Implementation audit

External audits carried out by second or third parties. They include a documentation audit, implementation audit, and the determination of the effectiveness of the system. 

The patentee should develop and implement a poHcy for auditing its patent portfoHo in the process of paying maintenance fees to the U.S. PTO. This practice should also be used to justify the further payment of aimuities to foreign national patent offices. Maintenance fees and aimuities can constitute a substantial portion of funds expended in the protection of patents over a year s time. Further, without a tangible, real commercial value or advantage stemming from the patent, there may be Htde justification for maintaining the patent over its last five years of life. 

In order to implement the program, an audit needs to be made, as described ia the foUowiag ... 

The impact of a knowledge-based application may appear in many ways improved competitive position, quality improvement, improvement in efficiency, cost reduction, and reduction in downtime, to name a few. Some of these benefits may be hard to quantify others may not be quantifiable at all. For example, the actual benefit derived from a diagnostic advisory system may not be apparent if the process behaves normally. To quantify the benefits, a careful post-audit may have to be done, taking into account the number of faults averted, and comparing the frequency of faults before and after implementation. 

It would not be unusual for some action plans to take a long time to complete. When extended implementation time is necessary, a follow-up mechanism should be used to document progress and show that an effort is being made to resolve the issues. Periodic (i.e., quarterly, semiannually) progress reports should be used as a follow-up method to ensure implementation. Future audits of the facility should include confirmation of the implementation of previous audit action plans. 

Step 1.1 Getting Ready. A thorough preparation for a P2 audit is a prerequisite for an efficient and cost-effective evaluation. Gaining support for the assessment from top-level management, and for the implementation of results, is particularly important. Otherwise, there will be no real action on recommendations. Early in the process, management needs to accept that, at a bare minimum, the audit is a worthwhile exercise and that resources - human and financial - should be diverted from other activities to the task of auditing. 

The audit team found that at Sites B and H, safety and health personnel had suflfieient authority in most eases to thoroughly implement the safety and health plans. To faeilitate safety and health eom-plianee, anyone who entered Site H, ineluding delivery personnel, was required to view a brief video that summarized the site history and remediation operations, identified the hazardous substanees monitored on site, and deseribed site evaeuation proeedures. Site B s SSAHP did not mention speeifie subeontraetors and their roles and responsibilities however, it did indieate that the prime eontraetor had oversight responsibility for all safety and health aetivities and the authority to diseontinue or modify site operations when unsafe eonditions were deteeted. 

Site H was the only site at which the contractor had implemented comprehensive and effective site control elements. The Site H contractor had established site work zones, a buddy system, and site communication procedures consistent with 1910.120(d). This contractor had also established exclusion zones and contamination reduction zones to control migration of site contaminants to clean areas of the site when work within these areas introduced the potential for exposure to hazardous contaminants. The audit team supported this contractor s use of flexible and temporary work zone boundaries based on monitoring results and hazard determinations. 

Contractors at Sites E, H, and J had documented confined space programs but had not fully implemented these programs. The Site H contractor had established a permit-required confined space entry program consistent with HAZWOPER requirements however, onsite procedures were not completely consistent with the written program or OSHA requirements. For example, the confined space permit form used at Site H was not the form included in the written program. The audit team also found evidence that employee training was insufficient for safe... 

El. Self-audit site inspeetion and abatement traeking programs must be formalized and effeetively implemented. 

As one ean imagine, the audit proeess ean be people intensive and expensive. And besides the audit proeess being expensive, one might find that findings from the audit indieate that eertain aetions are reeom-mended. At times, to implement these aetions ean be eomplieated, eon-troversial, expensive, and time eonsuming. 

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. 

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

While the plan itself is not auditable by third parties, it may be auditable by second parties i.e. customers. The third party or registrar is entitled to examine the plan to ascertain that it is what it proclaims to be. The particulars are of no concern except those aspects relating to quality, such as the resources, quality objectives, customer satisfaction plans, and performance metrics. Whatever is stated on these aspects, the auditors will expect to see evidence that the business plan is not merely a wish list and that provisions have been made to enable implementation through the quality system. 

The reason for an Exposition is so that there is a description of the system showing how it works and how it controls the achievement of quality. This is different from the policies and procedures. The policies are a guide to action and decision and as such are prescriptive. The procedures are the methods to be used to carry out certain tasks and as such are task related. They need to be relatively simple and concise. A car maintenance manual, for example, tells you how to maintain the car but not how the car works. Some requirements, such as those on traceability and identification, cannot be implemented by specific procedures although you can have specific policies covering such topics. There is no sequence of tasks you can perform to achieve traceability and identification. These requirements tend to be implemented as elements of many procedures which when taken as a whole achieve the traceability and identification requirements. In order that you can demonstrate achievement of such requirements and educate your staff, a description of the system rather than a separate procedure would be an advantage. The Exposition can be structured around the requirements of ISO/TS 16949 and other governing standards. It is a guide or reference document and not auditable. 

Once you have matched the policies with the procedures (a one-off activity), implementation is assured by verifying that the procedures are being adhered to by those to whom they apply. Simply auditing procedures will not ensure that policies are implemented unless you verify that the procedures themselves comply with the appropriate policies. 

Audit the implementation of the preventive action to verify that the agreed plans have been followed and conditions stabilized. 

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

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