Posted by Michelle Duerst on Jan 17, 2014

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How do you manage quality over multiple product lines if you do not have a system to adequately track changes and variances?

 

  

 

1. Identify what should be standardized, tracked, and controlled.

Quality control can be applied to products, packaging, processes, manufacturing, distribution, and all standard operating procedures.

Examples of Specification Types:

  • Products—including formulations, final BOM, and manufacturing instructions
  • Packaging—including CAD drawings, costs, labeling, artwork
  • Ingredients—including attributes, certifications, allergens, and costs for existing and trial ingredients
  • Procedures—including standardized operating procedures

2.  Clearly define data requirements.

Specifications should not only allow you to determine what data is categorized and stored, but also be configurable to add or manage the data within it. 

Initially, this will be highly detailed setup for each type of specification.  Once defined, these can be used as the foundation and copied to create new specifications and modified with the changes.

While this has been significantly simplified, one hierarchical group would be:

Spec_Hierarchy 

3.  Define specification workflow processes.

After defining data requirements, you must clearly state how they will be implemented across your enterprise.

  • Submission requirements—How should new specifications be created and what data is required?
  • Review process—Who will review each specification type? What is the notification process if there are changes to be made?
  • Review escalation—What is the overall org chart for how the specification will be escalated for review?
  • Approval – Who has the final approval for the specification? Will the specification be automatically live in the system or scheduled for a selected time?
  • Change requests—How will changes be submitted and tracked? What should the version numbering be to identify changes?  Who should be notified when changes occur?
  • Changes with defined approvals—Are there abbreviated processes for approval if key elements do not change? (Ex:  costs, regulatory compliance, allergens)
  • Vendor submission—How do you ensure vendors can upload their specifications? How are these reviewed and approved?

4. Create specifications.

After you define your initial structure and processes, you can begin creating specifications.

  • Initial: Create a specification by defining every aspect of each data requirement.
  • Copy: Copy an existing specification and modify it with changes.
  • Incorporate: Use multiple specifications to create a single specification.

5.  Manage specifications.

While there are numerous reasons for change, there should be a simplified process to creating, managing, implementing, and tracking changes.

  • Singular change— Open an existing specification to modify data. (Ex:  upload a new trial, labeling artwork, or a document).
  • Automatic updates—Data will automatically propagate and update into other linked specifications.  (Ex: an existing ingredient increases in cost)
  • Global changes—Modify multiple specifications with an overall change. (Ex: change vendor or manufacturing processing equipment).

5.  Track changes and variances.

Data is only usable when it is visible to the right resources.  Not only does your team need to be able to generate reports, but customize them to their specific needs, with the ability to:

  • Compare and contrast specifications
  • View variances
  • View status for pending specifications
  • View activity for a specification/group of specifications