Suppliers third party

According to the definition given by organization theory, companies are open systems that relate to other external entities - such as suppliers, third parties,... 

A toller may need to use resources outside their company to measure physical properties, conduct safety or other testing, engineer changes to piping or other facilities and equipment. This need frequently occurs for products in the initial development or commercialization stage. The toller should maintain confidentiality agreements with their suppliers and subcontractors commensurate with the proprietary nature of their client companies processes. Provision to allow disclosure of information to third parties should be addressed in the contract between the toller and the client. It may be structured so that the client must approve the toller s release of information to third parties. 

Toller An outsourced manufacturing company contracted to process materials to another company s specifications. Sometimes called third party service provider, toll processor, supplier of outside services, external contract manufacturer, contract processor, contract manufacturer, custom chemical manufacturer. 

Conformance with ISO/TS 16949 for third party certification shall be based on objective evidence of meeting each applicable requirement including customer-specific requirements at the time of the audit. The auditor needs to determine specific customer requirements that apply and verify compliance with each requirement - not a sample. If the supplier has several different customers then compliance with the requirements of each customer has to be demonstrated. 

Consultants to the supplier cannot participate in the audit. The auditor needs to establish whether consultants are present and if so what role the supplier intends them to perform. Consultants can be observers but cannot answer questions posed by third party auditors. 

The standard allows for undocumented verbal orders but requires that the order requirements are agreed before their acceptance. The third party auditor cannot confirm conformity with this requirement as there will be no objective evidence to substantiate the transaction other than the payment invoice. If the supplier confirms the agreement in writing a written statement of requirement exists. The standard does not stipulate that the agreement has to be documented only that the requirements need to be documented regardless of who produced them. The only evidence that the requirements were adequately defined is therefore the payment from the customer against the supplier s invoice. 

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. 

Assessments by second or third parties can be an acceptable alternative but it depends on the standards used for the assessments. An ISO 9000 assessment alone would not give sufficient confidence to remove all receiving inspection for deliveries from that particular supplier. You need to examine product as well as the system until you have gained the confidence to reduce inspection and eventually remove it. Subsequently continual assessment of the subcontractor should be carried out. 

Part of the company s quality control system should involve inspection of raw materials prior to use. Obviously contaminated products exhibiting one or more signs of microbial infection should not be used and any doubtful materials should be checked by the user, the supplier or a third party. 

The arm s length approach as a result of lack of funding associated with ethical trade, there is only limited use of third-party auditors. However, the partial use of independent auditors does occur mainly within the context of arm s length relationships between retailers, auditors and suppliers. This can be defined as the contractual relations between companies involving competitive bidding and playing-off of suppliers. Weak social ties and detached social relations are characteristic of such relationships (Doel, 1996, 1999). 

Quality still remains the No. 1 criteria for any outsourcing activity. Imports from third-party suppliers account for greater than 80% of APIs (active pharmaceutical ingredient) in the United States and 40% of medicinal products, yet the FDA (US Food and Drug Administration) continues to conduct far fewer foreign compared to domestic inspections (Mullin, 2011). Contaminated heparin was judged as the cause of 81 deaths in the United States in 2008. FDA traced the contaminated API to a Chinese supplier (Changzhou SPL Co.). 

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). 

Various activities come under conformity assessment all of them are based on sampling, testing and reporting. First-party testing is carried out by manufacturers and suppliers. Second-party testing is performed by buyers, users or consumers. Third-party testing is carried out by organizations independent of the above parties. 

ISO 9000 requires what is called a third party assessment but involves developing first and second party strategies. First party refers to the supplier company that requests ISO 9000 certification. Second party refers to the customer whose needs have been met by the first party through the use of quality management procedures achieved by ISO 9000 compliance. Third party refers to an outside reviewer who certifies that the first party has satisfied ISO 9000 procedures. 

Chemical Leasing business models can differ with regard to (1) location of the application of the chemical/ownership of the chemical -the chemical can be applied both on the site of the supplier and the user (2) the proprietorship of the equipment - the equipment can be owned either by the supplier, by the user, or by a third party equipment provider (3) the application of the chemical - in leasing contracts the application of the chemical can fall under the responsibility of the supplier, the user, or a third party (4) the operation of the equipment -the operation of the equipment may either fall under the responsibility of the lessor or the supplier and, (5) the recycling and/or the final disposal - the recycling and/or final disposal of the chemical may either be provided by the user, the supplier, or a third party5. 

The technical and economic constraints and the legal environment affect the choice of the contractual framework for gas deliveries via pipeline. For example, depending on the number of suppliers and clients, and the regulations governing the construction and operation of a gas pipeline, the role of the pipeline can be that of a gas merchant, a hybrid pipeline or a gas transporter. A merchant pipeline typically buys all the gas at the inlet point, transports it and re-sells it at outlets to different clients it does not provide third party access, unless specifically required to do so by law. In the latter case, it becomes a hybrid pipeline. A hybrid pipeline would engage in both gas sale and purchase and gas transportation activities, as well as in any of the associated services. Hybrid pipelines are a particularly difficult case to regulate and to ensure competitiveness and non-... 

There are several ways of implementing a system of third party access to the pipeline network. One option is that tariffs and the other terms and conditions concerning the pipeline owner s obligation to transport the gas of other suppliers are determined in advance of any request for access (regulated access). Alternatively, it could be left to the parties involved to negotiate the price and the other conditions (negotiated access). According to the Gas... 

Process flowcharts. A flow diagram should indicate the process steps and addition of raw materials. If possible, major equipment and special environmental conditions may be included in the flowchart. In-process tests may also be included. A second flowchart for activities, raw material suppliers, shipments, and testing would also assist in the overall picture of the aerosol manufacturing scheme, especially for multiple site or third-party activities. An example of a process flowchart for a fictitious suspension product (2160.4-kg batch size for 100,000 units) is shown in Figure 6. 

Project and quality planning by each company is important for multigroup projects, as it enables all those involved in the project—pharmaceutical manufacturer, vendor, or third party—to access a formal definition of project standards, schedule, organization, and contracted responsibilities and monitor interaction at all levels. If elements of the contracted work and supply are to be subcontracted the plan must detail how this work is to be controlled and reported. The supplier project and quality plan must be a contractual document agreed upon by the purchaser and supplier and needs to ensure that ... 

Based on technical report 32, PDA has established a third party inspection program in the field of software suppliers. It works like the one described for IPEC s BPE GMP audits. By March 2002, 117 auditors had been certified, and the audit repository center, as the service provider licensed by PDA, lists 22 audit reports [33]. 

Outsourcing by chemical producers as chemical producers faced up to increasing competition over the past decades, they attempted not only to expand their market positions geographically, but also to improve operational efficiency by focusing on their core activities. As a result, suppliers have continuously outsourced sales and logistics functions as well as related value-added services to third-party distributors. 

Improving purchasing performance remains one of the most important levers for chemical companies to boost profitability according to the German Chemical Industry Association (VCI), in 2002, chemical companies in Germany spent more than 50 percent of their gross production value at third party suppliers 31 percent went to purchase raw materials, 13 percent was spent on re-sale items, three percent on energy, and another three percent on maintenance services. 

With respect to raw materials provided by a third-party supplier, it is essential to monitor, track, and evaluate the performance of the suppliers involved. Qualification of materials, along with extensive qualification of the supplier or vendor, is a critical activity for maintaining compliance and quality. Recurring supplier issues can significantly assault product quality. Supplier profiles, coupled with adequate monitoring and trending of supplied materials, are useful indicators that can effectively support a recall prevention program. 

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