Quality Progress - March 2013 - 64

One GOOD IDea BY Lance B. coLeman Form by Design Using flowcharting techniques for robust form design filling out simple forms should be Using process mapping to help create a consider, shown in Table 1. We also had to consider that individuals easy, right? Yet, how many of us have had clear and concise form with a logical flow the experience in which a simple and easy- is one way of addressing this concern. could play more than one role in the pro- to-follow form took more than one time to The first step in this evolution is to ask cess. The corrective action team that was fill out 100% correctly? yourself: What is the form designed to do? to determine root cause, corrective action A truly robust form should not only be and effectiveness verification had to consist cated and the stakes higher. For example, clear and concise, but should also provide of, at a minimum, the process owner and a when you’re documenting records for the needed information in fields that are easily member of the quality assurance depart- medical device industry, there is huge po- searchable if the form were to be convert- ment. Additionally, a subject matter expert tential for costly mistakes. End users could ed into an electronic format. was required if neither the process owner Now, let’s make the forms more compli- While recently seeking to improve how nor the quality assurance representative we process and document corrective action was an expert on the issue under review. be harmed because of errors associated with poor documentation. Even in instances such as this, form and preventive action (CAPA) requests, design is an often underappreciated skill. my manager and I were struggling to come Strategy that works With forms and their associated instruc- up with a system that was robust, yet still After we had completed the process map- tions, there is a balance to maintain: too streamlined and easy to use. This was chal- ping, designing the form was easy. We little information and the instructions lenging due to the nature of most CAPAs, wound up with a four-page form, one page aren’t useful, and too much detail and us- which require input from multiple users and for each phase of the process. ers will skim over them, possibly missing disciplines and must have the potential for 1. Initiation. important information. multiple feedback loops due to some steps 2. Investigation. Roles and tasks in the CAPA process / Table 1 Role Task occasionally needing to be repeated. As we struggled with format, we decided to step back, map the entire process and begin again. Be- 3. Corrective action/effectiveness verification. 4. Closure. Having one page of the CAPA form for 1. Corrective action and preventive action (CaPa) initiator Identifies issue and initiates CaPa. cause of how our system worked, each phase of the process allowed us to we decided to depict how it func- save the form on a shared drive, type in 2. Process owner area manager where issue identified. expert with knowledge of subject issue. Reviews each phase of CaPa for appropriateness. Qa personnel who is part of CaT. tions using a swim lane diagram, information for greater legibility and print also known as a cross-functional it out for signatures after completion of flowchart, shown in Online Figure that phase. An email alert was sent to all 1 on this article’s webpage at www. CAPA participants as each phase of the qualityprogress.com. CAPA process was completed. 3. Subject matter expert 4. Quality assurance (Qa) reviewer 5. Qa corrective action team (CaT) member 6. CaPa coordinator 7. Qa manager 8. engineering manager 9. CaT 10. Document control assigns CaPa numbers, maintains log and tracks CaPa progress. Reviews CaPa for appropriateness before closure. Reviews CaPa for appropriateness before closure. Determines root cause, corrective action and effectiveness check. Receives and files closed records; maintains files. 64 QP • www.qualityprogress.com Going through the mapping We were able to design a form that was process and asking the questions user friendly, flowed logically, reflected our that we had to ask to properly process and provided needed information. map our process made us think It wasn’t master control, but it was the next hard about how it should work best thing, and it worked great for us. QP and allowed us to identify several opportunities to improve how we do things that had been previously overlooked. Per our procedures, we had eight individual roles and two group/department roles to Lance B. coLeman is a quality engineer and lean leader for Tech Group in Tempe, aZ. He has an associate degree in electrical engineering technology from Southern Polytechnical University in marietta, Ga. coleman is a senior member of aSQ and an aSQ-certified quality auditor and biomedical auditor. http://www.qualityprogress.com http://www.qualityprogress.com

Table of Contents for the Digital Edition of Quality Progress - March 2013

Up Front
LogOn
Expert Answers
Keeping Current
Mr. Pareto Head
The Right Ingredients
Before the Fact
Apples to Oranges?
Five at the Forefront
Innovation Imperative
Measure for Measure
Quality in the First Person
Career Corner
Statistics Roundtable
Standards Outlook
QP Toolbox
QP Reviews
One Good Idea

Quality Progress - March 2013

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