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John Gagliardi, MidWest Process Innovation, LLC
JGAGL777@One.Net
Purchasing Controls – a Global Wave of Compliance Initiatives
Introduction:
The Global Harmonization Task Force (GHTF) Study Group 3 has finalized the Quality Management
System – Medical Devices – Guidance on the Control of Products and Services Obtained from
Suppliers and this is just the beginning concerning the face lift that Purchasing Controls will get over
the coming year(s). Note: The Global Harmonization Task Force is comprised of representatives from
medical device regulatory agencies and the regulated industry.
Purchasing Controls, as part of your Quality Management System (QMS), is a business-driven process
in cGMP-QSR and ISO – based medical device companies. Purchasing Controls is not just about
buying components and raw materials and focused on the fact that these purchased items are
delivered on time and priced appropriately. It’s about strategic sourcing during successful supplier
evaluation and (then) continued monitoring efforts to track quality metrics in terms of pre-set
requirements and compliance. The activity-driven linkages between the purchasing controls
process and, for example, incoming disposition of raw materials and components, production and
process controls, design controls, risk management decisions and corrective and preventive
action(s) are an integral part of assuring that companies are manufacturing safe and effective
medical devices.
From a regulatory standpoint section 7.4 of ISO13485:2003 and the FDA 1996 Quality System
Regulation 21 CFR Part 820, sections 820.50 Purchasing controls, and 820.80 Receiving, in-process,
and finished device acceptance require organizations to control products and services obtained
from suppliers. These requirements call for the type and extent of controls to be established and
documented within the organization’s quality management system. Control could be defined and
documented in the form of contractual arrangements, quality plans or other types of documents.
From a business view one of the most prevalent trends in the medical device business today is
global sourcing using strategic initiatives and centralized purchasing data rather than just price and
delivery alone. Cheap labor in China or Mexico, for instance, can result in lower productivity, poor
quality, more defects, and communication woes. Unfortunately, recognized initial savings don’t
always equal total savings. The challenge for this regulated medical device community is to temper
low
costs with compliant products and services.
Process Orientation:
The process of establishing controls for products and services obtained from suppliers is basically
comprised of six phases:
 Planning for sourcing opportunities and compliance
 Selection of supplier
 Supplier evaluation and acceptance
 Controls are realized and implemented
 Monitoring activities
 Feedback and communication
During the planning and execution of product realization for a new or existing medical device the
manufacturer identifies products or services to be obtained from a supplier. A manufacturer’s QMS
may require products or services from suppliers, such as training, document archiving, etc., that need
to be planned for and controlled. Planning provides the direction for establishing the extent of
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John Gagliardi, MidWest Process Innovation, LLC
JGAGL777@One.Net
controls for product and services obtained from suppliers. These plans are documented and
approved, as part of your company’s policies and procedural requirements
Controls should be defined and documented and include any quality requirements. The
manufacturer should ensure that other relevant regulatory requirements, for example environmental
protection legislation, occupational health and safety legislation, Good Laboratory Practices, data
privacy, etc., are taken into account when developing controls.
.
A supplier’s business conduct, practices, reputation and financial viability may provide useful
information about the business capabilities of that supplier. A potential supplier’s business capability
could have an important effect on a manufacturer’s ability to deliver safe and effective devices
The outcome of this type of analysis, coupled with an analysis of the potential risks of the
product/service provided, may influence the manufacturer’s decision of how to control the products
and services obtained from suppliers.
The manufacturer should initiate planning to define criteria for the evaluation and selection to reduce
the number of potential suppliers to acceptable suppliers.
Evaluation of the supplier’s capability to fulfill the manufacturer’s requirements is to be performed
against a defined set of selection criteria. The manufacturer should consider a combination of factors
during the evaluation, depending on the risk and potential effect on device quality of the product or
service. Certification may play a role in evaluating suppliers but manufacturers should be cautioned
against relying solely on certification as evidence that suppliers have the capability to provide quality
products or services.
This section provides guidance for the finalization of the controls that are mutually agreed upon by the
manufacturer and the supplier. Determining the extent and degree of controls, as well as defining
clear lines of responsibilities, should be defined by the manufacturer. As a result of the supplier
evaluation and acceptance, the controls need to be finalized as previously defined in the planning
process. When the risk is involved, defined controls around second or further-tier suppliers may be
necessary. The manufacturer should agree with the supplier on their individual responsibilities and
deliverables. While the manufacturer is responsible for the medical device, the supplier also has
certain obligations such as exchange of information.
Provisions should be in place for the manufacturer to inform the supplier of whether the
manufacturer’s expectations are being met. Feedback should be both positive and negative.
The manufacturer should ensure that there are effective lines of communication open to both parties
to discuss problems/complaints or other matters. It is important that trust be developed between
parties so that any problems can be resolved quickly in a cooperative way.
When problems are identified and corrected there should be a determination as to whether
feedback for a successful correction is necessary, or whether feedback is given on an ongoing basis.
If a corrective action is initiated by a supplier because of defectives, additional feedback and
communication will be necessary. As part of this action, the manufacturer may need to re-evaluate
the continued suitability of the supplier. The overall responsibility for these activities resides with the
manufacturer.
In Conclusion:
The architecture of your company’s Quality Management System depends on purchasing controls to
operate in a manner to assure successful product realization activities. Companies with ineffective
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John Gagliardi, MidWest Process Innovation, LLC
JGAGL777@One.Net
and / or inefficient purchasing processes in place commonly struggle just before and during design
output and then into design transfer only to find that full scale manufacturing doesn’t get much
better. Like design, ineffective and / or non-compliant purchasing processes have an affinity for
causing product recall(s). This level of risk-based uncertainty during the early stages of product
realization will continue to affect productivity decision-making, levels of non-conformance, product
reliability, and will have an affect upon process capability with convoluted root causes.
Biography and Business Strategy MidWest Process Innovation, LLC, 7736 Woodside Court, Maineville, OH 45039 / JGAGL777@One.Net
John Gagliardi has had success over the past forty years in the Medical Device and Pharmaceutical
industries because of his practical approach to process-orientation and business. His career
functions have included active involvement in the areas of research and development, quality
assurance, training, operations, process architecture, FDA Inspections and regulatory affairs. John
specializes in building systems in a compliant and "business-ready" manner. “Having a compliant
quality system doesn't necessarily mean that your company has effective business systems in place
and visa versa.”
MidWest Process Innovation, LLC was founded in the year 2000 and has a core business plan and
strategy that is involved with, third-party audits, training / education, regulatory affairs, and
developing effective and efficient processes for companies seeking success with the requirements
involved with:
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ISO 13485
ISO 9001
ISO 17025 and
21 CFR, Parts 820 and 210/211
John’s background and experience with large and small companies has enabled him to see
compliance and training from both vantage points. John’s bottom line has to do with compliant
implementation and cost savings.