff members?

Activity

Do staff members know what the Authorization Matrix is?

Activity

Are staff members able to find the Authorization Matrix?

Activity

Are staff members able to explain how the Authorization Matrix works?

Activity

Is a personnel file present of each staff member?

Activity

Are all the records described in ISO 15189:2012 article 5.1.9 (ISO 15189:2007 5.1.2) present in the personnel file of each staff member?

Activity

Are the personnel files structured in an orderly fashion?

Activity

Is the Personnel Files folder stored in a locked cabinet that is only accessible to the Laboratory Manager and the secretary?

Activity

Does the laboratory have a Continuous Education Program?

Activity

Is budget available for the Continuous Education Program?

Activity

Is the Continuous Education Program included as element in the Quality Year Plan?

Activity

Does the laboratory have a job description for each position in the laboratory?

Activity

Does the job description for each position in the laboratory give a complete and clear impression of the tasks, responsibilities and authorities of each position?

Activity

Is the ability of all technical staff members to correctly perform examinations observed by letting them analyze external quality assessment samples and evaluating the results?

Activity

Have Personal Job Descriptions been made for all the staff members?

Activity

Are all job descriptions (both Position Job Descriptions and Personal Job Descriptions) up to date?

Activity

Are Personal Job Descriptions stored in an orderly fashion in the Personnel Files folder?

Activity

Has a laboratory staff member appropriately been trained in performing failure-mode-effect-analyses?

Activity

Has the personnel file of the staff member participating in failure mode effect analysis training been updated after completing this training?

Activity

Have all staff members adequately been trained in the procedures they are performing?

Ask several staff members this question for the procedure they are doing at that moment and cross-check with their Personnel File.

Activity

Is the folder Personnel Files up-to-date; i.e. have all certificates and diplomas been collected for all staff members and been stored in the personnel files?

Activity

Does the laboratory have a clear register of all the equipment present?

Activity

Does the equipment register contain the following details for each piece of equipment? (tick off)

  • Identity
  • Label
  • Serial number
  • Manufacturer name
  • Manufacturer’s contact person and contact details
  • Service provider name
  • Service provider’s contact person and contact details
  • Date of purchase
  • Date of putting into service
  • Location
  • Condition
  • Frequency of maintenance
  • Date of previous maintenance
  • Date of next scheduled maintenance
  • Remarks

Activity

Is all critical equipment functional?

Activity

Has the laboratory identified critical needs for specific pieces of equipment that must be present in order for the piece of equipment to function?

Activity

Does the laboratory have a standardized, documented procedure for procurement and reception of new equipment?

Activity

Does the laboratory have a standardized, documented procedure for acceptance or rejection of donated equipment?

Activity

Is the SOP for Procurement and Reception of Equipment stored at a logical location, accessible to all staff members?

Activity

Is the SOP for Procurement and Reception of Equipment demonstrably reviewed and verified by fellow staff members?

Activity

Is the SOP for Procurement and Reception of Equipment demonstrably authorized by laboratory management?

Activity

Are all technical and managerial staff members aware of the existence of the SOP for Procurement and Reception of Equipment and do they know when to use it?

Activity

Have all pieces of equipment that have a direct influence on the outcome of examinations been validated?

Activity

Are all findings of validations (both validation of examination methods and validation of equipment) documented in validation reports?

Activity

Are SOPs present for all pieces of equipment?

Activity

Are Equipment SOPs written in accordance with the procedure described in the Master SOP?

Activity

Are Equipment SOPs stored at a logical location (near the equipment they have been written for), accessible to all staff members?

Activity

Have staff members demonstrably read the SOPs that are relevant for them?

Activity

Has all equipment in the laboratory been labeled?

Activity

Do the equipment labels include the following data:

  • Equipment code
  • Date of last service/calibration
  • Date of next service/calibration

Activity

Are the equipment labels resistant to fluids, chemicals, light, and other daily factors causing wear and tear of the labels?

Activity

Is there an standardized procedure in place assuring that the laboratory determines and corrects the negative influence of defective equipment on laboratory testing after a piece of equipment has been discovered to be defective?

Activity

Is the procedure for determining and correcting the negative influence of defective equipment documented in an SOP?

Activity

Has procedure for determining and correcting the negative influence of defective equipment routinely been performed in the past when equipment appeared to be defective?

Ask the interviewee to show an example.

Activity

Is it documented who is responsible for each piece of equipment and who is authorized to use the equipment?

Activity

Do staff members who are responsible for a piece of equipment know their responsibilities?

Take a sample by asking such a staff member.

Activity

Are staff members authorized for use of a piece of equipment properly instructed/trained?

Activity

Does the laboratory have a Maintenance Log Sheet for each piece of equipment that shows what maintenance has been performed at which moment to which piece of equipment?

Activity

Does the laboratory use log sheets to record usage of specific pieces of equipment where necessary?

Activity

Do staff members know how and when to fill out Usage Log Sheets/log books for each piece of equipment?

Activity

Are the Usage Log Sheets placed near the piece of equipment they have been developed for?

Activity

Are Maintenance Log Sheets of equipment stored orderly in the Equipment Archive?

Activity

Does the laboratory have an Equipment Archive that contains all the documents and records needed for each piece of equipment as listed in ISO 15189:2007 article 5.3.4 or ISO 15189:2012 article 5.3.1.7?

Activity

Does the laboratory have a documented procedure that describes the following:

  • Activities that need to be undertaken when new equipment is introduced in the laboratory
  • The required measures for ensuring maintenance and calibration of the piece of equipment
  • Ensuring presence of the SOP for maintenance and use of the piece of equipment

Activity

Are Bench Aids used for various pieces of equipment?

Activity

Are these Bench Aids in accordance with the currently authorized versions of SOPs for equipment?

Activity

Is the method of maintenance and calibration of equipment documented?

Activity

Is the budget needed for the maintenance and calibration of equipment calculated and documented?

Activity

Have funds been identified for annual maintenance and calibration of equipment?

Activity

Have funds been identified for training of a staff member for internal maintenance and calibration of equipment?

Activity

Is a preventive maintenance program in place for all pieces of equipment?

Activity

Does the laboratory demonstrably adhere to this program?

Compare maintenance records for a piece of equipment from the equipment file with the dates this maintenance was planned in the Equipment Maintenance Schedule.

Activity

Is the procedure for ensuring equipment maintenance standardized in an SOP?

Activity

Does the laboratory have an SOP for Equipment Repair, including a clear procedure for disinfection and clear labeling the equipment as “defect”?

Activity

Does the laboratory have an SOP explaining the procedure to be followed for ensuring validation of equipment when it is returned into service after repair?

Activity

Are all items available in the laboratory stock recorded in a Stock Inventory Register?

Take a sample by checking for two or three supplies in the stock if their Stock Cards are in the Stock Inventory Register and check if the Stock Cards are up-to-date.

Activity

Is the stock register in accordance with the actual stock (i.e. is it up-to-date)?

Activity

Do staff members know the correct procedure of taking items from the stock?

Take a sample by asking random staff members.

Activity

Does the laboratory have an overview of all the items in stock?

Activity

Has the laboratory formulated key specification for each item in stock?

Activity

Does the laboratory perform a financial analysis on a regular basis to anticipate income versus expenditure for the coming year?

Activity

Does the laboratory have an Inventory Control Register that contains the following details:

  • Names of all the items in stock
  • The number of units of each item currently in stock
  • The average number of units used per day of each item
  • The minimum stock level of each item for which a new order must be made
  • Of each item the average number of days before orders arrive at the laboratory
  • The supplier details of each item
  • The key specifications of each item

Activity

Is the Inventory Control Register kept up to date by counting the items in stock and comparing this with the number of items shown in the register?

Activity

Does the laboratory have an SOP for Selection and Evaluation of Suppliers?

Activity

Does the laboratory select suppliers in a standardized way and documents this procedure?

Activity

Does the laboratory develop contracts for reception of services in a standardized way?

Activity

Does the laboratory evaluate contracts for reception of services in a standardized way and documents this procedure?

Activity

If contracts are amended/changed, does the laboratory have records/minutes explaining the amendments/changes and why they were made?

Activity

Does the laboratory routinely perform acceptance tests on newly delivered products before they are taken into service?

Ask for evidence.

Activity

Has the laboratory formulated the procedure for selecting referral laboratories? If the laboratory does not refer samples to other laboratories: is a statement included in the quality manual explaining that no samples are referred to other laboratories?

Activity

Has the laboratory formulated the procedure for monitoring referral laboratories on a regular basis?

Activity

Is a folder present containing documents with appointments between the referral laboratories and this laboratory and monitoring data?

Activity

Is a folder present containing records of samples referred to referral laboratories, including the result reports?

Activity

Does the laboratory have a documented procedure on selecting, ordering, acceptance testing and storing of new reagents and consumables?

Activity

Does the laboratory have a documented procedure on maintenance of the inventory?

Activity

Are all supplies stored under the right conditions in the laboratory?

Activity

Are records of supplies kept with the following details? [tick off]

  • Name of the supply
  • Preparation date/date of receipt
  • Whether or not acceptance criteria were met and any follow-up actions
  • Opening date (to be filled out when first opened)
  • Expiry date (can often be found on internet if not visible on supply package)
  • Possible safety warnings (Risk (R-) and Safety (S-) phrases or Health (H-) and Precaution (P-) phrases) if not indicated already on the supply package

Activity

Are all supplies stored such that they cannot fall from shelves or suffer damage in other ways?

Activity

In regions where earthquakes are a real risk: are supplies stored in such a way that they cannot be damaged due to an earthquake?

Activity

Are all supplies stored according to the first-in-first-out (FIFO) system?

Activity

Are all storage areas complying with the safety requirements related to the supplies stored in them?

Activity

Do storage areas protect the supplies from external influences such as humidity, light, insects, etc.?

Activity

Are all storage areas lockable to prevent unauthorized access?

Activity

Are all storage areas labeled with hazard symbols related to the supplies stored in them?

Activity

Is a list with R- and S-phrases/H- and P-statements provided on each storage area where this is relevant?

Activity

Do staff members know what R- and S-phrases and H- and P-statements are and how to find them?

Take a sample by asking some staff members.

Activity

Does the laboratory have a Request Form that includes at least the following details (tick off):

  • Patient details (name, address, telephone number, birth date, gender, etc.)
  • Requester details
  • Type of primary sample
  • Examination(s) requested
  • Clinical information relevant to the laboratory (HIV status, CD4 count, etc)
  • Date, time and place of sample collection
  • Date and time of receipt of the sample at the laboratory

Activity

Is the Request Form for Laboratory Testing clear?

Activity

Does the Request Form for Laboratory Testing provide clear guidance on how it should be filled-out?

Activity

Has the laboratory formulated clear and specific sample acceptation/rejection criteria for each type of sample used by the laboratory, leaving no room for interpretation?

Activity

Has the maximum allowed turnaround time been determined for each examination performed in the laboratory?

Activity

Is a table with the maximum allowed turnaround times for each examination included in the quality manual of the laboratory?

Activity

Is a table with the maximum allowed turnaround times for each examination included in the SOP on Reporting and Archiving of Results?

Activity

Does the SOP on Reporting and Archiving of Results include the procedure that the requester is immediately informed if the TAT of an examination is exceeded and this can compromise patient care?

Activity

Are staff members aware of the procedure for immediately informing the requester if an examination is exceeding the turnaround time when this can compromise patient care?

Activity

Is there an SOP that covers all the more simple procedures for which it is too laborious/inefficient to make separate SOPs but that are critical for proper functioning of the laboratory?

Activity

Has the laboratory identified and listed all the tests performed to determine which SOPs need to be written?

Activity

Does the laboratory have an SOP for Sample Collection to ensure correct collection of good quality samples for each test, protecting the safety of both the sample collector and patient as well as the privacy of the patient?

Activity

Does the SOP for Sample Collection include at least the following element? [tick-off]

  • Pre-collection:
    • Instructions for identification of the patient
    • Instructions to verify that the patient meets examination requirements
    • Instructions for protecting patient safety
    • Instructions for protecting safety of the laboratory staff member
    • Instructions for protecting the privacy of the patient
    • Instructions for correct treatment of the patient (with respect, friendly, and polite)
    • Instructions for information provision to the patient (what is going to happen, when can the patient expect the results and where can the patient get the results)
    • Instructions for preparation of the patient (including provision of information to the patient on sample collection and laboratory testing)
    • Guideline for completion of the Request Form, including identification of the person collecting the sample and the patient
  • Collection:
    • Instructions for correct collection of the sample, including reference to sample acceptance criteria to ensure collection of a good quality sample
  • Post-collection:
    • Procedure of labeling of the sample
    • Requirements for correct and safe packing of the sample
    • Instructions on sample transport (including time frame and temperature interval) and proper storage conditions if the sample is not transported directly after collection
    • Instructions for safe disposal of materials used for collection of the sample

Activity

Is the turnaround time monitored on a continuous basis for each examinations?

Activity

Is the result of turnaround time assessment included in the Quarterly Reports?

Activity

Are corrective and preventive actions implemented in an attempt to decrease the percentage of samples exceeding the turnaround time to a minimum?

Activity

When sudden increases are seen in the percentage of samples exceeding turnaround time, is an analysis performed to identify the cause and implement corrective and preventive actions?

Activity

Is the efficacy of corrective and preventive actions to minimize/counteract increase of samples exceeding turnaround time determined in subsequent turnaround time assessments?

Activity

Is correct transportation of samples monitored on a continuous basis by the laboratory by checking whether the transportation requirements in the SOP for Sample Collection are met?

Activity

If problems arise in transportation of samples, does the laboratory investigate these problems to find the cause?

Activity

If problems arise in transportation of samples, is a nonconformity form always completed?

Activity

Are corrective and preventive actions undertaken to solve problems in sample transportation?

Activity

Is the effect of the preventive/corrective actions to solve problems regarding sample transport evaluated to see if they worked?

Activity

Have SOPs been written for all the tests routinely performed at the laboratory?

Activity

Have all SOPs been written according to the procedures described in the Master SOP?

Activity

Do all SOPs have the same structure and lay-out, complying with the guidelines of the Master SOP?

Activity

Does the laboratory have an SOP for Sample Reception and Processing?

Activity

Does the SOP for Sample Reception and Processing cover the following procedures:

  • Checking sample integrity and deciding if the sample is accepted or rejected
  • Introduction of the sample into the laboratory register
  • Sample labeling
  • Sample processing
  • Procedure for processing urgent samples
  • Procedure for dealing with verbal requests
  • Periodical review of required sample volumes

Activity

Has the laboratory authorized staff members for reviewing requests and deciding which examinations must be performed?

Activity

Has the SOP for Sample Reception and Processing been read by all relevant staff members?

Activity

Does the laboratory use a Sample Reception Register?

Activity

Does the Sample Reception Register leave room for including the following information:

  • Patient name + label
  • Details of requester
  • Type of primary sample
  • Date of sample collection
  • Date of sample reception
  • Date of sample acceptance
  • Examination(s) requested
  • Results of examinations + name of the laboratory technologists performing the examinations
  • Date of reporting
  • Signature and initials of person sending the report

Activity

Has the laboratory standardized the procedure of validation of examination methods and equipment in an SOP?

Activity

Does the laboratory monitor correct performance of all its processes using quality indicators?

Activity

Is action undertaken upon detection of a sudden change in the value of a quality indictors to identify and solve the problem and prevent it from reoccurring?

Activity

Have limits of acceptability been set for each quality indicator?

Activity

Are actions undertaken to optimize the laboratory processes such that the limits of acceptability for each quality indicator aren’t exceeded any longer?

Activity

Does the SOP for Sample Reception and Processing have an appendix with a Sample Rejection Form?

Activity

Does the Sample Rejection Form include the following elements?

  • Identification of the patient
  • Identification of the person collecting the sample
  • Identification of the clinician (if different than the person collecting the sample)
  • Identification of the sample
  • Reasons for sample rejection
  • Action to be taken (does the sample requester have to send in a new sample? Does the sample collector have to change the procedure?)

Activity

Are copies of completed forms stored at the laboratory?

Activity

Has the laboratory validated all the examination methods performed in the laboratory?

Find evidence by asking for the validation reports.

Activity

When the laboratory, through validation, identified the need to change an examination method, was this change made (including adaption of the SOP for that method)?

Activity

Has the laboratory made flowcharts of all the procedures routinely being performed in the laboratory?

Activity

Has the laboratory developed a list of all SOPs needed to standardize the entire primary process?

Activity

Are all routinely performed procedures in the laboratory standardized in SOPs?

Take a sample by asking for several SOPs indicated in the flow charts and check the document control log of the laboratory.

Activity

Are all SOPs complete and in line with the Master SOP, covering all required elements such as quality control, safety, tasks, authorizations and responsibilities, references, appendixes, etc.?

Activity

Does the laboratory have a fixed format for the Result Report?

Activity

Does the Result Report include at least the following elements: [tick off]

  • Name of the laboratory
  • Personal details of the patient, including clinical information as received by the laboratory from the requester
  • Details of the requester
  • List of examinations performed
  • Date of the primary sample collection
  • Primary sample type
  • Comments on the quality of the sample (either adequate for the examinations performed or inadequate, which could influence reliability of results)
  • Examination results
  • Biological reference intervals/decision values, including the “alert/critical” intervals for all examinations performed, with interpretive comments on results, if applicable.
  • Details of the laboratory staff member reviewing the results and authorizing the report for release
  • Date and time of release of the report

Activity

Was the format of the Result Report discussed with regular clients of the laboratory during development?

Activity

Does the laboratory have an archive for laboratory records that is constructed in a logical way allowing for quick and easy access to information?

Activity

Is the laboratory archive lockable?

Activity

Does the laboratory archive protect records from deteriorating influences such as fire, humidity, insects, sunlight, etc.?

Activity

Is access to the laboratory archive controlled?

Activity

Is a procedure in place that ensures verification of correct transcription of results on reports?

Activity

Is a procedure in place for authorizing Result Reports for release only if review of results has taken place and correct transcription of correct results and other important information to the report has been confirmed?

Activity

Is the computerized system properly protected by a firewall?

Activity

Is the computerized system scanned for viruses on a weekly basis by a proper, up to date virus scanner?

Activity

Are specific staff members authorized to either I) access digital laboratory information, or II) access and enter digital laboratory information, or III) access, enter and change digital laboratory information, and is the Authorization Matrix adapted to indicate who is authorized to perform these activities?

Activity

Are the Personal Job Descriptions adapted of the staff members who are authorized to access and who are authorized to access and change laboratory information?

Activity

Does the laboratory have a procedure to ensure immediate notification of the requester in case results fall within critical intervals?

Activity

Does the laboratory record the occurrences in which results fall within critical intervals and requesters have to be notified directly (for verification purposes)?

Activity

Is a documented contingency plan present in the laboratory that should be followed in case of downtime of the computerized information system, to ensure access to laboratory information at all times?

Activity

Does the laboratory use a method for sending the Result Reports to the requesters with a minimum risk for losing reports?

Activity

Does the laboratory use a method for sending the Result Reports to the requester that ensures that reports are delivered as soon as possible?

Activity

Has the laboratory standardized the procedures for information management in an SOP?

Activity

Does the SOP on management of laboratory information include at least the following procedures:

  • Management and maintenance of the computerized laboratory information system, including procedures regarding:
    • Regular backup, regular virus scanning and the contingency plan protocols
    • Accessing laboratory information in the computerized system
    • Entering laboratory information
    • Changing laboratory information stored in the computerized system
    • Defining authorizations for accessing, accessing and entering laboratory information, and accessing, entering and changing laboratory information in the computerized system
  • Protocol for ensuring confidentiality of patient data
  • Management and maintenance of the laboratory archive, including procedures regarding:
    • Accessing information
    • Storing information
    • Changing information in the archive
    • Ensuring protection of records from external deteriorating factors such as humidity, fire, insects, sunlight, etc.
    • Defining authorizations for accessing, accessing and storing laboratory information, and accessing, storing and changing laboratory information in the archive

Activity

Are patient data (such as Request Forms, work forms, registers, copies of Result Reports, revised Result Reports, Immediate Notification Forms, etc.) stored securely, protected from unauthorized access?

Activity

Are patient data (such as Request Forms, work forms, registers, copies of Result Reports, revised Result Reports, Immediate Notification Forms, etc.) stored in a logical way enabling quick and easy retrieval of data?

Activity

Does the laboratory have an SOP for Recording, Reporting and Archiving of Results, describing at least the following procedures:

  • Recording of results
  • Reviewing and authorizing results for release
  • Normal procedure for reporting of results
  • Immediate reporting of results from urgent samples
  • Immediate reporting of results in critical intervals
  • Notification of clinician if turnaround time is exceeded
  • Reporting via telephone or other electronic means
  • Reporting of results of samples of inadequate quality but that were still tested
  • Alteration of reports
  • Archiving of results

Activity

Are the procedures in the SOP for Recording, Reporting and Archiving of Results routinely and correctly implemented in practice?

Activity

Are all staff members that are involved in any way in recording, reporting and archiving of results aware of the contents of the SOP for Recording, Reporting and Archiving of Results?

Activity

Is the laboratory able to trace back the staff members who signed documents based on signatures or initials?

Activity

Have all laboratory staff members signed a confidentiality agreement?

Activity

If the laboratory stores information digitally: are weekly backups being made?

Activity

Are backups of the computerized system stored behind lock and key in another building than the laboratory building where the computerized system is?

Activity

Does the laboratory have a Master SOP that explains how to write SOPs?

Activity

Does the Master SOP have different sections on how to write Analysis SOPs, Equipment SOPs and Procedure SOPs?

Activity

Does the laboratory have an overview of the time each type of record should be archived?

Activity

Does the laboratory have an overview of where each type of record should be archived?

Activity

Are SOPs available at logical locations, at least:

  • Near the place where the procedures the SOPs describe are routinely performed
  • In the office areas
  • In the dedicated quality documents archive

Activity

Are inconsistencies and errors found in documents recorded in a Document Revision Form?

Activity

Do staff members know where to find the Document Revision Form?

Activity

Do staff members know what the Document Revision Form is for and do they know how to use it?

Activity

Is a Document Control Log available that shows all the quality documents of the laboratory with at least the following details:

  • The document code
  • The document title
  • The name of the author
  • The names of the reviewers
  • The name of the authorizer
  • The current version number
  • The date on which it was released for use
  • The date before which the document must be reviewed
  • Distribution list
  • Remarks
  • The title of the previous version
  • The name of the author of the previous version
  • The names of the reviewers of the previous version
  • The name of the authorizer of the previous version
  • The date on which the previous version was released for use
  • The date on which the previous version was replaced

Activity

Is each quality document (SOP, quality manual chapter, Biosafety Manual chapter) supplied with a front page that contains the following information: [tick off]

  • Document code
  • The document title
  • The name of the author
  • The names of the reviewers
  • The name of the authorizer
  • The current version number
  • The date on which it was released for use
  • The date before the document must be reviewed
  • Distribution list
  • Description of changes compared to previous version

Activity

Does the laboratory have a document control system that ensures that all its quality documents are reviewed, and, when necessary, revised on an annual (or, after maturation of the quality management system, biannual) basis?

Activity

Are the Bench Aids used in the laboratory based on current versions of SOPs?

Activity

Have all quality documents currently in use been reviewed by at least one reviewer?

Activity

Are all the quality documents used in the laboratory authorized for release?

Activity

Are copies of replaced quality documents in the quality documentation archive clearly marked as “replaced” with the date on which they were replaced?

Activity

Are all the references in quality documents to other documents, locations and equipment correct?

Activity

Does the laboratory have a dedicated archive in which it stores all its current and replaced quality documents for a period of five years?

Activity

Are all the procedures related to the document control system standardized in an SOP?

Activity

Is staff aware of what they have to do when they detect an error in a quality document?

Take a sample by asking several staff members.

Activity

Are the Equipment SOPs complete, i.e. do they include the procedures that were developed in phase 2 such as calibration, preventive maintenance and corrective maintenance?

Activity

Does the laboratory have a database/register with regular customers?

Activity

Is a client satisfaction survey conducted at least once per two years?

Activity

Is a report drafted of the client satisfaction survey that shows the main findings and points for improvement that were identified?

Activity

Is a SMART action plan drafted to implement points for improvement identified in client satisfaction surveys in practice?

Activity

Have specific staff members been authorized to communicate with clients so that proper communication and information provision to clients is ensured?

Activity

Are correct biological reference intervals/decision values and alert/critical interval values included for all the examinations performed by the laboratory in the Laboratory Result Reports?

Activity

Is the correctness of the biological reference intervals/diagnostic decision values and alert/critical interval values regularly verified for all the examinations performed by the laboratory?

Activity

If the methodology of an examination is changed, does the laboratory verify if the biological reference interval/diagnostic decision value and alert/critical interval value is still correct for that examination?

Activity

Does the laboratory have a standardized procedure for entering into a contract for service delivery?

Activity

Does the laboratory maintain minutes of meetings to discuss the contents of the contracts for service delivery?

Activity

Are specific laboratory staff members authorized to participate in clinical rounds?

Activity

Do laboratory staff members participate in clinical rounds at least 4 times per year?

Activity

Are meetings between laboratory staff and clinical staff held at least 4 times per year?

Activity

Are minutes made of meetings between laboratory staff and clinical staff?

Activity

If action points arise from a meeting between clinical staff and laboratory staff, is feedback given in the following meeting?

Activity

Does the laboratory have a service manual that includes the following: [tick-off]

  • Description of which tests are available at the laboratory, including information on which the clinical situations require this test to be performed.
  • What sample is needed for each test, the volume/amount needed and, if applicable, special timing of collection.
  • How this sample must be collected, including:
    • Identification of the patient and verification that the patient meets possible pre-examination requirements.
    • How to prepare the patient.
    • How to label the patient specimen.
    • The type of container in which the sample must be collected.
  • How and under which conditions it must be packed and sent to the laboratory, including:
    • Time frame within which the sample must be sent to the laboratory.
    • Temperature interval in which it must be transported.
    • The method of packing the sample container to prevent leakage.
  • If applicable, requirements regarding patient consent.
  • The procedure for requesting routine laboratory testing, including how to complete the Request Form.
  • The procedure for requesting urgent laboratory testing if applicable.
  • The normal turnaround time for each test.
  • The biological reference intervals and, if applicable, the critical/alert values for specific tests.
  • A list of factors known to affect the performance of the examination or the interpretation of results of each examination.
  • The routine method of reporting.
  • A guideline to interpreting the Result Report.
  • The procedure for reporting urgent testing results.
  • Requesting additional testing, including the time-frame in which this is possible.
  • The laboratory’s policy on protection of patient information.
  • The laboratory’s complaint procedure (this will not yet be included in phase 2 as this will be developed in phase 4).

Activity

Has the Laboratory Service Manual been sent to all the clients of the laboratory?

Activity

When changes are made to the service manual, is the new version directly printed and sent to the clients of the laboratory, with the note that they have to destroy the previous version?

Activity

Are correct biological reference intervals/decision values and, if applicable, alert/critical interval values included for all the examinations performed by the laboratory in the Laboratory Service Manual?

Activity

If the biological reference interval/diagnostic decision value and/or alert/critical interval values turn out to be incorrect after changing the methodology of an examination, is this value directly adapted in both the Laboratory Service Manual and the Laboratory Result Report format and is the new version of the Laboratory Service Manual sent directly to the clients of the laboratory?

Activity

Has the laboratory formulated quality controls to guard the quality of each process step in each procedure?

Activity

Are internal quality control results recorded in a register?

Activity

Are internal quality control protocols included in all relevant SOPs?

Activity

Does the laboratory have an SOP for Internal Quality Control that contains:

  • An explanation on the concept of internal quality control
  • The general procedure for performing an internal quality control
  • Procedure for developing internal quality control materials
  • The procedure for periodic review of internal quality controls
  • The procedure to follow when an internal quality control fails

Activity

Does the laboratory monitor internal quality control results and act on quality control failures?

Activity

Is an appropriate number of staff members appointed as Internal Auditors?

With appropriate is meant that the number of staff members appointed as Internal Auditors is sufficient to achieve auditing of the complete quality management system and all the examinations every 12 months, without overburdening the Internal Auditors, creating an unacceptably high work pressure.

Activity

Is the Quality Officer appointed as Internal Auditor?

Activity

Have Internal Auditors been appropriately trained and certified?

Activity

Is a Position Job Description present for the position of Internal Auditor?

Activity

Have the Personal Job Descriptions of the staff members appointed as Internal Auditors been adapted to include the tasks and responsibilities for their position as Internal Auditor?

Activity

Does the Authorization Matrix include the tasks and responsibilities pertaining to the position of Internal Auditor?

Activity

Have staff adequately been informed about what internal auditing is, why it is done, and who the Internal Auditors are?

Activity

Has an external audit been performed to verify complete and correct implementation of the quality management system in compliance with ISO 15189 before the laboratory applies for accreditation?

Activity

Are internal quality control results continuously monitored?

Activity

Does the laboratory undertake action as soon as possible to solve internal quality control failures/deviations from trends?

Activity

Is reporting of results halted when internal quality controls deviate/fail?

Activity

Are internal audits planned on a yearly basis and is this audit plan communicated to all the laboratory staff involved?

Activity

Are action plans made to solve/correct the nonconformities identified in the external mock audit with corrective actions and control steps and preventive actions when necessary and applicable?

Activity

Is timely implementation of the action plans following the external mock audit monitored?

Activity

Is the audit report of the external mock audit with the action plan archived when all action points have been completed?

Activity

Does the laboratory participate in proficiency testing/inter-laboratory comparison schemes for all the examinations performed?

Activity

If participation in a proficiency testing scheme or organization of an inter-laboratory comparison for a certain test is not possible: does the laboratory have a rechecking/retesting system to compare results?

Activity

If results of proficiency testing/inter-laboratory comparisons are deviating/incorrect, does the laboratory act with performing an analysis to identify the causes of the problem and does it implement corrective actions, and, if possible, preventive actions?

Activity

Are internal audits carried out in such a way that the complete quality management system and all examinations are audited every 12 months?

Activity

Are observations made during internal audits reported and are nonconformities identified and scored according to severity?

Activity

Is the audit report submitted to laboratory management for translation into a SMART action plan to ensure correcting/solving of all the nonconformities noted?

Activity

Does the laboratory have an SOP for participation in a proficiency testing scheme and/or an inter-laboratory comparison scheme?

Activity

If the laboratory is the organizer of an inter-laboratory comparison scheme, does the SOP for External Quality Assessment include the procedure for organizing this?

Activity

If the laboratory rechecks/retests samples for a certain test (in case no PT or inter-laboratory comparison was possible), does the SOP for External Quality Assessment include the procedure for organizing this?

Activity

Are action plans made to solve/correct the nonconformities identified in internal audits with corrective actions, control steps and preventive actions when necessary and applicable?

Activity

Is timely implementation of the action plans following internal audit monitored?

Activity

Are Internal Audit Reports with action plans archived when all action points have been completed?

Activity

Is the procedure for planning, conducting and processing internal audits standardized in an SOP?

Activity

Does the laboratory have an SOP for Nonconformity Management that ensures that nonconformities are always solved/corrected in a standardized way with corrective and preventive actions and, if necessary and applicable, control steps?

Activity

Does the laboratory have an SOP on Handling of Complaints?

Activity

Are complaints handled in a standardized way?

Activity

Are complainers informed about how the laboratory has solved the issue of their complaint?

Activity

Has the laboratory procedures in place on how to act in specific emergency situations?

Activity

Is firefighting equipment in place?

Activity

Is an evacuation plan in place?

Activity

Are evacuation routes indicated?

Activity

Are there organizational emergency arrangements in place including a division of roles and responsibilities for specific emergency situations?

Activity

Are procedures in place on how to handle in different emergency situations?

Activity

Have failure mode and effect analyses been performed on all the procedures routinely performed in the laboratory to identify potential sources of nonconformity?

Activity

Have preventive actions, control steps and corrective actions appropriately been implement to prevent and control nonconformities?

Look into the reports of failure mode effect analyses and see if failure modes have reasonably been prevented and controlled by preventive actions, control steps and corrective actions in practice. With reasonable is meant that the implementation of preventive actions, control steps and corrective actions weighs up against the probability of failure modes in combination with the severity of the consequences.

Activity

Has the effectiveness of control steps and preventive/corrective actions implemented in the laboratory routine procedures following the Failure-Mode-Effect-Analysis been evaluated?

Activity

When control steps and preventive/corrective actions of the Failure-Mode-Effect-Analysis appeared to be ineffective, have they been improved?

Activity