How to Implement an IG Manufacturing Quality Procedure System Internal Audits

Learning Objective Plan an internal audit Participate in an internal audit Complete non conforming product reports Complete an internal audit summary What to do about the results

Internal Audit Preparation Determine the audit schedule for each area Should have strategic direction and approval of senior management Determine the area to be audited Gather the relevant documentation Process documentation Product quality control records Non conforming product reports Field Service reports Checklists Preparation is the key to ensure that the audit goes smoothly, all issues are addressed and that there is proper representation from the area being audited.

Lead Auditor Audit management capabilities Audit team leader experience Personal attributes Audit experience Acts a facilitator – understands the system, procedures, instructions and documentation Summarizes discussions and action items including areas of responsibility Requires an auditor with a substantial amount of experience that demonstrates leadership capabilities. Proper education and experience in auditing functions is a pre-requisite to ensuring a successful meeting.

Checklists Provides guidelines to ensure nothing gets missed Acts as a notepad Records results & actions

Documentation Review Review the documents which are relevant to the area being audited Manuals Procedures Quality control forms Supplier data sheets Non conforming product reports Field Service reports

Documentation Review Procedures Instructions Forms and Data Sheets Quality System Quality System Summary version of how the company meets the established standard Procedures A series of actions defining methods and responsibilities for two or more people, conducted in a certain order or manner, to perform a general activity Shows the who, what and where of an activity Instructions A series of actions defining methods and responsibilities for one person, conducted in a certain order or manner, to perform a specific activity Shows the how to of an activity Forms and Data Sheets May be customer or company originated Standards (collection of specifications, drawings or processes which serve as a basis to which materials, products or work should conform Guidelines (recommended courses of action) Procedures Instructions Four levels of documentation Forms and Data Sheets

Documentation Review Quality System Procedures Instructions Manuals which include objectives and guidance in order to direct desired courses of action May include a quality policy statement May include an organizational chart detailing reporting chains and inter-relationship of each department. Procedures Form the core of instructional documentation for the company Instructions Generated as need through the operating procedures Forms and Data Sheets Generally referenced in operating procedures and work instructions Manuals Quality control forms Supplier data sheets Non conforming product reports Field Service reports

The Physical Audit Audit Schedule Objective evidence Non conformances Observations Sample selection Audit trails Questioning techniques

The Physical Audit Observations by participants of processes and final products Written memos & reports Sample selection Samples can be increased in an area is in question or decreased if time is a factor Should not disrupt operations

The Physical Audit Non conformances Minor Major Observation Audit trails Objectivity Examples Confirmation

The Physical Audit Non conformance & Corrective Actions Who was present Area of nonconformance Date & unique ID# Details of problem Root cause analysis Course of corrective actions Who is responsible for corrective action? How will the effectiveness be verified? Verified by auditor

The Physical Audit Root Cause Analysis Don’t assume what the problem is, prove it. Keep asking “why did that occur?” When the answer to the question can no longer be attributable to another event, you have the root cause.

Seal Adhesion Failures Was the glass clean? Yes No – soap residue, cork pad residue, Low e edge deletion, water temperature, etc. Was the product stored properly? No – where was it stored, why was it stored there (new employee, storage area not available, contamination, etc.) Was the sealant batch checked for adhesion? No – Why wasn’t the batch checked (time, new employee etc.) Could it be a supplier manufacturing issue? No Keep asking questions until there are no more questions to ask. Also look for one more “why”. Remember non conformances can be caused by more than one condition so keep an open mind!

Objective Evidence Physical examples of non conformance supplier, product ID, lot numbers Equipment Final product Statements from employee with direct responsibility for area of concern Note the specifics. Use an example such as adhesion failure for sealant, failure of desiccant test

The Physical Audit Minor Non conformances Minimal occurrences where the supplier does not meet requirements of the standard or their own documented quality system Situation where a procedure or instruction has one or several incidences where it is not being completely followed A piece of manufacturing equipment is found to be past the required calibration date

Unidentified final product defects by the shipping doors The Physical Audit Major non conformance Many occurrences where the supplier does not meet the requirement of the standard or their own documented quality system An occurrence that in all probability will cause defective product to be shipped to the customer Minor non conformances are too numerous or non conformance is too serious Unidentified final product defects by the shipping doors Ask students for other examples of minor and major non conformances. What would they do if they discovered a minor non conformance? What would they do if they discovered a major non conformance? What if it was a health & safety issue? Do they know what to do? Do they know who to report to?

The Physical Audit Observations A poor practice observed by the auditor that unchecked may become a minor non conformance if not corrected Used as a warning tool for the company

Audit Summary Summary report of the audit results Number of samples reviewed, sampling restrictions Non conformances written as minor or major c/w corrective actions and designated an individual to be responsible for implementing the corrective actions and determining effectiveness Record who was present Determine next meeting

Verification Corrective Actions must be verified by the auditor as implemented and effective

Continuous Improvement Audits can be used as one of the vehicles for continuous improvements Opportunities for the auditor to recommend continuous improvement Can be used to focus departmental responsibilities

Internal Quality Audits Say What You Do! Do What You Say! ….and Be Able to Prove It!!!!