Metrics and Issues to Consider in SQM

Metrics and Issues to Consider in SQM (Supplier Quality Management) By 5 Big Industries

This is the second post in a three-part series on Supplier Quality Management also known as SQM. In the first post, Chuck Intrieri of The Lean Supply Chain, gave us 5 core metrics to evaluate supplier performance using supplier quality management and a 4 step process to execute. In today’s post, Chuck will take it a step further and break down metrics and issues to look out for by 5 main industries:

Pharmaceuticals
Medical Devices
Consumer Goods
Food
Technologies

Review of SQM Metrics and Issues Across 5 Core Industries

#1: Pharmaceuticals

Recommended Metrics for FDA Collection & a 6 Step Process for SQM Review

Trend Metrics Collected per Product:

Confirmed Product Quality Complaint Rate by Product
Batch Reject Rate by Product
Confirmed OOS (Out-of-Specification) Rate (Drug Substance & Drug Product) by Product

Trend Metrics Collected per Site

Confirmed OOS Rate (Drug Substance & Drug Product) by Site
Batch Reject Rate by Site

Metrics Identified as Important but Difficult to Compare

The following metrics are important and among the most difficult to make comparable for external reporting to the FDA.. Quality Metrics by Product

Process Capability (CpK, PpK, etc.) Rate: (CpK and PpK are ‘Short Term’ capability indicies using ‘Pooled’or ‘Within group’ Standard Deviation.)
Critical Investigations Rate
Quality Metrics by Site
CAPA (Corrective Action Preventive Action) System Performance
Effectiveness Rate
Critical Investigations Rate
Environmental Monitoring (excursions in A&B areas) Rate

Management should have a formal SQM process for reviewing the pharmaceutical quality system on a periodic basis. This review should include:

Measurement of achievement of PQS objectives
Assessment of performance indicators that can be used to monitor the effectiveness of processes within the PQS, such as:
Complaint, deviation, CAPA and change management processes
Feedback on outsourced activities
Self-assessment processes including risk assessments, trending and audits
External assessments such as regulatory inspections and findings from customer audit

#2: Medical devices

In their effort to successfully acquire new customer contracts and deliver quality products through SQM, medical device manufacturers face the following challenges.

Complying with ISO 9001/9002 and EN 46001/46002 guidelines, cGMP and other federally mandated standards
Developing a well-defined and adaptive product design process to optimize product cycles and provide collaboration capabilities with strong collaboration with OEMs on design changes
Creating and maintaining detailed documentation on Tier I, Tier II and Tier III levels of ISO/EN with appropriate controls for review, approvals and distribution
Providing leading sterilization procedures (STERRAD, EtO) and validation procedures that test the integrity of these processes and are compliant with FDA/ANSI/AAMI standards
Providing leading packaging procedures compliant with ISO 11607 requirements for terminally sterilized medical devices, and subsequent testing services including Peel strength testing and Bubble emission testing
Quickly detecting design and manufacturing process flaws and launch the necessary recurrence prevention actions
Establishing and revising training procedures for in-house staff on production instructions, sterilization, equipment certification and packaging

#3: Consumer goods

Eight dimensions of SQM can be used at a strategic level to analyze quality characteristics. The concept was defined by David Garvin. Some of the dimensions are mutually reinforcing, whereas others are not—improvement in one may be at the expense of others. Understanding the trade-offs desired by customers among these dimensions can help build a competitive advantage. Garvin’s eight dimensions can be summarized as follows:

Performance: Performance refers to a product’s primary operating characteristics. This dimension of quality involves measurable attributes; brands can usually be ranked objectively on individual aspects of performance.
Features: Features are additional characteristics that enhance the appeal of the product or service to the user.
Reliability: Reliability is the likelihood that a product will not fail within a specific time period. This is a key element for users who need the product to work without fail.
Conformance: Conformance is the precision with which the product or service meets the specified standards.
Durability: Durability measures the length of a product’s life. When the product can be repaired, estimating durability is more complicated. The item will be used until it is no longer economical to operate it. This happens when the repair rate and the associated costs increase significantly.
Serviceability: Serviceability is the speed with which the product can be put into service when it breaks down, as well as the competence and the behavior of the serviceperson.
Aesthetics: Aesthetics is the subjective dimension indicating the kind of response a user has to a product. It represents the individual’s personal preference.
Perceived Quality: Perceived Quality is the quality attributed to a good or service based on indirect measurement.

#4: Food SQM Requirements and Issues

Mandates by the FDA and the USDA such as HACCP procedures and ISO 22000-based food safety management systems are the basis for many SQM and compliance programs in the food and beverage industry. Companies know all too well that improperly trained employees, substandard products, or poor service can cost millions of dollars a year in lost sales and leave the door open to more severe consequences. A potential regulatory mechanism for rolling out quality metrics can be linked to Title VII (Drug Supply Chain Provisions) of the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012. Title VII gives FDA new authorities to help ensure the safety, effectiveness, and quality of drugs in the United States. The much talked about Quality Metrics are linked to Section 704 (Electronic System for Registration and Listing), Section 705 (Risk-based Inspection Frequency) and Section 706 (Records for Inspection). Section 704 requires FDA to maintain an accurate electronic registration and listing database that is searchable, and uses the Unique Facility Identifier (UFI) to link to other relevant FDA databases in order to identify and inform risk-based inspections. Section 705 requires FDA to replace the previous two-year drug inspectional frequency requirement with a risk-based inspection schedule for domestic and foreign drug facilities. Inspection criteria include the establishment’s compliance history and the inherent risk of the drug being manufactured. Section 706 allows FDA to obtain certain records from a drug manufacturer in lieu of, or in advance of an inspection. Quality metrics is one example of information that can be provided to FDA in advance of an inspection. In December 2013, the International Society for Pharmaceutical Engineering (ISPE), based on the work of the ISPE Quality Metrics Project Team, issued a White Paper (here) on quality metrics for submission to FDA which included a list of quality metrics that could be used for initial discussions with the Agency. The quality metrics (as identified by the relationship to the product and FDA’s six systems) include batch rejection rate, rework and reprocessing rate, confirmed out-of-specification (OOS) rate, unconfirmed OOS rate, confirmed “critical” complaints rate, and % Annual Product Quality Reviews completed on time. These metrics are better known as “lagging indicators”. The White Paper did not recommended reporting of recalls, field alert reports (FARs), biological product deviation reports (BPDRs) and inspection findings as part of the initial list, since these are already available to the FDA.

Protect brand image and market share
Ensure the highest quality and safety of products
Limit liability of food-borne illness events
Reduce materials and ingredients costs
Improve supplier product quality
Improve relationships with trading partners
Reduce product waste and downtime
Reduce costs of regulatory compliance
Ensure currency and integrity of quality document

The new FDA Food Safety Modernization Program (FSMA) is in the process of completion. New regulatory requirements

Food facilities are required to register with FDA biennially. Food from an unregistered facility may not be imported into the United States or introduced into interstate or intrastate commerce.
Registered food facilities are required to conduct hazard analyses and to develop and implement written preventive controls plans.
Registered food facilities must maintain additional records, including copies of their hazard analyses and preventive controls plans, related records, and additional records to assist FDA in tracking and tracing high-risk foods.
Food importers are required to implement foreign supplier verification programs and to take steps to verify that the food they import is safe.
Food facilities and food importers are subject to new fees, including a fee to be paid by each domestic food facility or importer that undergoes a re-inspection because of a material non-compliance identified during an initial inspection.
Laboratory tests to be used for regulatory purposes must be performed by either a Federal laboratory or an accredited non-Federal laboratory, and lab test results must be sent directly to FDA.
Food facilities will be inspected with greater frequency and not less often than once every 5 years.

New FDA powers

FDA has the authority to order a recall of food.
FDA has the authority to administratively detain food based only on a “reason to believe” the food is adulterated or misbranded.
FDA has the power to suspend the registration, and thereby suspend the operations, of any food facility if FDA determines that food manufactured, processed, packed, or held by the facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals.
FDA is authorized to require that an article of food offered for import be accompanied by a safety certification from an accredited third-party auditor as an additional condition of granting admission.
FDA is required to review relevant health data every two years and to issue guidance documents or regulations setting contaminant-specific performance standards for the most significant foodborne contaminants.
Registered food facilities are required to conduct hazard analyses and to develop and implement written preventive controls plans.
Registered food facilities must maintain additional records, including copies of their hazard analyses and preventive controls plans, related records, and additional records to assist FDA in tracking and tracing high-risk foods.
Food importers are required to implement foreign supplier verification programs and to take steps to verify that the food they import is safe.
Food facilities and food importers are subject to new fees, including a fee to be paid by each domestic food facility or importer that undergoes a re-inspection because of a material non-compliance identified during an initial inspection.
Laboratory tests to be used for regulatory purposes must be performed by either a Federal laboratory or an accredited non-Federal laboratory, and lab test results must be sent directly to FDA.
Food facilities will be inspected with greater frequency and not less often than once every 5 years.

FDA is required to establish a product tracing system within FDA to improve the agency’s capacity to effectively and rapidly track and trace food

#5: Technologies : SQM

LA means Service Level Agreement with a trading partner or company. SLM is Service Level Management

SLM	Manage quantity and quality of IT service needed:
SLM	percentage reduction in SLA targets missed
SLM	percentage reduction in SLA targets threatened
SLM	percentage increase in Customer perception of SLA achievements via CSS responses
SLM	percentage reduction in SLA breaches caused because of third party support contracts (Underpinning Contracts)
SLM	percentage reduction in SLA breaches caused because of internal Operational Level Agreements (OLA’s).
SLM	Deliver service as previously agreed at affordable costs:
SLM	total number and percentage increase in fully documented SLAs in place
SLM	percentage increase of SLAs agreed against operational services being run
SLM	percentage increase in completeness of Service Catalogue versus operational services
SLM	percentage improvement in the Service Delivery costs
SLM	percentage reduction in the cost of monitoring and reporting of SLAs
SLM	percentage increase in the speed and accuracy of developing SLAs.