Audits scope

The scope of certification shall include all products supplied to customers subscribing to the certification of ISO/TS 16949. A supplier cannot exclude products and services from the audit scope if any such products and services are provided to subscribing members - hence the auditor needs to know who the subscribing members are. 

Audits normally take 2-3 days to conduct. One-day audits are possible when the auditor and the firm being audited are well prepared or there is a reduced audit scope. Care must be taken with shorter audits to make sure that the assessment is not unacceptably superficial and lacking the required scope or depth. 

Defining the audit scope, including the key performance indicators against which current practices are assessed ... 

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.). 

The audit scope must enable the establishment of a "... high degree of assurance. .." in the supplier organization. A typical scope is presented in Table 2.3. Supplier audits are discussed in more detail in Chapters 14 and 15. 

Create a periodic audit system on the safety of operations and the state of the plant. Audit scope might be defined by such information as the hazard analysis, identified leading indicators of risk, and past incident/accident investigations. 

The plan will detail for each project date of audit, scope of the audit (SOPs) and expected... 

Make sure your staff are adequately trained in auditing, the audit scope, and audit etiquette. 

The technical package may specify a scope and frequency for periodic audits and performance criteria that could lead to changing the audit frequency. It may be a general safety and environmental performance audit or a special audit for items such as raw material storage and handling, quality control methods and documentation. The proprietary nature of a process or product or the complexity of the toll could be a reason to establish a more frequent audit schedule for certain tolls. Audits can also be conducted to follow-up on previously identified shortcomings to document that they were addressed properly. 

To receive ISO 9000 accreditation, a certification body must meet the requirements of ISO Guide 62 and EN 45012, which invokes ISO 10011. There is normally a mark of accreditation (a Grown and Tick in the case of UKAS accreditation) that certification bodies use to signify their credibility. Once accredited, a certification body may perform audits on suppliers offering products and services within the scope of accreditation. In theory, accreditation is granted only if the certification body has expertise (i.e. competent auditors) for the particular industry sectors (EAG codes) requested. 

If your organization is registered to one or more of the existing automotive quality system requirements and the scope is unchanged, the required man-days for the initial audit may be reduced by 50%, but if you decide to change certification body or have changed the scope, there will be no reduction. 

Don t limit the scope of your audit program to the procedures. 

These checklists may be used to indicate compliance with standard procedures. As indicated above, a checklist is easy to use and can be applied to each stage of a project of plant development. A checklist is a convenient means of communicating die minimal acceptable level of liazard evaluadon diat is required for any Job, regardless of scope. As such, it is particularly useful for an inexperienced engineer to work tlirougli die various requirements in the checklist to reach a satisfactory conclusion. However, a system checklist should be audited and updated regularly. 

The advantages to using MSDSs for chemical inventories are that MSDSs are publicly available and required by law. There is no extra cost or labour needed to supply them. The limitations to using MSDSs as a source of inventory data are that currently, in the United States, a standardized reporting format is not mandatory. MSDSs are not verified or audited and MSDS information can be incomplete and/or inaccurate. In addition, OSHA s definition of hazard does not include the broader scope of hazard used in green chemistry. Therefore, chemicals that are potential hazards from the green chemistry perspective but are not defined by OSHA as hazards, are not required to be identified on a MSDS. 

All aspects of the laboratory s work which might affect the validity of the final result should be inspected. This will include, for example, documentation, equipment, calibrations, methods, materials, record keeping, sample recording, labelling, quality control checks and log of daily checks, among many others. Some aspects, however, are outside the scope of such an audit, such as safety and security matters, which usually have separate arrangements for auditing. 

The paragraph that discusses the Inspection of a Testing Facility is of significant importance. It is found in both the EPA and FDA GLPs and, in essence, allows government representatives to enter the facilities and inspect and copy all records within the scope of the work at reasonable times and in a reasonable manner. A key statement here is that the EPA (or FDA) will not consider a study in support of an application for a permit if the testing facility refuses to permit inspection. Thus a facility must permit inspection. This inspection, or audit as it is often called, is therefore taken very seriously. 

The audit staffing requirements will vary based on the scope of the audit (facility size, complexity, and degree of risks). 

The fire protection audit element can be conducted with the scope of the audit focused only on fire protection. However, many companies in the process industries audit fire prevention as an integral part of the overall loss prevention effort and combine it into audits with other programs. 

Once a recommendation has been accepted for implementation, a clear, auditable document trail should be established and maintained. It is the prevailing opinion of many regulatory agencies in the US that any changes in the originally accepted recommendation should be thoroughly documented. If a recommendation is modified in scope or time commitment, or is otherwise not implemented as originally planned, then the basis for this decision should be documented. 

Within the scope of their assessment, or audit, experts ask questions, including ... 

Current quality system models call for audits to be conducted at planned intervals to evaluate effective implementation and maintenance of the quality system and to determine if processes and products meet established parameters and specifications. International standards provide guidance on auditing [13]. Audit procedures should be developed and documented to ensure that the planned audit schedule takes into account the relative risks of the various quality system activities. Factors that can be incorporated into a risk-based approach to planning audit frequency and scope include the following [6] ... 

Different audit approaches may be applied depending on the intended purpose and scope of the audit. A top-down approach first evaluates the overall structure of the quality system and its subsystems. Selected subsystems may be chosen for review. Systems identified and developed by the FDA in a six-system inspection model for the inspection of drug manufacturers [15] include the following ... 

---