Quality system review

To understand the difference between auditing a quality management system and conducting a quality system review. 

To appreciate the inputs necessary for a laboratory to conduct a quality system review. 

Describe the different kinds of audits that can occur, such as a mock FDA-style audit, quality systems review audit, gap analysis, documentation audit, and preapproval inspection audit. 

The purpose of a quality systems review is to review the manufacturer s quality system and to ascertain whether it has been shown to operate satisfactorily. 

Do executive management establish the continuing suitability and effectiveness of the quality system through periodic reviews ... 

The standard requires that the supplier s management with executive responsibility appoints a member of its own management with responsibility for ensuring that quality system requirements are established, implemented, and maintained in accordance with ISO 9001, and for reporting on the performance of the quality system to management for review and as a basis for improvement of the quality system. 

The standard requires that the quality system be reviewed at defined intervals sufficient to ensure its continuing suitability and effectiveness in satisfying the requirements of ISO 9001 and the supplier s stated quality policy and objectives. There is also a supplementary requirement in clause 4.2.8 for the performance of the system to be evaluated to verify the effectiveness of its operation. 

Although termed a management review the requirement is strictly referring to a review of the quality system and not the Corporate Plan. 

The elements of the system can be construed to be the 20 elements of ISO 9001. The components of the system are different. ISO 8402 states that a quality system is the organizational structure, procedures, processes, and resources for implementing quality management. It therefore follows that in reviewing the quality system one needs to review each of these aspects. 

Conduct periodic reviews of the quality system using the collected data. 

These are only some of the reasons for creating a quality system. Whatever your reasons are, define and document them and review them frequently. When you evaluate the system these reasons will help determine whether your system is effective (see Part 2 Chapter 17). 

In order to keep the system up-to-date with the needs of the business you will need to review the system when changes occur in the business. This review may be carried out at the same time as the management reviews described in Part 2 Chapter 1 however, as these reviews may be scheduled on a periodic basis, you should not allow the system to become outdated. The system should always reflect what you do and should remain ahead of actual practice rather than lag behind it. You should therefore integrate your system review with the business review so that changes in the business are implemented through the quality system rather than as an afterthought. 

The standard doesn t require a procedure for Management Review and while it does require procedures for Design Control it does not specify that a Design Review Procedure is required. The phrases consistent with and in accordance with have the same meaning as both imply compatibility and agreement. If you restrict yourself to a literal interpretation of the standard, you need produce no more than 43 documented procedures - possibly less if some aspects do not apply to your business. You can combine several procedures in one document, the size of which depends on the complexity of your business. The more complex the business the greater the number of quality system documents. The more variations in the ways that work is executed, the larger the quality system will need to be. If you have a small business and only one way of carry-... 

Quality plans are needed when the work you intend to carry out requires detailed planning beyond that already planned for by the quality system. The system will not specify everything you need to do for every job. It will usually specify only general provisions which apply in the majority of situations. You will need to define the specific documentation to be produced, tests, inspections, and reviews to be performed, and resources to be employed. The contract may specify particular standards or requirements that you must meet and these may require additional provisions to those in the quality system. Although ISO/TS 16949 requires the plan to include customers requirements, the intention is not that these requirements are reproduced if provided in a documented form by the customer, but that a cross reference is made in the plan together with any other relevant specifications referred to in the contract. However, when constructing the plan, it would make sense to refer to specific customer requirements and provide a response that indicates your intentions regarding those requirements. 

In planning for a contract or new product or service, the existing quality system needs to be reviewed against the customer or market requirements. One can then identify whether the system provides an adequate degree of control. Search for unusual requirements and risks to establish whether any adjustment to procedures is necessary. This... 

Produce procedures for preparing, reviewing, approving, publishing, and distributing quality system documents. 

Subcontractor/supplier performance will be evident from audit reports, surveillance visit reports, and receipt inspections carried out by you or the third party if one has been employed. You need to examine these documents for evidence that the subcontractor s quality system is controlling the quality of the products and services supplied. You can determine the effectiveness of these controls by periodic review of the subcontractor s performance what some firms call vendor rating . By collecting data on the performance of subcontractors/suppliers over a long period you can measure their effectiveness and rate them on a scale from excellent to poor. In such cases you should measure at least three characteristics quality, delivery, and service. Quality would be measured by the ratio of defective conforming products received delivery would be measured by the number of days early or late and service would be measured by the responsiveness to actions requested by you on scale of excellent to poor. The output of these reviews should be in the form of updates to the list of assessed subcontractors/suppliers. 

Don t work to instructions unless provided in the quality system procedures, product specification, production plan or in approved change notices or remedial action instructions or by the nonconformity review board. 

Failure investigation procedure Nonconforming material review procedure Customer complaints procedure Quality system document change procedure Specification change procedure Maintenance procedures... 

These lists tell us something about the nature of quality records, especially by what is not included. Absent from the lists are policies, procedures, instructions, plans, specifications, and any other prescriptive documents. The records all have one thing in common they describe the results of some activity - the results of inspections, tests, reviews, audits, assessments, calculations, etc. However, these lists are dominated by records relating to product quality rather than to the operations of the quality system. In addition to audit records, the following records may need to be maintained to demonstrate the effectiveness of the quality system ... 

The requirement is also somewhat duplicated in clause 4.1.3 on management reviews. You are required to conduct management reviews to ensure quality system effectiveness and conduct internal quality audits to determine the effectiveness of the system. It would appear that the audit collects the evidence and the review ensures that it is collected. 

Quality Management system priorities to consider are management responsibility, quality system principles, auditing, contract review, design control, corrective action, document control, quality records, training, product safety and liability, and statistical techniques, because these are critical aspects of the Quality Management system where Xmple Inc. already has some systems in place. 

Auditing the quality system ensures that performance is regularly reviewed and deficiencies identified and action to address these required. 

The audit also emphasizes the self-regulated nature of the industry and the ideal relationship between the agency and the industry. In theory and effective practice, a biomedical company utilizes its quality assurance (QA) unit (in this case, supplemented by credible Part 11 auditors) to maintain control of safety, effectiveness, and quality. The FDA can then review the quality system (QS) and spot-check the other systems such as laboratory or production for most efficient regulatory oversight. In effect, the QA regulates the company and the FDA regulates the QA. 

One of the alternative approaches under the 510(k) paradigm is Special 510(k) Device Modifications. This approach utilizes certain aspects of the Quality System Regulations (Quality System Requirements for Good Manufacturing Practices). The other alternative is the Abbreviated 510(k). This approach utilizes special controls in which standards or voluntary guidelines can facilitate 510(k) review and expedite evaluation. 

---