Quality system adequate

The term resource is often used to imply only human resources when there are in fact other types of resources. The standard is not specific although resources would normally include time, manpower, machines, materials, finance, plant, facilities in fact, any means available to the supplier for implementing the quality system. So when ISO 9001 requires that you provide adequate resources it requires that you provide all the human, finance, and material resources necessary to implement your quality system, including the allocation of sufficient time. 

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... 

Your quality system therefore needs to accommodate various corrective action strategies, from simple intradepartmental analysis with solutions that affect only one area, procedure, process, or product to projects that involve many departments, occasionally including suppliers and customers. Your corrective action procedures need to address these situations in order that when the time comes you are adequately equipped to respond promptly. 

This is probably one of the most powerful requirements in the standard, much underused in ISO 9000 quality systems. If you examine the words closely you will find that it can be applied to any situation where measures can be taken to prevent problems. A common weakness in many organizations is the absence of planning. Planning is a preventive action. We plan to achieve an objective which we would fail to meet if we didn t make adequate provision for the resources and activities needed to meet our objective. Therefore, although the standard does not require plans for every activity, if preparation is necessary before an activity can take place and such preparation has not been accom-... 

An audit carried out to establish that the quality system documentation adequately addresses the requirements of a prescribed standard also referred to as a documentation audit... 

All the planned and systematic activities implemented within the quality system and demonstrated as needed, to provide adequate confidence that an entity will fulfill requirements for quality (ISO 8402). 

Sec. 820.130 Device packaging - Packaging must provide adequate protection of the device Figure 11.15 Headings of the Quality System Regulations (QSR) from 21 CFR Part 820. 

Quality assurance is the part of quality management focused on providing confidence that quality requirements will be fulfilled. It is all the planned and systematic activities implemented within the quality system, and demonstrated as needed, to provide adequate confidence that the analytical service will fulfil the requirements for quality. Quality assurance is the essential organizational infrastructure that supports all reliable analytical measurements. It encompasses... 

The guidelines also stress that the perfunctory execution of any quality system will not guarantee the production of data of adequate quality. The correct procedures for feedback, remedial action and staff motivation must also be documented and acted upon. In other words, there must be a genuine commitment to quality within a laboratory for an internal quality control programme to succeed, i.e. the IQC must be part of a complete quality management system. 

Resources Sufficient resources should be provided to create a robust quality system that complies with the GMP regulations. Senior management or a designee should be responsible for providing adequate resources. 

Software validation is not separately defined in the quality system regulation. The FDA considers software validation to be the confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled [14]. Software validations have special concerns on software installation, implementation, and utilization. A software validation consists in several tests, inspections, and verifications performed to assure the adequate installation and use of software and that the tasks performed meet all the specifications defined. Software validations must be performed under the environmental conditions to which software will be submitted. This is particularly important in medical devices that are used under special conditions, such as close to or inside the human body. 

This chapter will focus on those additional GMP requirements for the manufacture of excipient ingredients under an ISO 9001 compliant quality system. While certification to ISO 9001 is unnecessary for compliance to excipient GMPs, many of the manufacturing-related requirements as noted above are essential for adequate GMP conformance. With the numerous ISO 9001 compliance resources available, this chapter will assume the reader has the knowledge to implement those relevant general ISO 9001 requirements. 

The quality system provides for a review to determine whether production capability and field support are adequate for the new or redesigned product. Depending upon the type of product, the review may cover the following points ... 

Organizational measures are based on human action for their performance. In the fine chemicals and pharmaceutical industries, reactor-charging operations are often manual operations and the product identification relies on the operator. In this context, quality systems act as support to safety, since they require a high degree of traceability and reliability. Examples of such measures are labeling, double visual checks, response to acoustic or optical alarms, in process control, and so on. The efficiency of theses measures is entirely based on the discipline and instruction of the operators. Therefore, they must be accompanied by programs of instructions, where the adequate procedures are learned in training. 

Complaints related to the quality of the product should also be evaluated. Complaint trends should be reviewed for evidence that recurring problems have been adequately resolved. The complaint trends should be examined for any correlation to the other quality systems. For example, any correlation between complaints and deviations related to the same lot or product line or any-increase (or lack of a decrease) in complaints after a corrective action has been made should be revealed and addressed during the APR process. 

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 )... 

In addition to descriptions of procedures to be followed, the quality system must provide for the creation and maintenance of records which show what has been done. This is necessary to enable the laboratory to replicate, if required, the analytical process that was performed for a particular sample. The process of audit is only possible if adequate records are maintained and the absence of adequate records will constitute a non-compliance with most quality management standards (see Section 5.2). 

Failure to adequately establish procedures for quality audits, to conduct such audits, and to determine the effectiveness of the quality system... 

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