SMT007 Magazine

SMT007-Aug2019

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AUGUST 2019 I SMT007 MAGAZINE 63 ing. The goal should be to bring the compe- tence and knowledge level of each employee to a higher level on a daily basis. 3. Eliminate Bureaucracy How many signatures are required to approve a procedure or process plan? How long has a corrective action been open for because you are waiting for a final signature? Is your qual- ity system built on LEAN principles or hierar- chical structure for it to function? Do not confuse a comprehensive review of a document requiring every manager to sign a document before it's released. You need to clearly identify roles and responsibilities to review and approve documents in your qual- ity system. There should also be a process to communicate and give the opportunity to oth- ers for informal reviews before a document is released. Here is an approach that works well in LEAN organizations: 1. Designated approvers of a controlled document should consist of your subject-matter expert, quality systems oversight, and a senior manager accountable for that process 2. Provide a 72-hour grace period where a pre-approved document is available for review by other subject-matter experts and managers in the organization. This gives the opportunity for anyone in the organization to identify a possible discrepancy or concern with the document. Ultimately, the accountable manager for that process determines what input(s) will be considered in the document 3. Once the grace period has passed without any further revisions, the document is released in the system as an approved document This approach addresses the most common form of bureaucracy in an organization. There should not be situations where improvements are not taken because a document is paralyzed in a review and approval cycle. 4. Walk in Your Customer's Shoes One of the defining elements of a quality sys- tem is the effectiveness of its corrective action and preventive action (CAPA) system. Custom- ers understand that every supplier will experi- ence product failures or shortcomings during the production and order fulfillment process. When a failure occurs, the customer will initiate a cor- rective action request to the supplier and this is where the supplier can shine or disappoint in the customer's eyes. Customers expect that a supplier will do diligent root-cause analysis and provide a technical approach in preparing a cor - rective action response. The customer will place faith that the supplier has taken the necessary steps to prevent the problem from reoccurring. The moment of truth will occur in two stages. The first stage will during the initial review of the corrective action response. Three factors are evaluated: 1. Did the supplier respond on time to this corrective action? 2. Did the supplier provide a comprehensive root cause analysis, containment, and corrective action plan that addresses the issue? The quality of the response should be remarkable 3. Has the supplier outlined how will the actions be verified for effectiveness? This is one of the differentiators between average supplier and outstanding suppliers The second stage will occur during the imple- mentation of the corrective action plan and mon- itoring phase. This is where the supplier should proactively monitor and provide objective data to the customer demonstrating that the prob- lem has been addressed and subsequent pro- duction runs don't show the failures. The cus- tomer will gain a higher level of respect and confidence with a supplier that has applied due diligence in preparing a response, implement- ing action plans, and providing objective evi- dence to prove the problem has been addressed. When you re-engineer the CAPA system, put yourself in your customer's shoes and make sure that your CAPA system is best-in-class.

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