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How to manage laboratory projects: running accreditation preparation on a board

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PureField
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Laboratory project management means breaking work with an end date, such as accreditation preparation, method validation or instrument commissioning, into cards with an owner and a due date, and following them on one board. The board coordinates the work; results, approvals, CAPAs and documents are recorded on their own screens. Everyone sees who does what by when.

Which laboratory work runs as a project?

Work with a start and an end, whose steps are spread across several people, runs as a project; routine sample analysis that repeats every day stays on the work list. Typical laboratory projects:

ProjectTypical steps
Accreditation preparation and scope extensionDocument revisions, validation files, staff authorisations, internal audit, application form
Method validationPlanning, experiments (precision, trueness, LOD/LOQ, linearity), calculation, report and approval (§7.2.2)
Instrument installation and commissioningPurchase and delivery, installation site, IQ, OQ, PQ, calibration, analyst training (§6.4.4)
New staff orientationFirst day, first week, supervised work, authorisation (§6.2.5)
Closing assessment findingsRoot cause analysis, corrective action, evidence sent to the accreditation body, effectiveness check (§8.7)

IQ, OQ and PQ are installation, operational and performance qualification: was the instrument installed correctly, does it work as the manufacturer specifies, does it give the expected result in the laboratory's own method? ISO/IEC 17025 asks the laboratory to verify that equipment conforms to specified requirements before it is placed into service (§6.4.4); these three steps are a common way to do that.

Why does a board work better than a spreadsheet and email?

A board keeps the status of the work in one place that everyone sees at the same moment; in a spreadsheet, the status depends on who last updated the file. A familiar week in accreditation preparation: on Monday the quality manager updates an Excel file and emails the owners, and the answers come back in separate threads. By Friday the only person who knows which row is current is still the quality manager.

TopicSpreadsheet and emailBoard
StatusThe "in progress" in a cell shows the last updateThe list a card sits in is the stage of the work
Owner and due dateIn separate columns; reminders by handOn the card; cards near or past their due date stand out
Sub-tasksOn other tabs or in notesOn the card's checklist, each item with an owner and a date
DecisionsIn email threadsIn the card's comments, with who wrote them and when
EvidenceA folder path or an attachmentA link on the card to the record or file

How do you set up an accreditation preparation board?

Set up the board with a few lists that show the stage of the work, and open every task as a card. A sample board starts with five lists: To do, In progress, Awaiting check, Done, and a separate Scope extension list for the scope extension work. Awaiting check holds cards whose work is finished but still needs a second person's look; the quality manager clears it once a week.

CardListOwnerChecklist
Updating the measurement uncertainty budgets (Nordtest)Awaiting checkQuality managerOne item per method in scope
Closing internal audit findingsDoneQuality managerLinked CAPAs, effectiveness check
Reauthorising analysts (§6.2.5)In progressTechnical managerWitnessing plan, repeat analysis results, proficiency testing performance, authorisation decisions
Reviewing the instrument calibration planIn progressEquipment officerChromatographs, balances, thermometers, pipettes
Revising the sample reception instructionIn progressDocument controllerDraft, review, approval, reading tasks
Preparing the management review agendaTo doLaboratory managerEarlier actions, quality objectives, audit results, resource needs
Adding the histamine method to the scope: validation fileScope extensionTechnical managerRepeatability, intermediate precision, trueness, LOD/LOQ, measurement uncertainty

Separate the kind of work with labels: Document, Instrument, Staff, Scope, Assessment finding, Urgent. Filter on one label and, for example, only the instrument cards remain.

Split a large card with a checklist. On the reauthorisation card each analyst can be an item with their own owner and date, and an item that grows can become a card of its own.

For the calculation behind the uncertainty card: How to calculate measurement uncertainty

Where is the line between the board and the record?

The board coordinates the work; results, approvals, CAPAs and documents are recorded on their own screens, and linking a record to a card leaves the record as it is. For example, the "Closing internal audit findings" card links to three CAPAs. Root cause analysis, actions and the effectiveness check happen on the CAPA screen and are signed there. Moving the card to Done and closing the CAPA are two separate steps; the assessor looks at the CAPA itself as evidence.

This line protects two things:

  • Record rules: Approval, e-signature and the audit trail run on the record's own screen; the board shows the way to that screen.
  • Permissions: A link on a card opens with the person's own permissions; records such as personnel files or complaints stay visible to authorised people only.

Who can do what on a board?

Three roles are enough on a board: the admin manages the board and its members, members open, move and update cards, and observers read and comment. Visibility comes in two kinds: a private board is visible to its members only, while everyone in the laboratory can see a laboratory board and join it.

PersonRole
Quality managerAdmin
Laboratory manager, technical manager, equipment officer, document controllerMember
Sample reception officerObserver

Open a laboratory board for work that concerns everyone, such as accreditation preparation, and a private board for sensitive work such as a staff appraisal or a complaint investigation.

How do you plan the weeks before a surveillance visit?

Plan the weeks before a surveillance visit backwards from its date: put the cards that must close into each week, and end each week by clearing the Awaiting check list. The plan below is a six-week example; adjust it to your scope.

WeekWork to close
6 weeks beforeSet up the board. Open cards for the previous assessment's findings, open CAPAs and scope changes; give each card an owner and a due date
5 weeks beforeSend changed document revisions for approval so that reading tasks are done before the visit
4 weeks beforeReview the calibration and intermediate check plan, and schedule calibrations that are about to expire
3 weeks beforeComplete staff authorisations and competence monitoring, and assess proficiency testing results
2 weeks beforeClose internal audit findings and CAPAs, and check the uncertainty budgets against current data
Final weekClear the Awaiting check list and prepare the records you will show the assessor, clause by clause

Every Monday, open the board in calendar view and look at the cards due that week. For a card past its due date, either close it or give it a new date with a reason; the change stays in the card's history.

How do you run projects in PureField LIMS?

The Projects module of PureField LIMS coordinates laboratory work with boards, lists and cards, and cards link to the laboratory's records.

TopicIn PureField LIMS
TemplatesA new board opens from the Basic board (To do, Doing, Done), Accreditation preparation, Method validation, Instrument installation and commissioning or New staff orientation template; the template sets the opening lists
ViewsBoard, Table and Calendar. The filter narrows by keyword, member, label and due date and applies to all three views
CardMembers, labels, checklists (each item with an assignee and a due date; an item can become a card), start and due dates, a reminder, a cover
AttachmentsPDF, PNG or JPEG up to 20 MB; a file opens after a security scan. Drive files are added as links
Related recordsSample, analysis, CAPA, nonconforming work, complaint, risk, internal audit, management review, instrument, calibration job, document, method, customer, supplier, purchase request and order, stock item, sampling plan, training plan, staff, contract, method verification. A record's number and title show only to people who may open it
My cardsCards you are a member of, from every board, grouped by due date: overdue, today, tomorrow, next 7 days, later, no due date
Record pagesA Cards linked to this record section at the bottom of sample, CAPA, instrument and document pages
NotificationsWhen you are added to a card or mentioned in a comment, when a card you are a member of or follow gets a comment or a due date change, when a reminder is due, and each morning for your cards due within 24 hours or overdue
RolesAdmin, Member, Observer; a board is Private or Laboratory
RetentionLists, cards, labels, checklists, attachments and links are archived or taken off the board and stay on record; a comment is withdrawn and its text kept. Every change goes into the laboratory's audit trail

A private board and its cards are visible to its members only; people who may view the audit trail (laboratory manager, quality manager, system administrator) can read the history of private boards there as well.

Evidence

ISO/IEC 17025 (2017 edition)
General requirements for the competence of testing and calibration laboratories. Staff authorisation and competence monitoring are in §6.2.5, verifying equipment before it is placed into service in §6.4.4, method validation in §7.2.2 and corrective action in §8.7. Source: iso.org

To see an accreditation preparation board in a sample laboratory, request a PureField LIMS account.

Frequently asked questions

How does a card relate to the record linked to it?

The card coordinates the work; the record is kept on its own screen. Moving a card to Done and closing a CAPA are two separate steps, and the CAPA's actions and effectiveness check are signed on the CAPA screen. In PureField LIMS a linked record's number and title show only to people who may open it; everyone else sees a placeholder for a record outside their access.

Which template should you start with?

Accreditation preparation if you are preparing for an assessment or a scope extension, Method validation for a new method, Instrument installation and commissioning for a new instrument, New staff orientation for a new starter. The template only sets the opening lists; you can rename, move and add lists later.

What is the difference between a private board and a laboratory board?

A private board, with its lists and cards, is visible to its members only. Everyone in the laboratory can read a laboratory board and become a member with Join board. On both, every change goes into the laboratory's audit trail.

Where are changes on a board tracked?

The board's Activity section lists every change with who made it and when. The same changes go into the laboratory's audit trail; the laboratory manager, quality manager and system administrator, who may view the audit trail, can read the history of private boards there as well.

Who is notified when a due date approaches?

The card's members and the people who follow it. PureField LIMS sends a notification when the card's reminder is due, and each morning for cards due within 24 hours or overdue. Each person turns email delivery on or off in their own notification preferences, on the project cards row.