Audits/auditing planning

Postaudit Process The postaudit process consists of preparation of a draft report, preparation of a final report, development of artion plans, and follow-up. A draft report of the audit findings should be prepared shortly after the completion of the on-site audit. The draft report usually undergoes review and comment by facility personnel involved with the audit, experienced auditors not involved with the subject audit, functional specialists, and attorneys. The review of the draft report is done to assure that a clear, concise, and accurate report is issued, and not to modify or change the findings. Once this review procedure is completed, a final report can be issued and distributed based on a distribution list provided by the facility personnel. The final audit report should be issued in a timely manner and meet the time requirement specified in the audit plan. 

In judging the adequacy of provisions you will need to apply the relevant standards, legislation, codes of practice, and other agreed measures for the type of operation, application, and business. These activities are quality assurance activities and may be subdivided into design assurance, procurement assurance, manufacturing assurance, etc. Auditing, planning, analysis, inspection, and test are some of the techniques that may be used. 

Remote locations shall be included in the initial and ongoing surveillance audits as addressed in the annual audit plan.O The auditor has to establish what constitutes a site and a remote location for a specific supplier. 

The entire quality system shall be assessed at a minimum of once every three years. The audit plan for a supplier has to cover all requirements, all sites, all locations, all operations, all functions, all customers, all processes, all procedures at least once in a three-year cycle, unless it is an upgrade certification (see clause 4.6). Hence the sample of operations taken on each audit has to cover at least Veth of the whole. 

The audit plan must include all elements of the supplier s quality system that meet the needs of those customers recognizing ISO/TS 16949 certification of their suppliers, even when these requirements go beyond ISO/TS 16949. 

Where a supplier has non-automotive customers or automotive customers that have not recognized ISO/TS 16949, any elements of the system that are specifically tailored to those customers must be excluded from the audit plan. 

Where a supplier has a quality system that covers the whole business, the audit plan must not include elements that are not implemented for automotive customer needs e.g. elements of Human Resources, Accounting, Finance, IT, Legal, Marketing, Sales, Public Relations may not serve automotive customers needs but company needs. 

The audit plan shall include evaluation of all supplier quality system elements for effective implementation of ISO/TS 16949 requirements as well as for effectiveness in practice. 

Auditor has to submit audit plan to CB prior to audit. 

Are internal quality audits planned and implemented in accordance with documented procedures ... 

The detail plan for each audit may include dates if it is to cover several days but the main substance of the plan will be what is to be audited, against what requirements, and by whom. At the detail level, the specific requirements to be checked should be identified based upon risks, past performance, and when it was last checked. Overall plans are best presented as program charts and detail plans as checklists. Audit planning should not be taken lightly. Audits require effort from auditees as well as the auditor so a well-planned audit designed to discover pertinent facts quickly is far better than a rambling audit which jumps from area to area looking at this or that without any obvious direction. 

Which documents constitute the internal quality audit plans ... 

The effectiveness of a QA-related independent Part 11 audit is dependent on the checklist or audit plan utilized. Here, provided as a model, is a two-part audit checklist. The depth of the evidence and support required is dependent on the results of the risk assessment All high-, medium-, or low-risk systems should be subject to the same general questions. 

Audit protocols are tailored to their subject and to the answer desired of the audit. CCPS (1993a) provides more details on audit planning, audit protocols and teams, and other audit issues. 

The inspection is performed according to the quality assurance programme and is based on the audit plan. There can be three types of audit ... 

The EPA and FDA audit is a formal process involving advance notice, planning and scheduling (Figure 8.2), and a follow-up report, as well as the actual on-site observations and interviews. The advance notice includes an announcement of what specifically is to be audited. When the auditors arrive, the study director and lab workers are interviewed as a group, in what may be called an "opening conference," and the audit plan is laid out for everyone s full understanding. Included here would be a review of the purpose... 

Auditing as described in QMS models is intended to assess the effectiveness of the overall quality system as designed and conformance to applicable standards. The overall quality system does not have to be covered in a single audit. Manufacturers may choose to employ a rolling audit approach in which specifically identified subsystems are chosen for evaluation in accordance with an approved audit schedule. Audit plans should be designed to effectively perform this assessment. 

The audit plan should be consistent with written quality auditing procedures included in the quality manual or other quality system documentation. The plan should include or refer to the objective criteria to be used to evaluate conformance to requirements. The plan should include or refer to other documents that will be used during the audit, including previous audit reports. If the audit is to include the review of batch or production records, such review should be conducted in accordance with a specified sampling plan or other appropriate statistical rationale as specified in a firm s quality system procedures. 

Manufacturers implementing a quality system that conforms to an existing standard may find it helpful to create a table or some other document that shows the relationship between cGMP requirements, requirements of the standard, and the element(s) of the manufacturer s quality system. Such a tool can help assure that all pertinent requirements are covered in the quality system design and that audit plans designs include assessment of all pertinent requirements. 

Before starting an on-site audit, plan the audit. Review past audits, note indications of possible problem areas and items, if any, that were identified for corrective action in a previous audit. If you are not already familiar with this facility, learn the type of product produced and how it is organized by personnel and function. What does your customer, that is, your superior or senior facility management, expect to learn from this audit ... 

An effective audit plan will include the following elements ... 

Once the audit plan is developed and approved, the audit team leader should formally notify the vendor in writing, typically 2 to 3 weeks prior to conducting the audit. 

Formal notification should include a copy of the audit plan, the audit checklist, and a proposed agenda. The audit team leader should also provide a copy of this audit package to the audit team members in preparation for the audit. 

For each individual audit, it is useful to prepare an audit plan to provide the auditee with an overview on the audit components and the conduct of the audit. An audit plan may also be useful as a basis for agreement between the sponsor, the (external) QA auditor and the audit team. It is common practice in clinical research to draw up an audit plan and distribute this information prior to the audit. 

ISO 19011 2002 (2002) suggests including the following information in the audit plan ... 

The following details may also be addressed in the audit plan, as required ... 

For announced audits, it is good business practice to inform the auditee in writing of the planned audit and to agree on a mutually feasible audit date. Once the audit is scheduled, the audit plan should be sent with a cover letter to the auditee, audit team members, technical experts (if involved) and the client/sponsor (in case of third party audits). 

QA should keep records of all correspondence with the auditee and should check during the audit that the announcement letter and audit plan were received at the auditee s site. 

An opening meeting should be held with the auditee and his/her management, if appropriate, and those responsible for the functions and processes to be audited, in order to confirm the audit plan and the sequence of reviews and topics and to present the audit procedures. The purpose of the meeting is also to confirm that documents to be audited and individuals to be interviewed are available. 

The auditee and/or the sponsor should be informed without delay in case serious deficiencies are uncovered which may pose a high risk for either trial participants or the clinical data. Likewise, if the audit scope cannot be covered during the scheduled time for the audit, the auditee and/or the sponsor must be notified and appropriate action should be determined (e.g. extension of the audit time or modification of the audit plan, etc.). 

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