Planning quality audits

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. 

Although checklists may be considered a plan, in the context of an audit they should be considered only as an aid to allow the auditor to follow trails that may lead to the discovery of pertinent facts. However, there is little point in drawing up a checklist then putting it aside. The checklist should represent the minimum aspects to be checked so that following the audit you have evidence indicating  

The standard requires the supplier to carry out audits to verify whether quality activities and related results comply with planned arrangements. 

The term quality activities is not defined in ISO 8402 and while it may seem obvious it can create confusion. If we list all the activities which can affect quality, we could say that these are all quality activities. But many of these are also design, purchasing, manufacturing, and installing activities. Can they also be quality activities Quality activities are not restricted to the activities of the quality department or other similar departments. The only clue in the standard as to what quality activities are is in clause 4.1.2.1 where it requires the responsibility of all personnel who manage, perform, and verify work affecting quality to be defined. So a quality activity is any activity that affects the ability of a product or service to satisfy stated or implied needs. 

The related results are the results produced by implementing the policies and procedures. They include documents, decisions, products, and services. It is not enough for internal audits to verify that procedures are being followed. They need to verify whether the outputs of these procedures comply with the prescribed requirements. 

---

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

Planning, conducting, and reporting on internal quality audits (clause 4.17.1) Identifying training needs and providing training (clause 4.18.1)... 

The standard requires the supplier to establish and maintain documented procedures for planning and implementing internal quality audits. 

The strategic quality audit to verify that the strategic plans of the organization address specified legal, environmental, safety, and market quality requirements. 

Which documents constitute the internal quality audit plans ... 

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. 

A comprehensive system of planned and documented internal quality audits is established to verify whether quality activities comply with planned arrangements and to determine the effectiveness of the quality system. 

A validation plan must be developed, based on the results of the quality audit and on the complexity of the proposed custom-built system, which describes the development methodology, inspection, and qualification activities. 

Any serious software developer will follow a formal software development methodology that includes the documentation necessary to support the software at each development step. A quality audit of the software developer will determine the adequacy of testing performed and whether the tests plan, procedures, and results are properly documented. The quality audit must include an inspection of the unit testing process. 

Additionally, every vendor qualification program should include provisions for quality planning. This allows the sponsor to plan for audit events across project schedules. Vendor qualification for any project can be divided into two sections, each with three tracks. Each section will contain atrack for regulated work products. Good laboratory practice, GCP, and GMP define regulated work products. 

A quality audit has been defined as A systematic, independent examination of a manufacturer s quality system that is performed at defined intervals and sufficient frequency to determine whether both quality system activities and the results of such activities comply with quality system procedures that these procedures are implemented effectively, and that these procedures are suitable to achieve quality system objectives 21 CFR 820.2 (t). Another definition is Quality Audit A systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives (International Organization for Standardization/American Society for Quality Control). 

A quality audit is an inspection made on a selected area of the laboratory, or of the quality system, in order to obtain objective evidence of the extent to which the planned arrangements for achieving and maintaining quality are met, and indeed whether or not they are adequate. Audits must ensure that day-to-day operations comply with the requirements of the system. (Is the laboratory doing what it says it does )... 

There are several reasons why a quality system must be fully documented. Firstly it is a pre-requisite of most quality standards. Secondly, in most laboratories it would be impossible to accurately remember and hence communicate all of the analytical methodology and quality management procedure to staff. This would lead to the quality system becoming compromised due to slalT turnover. Thirdly the process of audit (see Section 5.1) requires a precise definition of the planned quality system. This is provided by the documentation. 

Are internal quality audits/inspections conducted on a regular basis Planning... 

The excipient manufacturer should carry out a comprehensive system of planned and documented internal quality audits to verify whether quality activities comply with planned arrangements and to determine the effectiveness of the quality system. Audits should be scheduled on the basis of the status and importance of the activity. The audits and follow-up actions should be carried out in accordance with documented procedures. 

Safety Management and Regulation Group. It will cover topics such as worker training, job planning, quality assurance, audit, inspection, operation readiness review, and regulations. 

Next, each supplier submits the process control plan described earlier to the supplier. The QOS and process control plan allow the purchaser to conduct a quality audit. If there were any unacceptable findings during the audit, the purchasing firm requires the supplier to submit a corrective action plan that identifies what actions the supplier will take to contain and then eliminate the defect, the coordinator of the plan, and the expected completion date of the correction. The purchasing firm follows up on the supplier s progress through phone contacts with the action plan coordinator and through data submitted by the coordinator. 

Many firms model their supplier quality audit on either the ISO 9000 or the Malcolm Baldrige Quality Award (MBQA) criteria. The MBQA has eight categories leadership, quality planning, information and analysis, raw material quality control, manufacturing process control, human resource use, product quality results, and customer satisfaction. 

How to examine the process-control system in order to determine whether it functions as planned and is effective and suitable Chapter 14 presents the basic principles of quality audits. Audits may be used as a tool to answer these questions. Examples of questions for use in audits are also presented. 

Water supply is the safest bulk supply operation but it must comply with certain hygienic standards. Potable water tanks must be solely used for this purpose, maiataiaed under vessel s planned maintenance plan and audited under International Safety Management (ISM). Pumps and pipework should be flushed with super chlorinated water and than with fresh potable water prior refilling tanks. Hoses used for water transfer should be dedicated for this purpose and cleaned with chlorinated water on weekly basis. Each year hose need to be replaced. Water in potable water tanks of PSV typically may be stored for 7 da3 . After this time water is transferred to drill water tanks. Specific rules regarding water quality management usually are given in national regulations. 

The validation plan is really a plan to audit the quality assurance trail of the SIS. The main validation task takes place after installation and ideally before critical operation of the SIS. Experience of validation work teaches that the task can be lengthy and difficult to conclude if it has not been done as an ongoing task from the start of design. Catching up on neglected QA trails is called retrospective validation and it is a very inefficient and fiustrating thing to have to do ... 

In sub-chapter 18-2, the scope of audits is defined to be applicable to all research, development, design, procurement, construction, fabrication, operation, and decommissioning of the SRS reactors. It further establishes the commitment to report findings as either nonconformances or corrective action reports for tracking and ultimate resolution. Sub-chapter 18-3 sets forth a plan to audit external organizations for their compliance with the QA manual. This allows for the audits of vendors and suppliers and further demonstrates an overall commitment to the assurance of Quality in all aspects of design and its control. The items discussed above demonstrate that the requirements set forth in Restart Criterion 6 are satisfied. 

Do audits assess that quality and safety activities comply with planned activities, that the quality and safety system are effective and that defined procedures and methods are being followed ... 

Audits should assess whether the actual quality improvement and safety activities comply with planned activities. The effectiveness of the overall quality and safety system should be scrutinized. Fundamental procedures and methods should be investigated to insure they are up-to-date and being followed in actual practice. The focus of the audit should be prevention, that is, finding areas needing improvement before they actually turn into situations that generate iioiicoiiformaiice. 

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. 

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 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. 

---