Contracts audits

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. 

Tedesco, J. Auditing contract analytical laboratories. J cGMP Comp l(4) 33-43 (1997). 

Regulations generally require that employers periodically evaluate and audit contract companies and workers. If any problems or violations of company standards are observed, or if the contractor s safety record is deteriorating, the operating company must bring them to the attention of the... 

Quality Audit. Another important responsibiUty of quahty assurance is the audit function. Using the quahty audit as a tool, QA can monitor the operation of the manufacturing faciUty a toU, ie, contract, manufacturer or raw material suppHer to assure that written procedures are in place and that there is documentation to indicate the procedures are being followed. Properly executed audits allow QA to spot potential weakness in the quahty system that could allow errors to occur. Once identified, these weaknesses can then be corrected before they result in nonconformance. 

The client will want to ensure that it has access to and the right to audit the tolling facility. Factors that may be negotiated and formalized in the contract include ... 

The contract can specify the amount of time the client needs to remove its materials from the toller s facility and lays out notification procedures for dissolving the contract. Chapter 6, Closure and Audit, Example 6-1 is a sample contract termination checklist. It is an illustration of one company s inventoiy list for closing out a tolling project. It addresses material, financial, legal and environmental considerations. 

The client s personnel who had close involvement in the toll can best determine the toller s future status. A recommendation to use the toller again can be based upon the total experience including audit results and the toller s action item follow-up. A safe, responsive, conscientious toller that met the commercial requirements of the toll contract will most likely be given consideration on future tolls. As discussed in Chapter 2, The Toller Selection Process this recommendation can ease any future selection process for both parties when the toller in question is known to be technically capable. 

In the last chapter we discussed the importance of well-defined roles. This holds true for the inspection team. For many larger sites a union contract may exist that may specify who participates in the inspec-tion/audit process. At smaller sites, this may be open-ended. We believe that the personnel make-up of an inspection team should depend on the size, complexity, number of employees, and on-site hazards at the site in question. Again, preplanning coupled with a common-sense approach should be the driver. 

A postproject management audit (project audit) is performed to verify that project terms were carried out and that services contracted for were satisfactorily completed. Once these basic objectives have been achieved, it is important that all documents are properly assembled and the project file be closed and stored in a manner permitting rapid reference and retrieval. 

ISO 9000 is not a statutory requirement and neither is certification, hence certification is voluntary. However, suppliers may be under pressure to obtain registration to ISO 9001, ISO 9002, or ISO 9003 in order to tender for contracts. Within the ISO 9000 certification scheme, the certification industry is regulated by accreditation bodies. An International Accreditation Forum (lAF) attempts to harmonize accreditation practices world-wide through ISO Guide 61. The accreditation bodies authorize certification bodies to conduct certification to prescribed standards - a process that is called accreditation. The accreditation body performs witness audits and desk audits of the certification body to ensure compliance with the conditions of accreditation. 

Permitting only lATF qualified third party auditors who are sponsored by certification bodies contracted to perform ISO/TS 16949 audits... 

The document availability requirement applies to both internal and external documents alike. Customer documents such as contracts, drawings, specifications, and standards need to be available to those who need them to execute their responsibilities. Often these documents are only held in paper form and therefore distribution lists will be needed to control their location. If documents in the public domain are required, they only need be available when required for use and need not be available from the moment they are specified in a specification or procedure. You should only have to produce such documents when they are needed for the work being undertaken at the time of the audit. However, you would need to demonstrate that you could obtain timely access when needed. If you provide a lending service to users of copyrighted documents, you would need a register indicating to whom they were loaned so that you can retrieve them when needed by others. 

These details will help you keep track of the customer supplied product whether on embodiment loan or contract loan and will be useful during customer audits or in the event of a problem with the item either before or after dispatch of the associated assembly. 

Customer complaints Warranty claims Failure analysis reports Process capability studies Service reports Concessions Change requests Subcontractor assessments Performance analysis Deviations and waivers Contract change records Quality cost data External Quality Audit records... 

All audits should be conducted against a standard for the performance being measured. Examinations without such a standard are surveys, not audits. Audits can also be conducted against contracts, project plans, specifications - in fact any document with which the organization has declared it will comply. The standard now requires system audits to be conducted to verify compliance with ISO/TS 16949 and any other system requirements. 

Planned arrangements is another unusual term, especially when throughout the standard the terms documented quality system and documented procedures have been used. However, so that audits are not restricted to documented procedures and policies, the term planned arrangement has been used. It encompasses contracts, specifications, plans, objectives, strategies - in fact any arrangement made by the organization to satisfy customer needs. You therefore need to define what constitutes your planned arrangements. 

The coordinated approach contracting relationships built on collaboration, trust and close interpersonal ties define the coordinated approach. This approach means that the producer inherits the responsibility and costs of social auditing as they are passed down the supply chain. This is achieved, however, within the framework of close retailer-supplier relationships. Although subcontracting exists, known networks of traceable suppliers are involved. As such, it is possible to exert considerably greater control over the ethical trading process. 

For any new excipients, APIs or drug products (where new does not necessarily mean novel, but new to the receiving site) there are additional testing criteria, e.g. supplier audits, third-party contract laboratory audits, analytical method transfers, sample management/tracking, etc. For those key excipients, where there is on-site historical experience, it still behoves both parties to check whether the local grade/supplier used by the CMO is equivalent to that used by the supplier (Worsham, 2010). There are many examples of differences in excipient physical properties, e.g. particle size, which have been attributed to different excipient sources that could ultimately impact on the performance of those excipients in formulated products (Frattini and Simioni, 1984 Dansereau and Peck, 1987 Phadke et al., 1994 Lin and Peck, 1994). 

Linna, A., Korhonen, M., Mannermaa, J., Airaksinen, M., Juppo, A. Developing a tool for the preparation of GMP audit of pharmaceutical contract manufacturer. European Journal Pharmaceutics Biopharmaceutics, 69, 2008, 786-792. 

---