Case Studies

Quality
Integrating Quality Into Manufacturing

A company was looking for opportunities to optimize quality and costs in their manufacturing operation. By using a HACCP based approach for quality, critical quality parameters were identified and monitoring, corrective actions, documentation requirements, and audit protocols for those characteristics were implemented. One of the key factors in success was clearly identifying those quality parameters critical to consumer satisfaction and repurchase intent and managing them as an integrated part of the value chain.

Results:

Reduction in quality failures and withheld product occurrences by $8MM USD.
Consumer complaint reduction of 33%.

Product/Food Safety
Allergen Management

A bakery company experienced two Class I and one Class II recalls within 2 months. All of these were a result of food allergens ending up in products that did not contain them and were therefore not labeled accordingly. A comprehensive allergen management program was established which was integrated through the entire product life cycle (from design to post consumer use). Some of the key components of this program included but was not limited to:

Cleaning protocols, including validation and SMED protocols to optimize uptime in the manufacturing facility while minimizing risk.
Labeling protocols, including ingredient statement revision numbers, supplier validation of expired label print dies and inventory.
Label assessment and verification before and during use, including direct linkages to the product formula being manufactured at any given time (including change control for formula changes and associated labels).
Consumer response pathways / flowcharts to highlight potential field issues effectively and proactively.

Results:

No further allergen related recalls during the associated tenure.
Sustainable manufacturing controls embedded in operations to minimize potential risk effectively and efficiently.

Regulatory
Protecting Company Proprietary Information

With the implementation of FDA regulations permitting the review and copying / retaining food safety related documentation as part of FSMA, a company had both quality and food safety related information / requirements on work instructions and records. After assessing the regulations and criteria for FDA oversight, the associated documents were optimized to effectively separate quality / product specific proprietary information (e.g., moisture, physical parameters, texture, firmness, etc.) from food safety related information (e.g., Aw, pH, time & temperature for heat treatment, etc.).

Results:

Insulation of company proprietary information from possible FDA review / collection, and potential exposure from a competitor’s Freedom of Information Request (FOIA).
Optimized education / training content for employee understanding of the difference between the two aspects (quality vs. food safety).
Simplified document control, particularly when change control was required, as only the relevant document was changed, and content was limited to that product aspect / specification.

Organizational Optimization
Integrating M&A Companies

Organizations now, more than ever, need to consistently assess their organizational structures for optimization of talent, knowledge, and cost. A company had made two acquisitions and there was an opportunity to assess and optimize the Quality organization (while other functions were also doing the same). Although the quality organizations did similar work, there was both a cultural and skill set gap between the parent and the acquired companies. To address this, we first aligned all the titles across all organizations leveraging previous work done to align / optimize titles and roles in the parent organization. Subsequently, we reviewed potential overlapping roles and reviewed which one(s) made business sense to consolidate. Additionally, a competency assessment was performed on existing resources to identify which resources had the best skills, knowledge, and experience to lead the business into the future and where would they best fit. It was then time to optimize the organizational structure by consolidating work / roles and aligning on a standardized functional approach across the enterprise.

Results:

Optimized organizational structure and headcount, including cost savings and simplified quality requirements.
Focused and aligned / reduced titles & associated job descriptions.
Opportunities for cross-pollination of talent across the function.
Renewed interest and excitement from the employees in the function, as stabilization and future growth opportunities were important to them.

Education/Training
Increasing Employee Engagement

Organizations now, more than ever, need to acknowledge the war for talent. Pursuant to this, organizations / functions have the ability to create a culture where employees see an opportunity for a career and not just a “job” in the function and/or company. One way this was approached was to create a Competency Model for the Quality, Product / Food Safety and Regulatory functions. This model identified key areas of knowledge in the function across 3 career time frames (early, middle, later in career). Skills required to demonstrate competency were defined in each of the knowledge areas for each of the career time frames. These were then aligned to the standardized job titles / descriptions across the organization. The resulting model enabled each employee in the function to begin to “chart” their career trajectory. Identifying where they were in their career/ position vs. where they wanted to go (using developmental planning), each employee could create a “career map” identifying the knowledge, skills, and timing for them to achieve their career objectives. The competency model was also paired with a “Critical Experience Model” to identify skills and experience that, while can be taught, are better gained by “living” through the experience (e.g., product recall).

Results:

The function achieved the highest Employee Engagement score in the company.
Ability for employees to have a career at the company as opposed to simply a job.
Employees could translate skills across functions ) e.g., auditing is done in quality, EHS, finance, etc.) so cross-functional opportunities were created.
Employees had an easier time creating developmental plans as they now knew what skills, abilities, knowledge then wanted to pursue to achieve their career objectives.

Auditing
Minimizing Supplier Risk

In many organizations / industries, some of the biggest risk emanate from suppliers, particularly in a global supply chain. Assessing and mitigating this risk is crucial for brand protection, cost optimization, and consumer satisfaction (not to mention the mitigation of regulatory scrutiny). An organization had over 500 suppliers across the globe who were essentially all treated equally. We developed a risk-based supplier categorization model which grouped suppliers based on multiple categories. These categories accounted for inherent ingredient / packaging / service risk, along with other parameters aligned with overall business impact. The resulting model grouped suppliers into 3 overall categories aligned with risk, which was then used to establish criteria for approval, pre-shipment sampling requirements, COA / COC requirements, in-plant receipt testing / analysis schemes, and audit frequencies.

Results:

Over 500 suppliers became grouped into 3 manageable and sustainable categories.
Incoming sampling / analysis were optimized with associated cost reductions.
Supplier approvals were streamlined with turn-around time reduced significantly based on risk.
Internal resources were redeployed to focus on more value-added tasks.
Supplier audit / management cost was significantly reduced based on risk categorization.

Sustainability
Hidden Opportunity

A company was running bottling lines and had a defined sanitation schedule where the lines would be shut down and cleaned. While investigating the purpose / reason for the defined sanitation interval, it was discovered that the requirement came about due to a previous issue that happened years before. We then developed a plan to assess the appropriate, science-based interval for optimum quality and manufacturing uptime / efficiency. After many months of testing, analysis, and interpretation / challenging of results, the pre-defined frequency was able to be more than doubled. Not including the obvious benefit to manufacturing efficiency / uptime, this change in frequencies had an enormous impact on sustainability, which was not the intended purpose of the project.

Results:

Manufacturing capability doubled, and significant capital for manufacturing expansion / capability was avoided, totaling in the tens of millions of dollars.
Over 90 MM gallons of water were saved due to the decrease in sanitation frequency.
Quality and product safety were maintained in conformance with regulatory and customer / consumer requirements and expectations.

Crisis Management
Finding & Eliminating the Cause

A company experienced a product recall related to undeclared allergens. We were dispatched to investigate the situation and determine root cause and subsequent corrective / preventative, and improvement measures. Through auditing the facility and related corporate infrastructure supporting same, it was determined that there was a formula change in the product which added an allergen previously not present. The formula was updated, as was the label, but due to document / change control process failures, the formula was deployed in the facility without the requisite label update. This resulted in the product containing an undeclared allergen. Preventative / improvement actions included a tighter document / change control process, increased verification of formula / label compatibility, and change in how new formulations were developed and tethered to required label changes.

Results:

Revised / improved document / change control process, which included validation and multiple verification steps to ensure compatibility.
Roll-out of those changes across remaining company facilities.
Increased education / knowledge in understanding the criticality of formula and label alignment.
Technological innovations to ensure correct label copy in manufacturing (e.g., scanners).