Don’t guess or speculate – your response could be far off target if this is the case. The head of quality can, and often does, ask for assistance from other key representatives of the group. That person alone will be the one who questions any observation unless a person hears a point that is blatantly in error. The head of quality is the one who hosts the audit and will be the representative during the close-out.Will you question every observation and attempt to get them removed – analogous to a “Scorched Earth Policy”? Will you accept every observation even if there are errors present? Who will comment on the observations – everyone? Will people debate or disagree with valid observations? A good approach is typically one that abides by the following outline: Too few, it may seem that you are not taking the audit seriously.ĭecide in advance how you are going to approach the close-out meeting. Too many people and the auditor may become uncomfortable. It is important to keep the number of personnel in attendance to a reasonable level. These people usually represent Quality Assurance, Regulatory Affairs, Operations and a member of senior management. For internal, corporate or external auditors, there is usually a verbal close-out meeting followed shortly thereafter with a formal report.ĭuring the close-out meeting (especially during formal or governmental audits), it is important to have the appropriate personnel in attendance. The written list will follow in about two weeks. For the MHRA (Medicines and Healthcare products Regulatory Agency) in the UK, the firm will receive a verbal list of observations. For the US FDA, if a Form 483 is issued, the firm will receive it during this close-out. The close-out meeting is a review of the observations made by the auditor. Typically, the last prospect for obtaining feedback directly from an auditor is during the close-out meeting. This is an opportunity to understand the point being made. Hopefully, the auditor will provide feedback either when the observation was made or on a daily basis. Personnel involved with the audit should have input into the reasoning behind the issue. It is essential that the observations be understood and evaluated in the context in which they were given. Although the auditor or firm may divide their systems into various classifications, a good standard is provided by the US FDA. The auditor is looking for current implementation of programs AND how you plan to implement corrective actions to observations.Ī means of conducting an audit that evaluates the systems implemented by a firm to control their operations. Note: This last section of underlined text is very important to understand if one is to respond systemically to an audit finding. Planned, independent and documented assessments to determine whether agreed upon requirements are met.Īffirmative indication or judgment that the supplier of a product or service has met requirements.Īn affirmative indication or judgment that a product or service has met the requirements of the specs or regulationsĪn item of objective evidence found during an auditĪ systemic and independent examination and evaluation to determine whether quality activities and results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives. Without a base of understanding for these points, misunderstandings and confusion is bound to happen. Your actions before, during and after the audit will ultimately determine your level of compliance.īefore proceeding further, it is always best to define some of the main points being discussed. Quality should be built into the process and auditing alone cannot be relied upon to ensure quality. If done properly, systemic resolution to “issues” should eliminate the peaks and valley syndrome outlined above. The reason was simple – “ always being prepared” prevents (or at least minimizes) the “peaks and valleys” of audit preparation.Īs experience was gained not only at the front end (audit preparation) but at the back end (audit response), it was evident that if “Always be Prepared” was a number one priority, then a number two priority was “Respond Systemically” to any observation. It was a number one priority prevailing over our activities as a quality unit. One of the first things consistently drilled into my collective memory was the statement that we should “ always be prepared for an audit”. If you would like to receive the full version with graphs, please send me an email at July 2016: I found this article on the following link: Article This is a scaled down version of the original report published. Approaching the Response to Audit Observations
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