QC & QA vs QMS? What Quality Functionality Do You Require?

As a process manufacturer, your company probably has several documented policies, processes and procedures that support its corporate quality initiatives, as well as address your industry’s various regulations and guidelines (e.g. ISO, HACCP, OSHA, SOC, GHS, BRC/SQF, SOX). And if you are like many of our customers, you want to streamline all your quality related processes and reduce the amount of associated paperwork and spreadsheets using some form of quality management software.
To meet those objectives, running both a 3rd party QMS application and BatchMaster manufacturing application, with all its quality capabilities, may be redundant, as well as technically and economically infeasible.

So, let’s review the 3 levels of quality related functionality offered by BatchMaster that can help your company establish a comprehensive quality program:

  • Essential Quality Functionality
  • Advanced Quality Functionality
  • Quality Management Software (QMS)

The quality foundation of all BatchMaster applications start with these essential functions:

Quality Control Tests – QC tests are embedded within one’s formula specifications, which are then reviewed and approved by quality management via approval workflows.  QC test records address accepted values, tolerance values, samples, and recount values and are managed within a QC test library.

Standard Operating Procedures (SOP) – In addition to standard QC tests defined in one’s formula specification, ad hoc or customer specific quality procedures can be added to these specifications for execution during WIP. Like QC tests, SOPs within formula specifications are reviewed and approved, and are managed within a SOP library.

Version Control – Manage multiple specification versions, including roll back and security levels.

COA Documents – COA document formatting is user defined and can be manually and automatically generated.

Document Attachments – Quality related documents, such as 3rd party lab results, can be attached to various records, such as PO’s and formula specifications.

Dashboard & Reports – Quality dashboards provide various tables, charts and reports, allowing users to   look at trends and drill down into granular manufacturing data.

Building upon these essential quality functions, customers can expand the scope of quality management with these more advanced quality functions:

Supplier Management – Plan and execute checklists and sample inspections against vendor deliveries to ensure procedures and collect pass/fail or numerical data (e.g. paperwork accuracy, trailer temperature, raw material QC test).

Facility & Equipment Management – Plan and execute checklists and sample inspections against the facility physical locations equipment to ensure procedures and collect pass/fail or numerical data (e.g. room temperature, blender RPM).

Deviations – The capture and reporting of changes or deviations to batch formulas during WIP can automatically create non-conformance records.

Adverse Events / Customer Complaints – Encountered issues, including the capture and processing of internal and customer complaints, can lead to the creation of non-conformance records which require internal investigation.

Non-Conformance & Corrective and Preventative Actions (CAPA) – These records capture the information surrounding an incident and documents the investigation activities, the findings and any changes (i.e. improvements) to the current policies, procedures and parameters.

BatchMaster Software offers a QMS solution that supports Basic and Advanced Quality Functionality, plus these additional features:

Document Control – Document scanning, routing, escalation and approval processes, in addition to providing document search & retrieval for audits or inspections.

Change Management – Automates changes to policies, procedures, etc, providing multi-level notifications and historical audit logs.

Audit Management – Supports the complete audit process of policies, procedures, etc, from defining the plan, scope, maintaining requirements checklist, setting frequency, conducting an audit to evaluating results in compliance with corporate standards and industry regulations.

Employee Training & Certifications – Plan, execute and report on the progress and completion of employee training classes and attainment of certifications.

I should point out that our Business Intelligence application can play an important role in one’s quality management initiative, by providing users with a multi-dimensional view of granular manufacturing and quality data. Management can search and filter data to make more informed decisions, faster and improve their current business operations.

Quality management functionality at any level is a ‘must have’ to protect one’s brand and avoid unnecessary penalties or fines. So, may I suggest prioritizing your quality requirements and contact us for a software demo!