ISO 9001: Section 4 and Section 5 The ISO 9001 standard is... The post Ep 6: ISO 9001 Quality Management Systems appeared first on Kellerman Consulting ..read more

Internal Audit of a QMS For internal audits, the quality management system... The post Ep 5: Internal Audit and Management Review of the Quality Management System appeared first on Kellerman Consulting ..read more

Training of QA and QC As we begin to unpack what training... The post Ep 4: Internal and External QMS training for QA and QC Personnel appeared first on Kellerman Consulting ..read more

Reasons to Pursue ISO 9001 Certification Businesses can choose voluntarily to create... The post Ep. 1: ISO 9001 and Quality Management Systems in Operations appeared first on Kellerman Consulting ..read more

Food Safety and Quality Steps Prior to Contacting Co-Manufacturers Have the process of making your product defined by a Research and Development (R&D) team and have your product tested for shelf-life and food safety by a third-party ISO 17025 certified laboratory if it is deemed to be necessary for your product.  Some co-manufacturers offer this service, however, other manufacturers want you to have your process approved by an outside process authority prior to working with them.  Some universities and laboratories offer process authority services.  There may be unforeseen ..read more

What to Look for in an Applicant What job histories we are looking for What red flags we are looking for Inspections, Audits, and Regulatory/Certification Interface Experience Ideal QA Skills Could take over for any production employee Could re-write the HACCP/ Preventive Controls plan (if a food facility). Knows the difference between a Correction and Corrective Action Knows every Preventive Action added to the system Walks the floor constantly Knows every employee by name Traits Needed for QA Personality Traits for QA (need to have) Trustworthy Direct Assertive Careful Personality Trai ..read more

Simple measurements for KPIs Vs. Complex Measurements The simplest metrics for performance indicators are counting measurements. Simple measurements often are enough to give us a full picture, but for facilities engaging in complex operations, more sophisticated measurements are appropriate. Complex measurements are going to be appropriate for organizations that have changing circumstances within operational steps, or where inline measuring equipment is installed that can capture this information. Most companies that attempt complex measurements for key performance indicators have sophisticate ..read more

Setting up KPI Data Collection In breaking down data collection for key performance indicators, we need to start with the type of data that is being measured. One can select KPIs focusing on positive outcomes or negative outcomes. KPIs may be simple measurements or complex measurements. For all KPI data, we must have accurate information that is collected frequently enough to be representative. The simple measurements can be performed by hand, but for complex calculations, some sort of recording software that can assist in calculations is worth investing in. Select KPIs Across Departments  ..read more

ISO 9001 KPI Requirements For ISO 9001 there are two main sections where KPIs should be documented.   Section 5 addresses leadership and there should be written evidence that leadership was included in selecting KPIs. Section 6 addresses risks and opportunities and each KPI should be documented  and evaluated with risk assessment discussions.  To assure that KPIs are properly integrated into the QMS, we strongly recommend including the key performance indicators into the required policy statement for the program. Personnel are required to know the policy statement for ISO ..read more

Basis for Government Food Safety Inspections Laws are the source of timeframes and reports required of inspectors of food facilities – these are both federal and state laws Laws Governing Inspectors Actions: Food Drug & Cosmetic Act Food Safety Modernization Act (FDA) Meat Inspection Act (FSIS) Poultry Products Inspections Act (FSIS) Reasons for Food Safety Inspections Routine Inspection These Inspections are not planned, but they must occur within the legal time frame for regulators. Targeted Inspection Events/ Products that violate regulations Events/ Products suspected of fraud or ..read more