VIRTUAL AUDITS- LET’S CONDUCT SUCCESSFULLY!
As the COVID 19 outbreak has compelled entire world to perform possible activities virtually, pharmaceutical industry is also not an exception to this.
Manufacturing of pharmaceutical products can not be stopped, as medicines are essentials, but on the other hand accomplishment of regulatory requirements is imperative. Qualification of raw material and packaging material supplier and auditing a supplier’s site is a most unavoidable requirement, but during this epidemic situation actual audits are not possible, hence remote audits are emerged as an option to site /physical audit. Nowadays regulatory authorities are also asking for remote audits. This concept is very good and it is possible because of new era technology exist, however there are some limitations for success of remote audit. e.g., safety requirements do not allow video tour in side the facility, internet problems, time waste in scanning, waiting period for documents availability etc.
Making the successful closing meeting with no agenda topic pending is possible, if activities are managed effectively. Role of the host becomes very important throughout the audit day.
I would like to suggest some tips to auditee teams, based on my experience during virtual audits, to overcome from all the possible obstacle happening during the remote audit.
Know the audit agenda
Know list of possible documents may be asked during audit based on agenda
Know your path and names of your files and folders
Know the delegations for the day
Know the SMEs and Subject
Check your IT systems ready
Know the time
Know the audit agenda
Before every audit, auditor shares audit agenda to auditee team, audit host can read the agenda thoroughly and understand the expectations of auditor from agenda as well as understand the topic wise time allotment. Host can request auditor in advance to change sequence of review to avoid time waste and get the agenda finalized before audit day. Documents which cannot be shared on screen (Some companies do not share as per their policy) can be informed to auditor in advance and get the consensus with customer to save your time during audit.
Know List of possible documents for audit review
Based on the topics mentioned in audit agenda list out the possible documents which can be reviewed by auditor during audit. overview each document/record at least to know basic information about particular document /record before scanning. This practice will boost your confidence while explaining the particular document to auditor.
Know Document path
It is a common observation during audit that, auditor has to consider time for document / record folder/file searching, to avoid time waste. To avoid wastage of time for searching of scanned documents/records; understand storage location/path of scanned document/record. If possible, arrange all files/folders in chronologic order as per audit schedule. Check that all file’s name and inside documents are matching with each other, try to keep file in relevant folder.
Know Subject and SMEs
Basic understanding of audit products, Background of QMS documents, supporting departments etc. will add value to save time, but if auditor wants to know more detailed information, you have to be ready with the particular SME available as per time slot provided for respective subject, inform Him/her in advance and before start of topic review, makes sure that SME has joined virtual audit meeting room. One day before you have to make sure that SME is available for audit, if not available you can ask him/her to assign designee and you personally communicate the designee to avoid miscommunication.
Know delegations for the day
Plan you day with you audit day with the delegated team, assign the responsibilities them objectively. Make sure that assigned responsibilities are understood by them. e.g., arrangement of virtual tour, arrangement of documents from document archival. This supportive team can reduce your stress during audit.
Know Your IT Systems
IT systems and Internet plays very important role for successful completion of virtual audit. make sure one day before that required ancillaries like internet connection, projector, remote, Laptop/Computer web camera, Mic etc. are working. Make sure that application software (LIMS, Track wise SAP etc.) are installed at the computer selected for audit presentation.
Ensure your company presentation is ready to present, you can take mock trial of slide show before audit.
Know your time
And the last but most precious is the time! During remote audit it can be expected, that auditor may ask unexpected document for review. While arranging the document or record, utilize your time for next topic, you can request auditor to park the current point till the document get scanned, next topic or any pending document which is ready to display it can be reviewed. Reshuffling of the agenda topics based on the availability of scanned documents/ records/videos/photographs can reduce waiting period and lead to expedite document review.
